[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
REUSE OF SINGLE-USE MEDICAL DEVICES
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
OVERSIGHT AND INVESTIGATIONS
of the
COMMITTEE ON COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
__________
FEBRUARY 10, 2000
__________
Serial No. 106-89
__________
Printed for the use of the Committee on Commerce
U.S. GOVERNMENT PRINTING OFFICE
62-970CC WASHINGTON : 2000
COMMITTEE ON COMMERCE
TOM BLILEY, Virginia, Chairman
W.J. ``BILLY'' TAUZIN, Louisiana JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas RALPH M. HALL, Texas
FRED UPTON, Michigan RICK BOUCHER, Virginia
CLIFF STEARNS, Florida EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio FRANK PALLONE, Jr., New Jersey
Vice Chairman SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania BART GORDON, Tennessee
CHRISTOPHER COX, California PETER DEUTSCH, Florida
NATHAN DEAL, Georgia BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma ANNA G. ESHOO, California
RICHARD BURR, North Carolina RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California BART STUPAK, Michigan
ED WHITFIELD, Kentucky ELIOT L. ENGEL, New York
GREG GANSKE, Iowa TOM SAWYER, Ohio
CHARLIE NORWOOD, Georgia ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma GENE GREEN, Texas
RICK LAZIO, New York KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming TED STRICKLAND, Ohio
JAMES E. ROGAN, California DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING,
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland
James E. Derderian, Chief of Staff
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Oversight and Investigations
FRED UPTON, Michigan, Chairman
JOE BARTON, Texas RON KLINK, Pennsylvania
CHRISTOPHER COX, California HENRY A. WAXMAN, California
RICHARD BURR, North Carolina BART STUPAK, Michigan
Vice Chairman GENE GREEN, Texas
BRIAN P. BILBRAY, California KAREN McCARTHY, Missouri
ED WHITFIELD, Kentucky TED STRICKLAND, Ohio
GREG GANSKE, Iowa DIANA DeGETTE, Colorado
ROY BLUNT, Missouri JOHN D. DINGELL, Michigan,
ED BRYANT, Tennessee (Ex Officio)
TOM BLILEY, Virginia,
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Feigal, David W., Director, Food and Drug Administration..... 9
Feltner, Vern, President, Alliance Medical Corporation....... 123
Fielder, John H., Professor of Philosophy, Ethics Consultant,
Villanova University....................................... 113
Grossman, Philip............................................. 107
Lindsay, Bruce D., Associate Professor of Medicine,
Washington University School of Medicine................... 159
Maurer, Walter G., Cleveland Clinic Foundation, on behalf of
American Hospital Association.............................. 118
O'Holla, Robert H., Vice President Regulatory Affairs,
Johnson & Johnson.......................................... 103
Trotter, C. Griffin, Center for Healthcare Ethics............ 155
West, Laurene................................................ 100
Material submitted for the record by:
National Consumers League, prepared statement of............. 183
(iii)
REUSE OF SINGLE-USE MEDICAL DEVICES
----------
THURSDAY, FEBRUARY 10, 2000
House of Representatives,
Committee on Commerce,
Subcommittee on Oversight and Investigations,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:21 a.m. in
room 2322, Rayburn House Office Building, Hon. Fred Upton
(chairman) presiding.
Members present: Representatives Upton, Barton, Burr,
Whitfield, Ganske, Bryant, Bliley (ex officio), Waxman, Stupak,
and Strickland.
Also present: Representatives Eshoo and Pickering.
Staff present: Alan Slobodin, majority counsel; Anthony
Habib, legislative clerk; and John Ford, minority counsel.
Mr. Upton. Good morning, everybody. Sorry we are a little
bit tardy starting. For those not realizing what the buzzer
meant, we had a vote. So we are all ready to start promptly at
10, and then we had to walk over the Capitol and come back.
Before I proceed with my opening statement, I do want to ask
unanimous consent that other members of the full committee,
although not on this subcommittee, be allowed to sit in,
provide opening statements, and also proceed with the question
and answer period of both Dr. Feigal and the second panel.
Without objection that will be the order of the day.
Good morning again. Today this subcommittee holds a hearing
on the reuse of medical devices, labeled and approved by the
Food and Drug Administration for single-use only. Within the
last year there has been extensive debate, both on and off the
Hill regarding the practice of reprocessing medical devices
that have been designed, manufactured, and approved by the FDA
for single-use only.
As many of you know, before a device may legally enter the
market, original medical device manufacturers must submit
product approval applications to FDA which may include
extensive sterility and clinical data that demonstrate the
safety and efficacy of the device. The original manufacturer
must also comply with the extensive FDA regulations regarding
the manufacturing of the device, as well as post-market
controls that give both the FDA and the manufacturer the
ability to continue to assess the safety and efficacy of the
device, and ensure that patients are adequately protected.
For patients, original device manufacturers and the FDA,
this system works. However, there is a significant and perhaps
even a dangerous, gap in FDA's existing enforcement practices.
In some instances, hospitals, either using in-house facilities
or third parties, will reprocess a disposable medical device
that has been approved by FDA for use in a single patient only,
and reuse the device several times on additional patients in
most instances without notifying patients that the device may
have already been used.
Much to my surprise I have learned that this practice
includes reusing devices that have been inserted into other
patients, including biopsy forceps and catheters. This practice
raises two patient safety concerns. One, whether single-use
devices can be adequately cleaned and sterilized for use in
other patients, and two, whether attempts to clean and
sterilize these devices may lead to product failures or in any
way significantly affect performance and design specifications.
These concerns are not theoretical to me. I am alarmed by
reports that there may be unsterile and contaminated medical
devices on hospital shelves ready to be reused on patients.
There is the report of a broken heart catheter in a 32 year old
woman that lodged in the atrium of her heart. I am also
concerned about how one knows whether the reprocessed single-
use device has been used a second time, or an eighth time, or
maybe even a tenth time. We need to make sure that these
complex, hard to clean medical devices are really sterile and
functional.
These products may look fine and dandy to the naked eye, or
even one with Lasik, but under a microscope or in a patient it
could be a completely different story. I am well aware that
some hospitals and reprocessing companies take many precautions
and work very hard to produce safe and effective reprocessed
single-use medical devices. I am also aware of many studies on
this issue, some showing problems with reprocessed single-use
devices, and others indicating that single-use devices can be
reprocessed and reused safely. But in the end, there seems to
me to be too many questions about the risks to patients, the
lack of informed consent, regulatory fairness, whether the
newer and more complex devices really can be cleaned. That is
why we need this hearing to help us understand the issues
involved with reprocessing, to get some answers to some
questions, and to assure ourselves that the FDA is
appropriately regulating the practice of reprocessing. The FDA
has acknowledged that it presently has the authority under the
Federal Food, Drug and Cosmetic Act to regulate both on a pre-
market and a post-market basis. To date, the Agency has chosen
not to fully enforce all of the statutory and regulatory
requirements over reprocessing of single-use devices that
original manufacturers must comply with. Most notably, pre-
market review. I look forward to hearing directly from the
Agency about how it plans to address this issue, both now and
in the future to ensure that American patients are not
unnecessarily put at risk.
I welcome particularly Dr. David Feigal of the FDA before
this subcommittee. I want to express my deep appreciation to
Dr. Feigal who only a few months ago became the Director for
FDA's Center for Devices and has already helped lead the FDA to
a reassessment of an issue that the FDA has struggled over for
many, many years. I also want to thank Chairman Bliley for his
support of this hearing and the inquiry. I also want to welcome
Ms. Anna Eshoo for raising attention to this issue,
particularly with her legislation that she has introduced and
monitor work with her on behalf of patient safety.
We will be hearing from outstanding witnesses on both sides
of this medical controversy. I thank all of our witnesses for
taking the time to be here, and I also want to thank the staff
which has helped us prepare, not only Mr. Alan Slobodin, but
Mr. John Ford on the Democratic side as well. And with that I
will yield for an opening statement to my friend from the great
State--awesome State--of Michigan, Mr. Stupak.
Mr. Stupak. Thank you Mr. Chairman, and thank you for
holding these very important hearings. I appreciate the hard
work that you and our colleague, Ms. Eshoo from California,
have put into this issue.
Now, Americans expect when they go to the hospital that
catheters and devices used in their hospital stay are safe,
effective, and sterile. And Mr. Chairman, you commented a
little bit, and I know you have some of these with you too, but
the catheter it is basically all plastic. The little balloon on
the end there. And then you have another one over here which is
a little different device but it has a metal tip. And it is
more than just plastic versus metal. I think what we're all
looking for in these devices is to make sure that they are
sterile and safe for the patient. And I know that has been the
focus of your query here, but we have a number of these devices
with us. I know you have them with you too, but I think it
gives us a good opportunity to take a look at exactly what are
we talking about.
Because Americans want to ensure that when they go to the
hospital they have affordable health care at reasonable prices
and really they don't care to pay retail all the time if there
is a better way of doing it. Today's hearing is about striking
a balance, Mr. Chairman, between patient safety and controlling
costs in our health care system and all the devices that we use
in modern medicine. But patient safety must be our first
priority. Cost containment that puts patients at risk does not
control costs at all. If a patient develops an infection or has
complications due to a device malfunction, saving 50 percent on
the device is no savings at all. Even if it was, I would not
want to put the lives of my wife or our sons at risk to save a
few dollars. Thus, I believe our guiding light should really be
are we ensuring patient safety.
The FDA, the Food and Drug Administration, has up until
recently, had a policy of nonenforcement with respect to the
single-use requirement. In fact, medical device reprocessing
has been going on for over 20 years. However, due to the ever
increasing complexity of medical devices, much like I have
shown us today, the FDA has decided to review its enforcement
policy and increase the oversight of reprocessed devices. I
know some people believe that the FDA has taken too long to
act, but I applaud the FDA for beginning the process of
ensuring that reprocessed devices will be safe, sterile, and
effective.
I want to hear about the FDA's proposed guidance on
classification and enforcement of the reprocess and reuse of
single devices. I understand that some believe the guidance
goes too far, and others believe the guidance does not go far
enough or quick enough. I am interested in hearing all of these
points of view. Mr. Chairman, these issues are always difficult
for members up here on the dais. We are forced to chose between
competing business, patient safety, and healthcare cost
containment. I am hopeful that this hearing will shed some
light on these issues and help provide both this committee and
the FDA with input on where we go from here.
I want to once again thank you and Ms. Eshoo for your hard
work on this issue and I yield back my time, Mr. Chairman.
Mr. Upton. Thank you.
I would also make unanimous consent request that all
members of this subcommittee be allowed to put their statements
into the record in their entirety. Without objection, that will
be the rule.
Mr. Bryant from Tennessee?
Mr. Bryant. Thank you Mr. Chairman. I would simply echo
what the two previous speakers have raised in their opening
statements. And I think there are very important issues here
today. I know we have some very distinguished panelists to
testify.
The issue of the economy, of why this is done is important,
but certainly the issue of safety, the issue of functionality
of these products, all are very important and I look forward to
hearing testimony on both sides of the issue.
I think my main concern in reviewing this in preparation
for the hearing is with the FDA. And I am glad that, Doctor,
you are here today to open the testimony. I look forward to
hearing from you. I get a sense that the FDA is on the
sidelines, and I want to know when the FDA is going to come in
and start playing on this very important issue. And I look
forward to your testimony to that effect and would yield back
my time.
Mr. Upton. Mr. Whitfield from Kentucky?
Mr. Whitfield. Mr. Chairman, thank you very much and I
think all of us are looking forward to this hearing for a
number of reasons, obviously, its impact on good quality and
safe healthcare. Before a medical device can legally enter the
market we know that the manufacturer must demonstrate to the
Food and Drug Administration is safe and effective. And I know
from discussions that I have had with other colleagues, we are
disappointed by FDA's failure to enforce existing laws and
apply them to reprocessed medical devices.
It is difficult to understand how an Agency which
continually seeks to broaden its scope of authority can leave
the impression that it is not really doing very much in this
area. Yesterday we had a hearing on safety in hospitals and in
healthcare, and we talked about the number of deaths because of
mistakes made in the healthcare delivery system. And this is a
particularly important area, and it is squarely within the
jurisdiction of FDA. We all recognize the role that reprocessed
medical devices play in keeping medical care accessable by
containing costs, but this is not an excuse for FDA to leave
the impression and to permit unsafe medical devices to be used
in our hospitals.
Having said that, we are delighted that Dr. Feigal is here
today to talk about this issue, to let us know what he intends
to do about it, and I understand that he has been instrumental
in trying to move the Agency forward in that direction. And I,
for one, am disappointed, however, that we did not have an
opportunity to even review your testimony because I guess we
didn't receive it until this morning. But hopefully you will do
a great job of presenting that testimony and we thank you for
being here this morning.
Mr. Upton. Dr. Ganske from Iowa.
Mr. Ganske. I Thank you Mr. Chairman. I will be brief. We
want to make sure that patients are getting quality care. We
have medical devices that need to be safe and clean. As a
medical practitioner before coming to Congress I have used
disposable equipment. I am concerned about some of the data
that will be presented today. We want to make sure that it is
accurate and I think the FDA has a role in the oversight of
whether single-use medical devices can be reprocessed and used
again.
There are some questions about health costs that are
involved with this. I think it would be also useful at some
time, Mr. Chairman, to have the Healthcare Financing
Administration present, because I am concerned about how
charges are made to our Federal system for single-use devices.
For instance, does a hospital get paid the same amount of money
by Medicare if they reprocess a device that then costs them
half of what a new single-use device would be, and are they
just pocketing the difference? I am interested in finding out
how the calculations are made by HCFA for the device component
of some of the services that are being billed to the Federal
Government. Maybe we will get into that today. I yield back.
Mr. Upton. It is my understanding that the answer to that
question is yes. It is a very good question. Even without their
presence here today, I think maybe members of this subcommittee
can follow-up with HCFA in written form following the hearing.
Mr. Strickland, from Ohio.
Mr. Strickland. No opening statement, thank you.
Mr. Upton. Mr. Burr from North Carolina.
Mr. Burr. No opening.
Mr. Upton. Ms. Eshoo from California.
Ms. Eshoo. Thank you very much, Mr. Chairman, and I want to
salute you for holding this very important hearing on what I
think is a critical issue that is not only before the Congress,
but something that the American people deal with--patients deal
with really day in and day out. I know that I am a guest of
this Committee of Investigations and Oversight, and I
appreciate the hospitality, the legislative hospitality that
you have extended to me.
For those of you in the audience, I am not a member of this
subcommittee and so it's really up to the chairman to say that
it is absolutely fine for me to come and testify. I was a
member of this distinguished committee in my first term in
serving on Commerce. I come to this issue from the perspective
of both legislator and a consumer. As a legislator I have great
concerns about the FDA's failure to require that reprocessed
single-use medical devices meet safety and effectiveness
standards. It makes no sense to me that new medical devices
must meet these standards, yet the used ones do not.
As a consumer I was horrified to learn that complex
delicate devices such as cardiac balloon catheters and biopsy
forceps are being cleaned and used again on different patients.
Now, this could happen to any one of us and there is not
anything that is put before the patient to ask them whether
they chose to have a reprocessed device used on them or not. So
there is not any choice, there is not any disclosure to the
American patient today on this issue. I first learned of this
problem last August after reading reports of an outbreak of
bacterial toxins in a Colorado hospital that were traced back
to reprocessed cardiac catheters. One person died from this
particular outbreak, but it raises the question of how many
deaths, or injuries occur from reprocessed devices that are
unsterile or are made less effective due to the process that
they are put through to clean them today.
FDA files on adverse outcomes from reused disposable
devices tell of reprocessed electrophysiology catheters likely
weakened by the harsh chemicals and intense temperatures
required to sterilize them breaking inside of patients. I think
we should always just keep ourselves in mind before we ever
place this on a family member or anyone else. I certainly would
not want that happening to me. In one case, the tip of the
catheter remained lodged in the patient's heart requiring
constant monitoring. In another the four inch long tip traveled
from the patient's heart to his stomach. Surgeons had to open
the man's stomach to remove the tip. Premature babies have
suffered infections from unsterile sutures. A patient was
contaminated with Hepatitis B from reused biopsy forceps.
The source of this is U.S. News and World Report in their
September 20, 1999 edition. It is estimated that as many as one
in every three hospitals are reusing medical devices that are
designed, manufactured, and FDA approved for one use only. FDA
clearly has the authority to enforce safety and effectiveness
standards. Yet in my view, after reviewing the record and
seeing how the policies are working, they have essentially
looked the other way allowing the practice to go on, within my
view, very little oversight.
In fact, in a letter dated July 9, 1999, which I will
submit for the record, Mr. Chairman, with the committee's
approval, the FDA admitted that reprocessed devices are subject
to all safety and effectiveness standards, but said that they
had chosen not to enforce these standards. This approach fails
to ensure that devices designed for one use only can be
sterilized and reused safely and effectively. That is why I
introduced legislation on this issue. Mr. Chairman, the FDA
policy permits practice of withholding information from the
patient that he or she is getting a previously used device. It
is also common to charge the patient and the Federal Government
through Medicare for a new device when a secondhand one is
actually being used. Now, when we buy a part for our car, the
mechanic is required to tell us if that part is new or rebuilt
and we are charged accordingly. Now, why is it that our laws
are doing a better job covering car parts than they are
protecting patients in our country?
I am very proud, Mr. Chairman, to have you join me in
introducing the Reprocessed Single Use Medical Device Patient
Safety Act of 1999. The bill is H.R. 3148. The bill would
ensure the protection of patients by requiring reprocessed
medical devices to meet the same standards for safety and
effectiveness that new products today must meet. When the FDA
approves a device for single-use only, that is exactly what it
means--that the data submitted by the manufacturer has to show
that this device can be safely used once.
Thus, in order to avoid injuries and infections to
patients, I think that we should be requiring that those who
clean devices for reuse prove that it can be done safely and
effectively. H.R. 3148 will increase awareness about
reprocessed devices by requiring a patient's informed consent
before that single-use medical device is used on them, and by
requiring hospitals to monitor and report injuries or
infections that occur as a result.
We have very little information about the scope of patient
injuries that occur as a result of reused medical devices
because patient consent is not required, and tracking is not
required to determine if a reused device was involved in an
adverse event. I am pleased that the FDA has finally developed
a proposed policy with regard to reprocessing and reuse, but I
am still concerned that it is an extension of their current
practice of essentially looking the other way. In their
proposed enforcement guidance they again state that all
reprocessed single use devices are subject to the same pre-
market requirements to prove safety and effectiveness, as new
devices do, yet they do not or will not, as the way I read it,
and maybe Dr. Feigal will point this out in his testimony,
enforce these requirements unless the device is considered high
risk. How will we know whether reuse of a particular device
poses a high risk to patients without the data? Under FDA's
proposal reprocessors will never have to submit data to prove
the risk to patients of devices that are arbitrarily determined
to be moderate or low risk. Moreover, even for high risk
devices, no data will be required for at least 1 year. I
understand very well the fiscal restraints that our hospitals
all over the country are under, what they are operating under.
I have worked closely with the hospitals before I came to
the House of Representatives, and I still do today. So, I
understand very well the pressures that they work under.
Between managed healthcare and reduced Medicare reimbursements,
hospitals indeed do feel the intense pressure to cut costs
wherever possible. However, we can't put patients at risk in
order to save a few dollars. I think my colleagues that have
spoken before me have really stated that quite eloquently. We
have to always put patients before profits. I know it is a
struggle to do that, but I think the American people expect our
public policy to reflect that. The Reprocessed Single-use
Medical Device Patient Safety Act is about putting patients
first.
I think that it is sound public policy, and I have no doubt
that today's hearing is going to be very instructive to members
of this very important subcommittee about this issue. So I look
forward to working with you, Mr. Chairman, and the rest of the
members of this very distinguished subcommittee, all of the
members of the full committee, because this is the place where
the legislation obviously will be heard and considered. And
again I thank you for your legislative hospitality in inviting
me here and being able to speak to this issue today. Thank you.
Mr. Upton. Thank you. Mr. Pickering, do you have an opening
statement that you would like to----
Mr. Pickering. Not at this time.
[Additional statements submitted for the record follow:]
Prepared Statement of Hon. Tom Bliley, Chairman, Committee on Commerce
Mr. Upton, thank you for this hearing. I am eager to get action and
some answers for the American public about the safety of reprocessing
medical devices designed, manufactured, and approved by the Food and
Drug Administration for single-use only.
I am proud of this Committee's accomplishments in the last five
years to make the FDA a better scientific agency, one that serves the
American people, promotes innovation, and protects the public health.
We have streamlined FDA procedures and cut FDA red tape. We have made
the FDA more effective.
Today's hearing looks at reused single-use medical devices. I
believe FDA has acted with uncertainty about its own authority. For the
last several years, the FDA has sent conflicting signals about the
legality and safety of reprocessing single-use devices. The result has
been that patients without their knowledge have been exposed to unknown
risks from devices that were used on other patients. Thus, for example,
there is the possibility that tiny, hard-to-clean, disposable catheters
used in patients with hepatitis are being reprocessed and reused in
patients without their knowledge. That is an outrage.
But this is not all. The result of FDA uncertainty has been that
the original equipment manufacturers find their good name and liability
on the line because their disposable products have been reused without
their knowledge or approval. The result of FDA's confused policy has
helped lead to a surge of reprocessing single-use devices because
hospitals and health care firms had assumed FDA's acceptance of the
practice of reprocessing.
I want the inconsistencies and uncertainties to end today. We are
at long last getting some answers and actions from FDA and other
interested parties. FDA's leadership is late. I believe the FDA
deserves credit for its hard work over the last several months. I hope
FDA's new policy is reasonable and protects patients.
I commend Commissioner Jane Henney and FDA Devices Director David
Feigal, both of whom came on the scene during the past year to steer
FDA in a better direction on its reuse policy. I also commend Mr. Upton
and Mrs. Eshoo for their leadership on this issue. I look forward to
working with all concerned to give the American people the facts and
swift, common-sense action.
______
Prepared Statement of Hon. Henry A. Waxman, a Representative in
Congress from the State of California
Mr. Chairman, as the author of the Safe Medical Devices Act of
1990, I am pleased that you have convened this morning's hearing.
Ten years ago, the safety of medical devices and the practices of
the device industry came into serious question. Fatal product failures
like the Shiley heart valve taught Congress and the public an important
lesson--there is no substitute for stringent FDA enforcement of
rigorous standards of safety and effectiveness.
That lesson holds true today. Due in no small part to the efforts
of my friend, Senator Durbin, there is enormous interest in the
regulation of reprocessed devices. Consumer, patient and health
provider groups all agree that FDA must ensure such devices are safe
and effective whether they are used once or reused.
Clearly, there are categories of use for which devices may be
safely reprocessed. Just as clearly, there have been instances of
unsafe hospital practices or inadequate safeguards on the part of
reprocessors. From the written testimony submitted by both device
reprocessors and the manufacturers, it appears that they agree on the
need for rigorous FDA oversight and enforcement of risk-based
standards. As a result, I am pleased that FDA has issued its new
guidance document, which prioritizes the scrutiny of reprocessed
devices.
FDA clearly lacks the resources to do all it should. Last year,
Senator Durbin secured an additional $1 million for the FDA to
establish safety standards for reprocessed devices. But that is only a
small step towards closing the widening gap between FDA's obligations
and its resources. For years, Congress has forced FDA onto a starvation
diet while we look to the agency to do more--more about tobacco, more
about online drug sales, more about drug safety, and now, more about
reprocessed devices.
FDA also lacks the authority to adequately answer basic questions
about the products it regulates. The recent IOM report on medical
errors stresses the urgency of better understanding the rates and
severity of medical mistakes including medication errors. The GAO and
Inspector General recently concluded that we must enhance FDA's adverse
drug event reporting system and post-market surveillance authority to
help eliminate the 7,000 annual deaths from medication errors.
And in the case of devices, are we certain FDA has the resources to
properly analyze the 100,000 reports it receives annually? And does
anyone believe those reports comprise the whole universe of device
malfunctions and misadventure?
Mr. Chairman, I look forward to hearing from our witnesses. I look
forward to learning more about this important issue.
Mr. Upton. Okay. We are ready to proceed. Dr. Feigal is our
first witness, the Director for the Center for Devices and
Radiological Health, FDA. Dr. Feigal, we welcome you to our
subcommittee. We have a long standing honored tradition of
taking testimony under oath. Do you have any objection to that?
Committee rules also provide that you are entitled to counsel
if you would like such. Do you have any need to have counsel
with you today?
Dr. Feigal. Not yet.
Mr. Upton. Not yet.
If you could stand and raise your right hand.
[Witness sworn.]
Mr. Upton. You are now under oath. Your testimony in its
entirety is made part of the record. We would like to think
that you would sum up your testimony in about 5 minutes or so,
and the time is now yours. Welcome.
TESTIMONY OF DAVID W. FEIGAL, DIRECTOR, FOOD AND DRUG
ADMINISTRATION
Mr. Feigal. Thank you very much. Mr. Chairman, members of
the committee, and guests. I am pleased to be here today to
discuss our approach to the issue of reusing medical devices
labeled for single-use. I would appreciate if my entire written
testimony would also be entered into the record. We value your
interest and input as we study this complex issue and move
forward to change our regulatory approach.
The public expects and the law requires that all devices be
safe, effective, and manufactured in accordance with good
manufacturing practices. As you know, FDA is currently in the
process of reexamining its policy in the area of reuse of
single-use devices. Our primary goal is to protect the public
health by ensuring that reprocessed, single-use devices are
safe, effective, and well manufactured. Let me say at the
outset that I believe we have the regulatory tools to ensure
that this will happen. We are crafting a regulatory approach
that will apply equal treatment to the original manufacturers
of devices, and those who reprocess them, including commercial
reprocessing firms and hospitals. I think this approach will
assure the desired public health protection.
Just this week we posted on our Web site two draft guidance
documents that pertain to the reuse of single-use devices. One
describes a proposed risk categorization scheme for reprocessed
devices. The other describes our enforcement priorities based
on that risk categorization scheme. We will publish a notice of
availability of these documents in the Federal Register. I
realize that since we just posted these draft guidances, they
were not available for your second panel of witnesses to review
before they submitted their testimony. But we hope they will be
helpful in moving this debate forward.
By way of background, let me describe how reuse has grown
over the years and why it poses a problem today that did not
exist a few decades ago. The practice of reusing medical
devices intended only for one use began in hospitals in the
late 1970's. Prior to that time most medical devices were
designed to be reusable. Because most devices were made of
glass, rubber, hard plastic, or metal, early reprocessing
involved little more than heat sterilization, wiping, dipping,
or soaking in disinfectant. Things began to change as a result
of market demand for disposable equipment, the development of
new plastics, the miniaturization of devices, and the advent of
ethylene oxide sterilization.
These factors prompted the manufacturers to sell more and
more single-use only medical devices. And as a result,
hospitals began to receive products labeled single-use only
that were similar to reuseable devices. In fact, outside of
their packaging even today some of them look identical to
devices that had formerly been sold as reusable. The practice
of reprocessing single-use devices expanded when an increasing
number of hospitals found that reuse was a cost-saving measure
and when they became concerned about the amount of medical
waste generated by the use of disposable devices. The hospitals
themselves began reprocessing more complex products such as
balloon angioplasty and cardiac catheters.
Reprocessing of these devices required more complicated
decontamination and sterilization procedures and as a result a
new industry of third-party reprocessor evolved in response to
the reprocessing needs of the hospitals. All of this has
resulted in heightened concerns about the safety and
effectiveness of reused single-use devices, and about the
equitable regulation of the original equipment manufacturers
and the reprocessing firms.
Where does FDA stand on this issue? We have concluded that
the practice of reuse does need additional attention and
controls. We have come to that conclusion even though we do not
have clear evidence that the reprocessing of single-use devices
changes or increases the types of risks to patients beyond
those posed by the original device. We recognize that we may
not have some of the evidence because our medical device
reporting systems do not capture all of the information. But
patient injuries are not the only reason for our taking action.
Even without documented injury, the law still requires that we
assure that reprocessed devices are safe, effective, and
manufactured properly.
I do not want to leave you with the impression that FDA is
coming anew to this issue. Although we only received research
reports from the original equipment manufacturer industry
within the last year, we have been actively engaged in the
reuse issue for some time. In the past year, we have held
numerous meetings and conferences with industry, health
professionals, and consumers to determine the extent,
magnitude, and changing nature of the practice. We have
evaluated and conducted research to develop a scientific basis
for addressing the issue. We have inspected third-party
reprocessors and as a result have issued ten Warning Letters
for various violations. And, we have investigated reports of
patient injuries.
Now, let me describe what we are proposing to do in this
area. Fundamentally, our proposed strategy is based on the
degree of risk posed by the device. The primary factors we will
use to determine the level of risk are the risk of infection
and the risk of performance deterioration if a device is
reused. There are four steps in developing this regulatory
system which we proposed for comment last November. First, we
identified the need to develop a list of the commonly reused
single-use devices. Second, we developed a list of the factors
that will determine the degree of risk or complexity associated
with reprocessing. Third, we will use this information to
divide the list of commonly reprocessed single-use devices into
high, moderate, and low categories of risk. And fourth, we will
develop priorities for enforcement of our regulatory
requirement for hospitals and third-party reprocessors based on
this category of risk.
Since announcing this strategy in November, we have made
significant progress. On February 8th, we posted on our Web
site two companion draft guidance documents. One is entitled,
``Reprocessing and Reuse of Single-Use Devices: A Review
Prioritization Scheme''. It sets forth the factors that we
would consider in categorizing a reprocessed device as high,
moderate, or low risk. It also includes a list of commonly
reprocessed single-use devices and the degree of risk that FDA
believes each type of device poses when it is reprocessed. The
other draft guidance entitled, ``Enforcement Priorities for
Single-Use Devices Reprocessed by Third Parties and
Hospitals,'' sets forth our priorities for enforcing various
regulatory requirements, based on the level of risk associated
with reusing the device.
Specifically FDA intends to begin enforcing pre-market
notification and pre-market application requirements within 6
months of issuing the final guidance if the reprocessed device
is categorized as high risk, within 12 months if the device is
moderate risk, and with 18 months if the device is low risk. I
would like to close by giving a couple examples of how this
proposed risk categorization scheme and other enforcement
strategies would affect the reprocessors of various devices.
Let's take as examples oral and nasal catheters. These are
fairly simple devices. They are currently Class I and they are
exempt from pre-market notification. They would be considered
low risk under the risk categorization schemed just described.
Six months after a guidance became final, FDA would
actively enforce all post-marketing requirements for hospitals
that reprocess these oral and nasal catheters, just as we
currently do for manufacturers of original equipment and third-
party reprocessors. These include registration, listing,
manufacturer adverse event reporting, labeling, corrections and
removals, and adherence to the quality system manufacturing
requirements. At the other end of the spectrum let's consider
the percutaneous transluminal angioplasty catheters or intra-
aortal balloon catheters, which are Class III devices. Based on
our own studies and other information, we have determined that
cleaning and sterilizing these devices is very difficult, and
so they would be considered high risk under this scheme.
Hospitals and third parties that reprocess these devices would
be required to submit to us pre-market approval applications to
demonstrate that the reprocessing of these devices results in a
product that is safe, effective, and well-manufactured.
Where do we stand right now? After the Federal Register
publication of these guidances and review during the comment
period, we will issue final versions. At that point, we will be
ready to enforce the regulatory scheme for third parties and
hospitals that reprocess single-use devices. Mr. Chairman, let
me close by saying that although we have no clear data to
indicate that people are being harmed at a higher rate by the
reuse of single-use devices, the results of our own research
and the information provided by various stakeholders have
convinced us that this growing practice needs closer scrutiny
and oversight.
We are committed to addressing this in an open and
cooperative fashion with the industries involved, the
healthcare community, the public, and of course, Congress. We
want a reasonable and fair-minded policy, but at the same time
we want to ensure that when a single use device is reused it
doesn't expose the patient to more risk than a new device would
have. I thank you for this opportunity to be here today. I look
forward to answering any questions that you may have.
[The prepared statement of David W. Feigal follows:]
Prepared Statement of David W. Feigal, Director, Center for Devices and
Radiological Health, Food and Drug Administration
introduction
Mr. Chairman, Members of the Committee, I am Dr. David Feigal,
Director of the Center for Devices and Radiological Health (CDRH) at
the Food and Drug Administration (FDA or the Agency). I am very pleased
to have the opportunity to be here today to discuss the Agency's
approach to the issue of reuse of medical devices labeled for single-
use. As you know, FDA is currently in the process of reexamining its
policy on the reuse of medical devices labeled for single-use. Our
primary goal in doing so is to protect the public health by assuring
that the practice of reprocessing and reusing single-use devices (SUDs)
is safe and effective and based on good science. We value your interest
and input as we study this complex issue and move forward to change our
regulatory approach.
The public expects and the law requires all devices to be safe,
effective and manufactured in accordance with Good Manufacturing
Practices (GMPs). Let me say at the outset that I believe FDA does have
the tools to ensure the safety, effectiveness and manufacturing quality
of reprocessed single-use devices. We have been actively engaged in
reuse issues for some time and our efforts have included research,
outreach, inspections and compliance investigations. We are currently
in the midst of crafting a new regulatory approach that will treat
Original Equipment Manufacturers (OEMs), third parties and hospitals in
a similar manner to minimize risks associated with reused single-use
devices.
We have held numerous meetings and conferences with industry,
health professionals, and consumers over the past several years to
determine the extent, magnitude and changing nature of the practice.
FDA has evaluated and conducted research to begin to develop the
scientific basis for addressing the issue. We have inspected third
party reprocessors and issued ten Warning Letters for various
violations. We have evaluated and investigated reports of patient
injuries.
That being said, medical progress has been accompanied by changes
in technology, resulting in more devices with features that may make
reprocessing difficult or impossible. At the same time, economic
pressures create incentives for reuse. Despite a lack of clear data
that suggests that many injuries are occurring due to reprocessing
practices, FDA has concluded that the practice of reuse of SUDs needs
additional attention and controls. We recognize the limitations of our
medical device problem reporting systems in capturing this information.
We take the reports we do get very seriously, but at the same time,
even if there were no injuries, a driving question remains: Are
reprocessed SUDs being manufactured properly, that is, in accordance
with the Quality Systems Regulation (QSR)?
On February 8, 2000, FDA posted on its web site two draft guidance
documents that pertain to the reuse of SUDs. One describes a proposed
risk categorization scheme for reprocessed SUDs. The other describes
the Agency's priorities for enforcing various regulatory requirements
based on the risk categorization of a reprocessed SUD. We will be
publishing a Notice of Availability of the documents in the Federal
Register imminently and asking for public comments on these two
documents.
background
The History of Hospital Reuse
The practice of reusing medical devices labeled, or otherwise
intended, for only one use began in hospitals in the late 1970s. Prior
to this time, most medical devices were considered to be ``reusable.''
Because most reusable devices were fabricated from glass, rubber, or
metal, early reprocessing of reusable products, such as probes and
surgical instruments, involved little more than hand wiping, dipping,
and soaking in disinfection solutions. OEMs began to sell ``single-
use'' medical devices as a result of market demand for disposable
equipment, the development of new plastics, and the use of ethylene
oxide sterilization. Hospitals began to see products labeled ``single-
use only'' that were similar to devices that had been formerly
distributed or continued to be distributed as ``reusable.''
The practice of reprocessing single-use devices expanded when an
increasing number of hospitals decided that reuse was a cost-saving
measure and when they became concerned about the amount of medical
waste generated by the use of disposable devices. Hospitals started
reprocessing more complex products, such as balloon angioplasty
catheters and cardiac catheters. Reprocessing of these devices required
more complicated decontamination sterilization procedures. As a result,
an industry of third party reprocessors evolved in response to the
reprocessing needs of hospitals. Expanded use of third party
reprocessors and an increase in the types of single-use products
subjected to reprocessing heightened concerns regarding patient safety,
and equitable regulation of OEMs and reprocessing firms.
The Scope of Reuse Today
The Agency has developed a list of frequently reprocessed SUDs,
which includes devices that range from the technologically simple to
the complex. Examples include:
Surgical Saw Blades
Surgical Drills
Laparoscopy Scissors
Orthodontic (metal) Braces
Electrophysiology Catheters
Electrosurgical Electrodes and Pencils
Respiratory Therapy and Anesthesia Breathing Circuits
Endotracheal Tubes
Balloon Angioplasty (PTCA) Catheters
Biopsy Forceps
The list varies greatly in type of device, material, risk of use
and severity of clinical conditions of typical use. Some products have
features such as long narrow lumens, fragile plastic components, and/or
unsealed electronic controls that make them very difficult to clean.
Other products on the list, e.g., drill bits, are technologically less
complex and are relatively easy to clean.
A common type of reuse in hospitals occurs when a sterile product,
such as a suture, is opened during a medical procedure but not used.
Typically these are re-sterilized and re-packaged at the hospital.
OEM's often provide instructions for hospitals to do so. The Agency has
published applicable guidance on these products and does not consider
opened-but-unused SUDs to be reused devices that are within the scope
of the proposed strategy.
agency involvement in reuse
Reports of Patient Injuries
There have been stories in the media which have reported catheter
tip separations, faulty cataract surgical equipment, and other problems
attributed to failure of a reused SUD. A recent review of Medical
Device Reporting (MDR) reports received by CDRH from August 19, 1996
through December 7, 1999 revealed 464 reports (out of 300,000) of
adverse events that could possibly be attributed to reuse of a SUD. The
245 reports spanned approximately 70 different types of products. From
this data we can discern no pattern of failures with reused SUDs that
differs from patterns observed with the initial use of SUDs.
MDR reports do not enable accurate assessment of failure rates,
whatever the type of device. Detecting SUD problems is even more
challenging in that they are often not labeled as SUDs (other than on
the original packaging). In addition, device failures may be
particularly under-reported (to manufacturers) when the hospital
recognizes that the device that failed was a reused SUD. Also,
infections that may have resulted from an improperly reprocessed SUD
may be hard to trace back to the reused device.
Research Findings
CDRH has implemented a research program to explore safety and
effectiveness issues associated with the reprocessing of single-use
devices. Information on difficulty of cleaning the devices, effect of
sterilization on material, efficacy of resterilization, and alteration
in performance criteria are all being investigated. CDRH has had the
opportunity to examine SUDs after one-time use, compare them to devices
that have not been used, and do simulated reuse laboratory studies.
Loss of elasticity in inflatable balloons, persistence of blood and
biofilms, loss of original lubricants and the effect on catheter
threading, and crystallization of liquid x-ray contrast material are
just some of the factors that we have examined. This research program
has expanded our ability to evaluate reports, scientific studies, and
comments from the healthcare community.
Hospital infection control programs rarely identify specific
incidents of patient infection caused by reuse of SUDs. Our research
has shown, however, that the performance of some products is degraded
by the effects of biofilms and repeated use. We have presented our
laboratory findings at many scientific meetings. We continue to believe
that solid research by industry, academia and FDA is the best way to
understand the issues that need to be addressed and to develop
consensus standards for reprocessing practices.
Outreach
The Agency has conducted numerous outreach efforts to further
understanding of and participation in this issue. We have organized and
participated in public meetings and conducted videoconferences. We have
met with individual manufacturers and reprocessors; manufacturers' and
reprocessors' trade associations; the American Hospital Association;
the Joint Commission of Health Care Organizations (JCAHO); the Health
Care Financing Administration (HCFA); and medical professionals and
some of their associations on this issue. Two meetings with broad scope
that occurred in 1999 were particularly useful in furthering our
understanding of this issue.
On May 5-6, 1999, FDA and the Association for the Advancement of
Medical Instrumentation (AAMI) co-sponsored a conference on the
practice of reprocessing and reusing SUDs. Participants included
representatives of health care facilities, firms that reprocess
devices, OEMs, national oversight organizations, State governments,
academia, medical ethicists, and standards organizations. This provided
FDA the opportunity to hear a wide range of views and concerns from
individuals and organizations involved in or affected by this practice.
FDA received divergent opinions on how reprocessing and reuse of
single-use devices should be regulated. Some participants believed that
reprocessors should be regulated in the same manner as OEMs and that
510(k)s or Premarket Approval applications (PMAs) demonstrating the
safety and effectiveness of the reprocessed device should be required.
Others believe that OEMs should be required to provide instructions on
how to reprocess their devices unless they can demonstrate that the
device cannot be reprocessed. Still others stated that the general
controls under which reprocessing is regulated currently are sufficient
to ensure protection of the public health.
Participants identified the need for additional guidance on
reprocessing. Among the suggestions were: standards to assure that
cleaning, disinfection, and sterilization processes are validated and
that reprocessing may be performed properly; a determination of what
types of devices can and cannot be reprocessed; a classification scheme
establishing critical, semi-critical, and non-critical categories for
reprocessed devices; and clearer definitions for the terms ``reuse,''
``reprocessing,'' and ``resterilization.''
Participants suggested that clinical data and experience on reuse
could be obtained through hospitals' existing surveillance activities;
long-term clinical studies; the establishment of a clearinghouse for
data; National Institutes of Health funds and studies of reprocessing;
and research by professional societies with funding provided by OEMs
and reprocessors.
FDA held an open meeting, on December 14, 1999, to obtain feedback
from stakeholders and interested parties on its proposed strategy on
reuse of SUDs. Twenty-eight public presenters voiced a variety of
concerns during the first part of the meeting, and workshops in the
afternoon provided attendees with an opportunity to explore particular
issues in smaller groups. An Executive Summary which describes the
input we received on many aspects of this complex issue is available on
our web site at http://www.fda.gov/cdrh/reuse/1214execsum.pdf.
fda's current policy
As I noted at the outset, the American public expects, and the
Federal Food, Drug, and Cosmetic (FD&C) Act requires, that devices be
safe, effective, and manufactured in accordance with GMPs. When a SUD
is prepared for reuse by cleaning, repairing, or refurbishing, it is
being remanufactured and the FD&C Act provides controls to address
these reprocessed devices, however, FDA has not regulated OEMs, third
party reprocessors and hospitals that reprocess devices in the same
manner.
Original Equipment Manufacturers (OEMs)
OEMs are subject to all requirements of the FD&C Act including:
registration and listing, premarket notification and approval
requirements, submission of adverse event reports under the MDR
regulation, manufacturing requirements under the QSR; Labeling
requirements, Medical Device Tracking, and Medical Device Corrections
and Removals. The Agency has enforced all of these requirements with
respect to OEMs.
Third Party Reprocessors
Third party reprocessors are subject to the same regulatory
requirements as other manufacturers, including premarket requirements.
As discussed previously, FDA has issued Warning Letters to third party
reprocessors for various violations; however, to date, FDA has not
actively enforced premarket requirements against third parties. (Note
that many devices that are commonly reprocessed are exempt, by
regulation, from premarket requirements.)
Hospitals
According to the Agency's Compliance Policy Guide, hospitals that
reprocess single-use devices assume full liability and responsibility
for their reprocessing actions and should ensure that the products are
adequately cleaned and sterilized, and that device safety,
effectiveness, and quality are maintained. The Agency currently
provides no direct oversight or routine enforcement for in-hospital
reprocessing. If a serious adverse event involving a reprocessed (or
any other) device occurred in a hospital, however, FDA would conduct an
investigation and take appropriate action, as necessary.
fda's proposed strategy
As I stated earlier, FDA is reevaluating its position on the reuse
of single-use devices. In November 1999, the Agency made a document
available on its web site for public review and comment which described
a proposed strategy to address reuse of SUDs. One of the principal
components of FDA's proposed strategy was the establishment of agency
enforcement priorities concerning regulatory requirements for third
party and hospital reprocessors of SUDs. FDA proposed to prioritize its
enforcement activities based on the degree of risk posed by the
reprocessing. To accomplish this process, FDA proposed the following
steps:
(1) develop a list of commonly-reused SUDs;
(2) develop a list of factors to determine the degree of risk
associated with reprocessing devices;
(3) use that list of factors to divide the list of commonly-reprocessed
SUDs into three categories of risk--high, moderate, and low;
and
(4) develop priorities for enforcement of regulatory requirements for
hospitals and third party reprocessors, based on the category
of risk.
Since the announcement of FDA's proposed strategy, FDA has made
significant progress. On February 8, 2000, FDA posted on its web site
two companion draft guidance documents. One is entitled, ``Reprocessing
and Reuse of Single-Use Devices: Review Prioritization Scheme.'' This
draft guidance set forth factors we would consider in categorizing a
reprocessed devices as high, moderate or low risk and includes a list
of commonly-reprocessed SUDs and the degree of risk FDA believes each
type of device poses when reprocessed. The other draft guidance,
entitled ``Enforcement Priorities for Single-Use Devices Reprocessed by
Third Parties and Hospitals,'' sets forth our priorities for enforcing
various regulatory requirements, based on the categorization of a
device, as described in the Risk Categorization guidance.
The risk scheme guidance describes specific factors FDA would use
to determine whether reprocessing posed high, medium, or low risk. This
guidance has two flowcharts to help FDA and industry categorize the
reprocessing risks. One flowchart addresses factors that relate to
risks of infection that may accompany reprocessing. The other flowchart
addresses factors that relate to risks of performance failures that may
accompany reprocessing. Using these two flowcharts, FDA has categorized
all currently known reused SUDS into three categories of risk--high,
medium, and low. We have clarified that the risk categorization scheme
does not in any way change the classification of a device under the
statute.
The enforcement priority guidance bases the Agency's timing of
enforcement of premarket requirements on the level of risk determined
under the risk categorization scheme. Specifically, FDA intends to
begin to enforce premarket notification and premarket application
requirements within six months of issuance of a final guidance if the
reprocessed device is categorized as high risk, within 12 months if the
device is categorized as moderate risk, and within 18 months if the
device is categorized as low risk. Although FDA has not previously
enforced premarket requirements for third party reprocessors, FDA
currently enforces all other requirements applicable to manufacturers
against third party reprocessors. The issuance of this draft or any
final guidance will not change the continuing obligation of third party
reprocessors to comply with those provisions of the FD&C Act. FDA would
not enforce those requirements for hospitals, however, until six months
from the issuance of a final guidance document.
I would like to give a couple of examples of how this proposed risk
categorization scheme and our enforcement strategy would affect
reprocessors of devices of disparate complexity and risk. Oral and
nasal catheters, fairly simple devices, are currently class I and
exempt from premarket notification. They would be considered ``low
risk'' under the risk categorization scheme I just described. Six
months after a guidance became final, FDA would actively enforce all
non-premarket requirements for hospitals that reprocess oral and nasal
catheters, just as we currently do for OEMs and third party
reprocessors, including registration, listing, manufacturer adverse
event reports, labeling, corrections and removals, and quality system
manufacturing requirements.
Percutaneous transluminal angioplasty catheters or intra-aortal
balloon catheters, class III, would be considered ``high risk'' under
the scheme. Based on our own studies, we have determined that cleaning
and sterilizing these devices are very difficult. Hospitals and third
parties that reprocess these devices would be required to submit to the
Agency PMAs demonstrating that their reprocessing of these devices is
safe and effective, in addition to conforming to the general controls
of the FD&C Act.
At this time, the Agency is limiting its focus to SUD reprocessing
by third parties and hospitals. The draft SUD enforcement guidance does
not apply to permanently implantable pacemakers (the reuse of which is
already addressed in a Compliance Policy Guide), ``opened-but-unused''
SUDs, and healthcare facilities that are not hospitals.
next steps
Issuance of Final Guidance Documents
The guidance documents I mentioned are not final, nor are they in
effect at this time. These documents incorporate comments to our
proposed strategy that we received at the December 14 public meeting
and written submissions. We are in the process of publishing in the
Federal Register of a notice of availability of these documents and are
asking for comments. After reviewing the comments received, the Agency
will issue final guidance documents.
Phased-In Enforcement
As I have stated earlier, FDA is planning to phase in the
enforcement of regulatory requirements for third parties and hospitals
that reprocess SUDs. After receiving public comment on our draft
guidances, including factors used to categorize risks, and timing of
our enforcement based on those risks, we will issue final guidances and
begin implementation of our enforcement strategy that would regulate
OEMs, and third party and hospital reprocessors in the same manner.
Collaboration with Other Parties
The direction in which we are headed could impact significantly on
the Agency's resources, particularly for conducting inspections of
hospitals that reprocess. We will be collaborating with third parties,
such as JCAHO, HCFA and State agencies that currently perform oversight
of the health care sector to assist us in implementing the new policy.
Outreach
We will be continuing our outreach efforts to ensure that the
health care community, manufacturers, reprocessors, patients, and the
public are fully aware of the issues involving the reprocessing and
reuse of SUDs. Our efforts will include talk papers, public health
notifications, and lay articles on an FDA web page.
SUD Labeling
We will be considering changes to the labeling of SUDs by OEMs. One
option the Agency is considering is requesting OEMs who label their
devices ``single-use'' to provide, as part of the device's labeling,
any information of which they are aware regarding the potential risks
associated with reusing their SUDs. This information would serve as a
caution to users and reprocessors who might attempt to reprocess these
SUDs.
Institute an Expanded Research Program for Reuse
The Agency has conducted several in vitro studies on reused SUDs
and is considering additional studies on the effects of reprocessing.
Expansion of our research efforts may facilitate collaboration with
stakeholders and interested parties to conduct more in vivo and in
vitro studies.
conclusion
Mr. Chairman, although we have no data to indicate that people are
being injured or put at increased risk by the reuse of SUDs, the
results of our own research and the information provided by various
stakeholders have convinced us that this growing practice needs closer
scrutiny and oversight. We are committed to addressing reuse in an open
and cooperative fashion with the industries involved, the health care
community, the public, and, of course, the Congress to craft a policy
that is reasonable yet effective in minimizing the risks associated
with this practice. Thank you for the opportunity to be here today. I
am happy to answer any questions you may have.
Mr. Upton. Thank you very much. Now we will work this clock
for us. We are going to take 5 minutes each, rotating on both
sides for questions. One of the items that you used last in
your testimony was, in fact, this one right here, which is--I
don't know if I want to take it out because then no one would
be able to use it. This is an emergency coronary artery bypass
graft surgery instrument?
Mr. Feigal. Yes.
Mr. Upton. And as you have indicated, it is a Class III.
Okay. Currently this could be reprocessed, is that right,
without the new regulations in place?
Mr. Feigal. That is correct. We have not been calling for
pre-market applications for reprocessors for such devices.
Mr. Upton. But in fact this could be used more than once?
Mr. Feigal. Yes, that is correct.
Mr. Upton. And under the regulations that you put on the
Web page earlier this week, if they become final then for this
to be used a second, third, or however many times, the
reprocessor would have to, in fact, demonstrate that it was
absolutely clean and safe, and there should be no problems, and
it would only be used X amount of times, is that correct? Is
that basically how it is going to work?
Mr. Feigal. They would need to demonstrate that their
cleaning process could assure that the product was clean and
free from infection risk, and that the cleaning process did not
degrade the performance of the item. The exact mechanism for
doing that may involve testing and assessing the devices or
tracking the number of times a device is used. I think there is
not a single answer for all types of devices, but it would be
up to the applicant to tell us that they had a way to assure
that each time that device was going to be used that you could
expect that it would perform as intended and be safe and
effective.
Mr. Upton. Assuming that they could show that it was safe
and clean, they would have to somehow tag this so that it
didn't exceed so many, whatever you defined as the number of
uses, is that right?
Mr. Feigal. It has to be accurately labeled. A reused
product should identify the fact that it has been reused. The
hospital should know whether it is opening something that is
new or opening something that is reprocessed. I think whether
each device needs to be tracked each time it is used will vary
with the type of device. That would be one way that someone
could propose that they would control the aging of the device.
Our concern would be if someone said well, we could always
use these four times so we'll count to four and throw it away,
when in fact, it might show degradation after the second use.
So, in fact, each time it is cleaned they need to assure that
the product will perform as expected, and that may require a
different approach than actually counting the number of uses to
assure that it met adequate performance specifications.
Mr. Upton. How would they determine the number of uses?
Would there be a clinical trial? Would they like test it or
just stand back until they figured out when it broke down?
Mr. Feigal. This is one of the questions that we've been
trying to address with our own laboratories looking at some of
the research methods. For example, a common problem with
catheters. When they are first manufactured they are coated
with a lubricant to facilitate threading. As you clean it the
lubricant is stripped.
Mr. Upton. That's right.
Mr. Feigal. And so rather than finding out in patients
whether or not it is tougher to thread these things after the
lubricants are stripped, we have actually done a bit of
research to try and develop a mechanical way of measuring how
smoothly something moves through narrow spaces. This is the
kind of evidence and research we would expect the applicants to
provide to address all the aspects of why products perform well
and why they are failing. The issue of brittleness has been
raised a number of times. That is another example of something
that probably can be assessed by looking at multiple cleaning
cycles and simulated use. Breakage of these fragile devices is
something that even new devices are susceptible to, and I think
we can learn more about product mode failure through this
process.
Mr. Upton. Now, in your deeming whether this should remain
a single-use or not, would you, as part of the regulations or
part of the design, would you go back to the manufacturer of
this and get their comments as well?
Mr. Feigal. Well, what the reprocessor is doing is taking a
discarded single-use device, if you will, and using that as his
starting material. Obviously he can do a better job of
assessing what he is up against in reprocessing if he has
information from the original manufacturer. But we do not have
any authority to require this. In fact, our authority and our
requirements actually protect the trade secrets of the original
manufacturers.
So, actually the burden on the reprocessor would be to show
that he could clean it, not even knowing exactly how well it
was made. We would certainly have the information in most cases
ourselves as to how it had been manufactured, but we would not
be allowed to share that with the reprocessor.
Mr. Upton. Just to finish then, so it is or is not part of
the process that you would have to go back to the original
manufacturer to get their comments as to whether or not this
should be used a second time?
Mr. Feigal. The application actually of the new
manufacturer is a trade secret as much as the application of
the OEM is a trade secret. And so that is one of the
difficulties in this.
Mr. Upton. You have got to make the judgment as to----
Mr. Feigal. Yes.
Mr. Upton. [continuing] whether or not it is going to be
effective as it was the first time that it was used, and
therefore you would have some statistics that they, I would
think they, would be willing to offer to say yes or no.
Mr. Feigal. Yes. Well, that is why the law gives us the
ability to know all the information from both manufacturers and
to consider everything we know in assessing safety and
effectiveness, including all the information we have across
manufacturers for multiple different types from our adverse
experience reporting. There are a lot of details, I think, that
you are bringing up that are important in how this will
actually work. We need to do it in a way that both insures the
public health, but also respects the trade secrets of the
manufacturers who have applications before us.
Mr. Upton. Okay. Mr. Stupak.
Mr. Stupak. Thanks, Mr. Chairman. Is there reported cases
of infection associated with single-use instruments?
Mr. Feigal. I'm sorry. Could you repeat the question?
Mr. Stupak. Single-use instruments, first time they have
been used, has there been reported cases of infection
associated with them?
Mr. Feigal. That would be very unusual. What is more common
is to have cases of infection reported to us from the lax
cleaning procedures of devices designed for reuse. So, for
example, bronchoscopes and endoscope, there have been reports
of infections that have been spread because these devices,
which are designed for reuse, were not properly cleaned by the
hospitals. So, that is the more common type of infection that
we have reported associated with devices.
Mr. Stupak. Those scopes though, when they are
manufactured, are they manufactured and received from the
manufacturer as being a single-use item?
Mr. Feigal. No. They are not. They are actually marketed
with detailed instructions for cleaning and disinfecting. And
despite that, in hospitals, we still have infections.
Mr. Stupak. Okay. So they are manufactured, and when they
come in the package or whatever, there are instructions on how
to reprocess them for reuse and how to sterilize and take care
of them?
Mr. Feigal. Yes. And that information is provided by the
manufacturer in their application to us so we can assess
whether they have adequate instructions for cleaning and
sterilization.
Mr. Stupak. So the sterilization, the chemical reaction,
the lubricants, that is all taken into consideration if they
allow it to be a reused item?
Mr. Feigal. That is right. We have to consider all of that
for reused items.
Mr. Stupak. If I am a hospital and--it may not be a fair
question to you, but if I am at the hospital and I get a
single-use item, am I required before I use it to go through
some type of sterilization, or can I take it out of the
packaging knowing I can use it immediately, or is there a
requirement of the hospital to also do sterilization before
they ever use a single-use item?
Dr. Feigal. Most devices that are intended for sterile use
are shipped sterile in packing that can be opened. A common
challenge for hospitals is that often devices are opened and
made available in the operating room that are not used, and
then the hospitals have to know how to repackage and re-
sterilize those. The most common product for which that occurs
is sutures, but it occurs for hip implants, all sorts of
different things. So hospitals actually do this day in, day out
and have considerable skill at doing this.
Mr. Stupak. Okay. And Doctor, the issue of alteration of
performance criteria is mentioned in your description of FDA's
research on reuse issues. Could you tell us how alterations of
performance criteria are handled in the draft guidance?
Mr. Feigal. Well, this is one of the two key factors that
are identified to establish the level of risk and our level of
concern about the product. The device laws are risk-based and
devices are risk-stratified. We do not have the same
application process for all devices. We have taken the same
approach with the reusable devices in that we will start with
the products that concern us the most and work our way out from
there. Eventually we will cover them all. But we will start
with the products of greatest concern, either because of risk
of infection or difficulty in cleaning. The other factor is
evidence that the material or product will not be degraded with
repeated use and cleaning.
Mr. Stupak. What are the ones that concern you the most?
Mr. Feigal. The products that have delicate materials or
that were already Class III devices concern us the most. For us
to even approve them in the first place required clinical data.
Many of these devices, if you look at our prioritization
scheme, are at the top of the list. The things that are low on
the list are things that have large lumens or are made out of
hard materials and are relatively straightforward to clean.
There are many single use products. Many are not labeled as to
why they are single use and many of the single-use products are
labeled that way for convenience. If you look at some of the
products in the low risk categories probably relatively
straightforward to clean.
Mr. Stupak. Okay. Using one or two devices as examples,
could you give us a brief overview of the similarities and the
differences between the quality system regulations for OEMs and
reprocessors?
Mr. Feigal. There will be none under our proposed scheme.
Whatever standard the OEM has to meet, the reprocessor has to
meet. If there are differences, the differences have to do with
the starting material. The OEM builds their device from
scratch. The reprocessor starts with a used device. So there
would be differences in the manufacturing steps, differences in
some of the things that the OEM might have to do to fabricate a
device. But in terms of the nature of the law and the
requirements, our proposal makes them identical. There will be
a completely level playing field for OEMs and reprocessors.
Mr. Stupak. Okay. Well then would the guidelines then
permit significant variability among reprocessors in terms of
the number of times devices are used, reused?
Mr. Feigal. We will ask the reprocessors to tell us how
they know that a device addresses our concern of infection and
integrity of performance. If they can do that without counting
the number of times it is used, for example, by testing it
before re-release, that may be adequate. And I think that there
will not be a single way to safely clean and reprocess all
devices. We will ask for the applications and we will review
them critically. There may be times when it will be appropriate
to keep a detailed record, and others when it may be more
important to test to see how brittle the device is, no matter
how many times it has been used.
Mr. Stupak. The reprocessors in this case would that be
like the hospitals, or could it be the manufacturer?
Mr. Feigal. The reprocessor is either the hospital or a
third-party commercial reprocessor. There is, of course, some
level of reprocessing that occurs, mostly in the setting of
open-but-not-used devices, that is actually done cooperatively
between the original equipment manufacturer and the hospital.
So I think we are going to see a variety of different ways that
this problem is approached, and I think some of the economic
pressures will change. We may see new partnerships develop and
problem solving in some of these areas. We would welcome
research to develop reusable devices that can be safely
manufactured, and currently are only labeled single-use for
convenience or other reasons.
Mr. Upton. We can go another round if you want?
Mr. Stupak. Okay. Can I ask one more question? Economics I
just want to ask.
Mr. Upton. Sure. Okay.
Mr. Stupak. One question on economics, Dr. Ganske had
brought that up, and there is obviously a savings here, but is
some of the pressure on reprocessing because the DRGs, I mean,
you get paid a certain amount if you are doing a procedure
underneath a DRG, correct? And if you can cut the cost of doing
it by using a reprocess you would make cost benefit then would
be--go to the hospital then because you get paid an amount
whether it is reused or new, correct?
Mr. Feigal. This is a question outside of my authority, but
it is a question I happen to know the answer to so I will be
brave and answer it for HCFA. The DRG does pay a flat fee, and
in fact, one of the questions about reuse is, ``Are used
devices billed individually in an itemized bill?'' Under that
system, and many other types of systems, they are not. The
hospital makes its own choice in the equipment it purchases,
the professional services it uses, and they provide that
service for that cost. And there is no representation to the
third party, where the products came from or what they were. If
you want any more detail than that, I am completely out of my
element so you are best to discuss this with HCFA.
Mr. Stupak. Thank you Mr. Chairman, for allowing me that
last question.
Mr. Upton. Dr. Ganske?
Mr. Ganske. Thanks Mr. Chairman. As a surgeon who goes
oversees on surgical missions we take all of our own medical
equipment provided for free, and I am always interested in the
fact that for all the single-use tubing and equipment that we
take over, that in this country is typically just thrown away,
we will frequently see the hospital workers in these third-
world countries pulling them out of the garbage, cleaning them
out, sterilizing them and using them many, many times because
they just simply cannot afford the equipment otherwise.
It is clear to me that there are some types of single-use
items that probably can be safely cleaned, assuming that they
are adequately cleaned and sterilized and reused. It also looks
to me that it is possible for us to be comparing apples to
oranges. There is a dispute between the medical manufacturers
and the reprocessors. It is fair to say that there are
economic, big economic factors involved. Some would say that
manufacturers will label a device a single-use device for their
own purposes so that it should be only used once and then they
have to buy another one.
There are also allegations of, and I am sure we will see
some testimony today, inadequately cleaned devices. Does your
organization have any information on who has done the
``inadequate cleaning'', for example, a lot of re-sterilization
is done by individual hospitals. They are under the auspices
for doing sterilization properly, of the JCAH, and they have
protocols, but obviously if you are sterilizing millions and
millions of pieces of equipment every day, it is dependent on
how thorough those pieces of equipment are cleaned. As you
pointed out in your testimony, not just for single-use items,
but for permanent items.
Mr. Feigal. Uh-huh.
Mr. Ganske. Like for a steel bronchoscope that is clearly
meant to be used thousands and thousands of times, but if it is
not cleansed properly by the technician in the hospital, then
it does not matter whether it is a single-use device or a
permanent device, you have the risk of contamination. And I
guess my point is this--my question to you is have you looked
at any of the data that the manufacturers are presenting that
distinguishes between whether hospital contaminations after
``reprocessing'' were done by reprocessors, commercial
reprocessors, as versus hospitals.
Mr. Feigal. The types of research submitted to us last
February by the manufacturers came from a variety of sources.
Sometimes the devices were not being sold as reprocessed
devices, they were simply devices that had been used. And the
purpose of the research was to identify the kind of condition
that the device was in after use and how use had changed it.
Other types of research has actually tried to look at devices
which were purported to be cleaned, usually by third-party
reprocessors. We, ourselves, have gone into the reprocessors
and done inspections and if you look through our findings and
our Warning Letters you will see the public comments that we
have made about how they do their business.
Mr. Ganske. Well, summarize that for me.
Mr. Feigal. That industry is not terribly different than
many device manufacturers, in that if you go in and look in
detail at how they follow their good manufacturing practices
and their quality systems, you find areas where they need to
make improvements. What we did not find were devices that were
volatile and needed to be seized, or products that required
public health alerts, or other types of problems.
Mr. Ganske. When you went into those reprocessors and
looked at their results, in their reprocessed equipment sealed,
ready to be sent back, did you find pieces of tissue?
Mr. Feigal. We did not do those types of studies. The
research that we have done on devices has been done with
single-use devices that have been donated to us from other
Federal hospitals that were not going to reuse those devices,
so we could study them. One of the issues that addresses both
the reprocessor and the hospital, to get back to one of your
earlier points, is to look and see what the role of cleaning
and reprocessing standards would be.
Certainly the OEMs are not calling for an application from
hospitals on their cleaning procedure model by model, device by
device, for their reusables. We need to look and, again, our
approach is to look at the risk of the product and say which of
the devices concerns us enough that we really want to see a
pre-marketing application, and which are the ones for which the
rigor of the quality systems regulation and adhere to certain
standards can do the job.
Mr. Ganske. Let me give you an example of this then.
Mr. Feigal. Okay.
Mr. Ganske. Let's say you have a balloon angioplasty
catheter that has a little, you know, latex balloon on it that
you put into the coronary artery, and you blow it up, and you
can crack open a narrowing of the coronary artery. Now, are
those catheters, which are probably labeled single-use, are
they being sterilized--cleansed and sterilized in hospitals?
Mr. Feigal. In some hospitals, yes.
Mr. Ganske. Okay. Now, do those hospitals have the ability
to determine whether that little latex balloon after it has
been re-sterilized, has the same dimensions as it came from the
manufacturer?
Mr. Feigal. We don't know what the practice is in the
hospitals, to date, because we have not been in the hospitals.
This is an issue that needs to be addressed. There are other
issues that we have identified, such as persistence of
crystallized dye in the catheters and in the lumens.
Mr. Ganske. Do reprocessors routinely check for that?
Mr. Feigal. Yes.
Mr. Ganske. A commercial reprocessors?
Mr. Feigal. The reason I cannot answer that is we have not
yet asked them to file applications with us to show how they do
these things: how they clean them, what they know. What our
framework says is that they will have to tell us that in the
future. That will be our approach. We will know what they are
doing, what their standards are, and we will assess those to
assure that a reprocessed device is safe and effective and
manufactured to the kind of quality we would expect of an OEM.
Mr. Ganske. Thank you Mr. Chairman.
Mr. Upton. Okay. Thank you. Mr. Strickland.
Mr. Strickland. Thank you Mr. Chairman. Dr. Feigal, Boston
Scientific has done a study, which I am sure you are aware of,
35 reprocessed devices were pulled from hospital shelves and
tested for sterility. Of the 35, 25 had been reprocessed by the
hospital, and 10 by a third party. They found that 6 of the 35
were sterile. And my question has to do with FDA research and
attempt to replicate this study. I understand that FDA has
attempted to replicate the study and I would like to ask you
what the results of that study by FDA found.
Mr. Feigal. When we repeated the study we did not find that
the catheters would have transmitted infection. Part of the
issue comes down to the definition of what the findings were,
that is, whether we are talking about a clean but residual
tissue or clean but residual films on the forceps. Those may be
other issues that are also important to address. Where we are
at this point is that we have compared notes with Boston
Scientific, we have asked to see their methods so we can see if
we can repeat the experiment exactly the way they did it and
see if we get the results. And that is in progress. We would be
happy to report back to you our findings when we complete that.
Mr. Strickland. So are you telling me that there may have
been residual materials found, but that they were not found to
be a threat for infection?
Mr. Feigal. That is correct.
Mr. Strickland. And I have also been told, and I would like
for you to deny or confirm this, that at least in one of the
studies that the devices were subject to bleach before they
were examined for being sterile or being safe. Can you tell me
whether or not that is a----
Mr. Feigal. I can answer that question, but I will have to
submit it as part of the record. It depends on where we got the
samples. Some of the hospitals that have been donating the
equipment do soak them in bleach to disinfect them. Bleach is a
good antiviral, virucidal agent. But I am not sure that is
related.
Mr. Strickland. But it does seem to be related to the
validity of the attempt to replicate the study and that is what
I am getting at.
Mr. Feigal. Well, that is correct. And if, in fact, we did
the study in some way that clouded the issue, we are trying to
do the study exactly the way they did it and see what we can
find.
Mr. Strickland. And are you saying to me now that based on
your current knowledge you cannot say that you have done a
study that, in fact, replicated the methodology of the Boston
Scientific study?
Mr. Feigal. Not every detail, but we tried to do it
according to our understanding of how they did the study and
then when we got the results, we compared notes with them and
said well, what might we have done different. And that is what
we are trying to----
Mr. Strickland. I guess an observation I would make, if you
found materials on these reprocessed devices, that the
materials were not considered to be a danger of infection, is
it possible that they were not a danger of infection due to the
fact that they had been bleached?
Mr. Feigal. I take your point that it depends on how the
materials were handled, and we should make sure that the two
experiments were done the same way.
Mr. Strickland. No more questions, Mr. Chairman.
Mr. Upton. Thank you. Mr. Whitfield.
Mr. Whitfield. Thank you Mr. Chairman. I am sorry I missed
the testimony after saying how much I wanted to hear it. But I
was called to the House, but I will read your testimony, Dr.
Feigal, and one question I had. In the European Union, do they
allow reprocessed medical devices in European countries or do
you know?
Mr. Feigal. European device laws vary considerably from
country to country. Some of the device laws do not require any
type of pre-market application and rely on quality system
requirements, and there is some effort to harmonize those. I
think if we would go country by country I think we would find
countries that ignore the problem entirely and others that have
some rules about it. And we could provide more detail as
follow-up if you like. I don't have that information with me
today.
Mr. Whitfield. That's okay. Now it is my understanding that
on many of these devices the name or the initials of the
original manufacturer are on the device, and then once it is
reprocessed that would still be on there.
Mr. Feigal. Yes. Although we heard, actually we heard on a
visit to Michigan stories of someone who was grinding off the
name of the OEM and claiming that the product was just as good
as the OEM's product, which was a fair statement because it was
the OEM's product, just with the name ground off, but recleaned
and reprocessed. That is right.
You usually can identify it, but I think one of the
challenges for hospitals is, if you look at some of the
catheters the members of the committee brought or that I
brought today, you see there isn't very much room for very
large lettering or detailed descriptions. So it usually takes
someone who technically knows exactly what they are dealing
with to identify the manufacturer and the model in some of
these cases.
Mr. Whitfield. Would that subject a reprocessor to a charge
of misbranding or not?
Mr. Feigal. I think it depends on what they claim. You need
to claim accurately what you have got. If you claim you have
got a reprocessed device that was originally manufactured by a
specific company, then that is the truth. Now, whether you are
infringing on their patents or other kinds of things, that
would be Better Business Law. But I think that they need to
disclose what they know about the product that is relevant for
the safe and effective use of the product.
Mr. Whitfield. It is my understanding that in the past the
FDA has claimed that they have been unable to find clear
evidence of adverse patient outcomes as a result of using
reprocessed devices. Is clear evidence of adverse patient
outcomes the sole basis on which the FDA would determine if
there is a major public health problem?
Mr. Feigal. No, it is not. There are times when a single
serious failure of a product can result in an FDA action to
correct a product. So it is not that it takes large numbers,
and it is not that we do not have any reports. In fact, if you
go through our MDR reporting system over a several year period,
we have about 245 reports of injuries associated with reused
devices. The difficultly for us is that the system does not
tell us the volume of use of the product or of the different
types of problems.
And so, for example, we have reports of broken catheter
tips, but we also have 11 reports of catheter tips that broke
in brand new devices the first time they were used. And we
don't have the kind of information and the type of system to
tell whether the reused device has a higher risk. Your other
question is one that I think is an important one, which is that
the law does not just require that the products be safe and
effective. They also require that they be well manufactured,
that is, manufactured under quality system regulations
according to good manufacturing practices. So even if they were
safe enough and usually did not cause problems, we still expect
that the reprocessors and the remanufacturers of these products
will meet the same standards that we expect of the original
equipment manufacturers.
Mr. Whitfield. Mr. Chairman, thank you. I just want to
thank Dr. Feigal for being here, and we all recognize that you
have been sort of a leader in trying to reestablish focus on
this issue. And thank you very much.
Mr. Upton. Thank you. Mr. Bryant.
Mr. Bryant. Thank you Mr. Chairman. Dr. Feigal, let me also
join with my colleague to thank you for what you have done in
the short time that you have been at FDA. I think everybody
from hospitals to all sides of this issue are really desirous
of the FDA moving on this and issuing the instructions and
advice that is necessary so that we can have clarification in
this issue. And I think that is the goal of everybody. I sit
here thinking what we are talking about here is reusable
single-use equipment. And is that an oxymoron or what?
Mr. Feigal. It sounds like it, doesn't it?
Mr. Bryant. Why did we ever go from reusable equipment to
single-use equipment?
Mr. Feigal. There are a variety of different reasons.
Sometimes there was a request for disposable equipment for
convenience and it was more expensive to clean the product than
it was to manufacture a disposable product. There are times
when a product changes status. It has been on the market as a
multiple use and the manufacturer changes it to a single-use
and it is not clear always why that happens.
If someone is coming in for the first time it is a simpler
application to have it be a disposable device than a device
which is cleaned. If they are asserting to us that it can be
cleaned, they have to include in their application the studies
that show how to clean it and that those studies do not damage
the device. And so there are probably some business decisions
that at times they will get to market more quickly with a
product if it is labeled for single-use only.
Mr. Bryant. But originally wasn't the dominant reason had
been infections and simply the safety of the product?
Mr. Feigal. I don't believe that there are really very many
reports with medical devices that are being reused causing
infections. The manufacturers are required to tell us what they
know.
Mr. Bryant. I mean originally, back in the 1950's or
whenever.
Mr. Feigal. Well, this sort of started in the 1970's and it
would be interesting to ask some of the manufacturers who have
been in this business a long time the history from their
individual companies. We can only speculate, but I think it is
often many reasons.
And one of the things that we have asked for feedback about
is whether it would be useful, if a company knows that
reprocessing damages a product or that if a product is
susceptible to infection if it is reused, that they should
include that information in the labeling. Now there is concern
by the OEMs that that is requiring them to say something about
a use for the product they never intended and puts them at a
marketing disadvantage. So we understand that. On the other
hand, if it is a common practice and the device looks very
similar to devices that once their labeling is off, their
packaging is off, all look alike, then if they know their
product can be damaged or made less effective that information
would be useful to the medical consumer.
Mr. Bryant. Right. And I would assume trial lawyers to know
also.
Mr. Feigal. Uh-huh.
Mr. Bryant. Did I understand you correctly to say that when
a manufacturer comes to the FDA they have to, on a single-use
product, they have to provide you with instructions on how to
clean it?
Mr. Feigal. Only if it is a multiple use. If they have a
device that is going to be reused again and again, then part of
the application process is to show the performance of that
device with multiple use.
Mr. Bryant. Okay. All right. You testified that the FDA had
no clear studies, and I think I wrote that down correctly. I am
just wondering that maybe you have been unable to find any
clear evidence of adverse patient outcomes associated with the
reuse of single-use devices from any source. Is the clear
evidence of adverse patient outcomes the sole basis of the FDA
to determine if there is a major public health problem? And if
not, what else would the FDA rely on?
Mr. Feigal. Certainly anything that resulted in patient
injuries would be an important criterion, but when we are
looking at the device we look at how complex is the cleaning
process, how delicate are the materials with which it is
manufactured? Is it likely that you are either not going to be
able to clean it because you have got lots of crevices and
narrow lumens, and areas where you are going to get residual
body fluids or biofilms or even tissue?
Beyond that, even if someone can clean the device well, we
look at whether or not the cleaning process itself is likely to
damage the device and make it less effective. So the two
primary criteria that we look at is whether you can clean it in
a way that makes it safe and does not degrade the performance.
So, those are the two key issues that we have said we would use
to determine our level of concern with the device and how
rapidly we would move it into our priorities for taking action.
Mr. Bryant. Given what I understand to be your testimony
that the FDA believes this issue of reusable equipment ought to
have more oversight and regulation, do you think it would be
appropriate at this time that a patient should be informed
ahead of time that reprocessed equipment might be used on them?
Mr. Feigal. I think this is a question about which you will
hear testimony from the other panelists. When it is not in the
setting of an experimental device, then we are looking at the
use of informed consent and the practice of medicine. And there
are many things that you do in the practice of medicine, such
as agreeing to surgery or agreeing to the examination of a
child, where national norms state that informed consent is
appropriate in that setting. The kinds of details, the kinds of
issues that are disclosed, I think, are part of that broader
issue of informed consent relating to the practice of medicine.
And so our position as the Agency is that that would not be
something that we would consider, but it is a very important
issue for the healthcare community to address and decide what
is appropriate.
Mr. Bryant. Thank you, doctor. I see my time is up and I
would yield back.
Mr. Upton. Mr. Burr.
Mr. Burr. Thank you Mr. Chairman.
Dr. Feigal, welcome. Do you regret the move from biologics
to devices?
Mr. Feigal. Well, I came from drugs before that, so I am
not yet looking for my next home.
Mr. Burr. Have you figured out which direction they are
sending you yet?
Mr. Feigal. No. I am enjoying myself very much, thank you.
Mr. Burr. Let me take the opportunity to thank you. Since
1976, I think, that we have had in the law the responsibilities
for this area, and I think since you got there you have taken
this in a very serious way as a safety issue and as an equity
issue within the world of OEM and reprocessors. And I think to
a large degree taking into account the need that hospitals have
and for that I am very thankful. There are not too many people
that would try to sort through this. And I realize that it is a
process in work. But let me be real specific on some questions
if I could.
Now, you said that under the scheme that FDA has designed,
that reprocessors would file a 510(k) application and they
would have to prove that the device was safe, effective, and
well manufacturerd. How could we expect a reprocessor to prove
that it was well manufactured?
Mr. Feigal. Let me start by saying that the reprocessors
would have to file the same kind of application that the OEM
would have to file for the same device. And so in some settings
that would be a PMA, in some settings it would be a 510(k), and
in still other settings where the OEM is exempt from pre-market
application the reprocessor is exempt from a pre-market
application. They are still required to meet all of the other
standards, including our inspectional standards and their
requirements for quality systems.
The cornerstone of this is that you have processes in place
where you identify where the hazards are to your product, and
you identify the kind of controls that are necessary in your
manufacturing that can address those hazards, and you do it in
a way that you can document and quantify. You do not wait for
them to fail and work backwards from failure analysis, but you
work forward from the start and say there has to be integrity
in this system, it has to be a high quality system. Certainly
as you get failures and complaints you feed those back in and
you see why those were missed.
Mr. Burr. I think it is also safe to say that we would not
design a system that would not work, right?
Mr. Feigal. That is correct.
Mr. Burr. And you mentioned earlier the proprietary
information and the FDA's position on that information, and
certainly this committee has learned in the past what happens
when that information leaks out of the FDA, especially as it
relates to laser surgery. Let me ask you, given the need to
withhold so much information about the product, is it fair to
believe that they can prove the well manufactured part, or is
that just the wrong word?
Mr. Feigal. Well, withhold is probably the wrong word. We
certainly don't share the companies' information with each
other, but we don't withhold our concerns. And we can express
our concerns and what the issues are that they need to address
for a product--we learn across a whole product class what the
issues are with that product.
And we lay those out for the manufacturers and now whether
they are an OEM or a reprocessor, and those are the things they
need to address. You have allowed us in the way that you have
structured us to use all the information we have without being
required to share or disclose it in order that we can meet that
balance of protecting the public health but still maintaining
the trade secrets that are useful in commerce. And so that is
the balance that we need to do. It is a process that has to go
device by device and model by model to look at how this is
done.
Mr. Burr. Who determines the single-use labeling?
Mr. Feigal. The manufacturer.
Mr. Burr. And in the absence of any request on their
application, what does the FDA put on the labeling?
Mr. Feigal. The manufacturer does the labeling. In fact,
they have under the law the ability to actually make some
changes in the label without even informing us. It has been our
practice in the past if the manufacturer asked to label for
single-use, to take that at face value and to evaluate how it
would perform with one use.
Mr. Burr. Under your proposal, would a reprocessor be
required to test every device for functionality?
Mr. Feigal. They have to think about the device they are
dealing with and say what are the critical performance aspects
of this device and how can I assure that every time I release
this device it still meets those standards.
Mr. Burr. Are original equipment manufacturers, do they
test every device for functionality or do they batch test, do
you know?
Mr. Feigal. It depends on the type of testing. Some types
of product testing are destructive and so you would not have
any product if you tested them all. In those kinds of settings
manufacturers typically sample. But the important thing about
the way that the law and our regulations have constructed the
manufacturing process for human medical products, whether it is
a drug, biologic or device, is to emphasize the integrity of
the manufacturing process. We emphasize the quality of the
manufacturing process, rather than defect analysis at the end
of the game. And we would expect that same philosophy to be
adopted by re-manufacturers.
Mr. Burr. When you look at reprocessors, and I put third
party in hospitals.
Mr. Feigal. Yes.
Mr. Burr. Do you look at them separate? Are they different
or are they one in the same as you wrote this regulation?
Mr. Feigal. Our proposal is to begin treating them all the
same. Each one that is its own business entity will have a
separate relationship with us.
Mr. Burr. How long does it take for 510(k) to get approval
in the FDA on average?
Mr. Feigal. The average is about 180 days, I believe, but
there are types of 510(k)s that are simpler and actually are
approved in as short as an average of 29 days. So it varies.
But you raise an issue that we thought about, which is how this
is going to impact our resources since the average number of
reviewer hours to assess a 510(k) is about 55. But that's for
all 510(k)s and they vary widely in complexity. We imagine some
of these would be simple, others would be very complex.
Mr. Burr. I found it a little odd that in this years budget
there was four times as much money sought for tobacco out of
FDA than the issue of reprocessing of devices. And I would ask
you to share that with the Administrator when you get back that
it was noticed. Let me just ask you, under FEDMA we created the
ability for 510(k)s specifically to go through a third party
approval process. Do you see this as an appropriate area for
the trial of third party approval?
Mr. Feigal. The way that we constructed the third party
system was to establish standards so that both the third party
and the applicant would know what the review criteria were. And
I think certainly that in some of the areas of very commonly
used devices this could potentially work very well with third
party. We are very committed to expanding that program. We have
actually put specific proposals in this year's budget to expand
that program and whether it is expanded in the way that is
proposed in the budget or not, we are committed to seeing that
program succeed. It is one of the ways in which we can expand
our scope without always doing it with Federal workers.
Mr. Burr. Last question, Mr. Chairman. You have been there
a limited amount of time, I realize that. But in your research
of this issue, which is not new, did any point did reprocessors
come to the FDA seeking guidance or seeking the process that
the FDA expected them to follow?
Mr. Feigal. We have met with the reprocessors, and the
reprocessors actually have asked us for letters clarifying----
Mr. Burr. But prior to your passion for this issue, do the
records show that at any point that this industry----
Mr. Feigal. Yes.
Mr. Burr. [continuing] be it hospitals or be it third party
reprocessors, look to the FDA for the guidance for the
procedures or to set up the procedures?
Mr. Feigal. Yes. That did occur, and many of the efforts
actually predated me. You have been kind to attribute as much
progress to my getting there as you have.
Mr. Burr. I thank you for your willingness. I yield back.
Mr. Upton. I would just like to note that we will proceed
with Mr. Barton and we will take a brief recess for folks to
vote. Mr. Burr is going to be asked to come back and chair
while I vote and after that we will proceed with the other
members that are here. Mr. Barton.
Mr. Barton. Thank you. Mr. Chairman is this 5 minute or 2
minute questions?
Mr. Upton. You get 5 minutes, and if you want more time we
can have another round.
Mr. Barton. No, sir, I can comply with it. I want to ask
unanimous consent that my opening statement----
Mr. Upton. It. That has already been done.
Mr. Barton. Thank you. Doctor, we are glad to have you. I
am going to be very quick because we have a vote on. The first
question I have is there any reason not to treat all
manufacturers and reprocessors the same?
Mr. Feigal. No. And that is why the approach that we
proposed just this week in our guidance really does take that
philosophy.
Mr. Barton. Okay. And on the informed consent issue, is
there any reason not to require informed consent for a device
that is going to be reused? Why would we not do that
permanently?
Mr. Feigal. I think that that is a good question, but I
don't think it is an FDA question in the same way that we don't
specify the informed consent for putting in a hip implant or
other types of things. These are the kinds of informed consent
that are done in the practice of medicine and I think it is
important to get some consensus on whether this is one of those
things, like the examination of a child or surgery where
informed consent is routinely used. But it is not something I
think that is part of FDA's purview.
Mr. Barton. If we want to give some Congressional guidance,
the FDA would not object if we had some truth in advertising
requirements so to speak that informed consent should be
allowed? If I go buy a car I want to know if it has been pre-
owned, you know, whatever I purchase I would like to know
whether it is brand new or somebody else has owned it. I mean,
I would think if you are going to put something in my body I
have a right to know that it may have been in somebody else's
body.
Mr. Feigal. Yes. One thing to consider is that part of our
approach is to assure that the reused device will perform as
well as the original device. And I think that needs to be part
of the debate about the role of informed consent. And then
beyond that there is the issue, if informed consent is needed,
do you try and do that with labeling on the packaging or
exactly what is the mechanism for that? But I think our
fundamental start was we shouldn't be in a position where
someone has to be informed that we are using a device on you
that may not be very good.
Mr. Barton. Right.
Mr. Feigal. We think the quality of the device is the
fundamental issue, and then it makes the informed consent less
of an issue.
Mr. Barton. Well, I have read your testimony on page 11 as
you go through the process of looking at your existing
proposal. You have a list of five steps here, or four steps.
The only question I have, what kind of procedure do you have in
place for interested parties and stakeholders to interface with
the FDA?
Mr. Feigal. We have a comment period open now on the two
guidances that identify a list and give our proposal for risk
scheme and for an enforcement time table. And those policies
will not be made final until we have had that input. We also
have had public meetings. There have been three or four in the
last year and workshops, and there are ways to address us
through our Web pages, through other types of things.
Mr. Barton. Now, we assume that you are going to have an
open process, that if you are a remanufacturer, an original
equipment manufacturer, or an advocacy group or hospital group,
you can have an honest dialog with the FDA and the FDA will
listen?
Mr. Feigal. Absolutely.
Mr. Barton. Okay. Mr. Chairman, that concludes my
questions. I appreciate you holding this hearing and I will
follow it very closely and work with the chairman and other
interested parties on this issue.
Mr. Upton. I know that you will. But we will take a brief
adjournment. Mr. Burr will vote, come back. We will start with
the members that have not asked questions and proceed from
there. So it will probably be about 10 minutes.
[Brief recess.]
Mr. Burr [presiding]. If I could call the hearing back to
order and ask Dr. Feigal to return to the table. I actually
thought they would finish with you before that break. As is
tradition here, that means that other members will have
additional questions, so I can't swear to you this is the last,
but the Chair would recognize Ms. Eshoo for 5 minutes of
questions.
Ms. Eshoo. Thank you Mr. Chairman. I have several questions
as you might guess, Dr. Feigal. What I want to do is to read
the questions first. My experience is I ask the first question,
most of the time is used up and then we never get to the
others. So, it is going to be up to you to divide the time
judicially so that you can answer them all. First of all, thank
you for your testimony today. I just have a couple of
observations. One, in how we use the words single-use. I think
it is a real contradiction to be talking about the reuse of
single-use. If we are going to be talking about the reuse of
medical devices we should just say so. And we should establish
a national policy that guarantees patients across the country
that they are indeed safe. But to continue to use this reuse of
single-use, I really do find it to be a contradiction.
Second, most of your testimony, and I think that it was
excellent. You have been very direct, honest. You are a
wonderful professional, and I am proud that you are in public
service. Most of your testimony has really been directed toward
what the FDA hopes to do--with your proposed guidelines. I want
to remind members of the committee that that is not in place.
There is not the kind of system that has been eluded to or
spoken to during this hearing. So here are my questions.
FDA has an approval process today for medical devices, and
you know that I have a lot of experience in that, having
launched from the Democratic side with Joe Barton on the
Republican side the reforms that we brought about, as well as
many members of the committee on this issue. So you have a
process for medical devices that is in place today. The PMAs,
the 510(k)s, and it goes along the lines of risk. In your
proposal do you bring the same consistent policies for the
reuse of medical devices? Do your proposals contain that?
Would the FDA oppose, would you come out against the issues
of tracking and consent? I know that you have commented on
them, but I would like to know if the FDA would oppose those--
if those directives came from the Congress. Of course, those
are two issues that are in the Bill that I have introduced. Is
the Federal Government actually paying first rate medical
device prices or reused products? Is Medicare reimbursing for
that? And if so, would FDA have any voice in this or do you
plan to? And can you tell us how many times a ``single use''
device, has actually been reused?
And what exactly is FDA's oversight today for reused
products? I am very pleased that 2 days before the hearing you
have come out with your proposed policies. I would like to
think that maybe my legislation has spurred FDA to really take
this issue, not only seriously, but to take action on it. So,
if you could address yourself to those. If you do not finish
answering them, hopefully you can, you know, get the written
answers back to us. And I also, Mr. Chairman, in my opening
statement I made reference to a letter that the FDA wrote and
asked that there be unanimous consent that that be entered into
the record, and I would like that. We didn't do that----
Mr. Burr. Without permission, of course.
Ms. Eshoo. Thank you. Okay. He doesn't know what I asked
for, does he? Okay. No, he does. I'm teasing. Thank you.
Mr. Feigal. Well, thank you for your questions. And we
actually appreciate your interest in this area and look forward
to working with you, and looking at your proposals and seeing
how they fit in the area. I began my testimony by asserting
that we felt we had the authority. We didn't want any confusion
out there that we needed new legislation before we acted, and
that we can act within our existing authorities. And part of
the reason that we are doing this with guidance rather than
regulations is that we feel our regulations have the authority
for us to do this. Part of the reason for a staged approach is
because this process should not be brought to a screeching halt
with supply problems, disruption of patterns. There are people
on both sides of this issue, as you will hear today, that we
wanted to engage.
One of your fundamental questions is, will we treat
everybody the same? We will. That is one of the basic issues.
One of the things I think underlies some of the questions is
that, in the past, when we classified a device we really did
not pay much attention to whether it was single-use or multiple
use. One of the things we will have to address is whether
single-use and multiple use of the same device actually might
in some cases even have different classifications one might be
exempt but by reusing it you have changed the safety profile.
And so I think there are some issues there, but our approach to
that would be to say, what applies to the reprocessor applies
to the OEMs. If it is an issue for the reprocessors, then it is
also an issue for the OEMs.
Ms. Eshoo. I didn't hear that in your discussion of the
proposals, but if they are going to be equal, than I think that
that's a big step.
Mr. Feigal. On the consent, I think we don't view that as
our responsibility for this type of consent, and it probably
wouldn't be most effectively implemented through a change in
labeling.
Ms. Eshoo. But would you oppose it, that is what I asked.
Mr. Feigal. I personally would not oppose it.
Ms. Eshoo. Okay. I'm not talking about personal. This is
all public.
Mr. Feigal. Well, when I say speak personally, I mean my
part of the Agency. We could give you a more thoughtful answer
about what we see are the pros and cons to this type of
approach. I think the issue relates more to a device which is
being cleaned and reused again and again, whether that is the
element of consent. In which case it would apply more broadly
than if the issue is simply that someone wanted to use a
disposed of device as their starting material to craft a new
device with an application for it to be used again. Your
questions about payment are questions you need to ask HCFA----
Ms. Eshoo. Tracking?
Mr. Feigal. [continuing] ask HCFA and others.
Ms. Eshoo. Tracking?
Mr. Feigal. Oh, and tracking.
Ms. Eshoo. I keep track, see.
Mr. Feigal. Yes. You do. That is good. That is the third
time. We have tracking authority in a different context for
products. We do not apply it to all products. Not even all high
risk products. I think again if this is an approach that would
increase the safety and would be the best way to make a product
safe and effective, then it would be appropriate to use it.
Whether it would be the approach for all devices, I do not
think would be the case. I think there are probably some
disposables that would not need to be tracked, you would just
need to look at what has happened to them as they were being
cleaned.
Ms. Eshoo. Uh-huh.
Mr. Feigal. The issue about the tracking and putting
information into patient's medical records, that is a practice
that is commonly done with implantable devices. They are an
example of a product area where it is common for manufacturers
to have a peal-off label that goes on the chart. Sometimes even
the patient gets a card if they are being tracked. So there is
precedent for this. I think what I would do is say let us take
a look at the kinds of products where this makes the most sense
and where it adds something. It is more cumbersome than some of
the other mechanisms. Getting hold of the right chart that has
the label in it is not totally straightforward in our medical
system. And so I think we need to make the solution fit the
problem. But it is something that has been done. It is
something that we should talk about more.
Your one last question is, do we have a Guinness Book of
World Records for the single-use device that has been used the
most times. And probably not. I would suspect it is probably an
anesthesia circuit somewhere that has been cleaned and cleaned
again. The real challenge, even for the people who clean these
things, is that there is no marking on the products themselves
to indicate that they were a disposable device for the vast
majority of these devices. And many of them look identical to
the reusable devices, and I think that is another issue that I
mentioned before that we need to deal with.
Ms. Eshoo. And what exactly is FDA's oversight today? How
does it work? What do you actually do?
Mr. Feigal. Well, I am not sure I understand the question.
In terms of rolling out this framework?
Ms. Eshoo. No. I am not talking about----
Mr. Feigal. Or in terms of our oversight?
Ms. Eshoo. I am talking about today.
Mr. Feigal. Yes.
Ms. Eshoo. What is your oversight with the reuse of
manufacturer's----
Mr. Feigal. Okay. What we have done today is that we are
actively inspecting and looking at the manufacturing practices
of the reprocessors of----
Ms. Eshoo. Since the late 1970's, what has the FDA's
practice been?
Mr. Feigal. Well, in the late 1970's FDA wrote a letter
strongly discouraging the practice and telling the hospitals
that they accepted complete liability if they did this. Then
there was a long time period where this issue really did not
get very much attention, and I think the assumption was that
not very much of that was going on. It has really only been in
the last year that there has been more attention to this. Some
of that has been economic and there have been attempts to focus
on the ethics of doing this. Some of this has been because of
patient's insurance. Some of this has been because of reports
of injuries. Our approach is to investigate the reports of
injuries, to contact the reprocessors. Some of them, when we
first contacted them didn't think they were manufacturers. We
have let them know that they are.
Ms. Eshoo. But who do you react to? Your oversight is
essentially reacting or responding to something that is----
Mr. Feigal. Not entirely. But it is appropriate for us to
be reactive when we get a report of an injury or of a problem.
Ms. Eshoo. No. I am not suggesting that it isn't.
Mr. Feigal. Yes.
Ms. Eshoo. But if that is your oversight----
Mr. Feigal. No. No. It's not.
Ms. Eshoo. [continuing] I think the committee needs to----
Mr. Feigal. We are also being proactive. We have sought
out, for example, detailed lists of who is remanufacturing. For
example, we have identified the companies who specialize in
cleaning Sharps containers, which come in both single-use
disposable and reusable varieties, and to inspect those and
look at those patterns in a very, very narrow area. But we have
not just been reactive. We have proactively sought feedback on
the approach, on how to prioritize, how we begin with this
problem, and we haven't waited to go out and inspect. We have
gone out and actively engaged these companies.
Ms. Eshoo. So, you only inspect those places where items
are reprocessed or the devices are reprocessed? The devices
themselves or?
Mr. Feigal. Our normal inspection process is to, in fact,
regulate the manufacturer who produces it and not to inspect
devices.
Ms. Eshoo. I think this is a very important distinction
though to many members to hear.
Mr. Feigal. Well, this is also true for original equipment
manufacturers. We do not inspect their devices. Now there are
cases where the device fails, where we actually bring the
device into our laboratories and work with it. In fact, if
there had not been so many samples brought by members of the
committee I would have passed out my own. And we do work with
the devices themselves in a hands on sort of way. But the
fundamental way that the law is written to regulate devices, as
you know, is to really ensure the integrity of the
manufacturing process. We go in and look at the company's
quality systems and the way that they have dealt with the
problems that have been reported to them. And that is our
fundamental way of addresing the problem. This occurs more
often where there has been a specific problem with a type of
product and we have been asked to look into it.
Ms. Eshoo. Can I ask the indulgence of the chairman to ask
one more question?
Mr. Burr. Okay. One more.
Ms. Eshoo. One more?
Mr. Burr. We are going to have another round, I just want
to--for those members with additional questions.
Ms. Eshoo. Is there a problem inside the FDA relative to
resources in order to wrap up this policy you may need more
people to implement it, is there, you know, to ask this
publicly may not be all that comfortable for you. But I have
found with Federal agencies that at least sometimes they are
reluctant to take on more responsibility, because as they carry
out what they are directed to do, they know that there is going
to be a strain of resources, and in my view there already is a
strain at the FDA, given the very important legislation, I
think needed legislation we passed relative to, you know, the
reform on medical devices in another areas that you have
jurisdiction over.
So have you undergone or undertaken any kind of analysis of
your proposals and what that would call for monetarily inside
the Agency that you can tell us about? Because I do not want
one to get in front in the way of the other. I think that
public policy has to take precedence here, and then it is up to
the Congress to deal with what you may come forward with and
say we need more to implement this. We have done it in other
instances, we have risen to that occasion I think pretty
fairly, and I think we have the capacity to do so again. But
can you just touch on this?
Mr. Feigal. Sure. If you look at the current budget
proposal that the President announced you will not see a
specific request for reprocessing in this years budget. That is
for two reasons. The most practical one is that with the long
budget cycle, that budget was prepared about 18 months ago. And
the activities have significantly evolved only in the last
year.
Ms. Eshoo. Well, I was calling and writing in December, in
the beginning of January, so I do not necessarily agree with
that, but go ahead.
Mr. Feigal. In our appropriation language last year there
was language that we should spend at least $1 million on the
issue of reprocessing in this year. That was not difficult for
us to agree with because our effort, even last year, was
approximately that magnitude and this year it is somewhat
larger than that. One of the things that makes it difficult for
us to plan is that we do not know how many hospitals are going
to decide to file pre-market applications. We do not know how
many places are going to register and list and need to be
inspected.
At this point because our change in the policy is so
recent, there are not the kind of resources that we need. It
has mostly been in the area of policy development, research,
and other areas. And we have the capacity to turn and focus on
an issue and not wait for a funding cycle to catch up to a
public health program. One of the natures of FDA in general is
that we are asked to prioritize risks and act on them. And
there have been decisions that have been made in the past where
this one, quite frankly, did not rise to the top of the list
and other things, such as reducing backlogs to get products to
market more quickly, implementing FDAMA and other things got
more attention. But as the committee is aware within the last
year there has been much more intense interest in this and we
have turned our resources to this problem now. We do not, yet,
have a proposal of where this is going. I think we need to hear
more from the effected parties, what their reaction is going to
be, to have an idea of the scale of what we will need. And as
we need resources we will request them.
Ms. Eshoo. Thank you. Thank you Mr. Chairman.
Mr. Upton. You are welcome.
Mr. Pickering?
Mr. Pickering. Mr. Chairman, thank you.
Dr. Feigal, if a device is FDA approved for single-use, why
is it possible to reuse these devices?
Mr. Feigal. Well, the simplest way to explain that is that
there is nothing that is illegal about using a pre-existing
device as a starting material for a new device. In fact, there
is sort of a misconception that the remanufacturer is trying to
restore something identical to what the original manufacturer
produced. That is not the requirement. The requirement is that
they produce a device that is well manufactured, safe and
effective for its intended use, and that they show us that they
can do that. And the difference is that they are using a used
device, they are using the components of the used device as a
starting material.
And if you look at refurbishers, particularly of more
complex materials, that is not even the case that they use the
entire device. They may just salvage part of it. And so this is
something that is common, I think, throughout many industries
and so long as the device is well made, safe, and effective,
there is nothing in the law that precludes someone from doing
that, despite the fact that the manufacturer wanted it thrown
away after the first use.
Mr. Pickering. Yes. But does the FDA need to clarify their
approval description? If it is FDA approved for single-use, but
you are saying that it is legitimate for multiple use, should
you change your labeling?
Mr. Feigal. Well, the manufacturer brings the labeling to
us and then we determine whether or not the product will be
safe and effective as labeled. One of the complexities of the
device laws is what FDA approval means. In some cases, such as
a PMA, it is an evaluation of whether or not the product is
safe and effective for use. But more often the standard is that
the device is substantially equivalent to another device that
is legally marketed. And within that framework some of those
devices are exempt from pre-market applications and only are
required to have registration and listing--actually I shouldn't
say only.
It is actually a relatively long list of things that they
are required to do. But that is one of the complexities for the
public to understand. The way that the device laws have been
written is that there are a variety of standards depending on
the type of the device. The underlying principle that we are
trying to apply to this situation is to say that there should
be no distinction between the OEMs and the reprocessors. If you
are manufacturing a device from another device, that should
have the same standards as if you are manufacturing a device
from first components, you know, from scratch.
Mr. Pickering. Now, do you give any guidelines for
hospitals who may have a device that is open but unused and
then they take precautionary steps to make sure that it is
clean and sanitary? Are you looking at any----
Mr. Feigal. Those types of instructions and the testing and
the adequacy, that is provided by the manufacturer. It is part
of the instructions for use. We evaluate the adequacy of those
instructions and that is a very common phenomenon. In fact, it
lead to some of the confusion when we put together some of the
initial lists, about commonly reused devices. Very many of them
on the list were things that were simply being opened in the
operating room and then being repackaged and sterilized for
another day.
Mr. Pickering. And you have no problem with that? You don't
see a problem?
Mr. Feigal. It has to be done with attention to detail and
that is what the manufacturers have to assert to us that they
know how to do. So, for example, if you are reprocessing suture
material, for example, you have to know that the way that you
are going to repackage and sterilize that does not damage even
the packaging which could breach the sterility of those
sutures. But again, the manufacturers have worked with the
hospitals because they have a need to do that. If we wanted to
replace your hip today, in the operating room they would open
and have available for the surgeon several different closely
related sizes, because they would not be able to know in
advance which one would fit you. And rather than charge you for
all three sizes if they opened them up, they would use the one
that fit and then they would take the others back and re-
sterilize them and use them again. And we think this is a
legitimate practice. It is one where the manufacturers work
with the hospitals to provide instructions on how to do this.
It is a different problem, I think, than the reuse of an
already used single-use device.
Mr. Pickering. Now in that context, has FDA reviewed the
cleaning processes utilized in the reprocessing of medical
devices, and if you have reviewed it, are you confident that
the processes used are effective and safe?
Mr. Feigal. Our first approach to this is to say that the
cleaning and the re-sterilization and the refurbishing is
device and model specific. So there is not a single standard or
answer. Now, that said, there has been tremendous interest in
the device manufacturing community and in the FDA to approve
standards for things that are commonly done so that they do not
have to be reinvented for every model and every device. And so
that is one of the areas where we will be working with the
people who do the cleaning to look at those standards. These
are the same issues for reusable devices, and the majority of
devices are reusable. And these kinds of issues are not new to
us. The hospitals have been using the procedures on single-use
devices that they have already found to work effectively for
reusable devices.
Mr. Pickering. And when do you plan to issue further
guidelines on the cleaning process?
Mr. Feigal. Well, the burden is actually on the
manufacturers, on the hospitals, and the refurbishers to
actually show to us that they have cleaning processes that are
adequate. That is their burden to demonstrate in the
application process, just like it is for an OEM who claims that
they have a device that can be cleaned. The OEM has to show us
the evidence that validates that their process can clean.
Mr. Pickering. So, if the burden is on them, do they have
to demonstrate that before they can reuse?
Mr. Feigal. That is correct. As we roll out the enforcement
strategy what we are saying is that these products, as we get
to them in order of risk, the single-use product should no
longer be cleaned until they have met the same application
processes that would be required of an OEM.
Mr. Pickering. Now, has FDA taken a position on what is the
recommended life cycle for reprocessing of single-use devices?
Mr. Feigal. Again, there would not be a single answer to
that. It would vary on the device and on the model, and that is
something to be determined by empiric data. There would not be
a single answer for that.
Mr. Pickering. And what empiric data do you have?
Mr. Feigal. Well, the data has to come from the
manufacturer. They are the ones that are claiming that they can
take this single-use device and put it back into use and have
it be used effectively. So, they need to develop the data in
their application to us to show us that they can do that.
Mr. Pickering. Are you telling the committee today that
until that data is provided, that burden of proof is met, that
the current practice of multiple use will not be allowed on a
going forward basis?
Mr. Feigal. That is the guidance. The guidance gives the
timeframe for the types of devices and when the applications
would be needed for those devices. And if those devices remain
on the market, that is what our second guidance about the
compliance timeframe is all about. We are asking in the
simplest terms that the reprocessors provide the same kind of
information that the manufacturers provide when they bring to
market a multiple use device.
Mr. Pickering. Mr. Chairman, I hope you forgive me for just
a couple more questions. Now, there are three issues basically
here. There is public health, public confidence, and in that
confidence the right to know. Earlier this week I sent a letter
to the FDA, what is the FDA's position on allowing patients to
know if there is a device that is being reused, is there a
simple way to provide that information to patients without some
type of complex regulatory process and burden upon the
providers and the doctors?
Mr. Feigal. The issues you bring up are intertwined. On the
one hand there is safe and effective use, and there are times
when for a patient to really make a choice, they need to
actually know what they are getting. And so there are cases,
there are products, where the information that the patient is
provided is explicitly provided in the product labeling,
considered inherent in the safe and effective use of the
product. There are other issues about what should your doctor
tell you when they do surgery.
Should they tell you the make and model of the machine?
Should they tell you how long they have owned it? Should they
tell you the last time it was repaired? Many of those things, I
think, relate much more to what society feels is appropriate to
know to be able to be medical consumers, and relate less to the
product labeling responsibilities assigned to the FDA. I think
where we would be enthusiastic about being involved is where
the patient's consent is necessary for the safe and effective
use of the product. So we would be happy to continue to
participate in these discussions, but I think we would
encourage you to really broaden the discussion to involve the
medical practice community and others who really need to
implement this. If it is something that is buried in the fine
print on the product labels, which are usually attached to
packaging which is thrown away when the package is opened, that
is not going to do the patient much good. If it is the advice
of Congress, if it is the demand of the public to know about
these things, then you have to change the practice patterns of
the physicians that provide informed consent for procedures.
Mr. Pickering. Is the FDA planning to post that type of
possible information as to possible risk of reuse or proper
standards for reuse to create the public confidence and the
public knowledge?
Mr. Feigal. We have a Web site that is very actively used.
It is mostly used by industry. But we do have consumer parts of
it and there are some consumer products that generate a lot of
interest in our Web sites. We are more than happy to spell out
in consumer's terms the issues of these debates and our
approaches and translate some of the regulatory language of our
guidance for industry so that consumers can see our vantage
point on this. I think that some of the broader issues about
informed consent are things that involve other professional
groups, so we would not be the only source, but we are
certainly welcome to be a source.
Mr. Pickering. Mr. Chairman, just one final question.
Mr. Upton. I've heard that today.
Mr. Pickering. And I guess this gets down to the crux of
the issue. As I talked to a friend of mine who is a
cardiologist, who actually takes a persons heart into his hands
and uses many of these devices, he feels confident that they
are safe and feels confident in his use of them. In talking
with the manufacturers concerns are raised. Is this, in your
opinion, driven by true health and safety concern and risk or
is this more of an economic and cost and competitive issue
among manufacturers?
Mr. Feigal. Well, for the hospitals and the manufacturers
and the physicians who are involved with this, I think the
economics is a fact of life. It is actually not a factor that
you have asked FDA to consider when we make approvals or take
regulatory actions. And so we are bystanders on the economic
issue. I think it is not an ``either/or'' question. It is both
an economic and practice of medicine issue, and an issue that
affects the safety and effectiveness of these products. You
mentioned there needs to be confidence that products are well
manufactured and will perform as expected, even if there is not
a major safety problem. And that is actually in our minds the
most common problem with reusables, the integrity of the
manufacturing, not the explicit risk or safety to the patient.
Mr. Pickering. Thank you Dr. Feigal. Thank you Mr.
Chairman.
Mr. Upton. Thank you. We are going to go to a second round.
A couple of us have a couple of questions remaining. And I
wanted to say to start off, too, Dr. Feigal, by thanking you
for allowing a member of your staff to stay for the second
panel and thus being able to address additional questions that
we may have based on that panel. A couple of things. Not
counting hospitals that might reprocess something on their own,
do we know how many reprocessors there are across the country?
Mr. Feigal. Yes. We probably do. I think we probably have
identified the majority of them. We still get referrals.
Sometimes if we visit one reprocessor he will be aware that we
have not visited one of their competitors and they may add to
our lists sometimes. But I think we actually do have pretty
good knowledge. In fact, there are even reprocessors that have
filed 510(k)s with us. So it is not that we are, you know,
starting cold.
Mr. Upton. What happens on liability on one of the devices
or instruments or whatever it may be, that may fail or perhaps
has been reprocessed? Historically what has been the case? Do
they go after the OEM? Do they go after the reprocessor? Do
they go after both? Have there been cases that have been used?
Mr. Feigal. You are asking something that is really outside
of FDA's expertise. We are actually only aware of a limited
number of actions that relate to reuse. I think one of the
difficulties for patients who think they have been injured by a
device is that it is very difficult for them to identify
whether the device was reused or not. Some times their
physicians may not know because the devices look the same and
they do not know if they are dealing with something that has
been opened and re-sterilized, or if it has been reused before,
or if it is brand new. So I think the whole scope of that we do
not really know.
Mr. Upton. Well, as we know in the physician data bank when
there has been a judgment issued against a physician, that
record is kept and available to hospitals and other providers.
Is there such a log for devices that may fail or not?
Mr. Feigal. Not in terms of liability. Actually our
interests are broader than that. I am really out of my element
talking about law, but I will try a little bit. Liability in
medical malpractice relies on establishing negligence. We are
interested in things that fail, whether there was negligence
involved or not. So, manufacturers are required to report to us
device failures that they know about. The voluntary system by
health providers has tremendous under reporting. But if a
manufacturer knows about something they have to tell us. When
we inspect them, we look at their records. So we think that if
the manufacturer knows about a device failure, whether it is
going to be involved in a suit or not, we know about it. We are
able to get those kinds of statistics.
Mr. Upton. Would that same standard that is on the
manufacturers then be under the regulations you have proposed
be followed for the reprocessors as well or not?
Mr. Feigal. Yes. The principle underlying all of this is
that the same requirements would be applied.
Mr. Upton. So, if this is reprocessed and it fails----
Mr. Feigal. Right.
Mr. Upton. [continuing] the reprocessor would have to file
with you all----
Mr. Feigal. That is right.
Mr. Upton. [continuing] if your regulations are made in
order?
Mr. Feigal. That is right. Even if the reprocessor is a
hospital.
Mr. Upton. Right.
Mr. Feigal. They would then have the kinds of mandatory
responsibilities and if they have asserted to us, in an
application that they know how to reprocess those, we would
treat them like any other manufacturer.
Mr. Upton. Good. Now, reading through your testimony that
we received last night, I think that the answer to this is yes.
Is the reprocessing of medical devices labeled for single-use
without pre-market submissions a violation of the Food, Drug,
and Cosmetic Act? It is a violation, is that not true? They
just have not been enforced until these regulations are in
place, is that right?
Mr. Feigal. It would be a violation of the Act if the
labeling of the product was false and misleading, or if the
manufacturer was placing into commerce a product that did not
have marketing clearance or marketing approval. That is why we
say we do not need new authority. We already have the authority
to require these.
Mr. Upton. Great. And last as my light is going to light
now, Mr. Stupak had to testify before another subcommittee and
he will be back, but he asked me to ask you for him: please
discuss exempt devices and how they are dealt with under the
guidance for reprocessing.
Mr. Feigal. Okay. Well, an exempt device is only exempt
submitting a 510(k) application. They are not exempt from any
of the other standards that establish the quality of devices:
registration and listing, the device failure reporting, special
controls, being subject to inspection. For exempt devices we
have said the OEMs can manufacture and not get pre-market
clearance. Our proposal says that those who remanufacture those
products would also be exempt from the pre-market clearance.
But that is all that they are exempt from.
Now, someone might make the case that in fact the
classification is not correct when you begin reusing certain
types of devices. We have devices that are both single use and
multiple use and in almost all cases they are in the same
classification. In fact, I do not know of an exception. One of
the things in this process of comment we will be looking at is,
should that be the case, or are there cases where it is
appropriate to exempt only the disposable product. If that is
the case, that would apply as much to the OEMs as the
reprocessor because we want the same standard of quality no
matter who makes it.
Mr. Upton. Thank you. Mr. Burr.
Mr. Burr. Dr. Feigal, Med-Watch is an FDA voluntary program
primarily for drugs.
Mr. Feigal. Yes.
Mr. Burr. It includes devices as well, doesn't it?
Mr. Feigal. It includes devices, yes.
Mr. Burr. Did I just hear you earlier to say voluntary
programs do not work?
Mr. Feigal. No. They have under reporting for a variety of
reasons, and it is true in almost every country that uses them.
But the under reporting does not mean that we do not get
signals that are very useful to us to identify the problems.
What the programs that are voluntary do not do is give us good
numerators and denominators. So it is very hard for us to
tell----
Mr. Burr. So, are you an advocate of a continuation of Med-
Watch in its current form or would you be a proponent to change
to a system that was more reliable on the indicator?
Mr. Feigal. Well, I think Med-Watch in its current form is
very useful and has identified problems with products that have
resulted in actions.
Mr. Burr. Is that for devices, or devices and drugs?
Mr. Feigal. Devices and drugs.
Mr. Burr. Let me ask you if I could. Do you believe that
the legislation that guides FDA requires FDA to make sure that
proper labeling follows specific products?
Mr. Feigal. I'm sorry. Could you say that again?
Mr. Burr. Do you believe that the legislation that guides
FDA's work in fact requires FDA to make sure that proper
labeling is assigned to all products?
Mr. Feigal. Yes. Yes.
Mr. Burr. Give me FDA's reason for allowing single-use
devices to be reused and why as you as the head of the device
area would spend so much time trying to figure out a process
for single-use devices to be reused, given that one of the
primary roles of the FDA is to make sure that the labeling is
an accurate description of the use of the product?
Mr. Feigal. Now, one of the fundamental questions is, if I
own the device can't I do anything I want with it? That is sort
of the off label drug question rephrased for devices. If I own
that device I can't clean it and fix it up a little bit and use
it again? I am now the owner. And our response is, the practice
that has grown up in hospitals, and certainly third parties, of
taking devices and trying to refurbish them, has actually
turned them into, not owners of the device, but manufacturers.
And that that is the reason that they now have to describe the
integrity with which the device is manufactured and develop
appropriate labeling, and adhere to the same regulations as any
other manufacturer. Part of the reason that this process may
look so tortuous is that we are aware that this is a process
that probably cannot be stopped overnight, and that is probably
a comment that you will hear debated by your next panel.
Mr. Burr. But you would not consider that the labeling of a
single-use device that could pass the test of reuse was
mislabeled? You said in your opening statement, if I remember
correctly.
Mr. Feigal. Yes.
Mr. Burr. Correct me if I am wrong, that many of the
single-use devices today are configured in the same way with
the same components as the multi use devices prior.
Mr. Feigal. Yes.
Mr. Burr. What, in your mind, distinguishes the difference
between the multi use status that FDA agreed to and the single-
use status that FDA agreed to after the application was
changed?
Mr. Feigal. We evaluate the claims in the label from a
specific manufacturer for a specific product and see if they
have the evidence to support the claims. When it is re-
manufactured, actually the manufacturer changes. We are no
longer dealing with the OEM and his label.
Mr. Burr. Is it your interpretation then that liability
would not extend back to the original equipment manufacturer,
given that your----
Mr. Feigal. I am not the person to ask about tort issues.
Mr. Burr. But I am sure that the FDA has looked at that,
haven't they?
Mr. Feigal. Well, and actually liability is----
Mr. Burr. I think there are some lawyers over there if I am
not mistaken.
Mr. Feigal. There are lawyers around here, but they are not
tort lawyers. They write regulations and things like that. But
I think this is definitely an issue you have identified for the
community that reuses devices. I do not think it is really much
of a factor in consideration of our work.
Mr. Burr. What is the definition of FDA of an already used
device?
Mr. Feigal. That is a very good question because the
variations that we have discussed of open but unused and any
used device----
Mr. Burr. If history is any indication there will be
another director at some point in the future at FDA of the
device area. What does the FDA have in place to guide them as
far as this definition so that when they come in their
interpretation is not an unsterile device that was in the OR in
case it was needed.
Mr. Feigal. Right. Well, I think the first principle in FDA
labeling is that you should say what you know. And the original
manufacturer said that this is a single-use device. It is their
responsibility to define when the device has been used so it is
not used again. So does that mean, for example, in the
operating room when someone may have, with their glove on,
handled a couple of different hip pins to pick the right one
out, that is now a used hip pin or is that still in the open-
but-unused category which----
Mr. Burr. Would it also be the original equipment
manufacturer's responsibility when they file the initial filing
to tell you if this could be reprocessed it could be used this
many times based upon our clinical studies?
Mr. Feigal. Yes. The type of use that they envision and the
type of use that they are claiming is safe and effective has to
be described. And actually we discuss these issues in the
guidance that we have just released.
Mr. Burr. And should the original manufacturer and FDA
supply guidance to the reprocessors as it relates to the
reprocessing of the device or sterilization?
Mr. Feigal. Our stance is that the reprocessor is a new
manufacturer and so there might be a business relationship
between two manufacturers, but it is not required. The
reprocessor is someone who is taking a disposed of device as
their starting material and saying, ``I can build a safe and
effective and well manufactured device out of this.'' And so it
is not the OEM's responsibility to tell the reprocessor how to
do this. If there are things which damage these delicate
devices that are commonly encountered in hospitals, it is a
little bit disingenuous for the OEMs to act like these things
will never happen. What if something was opened-but-unused and
the product is damaged by ethylene oxide? That normally would
be used in the setting of remanufacturing but, you know, we
would like to have some dialog with the OEMs about when is it
appropriate for them to disclose that information in their
labels.
Mr. Burr. Well, I would--again, I commend you for your
willingness to jump into what is a very, very difficult thing
to figure out what the right balance is. I would encourage you
to work with the OEM manufacturers, the reprocessors, the
hospitals, to work out some of the areas that you pointed out
are good questions. Because clearly I think we are going to
continue to think of some questions that we have not thought of
and I would encourage you also to focus on the future
interpretation of others by what action you take and possibly
what action Congress takes, because I think it does have an
effect on the quality of health and the cost of health in the
future. I thank the chairman. I yield back.
Mr. Upton. Thank you. Mr. Bryant, do you have additional
questions?
Mr. Bryant. Mr. Chairman, I really don't. I would just--it
is almost entertaining to hear this discussion, not that, you
know, it is humorous or anything but we are just one giant
circle and some of the questions that are asked, and, you know,
is it a single-use item a single-use item, and reusing a
single-use item, and who decides whether it is a single-use
item, and then a new manufacturer taking that item and cleaning
it and saying it is now my product. I suspect in the end it
would be great to have some guidance from you, but it seems to
me that is one of the questions we have to decide is, and I
don't know.
The FDA is probably not involved in making that decision as
to whether or not this is really a single-use item. As you say,
the OEM comes to you and you accept the labeling and if they
say it is, it is. Question, why don't they put on there this
can only be used one time and you do it otherwise you are
subject to all kinds of problems. They don't want to do that,
but I suspect in the end it is going to be up to the courts of
law, the trial lawyers out there, the plaintiff's lawyers, to
litigate this. And it is going to take a few big cases to sort
things through. But there is tremendous potential of liability
here among the reprocessor, the hospitals, and maybe even
reaching back to--ingenious lawyers can reach back sometimes
and find those original manufacturers, too. So, it is a
complicated situation and I just again urge the FDA to move as
quickly as you can to give us all some guidance and assistance
in this. And thank you for your testimony.
Mr. Upton. Ms. Eshoo, did you have additional questions?
Ms. Eshoo. Yes. Thank you Mr. Chairman. I would like to go
back to something, doctor, that you said just a few moments
ago, and I think that you stated earlier in your responses to
questions, and that is that the FDA considers reprocessors to
be manufacturers, but your policies do not reflect this. You do
not treat--if, in fact, you consider them to be manufacturers
how do you apply the same policies that you told me earlier are
applied? I think that there is a discrepancy here. And I would
also like to ask you about enforcement. What exactly are FDA's
enforcement measures that are brought to bear today? I mean, we
could have all kinds of policies on the books. We know if they
are not enforced then they are not worth the paper they are
written on, so today what are your enforcement policies and
give us examples of how you have a manifestation of the
enforcement.
Mr. Feigal. Well, one example that I mentioned earlier is
that we have been inspecting reprocessors and we have issued
them Warning Letters for the kinds of manufacturing problems
that an OEM----
Ms. Eshoo. Is this on the enforcement side?
Mr. Feigal. Yes. On the enforcement side. And we have not
treated those inspections as having any different standards
than we would for any other type of manufacturer. There are
many different levels of enforcement. Because we have had this
policy of not regulating this area in the past, there is a
period of time when we are going to find people who do not
believe that they are regulated by us and are putting into
commerce what we consider new devices and we will----
Ms. Eshoo. And your new guidelines, does the enforcement
change? Is it beefed up? Is it less? Is it----
Mr. Feigal. The new guidelines takes the principle that the
enforcement will be the same for a manufacturer, whether the
manufacturer is a reprocessor or if it is an original equipment
manufacturer. What the guideline does is that it gives people
lead time to prepare for the change in policy, but it asks the
manufacturers of high risk or high complexity devices by our
definition to come into compliance more quickly. And that will
mean having the same standards for applications and following
all the same policies that we would expect of an original
equipment manufacturer.
Ms. Eshoo. So you are maintaining that your designation of
a reprocessor as a manufacturer, as well as the OEMs that the
policies that you have in place now, and the enforcement
policies, are exactly the same as what your proposed guidelines
are? That they are the same across the board?
Mr. Feigal. Once they are fully implemented, it won't
matter if a device is manufactured or a new manufacturer is
remanufacturing it. That the same standards will apply.
Ms. Eshoo. But see, I am confused, because I think that
there is--it is very confusing to me whether you are referring
to proposed guidelines and what you hope to do and what you
hope to implement and/or what we have on the books today. Is it
all the same? Is there enforcement across the board whether
someone is an OEM or a reprocessor? Yes or no.
Mr. Feigal. No. It is not because the----
Ms. Eshoo. All right. Will there be consistency brought to
both with the proposed guidelines?
Mr. Feigal. Yes.
Ms. Eshoo. As well as enforcement?
Mr. Feigal. Yes.
Ms. Eshoo. Across the board?
Mr. Feigal. Yes.
Ms. Eshoo. Not just in some areas?
Mr. Feigal. Across the board and it will be phased in.
Ms. Eshoo. You said earlier when I asked you about
standards which is something about which I am talking about
now. Today you only inspect the place where devices are
processed. Is the place clean? Is the process a good one, is
that correct?
Mr. Feigal. These are GMP inspections. When we inspect a
reprocessor, we look at him in the same way that we look at an
original equipment manufacturer. The reprocessor, to us, is a
different manufacturer than the OEM. They just have a different
starting material.
Ms. Eshoo. But you said you consider them both
manufacturers.
Mr. Feigal. That is right.
Ms. Eshoo. So what is the difference in what you just said
then or the piece that you just mentioned? How does it affect
what you said previously?
Mr. Feigal. The starting material that the manufacturer
makes his product out of is different, but we treat them both
as the same kind of manufacturer with a device that is
classified as the same, with a device that has the same pre-
market requirements, with a device that has the same safety
reporting requirements.
Ms. Eshoo. Well, the reason that I am asking these probing
questions is most frankly I do not think it is the same across
the board. You are saying that it might be or that it will be
if you get to implement your proposed regulations. But with new
devices you require that all sorts of data be accumulated
before they ever get to the patients, but that is not the case
with the reprocessed pieces. So I do not think that there is a
consistency, with all due respect. You are getting lots of
notes on this so I must have----
Mr. Feigal. Yes. I am.
Ms. Eshoo. You know, by reusing the three tier risk system,
the practical effect will be that enforcement, I do not think,
will be the same across the board. FDA, I think, is sending a
message to reprocessors that you are not going to enforce the
same standards on them. And that may be your direction. I do
not think it is good enough. Now, you talked about equipment
that is the operating room earlier, but the equipment that you
referred to is not being placed inside the patient's body. So I
do think that there is a clear difference and that is why I
think the standards really need to be much higher. So you may
want to comment on this.
Mr. Feigal. Let me be clear. Right now there are
differences in the way they are treated because of the policy.
The guidance that we have put forward are things which we
intend to do. We are asking for comments. We have given the
specific time table and told you when we intend to do them. We
have done what Congress has consistently asked us to do with
devices, and what the public has asked us to do, which is get
to the highest risk things first. Whether something is a
reprocessed device or an original device, it will have the same
pre-market requirements. There will not be differences in
requirements. The risk staging has more to do with how we phase
in the change in policy, than it has to do with where we will
be in 2 years, or 3 years, or whatever it takes to get there.
There will be some differences in the types of applications
because the companies building the same product are taking
different paths to build it. There still will be the same
standards, whether it is an original equipment manufacturer or
a refurbisher.
Ms. Eshoo. But reprocessors do not build products, do they?
Mr. Feigal. Yes, they do.
Ms. Eshoo. How?
Mr. Feigal. They take a product that has been disposed of
and----
Ms. Eshoo. Do they reconstruct it?
Mr. Feigal. They do things to it----
Ms. Eshoo. They redesign it?
Mr. Feigal. They have to understand----
Ms. Eshoo. Or do they clean it for reuse?
Mr. Feigal. They may do all of those things, or it may be a
simple issue of recleaning, but once they take responsibility
for remanufacturing a device, they are a manufacturer with the
responsibility to explain all of those things: the design and
controls, the performance standards, all of those things.
Ms. Eshoo. This is in the new policy.
Mr. Feigal. That is the new policy.
Ms. Eshoo. The proposed policy.
Mr. Feigal. The new policy is that they are no different
than an OEM.
Ms. Eshoo. That is not the case today?
Mr. Feigal. That is not the case today, no. We have been
very----
Ms. Eshoo. Thank you. Mr. Chairman, I would like to ask a
unanimous consent to place into the record a series of national
articles that have been carried over a good deal of last year
and some from this year about this issue. Many in national
publications, grey sheets, etc., and I think it is information
that is important to have as part of the record on this.
Mr. Upton. Without objection.
Ms. Eshoo. Thank you.
[The information follows:]
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Ms. Eshoo. Thank you Doctor.
Mr. Burr. Mr. Chairman, could I ask unanimous consent for
one additional question?
Mr. Upton. Yes, you may.
Mr. Burr. I just want to clarify one thing. If a hospital
unpackages but does not use a sterilized device, is it your
position that they are, in fact, a manufacturer when they re-
sterilize it for additional use?
Mr. Feigal. It depends on how it is labeled. If the
original equipment manufacturer provided instructions on how to
re-sterilize, then they are using the device in one of the ways
that it was intended to be used, which is to have it open and
available but be able to close it back up and sterilize it. If
the hospital is doing this for other types of products for
which there are no instructions on how to sterilize, then we
are back in the area of manufacturing. In general though, this
is a practice that hospitals know very well how to do and it is
part of routine practice, and this is one of the lower
priorities on the risk scale for us to address this particular
practice of repackaging products which have been opened.
Mr. Upton. If the gentleman will yield just 1 second, I
note on this particular device which I did not open, but
somebody did maybe. I do see a warning. This device is intended
for one time use only. Do not re-sterilize and/or reuse it as
this can potentially result in a compromised device performance
and the increased risk of inappropriate sterilization and cross
contamination. But if that happened, they open this up and it
goes in the trash if they do not use it.
Mr. Burr. I guess my question would go a little deeper,
given that the hospital did not repurchase it or resell it.
Mr. Feigal. Right. No, that is right.
Mr. Burr. The commerce question comes in and the question
of your jurisdiction as well.
Mr. Feigal. Yes, that is right.
Ms. Burr. So, can you sort that out for me?
Mr. Feigal. Well, that does get back to the issue of where
do we get the definition of placing a device into trade. One of
the factors that we have thought about is if the hospital is
charging for it more than once, they are putting it back into
trade, whether they are using something that they own or not.
But it is a complex issue. The hospital oftentimes is acting as
a third party for the physicians that practice there. And so
they, in that sense, are much more like the third party
reprocessor than they are the physician who owes the device who
wants to modify it in some way and use it in his own practice.
Ms. Burr. But clearly based upon what you have told me,
there could be a situation where a device was never used, but
it was unpacked, it needed to be re-sterilized, the
manufacturer did not have re-sterilization instructions with
it, no commerce took place, but they would still be considered
a manufacturer when they repackaged it and reused it?
Mr. Feigal. If this was something that was a very common
practice, it would be a practice that we would say needs to
come under some control, because in fact they do not know if
they are damaging that product by trying to re-sterilize it. In
most cases OEMs will work with hospitals to provide
instructions when a product can be re-sterilized. And if they
said it cannot be, I think that the hospitals are taking on the
responsibilities of a manufacturer.
Ms. Burr. The FDA does not currently ask for reporting of
re-sterilized devices, do they?
Mr. Feigal. No.
Ms. Burr. Okay. Thank you Mr. Chairman.
Mr. Upton. Thank you. Well, as you can tell Dr. Feigal, I
was thinking maybe we ought to have a 2-day hearing. We
appreciate your expertise and help certainly with our
subcommittee. It has been a very good process for all of us. We
look forward to seeing the regulations made permanent so that,
in fact, we do have some enforceability that is out there. We
appreciate your dialog with us, and we look forward to working
with you in the future. Again we appreciate having a member of
your staff remain to listen to the testimony from the next
panel and to be able to respond to questions that may arise.
You are formally excused. Thank you.
Mr. Feigal. Thank you.
Mr. Upton. Thank you.
Okay. The second panel includes these individuals, Laurene
West, R.N., Dr. Robert O'Holla, Vice President of Regulatory
Affairs from Johnson & Johnson, Dr. Philip Grossman, Dr. John
Fielder, Professor of Philosophy, Ethics, at Villanova
University, Mr. Vern Feltner, President of Alliance Medical
Corporation, Dr. Bruce Lindsay, Associate Professor of Medicine
at the Washington University School of Medicine, Dr. Walter
Maurer from the Cleveland Clinic on behalf of American Hospital
Association, and Dr. Griffin Trotter, Center for Healthcare
Ethics at Saint Louis University.
I appreciate all of you being here this afternoon. As you
may understand all of us are on multiple subcommittees. It
seems like they are all meeting today. In addition to votes on
the floor, and because this hearing has gone much longer than
anticipated when we started, members scheduled are being
telescoped so we will see a number of members coming in and
out. We have a general rule that we would like you to limit
your remarks to 5 minutes. As I am not real careful with the
gavel, I will try to be a little more attentive to that clock.
As you understood, I think, your testimony in its complete form
is made already part of the record as earlier made under
unanimous consent. As you may have also heard, it is our
committee practice always to take testimony under oath. Do any
of you have any objection to that? Seeing none, we also allow
under committee rules the possibility of you being represented
by counsel. Do any of you need counsel to represent you at your
own expense? And last then, if you would rise and raise your
right hand.
[Witnesses sworn.]
Mr. Upton. Okay. You are now under oath and we will start
with Ms. West, if that is okay. Also for those behind you,
particularly if you would make sure that you bring that
microphone close to you, it would be helpful for all in the
room. With the clock, a little warning light will go on with a
minute to go, if that is okay. I can change that if you do not
like that, but that is the way it will be. Ms. West, we
recognize you.
Ms. West. Thank you.
Mr. Upton. Go ahead.
STATEMENTS OF LAURENE WEST; ROBERT H. O'HOLLA, VICE PRESIDENT
REGULATORY AFFAIRS, JOHNSON & JOHNSON; PHILIP GROSSMAN; JOHN H.
FIELDER, PROFESSOR OF PHILOSOPHY, ETHICS CONSULTANT, VILLANOVA
UNIVERSITY; WALTER G. MAURER, CLEVELAND CLINIC FOUNDATION, ON
BEHALF OF AMERICAN HOSPITAL ASSOCIATION; VERN FELTNER,
PRESIDENT, ALLIANCE MEDICAL CORPORATION; C. GRIFFIN TROTTER,
CENTER FOR HEALTHCARE ETHICS; AND BRUCE D. LINDSAY, ASSOCIATE
PROFESSOR OF MEDICINE, WASHINGTON UNIVERSITY SCHOOL OF MEDICINE
Ms. West. Mr. Chairman, members of the committee, I
appreciate the opportunity of expressing my concerns this
morning, actually this afternoon, sorry. I am here today not as
a spokesperson, not as a lobbyist for any group that is paying
me, but as a classic example of a patient who has suffered from
the reuse of a single-use device. My perspective on this
pandemic healthcare issue comes from not just being a patient,
but also having been a registered nurse with a critical care
certification and current licensure for 25 years.
There are actually two ways that a single-use device can be
used twice. One is if you have an incompetent staff member who
does not follow sterile procedure and is using the device for
the second time. And then second, as we have just talked about,
the sterilization of a device, excuse me, autoclaving a device,
perhaps, to make that single-use device into a multi use
device. My personal example falls into category one which comes
from an incompetent staff member not following sterile
procedure. Just a little bit of history so that you will
understand why I was in this position. In 1983 I was diagnosed
with a tumor in the center of my brain and, in order to remove
that tumor, I went through a procedure which is called a
transsphenoidal hyphysectomy.
I can describe that for you, but there are some people that
perhaps would prefer not the clinical aspect of that. In order
to get to that part of the brain the surgeons need to go
through the bottom of the brain. So they went through my
sphenoid sinus in order to do that. And while I was having that
surgery there was a break in sterile technique. I was exposed
to and infected by the bacteria known as staphylococcus aureus
commonly known as staph. And because that infection was
acquired during a hospital stay it is referred to as a
nosocomial staph infection. And I have actually battled that
infection for 17 years. As the purpose of this hearing is to
describe the reuse of single-use devices, I am going to
concentrate my testimony on an incident that occurred when I
was ill in 1988.
I had had two surgeries that year to remove infected bone
from both my head and my facial structure in an effort to try
to prevent Meningitis. Meningitis is where the infection is
collected on the outside of your brain. The cultures that were
taken of the bacteria in my head indicated that the bacteria
had mutated to the point that I was no longer sensitive to any
antibiotic other than one called Vancomycin which needs to be
administered intravenously. So, I was admitted to the hospital
and what is referred to as a central line was inserted. That
goes into your antecubital vein, it is threaded up into your
arm, and up into the superior venacava of my heart.
For the first day I had a phenomenal nurse who followed
sterile procedures. She changed the needles, she changed the
tubing each time she hung the doses of Vancomycin. However, the
next day I did not have such luck. The nurse who took care of
me, as she took the needle out to end the dose, she put the
needle on the table. My thought was well, you know, that is the
end of the dose. The sterile procedure is that you would then
hang a new bag, put new tubing, put a new needle on there. She
did not do either, and before I realized what she had done she
had picked the needle up off the bedside table, without any
cover, not even wiping it off with an alcohol swab and then put
that back into my central line which flowed directly back into
my heart. Actually I would have been much better off had I just
taken care of myself at home.
My physician ordered blood cultures because we needed to
know what additional bacteria that I was now exposed to. It is
flashing red. Have I already gone 5 minutes?
Mr. Upton. You have.
Ms. West. Okay. I will make this very, very quick. In order
to save my life, I went on a regime of three IV antibiotics. I
have continued to suffer from that process of having had that
device reused. I will skip over just very quickly that the
reuse of a vital medical device can be a result of a bad habit,
a result of not having appropriate quality assurance within a
facility. However, every organization has a responsibility of
maintaining a patient relationship that allows for a sterile
procedure. As we are mutating bacteria year by year, the
essentiality of sterilization is more, and more, and more
important. As patient we deserve the right to be given
treatment by trusted, trained professionals.
Very quickly I will explain that. The implementation of the
1996 Health Insurance Portability and Accountability Act known
as HIPAA-96, that was intended to standardize and simplify
administrative procedures for nurses, who are currently
spending 50 percent of their time taking care of paperwork. So
if there is proper implementation of the HIPAA legislation,
then we then have nurses back on the floor who can monitor, and
train, and certify and make sure that devices are not reused.
Since I am over my time, I would be happy to answer any
questions that you have. I appreciate the opportunity of
sharing with you part of my story and hope that we can find a
way so that all patients have access to quality care.
[The prepared statement of Laurene West follows:]
Prepared Statement of Laurene West
Mr. Chairman, members of the committee, my name is Laurene West. I
would like to ask that my full statement be inserted into the record of
this hearing.
I am here today not as the spokesperson or lobbyist for any
organization, nor for any group that is paying me to testify--but as a
classic example of a patient suffering from the results of a re-used,
single use biomedical device. My perspective on this pandemic
healthcare issue is derived from being both a patient and a Registered
Nurse with Critical Care Certification and Licensure for 25 years.
There are two ways in which single-use devices can be re-used; 1)
staff incompetence or failure to follow sterile procedures and perhaps
inadequate training 2) cost containment but high risk procedures of
autoclaving single-use devices to become multi-use devices.
My personal example falls into category 1--staff incompetence or
failure to follow sterile procedures and equally likely, inadequate
training.
In 1983 I was diagnosed with a tumor in the center of my brain. The
tumor was surgically removed by a procedure called a Transsphenoidal
Hyphysectomy. During my surgery there was a break in sterile technique
and my brain was exposed to and infected by the bacteria staphylococcus
aureus, or more commonly known as staph. Because this infection was
acquired while in the hospital, it is referred to as a nosocomial staph
infection.
As the purpose of this hearing is to describe incidents directly
related to the re-use of single use devices, my testimony will
concentrate on an incident in 1988 where this common, hospital wide,
cost saving practice nearly took my life.
1988 was a rough year. I had two surgeries within three months
trying to prevent meningitis--which is where the lining of the brain
becomes infected. The infection in my head had traveled to my frontal
sinus and the cultures revealed that the staph had mutated so that it
was no longer sensitive to any antibiotic except Vancoymcin, which must
be administered intravenously.
I was admitted to the Hospital, a central line was inserted via my
antecubital vein into the superior venacava of my heart. For my first
day, I had a wonderful nurse who followed sterile procedure correctly,
used only new IV tubing and needles as appropriate--and my temperature
of 104 degrees began to decline. However, my next nurse, a foreign
national, barely able to speak English, did not follow sterile
procedure. When the current dose of Vancomycin had been infused, she
took the needle out of the mainline and laid it on the bedside table. I
assumed this was her way of reminding herself that she needed
additional tubing and a new needle for the next dose. The correct
procedure for administering the next dose would have been to hang the
Vancomycin with new tubing and a new needle. However, she did neither.
Before I realized what she was doing, she re-inserted the old needle
with the old tubing into the mainline for that dose of the antibiotic.
The damage was done--I had now been contaminated with additional
bacteria from the table. Within 12 hours my temperature had spiked to
108 degrees and I developed septicemia, meaning that the infection in
my head had traveled to my blood system as well.
I would have been better off taking care of myself at home.
My physician, ordered blood cultures drawn so that he could
determine if there were additional bacteria causing the increased
temperature. However, my rapidly deteriorating condition caused my
doctor to immediately start a regime of three IV antibiotics, each with
exhaustive lists of negative side effects, to save my life.
I was very lucky and after weeks of therapy, recovered from the
sepsis and returned to my normal battle with just the routine staph
infection.
My case is only one of a vast undocumented number of similar if not
worse life-threatening stories. Most patients entering the hospital or
clinic do not understand what is happening to them and without a
clinical background they do not know they need to be cautious. They go
into a facility, trusting that they will receive the best possible care
from trained and responsible professionals. They don't know the
difference between a single-use or multi-use device.
Earlier in my testimony I referred to two ways single use devices
can be reused. I suffered from professional incompetence and the
failure of an allegedly trained professional to follow appropriate
procedures.
The reuse of a biomedical device could simply be the result of bad
habits not recognized during training and quality assurance review. A
health care organization has constant follow-up and training
responsibilities in every single patient relationship. With infection
rates growing and bacteria being mutated to new forms that are no
longer sensitive to existing antibiotics, the essentiality of
sterilization is of the utmost importance for patient safety.
The implementation of the 1996 Health Insurance Portability and
Accountability Act, known as HIPAA 96', is intended to standardize and
simplify administrative procedures, known as paperwork. Currently
nurses are spending 50 percent of their shift time on these
administrative procedures. Appropriate implementation of HIPAA 96'
would allow for greater time spent in training, practice certification
and supervision of licensed caregivers. Put nurses back on the floor
taking care of patients rather than doing paperwork.
Category 2, reuse of biomedical devices as a cost containment
effort, is either sanctioned or not sanctioned by the health care
organization. If the organization chooses to reuse these devices firmly
labeled as single use, they are violating the implied sterilization
warranty and putting patients at high risk of infection. This
ultimately increases patients morbidity and mortality rates.
This silent epidemic radiates throughout healthcare, from large
acute care facilities to home health agencies and nursing homes--
regardless of the owner organization. I have shared with you my own
story but can give you example after example of things that I have seen
and heard from other healthcare professionals and from the 55 million
patients I represented last year on the Year 2000 Project as the
National Patient Advocate.
Autoclaving IV tubing for second and third patient use.
Autoclaving Pacemaker wires for use on additional patients
Saving neonatal ambu-bags and pulse oximeters without being
autoclaved, to be given to 3rd world countries.
Subclavian guidewires autoclaved to be used on additional
patients
Suction catheters being used by multiple patients without any
cleansing process in-between patient contact.
Most caregivers are not able to document cases of increased
infection, morbidity or mortality from the re-use of single use devices
as doing so would cause them to lose their jobs.
Ladies and Gentlemen, healthcare must be driven by quality,
compassion, honesty, and with respect for the rights and wishes of the
individual. It must be provided by trained and competent staff.
I offer my assistance in any way possible to this committee or any
organization to help further awareness of this issue, to help better
train hospital staff and make patients more enlightened consumers.
I want to thank the members of the Committee for allowing me to
testify today and will be happy to answer any questions you may have.
Mr. Upton. Thank you very much.
Mr. O'Holla?
TESTIMONY OF ROBERT H. O'HOLLA
Mr. O'Holla. Good afternoon, Mr. Chairman. Thank you.
Members of the committee, my name is Robert O'Holla, I am Vice
President of Regulatory Affairs for the Medical and Diagnostic
Group at Johnson & Johnson. I am also Chairman of the
Association of Disposable Device Manufacturers, you have come
to know as ADAM. Mr. Chairman, I would like to thank you and
Mr. Bliley for raising the visibility of this important issue
through this hearing and also by introducing a bill along with
Congresswoman Eshoo on this issue.
I am going to do my best to control my passion for the
issue this afternoon. I have worked for approximately 30 years
in the medical device industry, and I am seriously concerned
that anyone would attempt to clean and reuse a medical device
that was designed for use in a single patient and approved by
FDA for only one use. Just as concerning, and I share the
concern raised by this committee all morning, was the apparent
disinterest on the part of FDA until very recently in this
threat to the health and safety of U.S. patients. I have
submitted my written testimony, but because my time is limited,
today I would like to concentrate on just one aspect: The
threat that reprocessed single-use devices present to quality
healthcare for patients. The evidence for action is clear to
me. There are reports of two patients who have been blinded in
one eye, a premature baby whose foot was burned, increased
pneumonia rates in children, and a 32 year old woman who we
heard about earlier this morning who has a piece of metal
lodged in her heart.
In addition, ADAM members have retrieved approximately
1,000 reprocessed devices from hospitals where they were
awaiting use in patients. The results of the tests are
chilling. Approximately 75 percent of the samples collected
failed either due to the presence of blood and/or proteinaceous
matter, bacterial contamination, functional failures, or
defective packaging leading to non-sterile devices. And I
brought some pictures along so you can have some appreciation
for what we found. I would like to note that these are not
unique pictures. These are representative of what we found. The
first photograph shows a piece of proteinaceous material that
was ejected from a reprocessed surgical clip applier when we
fired it in the laboratory. This is a device that is used to
close bleeding blood vessels. That piece of material is not
actual size by the way. That is about a quarter inch to an
eighth inch piece of material that would have been injected
into the next patient. The interesting thing about this is that
as we tried to fire the device further, there was so much
tissue in the mechanism of this device that the device clogged
and became nonfunctional.
The second picture is in the anvil of a surgical stapler
contaminated again with similar material. The next set of
pictures we see a reused electrophysiology catheter that pulled
apart while inserted in a second patient's heart making it
difficult for the doctor to remove. Last is a photograph of
another electrophysiology catheter. What we see is
contamination with tissue residue. We found that this residue
was indeed one that caused a marked increase in blood clot
formation. In addition to all of this, FDA's own data indicate
problems with the reuse of angioplasty catheters,
electrophysiology catheters, and biopsy forceps. One FDA study
revealed that the tiny tubes inside reprocessed angioplasty
catheters were often kinked and clogged with blood and cleaning
chemicals. Most disturbingly, some reprocessed balloons ended
up being at least one size larger than they were supposed to
be.
Now, the proponents of reprocessing have said that they do
not put patients at risk and they have no evidence that the
practice is unsafe. Yet, by simple random sampling and without
any trouble we found reused products that clearly increased the
risk to patient's health and safety. A large portion of the
devices we found were non-sterile. How many infections and more
serious diseases such as Hepatitis-C and perhaps even HIV, have
been spread to unknowing patients as a result of this practice?
The sad answer to that question is, we do not know because
nobody has been looking. There is a clear increased risk of
disease transmission and functional failures. Is this an
acceptable standard for medical device performance, or are we
just inviting an increase in medical errors? It certainly is
not the standard that FDA has applied to new medical devices
for the last 24 years, and should not be the standard applied
to reprocessed devices. It is time that FDA enforced the full
requirements of the law so that the second, third, or sixth
patient has the exact same level of FDA protection FDA
oversight provides to devices used on the first patient. No
other standard is acceptable. Thank you.
[The prepared statement of Robert H. O'Holla follows:]
Prepared Statement of Robert H. O'Holla, Vice President of Regulatory
Affairs, Johnson & Johnson
Good morning, Mr. Chairman and members of the Subcommittee. My name
is Robert O'Holla and I am Vice President of Regulatory Affairs for the
Medical Devices & Diagnostics Group at Johnson & Johnson. I am also
Chairman of the Association of Disposable Device Manufacturers, a trade
association of single use medical device manufacturers. Thank you for
the opportunity to address this important patient health and safety
issue. I have worked for 30 years in product development, quality
assurance, microbiology and regulatory affairs. As a long time
professional in this area, I cannot understand why anyone would believe
it is acceptable to clean and reuse a delicate, complex medical device
that was designed for use in a single patient and approved by FDA for
only one use. Just as concerning is the apparent disinterest on the
part of FDA until very recently in this threat to the health and safety
of patients.
FDA has said that it is now going to regulate the practice of
reprocessing. I hope that means that FDA is now going to apply all of
the provisions of the Federal Food, Drug, and Cosmetic Act (FDC Act).
No evidence of harm is needed before FDA can and should apply the law.
The FDC Act and its implementing regulations establish a presumption
that all medical devices are unsafe, and require that the safety and
effectiveness of new or substantially modified devices be affirmatively
demonstrated prior to their introduction into interstate commerce.
Claiming that a single use device may be reused causes the device to be
treated as a new device under FDA's regulatory scheme. Yet, for years
FDA has chosen to ignore this clearly stated Congressional intent by
allowing reprocessed single use devices to be used on patients without
requiring or reviewing the necessary data to establish their safety and
effectiveness.
Risk to Patients
FDA is aware of reports of two patients who have been blinded in
one eye, a premature baby whose foot was burned, a thirty-two year old
woman with a piece of metal lodged in her heart, and increased rates of
pneumonia in children.
Nevertheless, FDA's first step in regulating reused devices was to
improperly shift the burden by refusing to require that reprocessors
demonstrate safety and effectiveness of their products, and suggesting
instead that OEMs provide data regarding the risks associated with
reprocessing. Despite this improper move, the original equipment
manufacturer (OEM) industry expended substantial effort to test
reprocessed single use devices. The data from that testing, all of
which has been submitted to FDA, overwhelmingly demonstrates serious
safety issues. Moreover, FDA's Office of Science and Technology (OST)
simultaneously generated its own independent data confirming the risks
of reusing certain single use devices.
At least nineteen scientific studies involving approximately 1000
individual devices have been submitted to FDA on this topic. These
studies have been conducted by independent scientists, hospitals, OEMs
and, as mentioned above, FDA's own laboratory personnel. Many of the
devices used in these studies were obtained directly from hospital
shelves where they were ``ready for use'' in seriously ill patients--
patients suffering from cancer or heart disease, and requiring major
abdominal, cardiovascular or thoracic surgery.
Devices studied included biopsy forceps, angioplasty balloon
catheters, electrophysiology catheters, surgical trocars, staplers,
papillotomes, and other general surgical instruments. Approximately 75%
of the samples studied failed, either due to the presence of blood and/
or proteinaceous matter, bacterial contamination, non-functionality, or
defective packaging. In each of seven studies of reprocessed biopsy
forceps, a lack of sterility assurance was reported in over 45% of the
samples tested. This particular failure was not unexpected. As recently
as last October, FDA issued a warning letter to one of the largest
commercial third-party reprocessors specifically citing the
reprocessor's failure to adequately validate the sterilization process.
These studies also found devices with mismatched parts, a scalpel blade
designed to be blunt that was, instead, sharpened, a surgical stapler
contaminated by a large piece of proteinaceous matter, and devices
lacking warnings about latex content. These nineteen separate studies
clearly demonstrate that reusing a single use device may seriously
compromise the integrity and subsequent safety and efficacy of that
device.
To date, FDA has failed to make public any study reports
summarizing OST's data. Nonetheless, public presentations by OST
scientists clearly indicate that these findings include safety and
effectiveness concerns with percutaneous transluminal coronary
angioplasty (PTCA) catheters, electrophysiology catheters, and biopsy
forceps. One presentation revealed PTCA catheters with non-patent
lumens, crimped guidewire lumens, and plugged balloons or balloon
channels. In some instances, cleaning chemicals and blood could not be
removed from the device lumens. Some reprocessed PTCA balloons varied
in size by more than 10% of the approved specifications. As a result, a
cardiologist has no assurance he or she will get the particular balloon
size intended for the patient.
FDA has failed to acknowledge the demonstrated patient safety risks
associated with reprocessing single use devices despite volumes of data
to the contrary. Reprocessing amounts to a misuse of medical devices
that can only add to the nation's preventable medical error rate. The
agency's Congressional mandate to protect the public health will not be
served by reversing the burden of proof and awaiting a proven public
health disaster before taking action.
Requirements of the FDC Act
The FDC Act requires that, prior to their introduction into
interstate commerce, all new medical devices must be FDA-cleared or
approved through the premarket notification (510(k)) or premarket
approval (PMA) process. This process requires submission of data by the
party that intends to market the device. For a single use device, the
OEM demonstrates that the device is safe and effective for use on a
single patient in a single procedure, and the device is then cleared/
approved for only that use. Under FDA's own rules, reprocessing
significantly modifies a single use device by changing its intended use
to multiple use, creating, in effect, a ``reusable'' device. FDA
requires manufacturers of single use devices that wish to market those
devices as reusable to submit a new 510(k) or PMA, including data to
support the safety and effectiveness of the device for multiple use,
prior to marketing the device for that new use.
FDA agrees that reprocessors of single use devices are
manufacturers under the FDC Act and its implementing regulations, and,
as such, reprocessors are subject to the provisions of the FDC Act that
require manufacturers to obtain clearance of a 510(k) or approval of a
PMA. Despite this recognition, the agency clearly announced its
intention to permit reprocessed single use devices to be marketed
without its prior clearance/approval, and, to date, has subjected them
only to some degree of post-market regulation. In a letter dated July
9, 1999, FDA stated that, ``third-party reprocessing of devices labeled
for single use is unlawful unless those engaged in this practice comply
with all regulatory requirements for manufacturers, including premarket
notification requirements.'' However, the agency then reversed itself
by announcing in the same letter that ``FDA has exercised and will
continue to exercise regulatory discretion for all premarket
notification requirements.'' This unjustifiable use of enforcement
discretion is perpetuated for many reprocessed single use devices under
FDA's recently issued strategy for regulation of single use device
reprocessing.
The FDC Act requires pre-clearance of reprocessed single use
devices by all device manufacturers, whether they are OEMs or
reprocessors. The Medical Device Amendments of 1976 (MDA) were enacted
for the purpose of implementing pre-market review of devices because
Congress was concerned that post-marketing regulation of medical
devices was inadequate to protect the public health. The design of the
MDA is consistent with Congress' belief that post-market controls are
insufficient to regulate medical devices. In today's world of
increasingly complex medical devices and heightened concern over
disease transmission, the regulatory discretion FDA has proposed to use
under its new strategy, is inconsistent with Congress' intent. In
enacting the MDA, Congress' goal was to protect patients from unsafe
and ineffective devices, regardless of the identity of the device's
manufacturer. As such, there is no justification for a patient to
receive less protection from FDA merely because the device used for the
patient's treatment is a reprocessed single use device rather than an
FDA-cleared reusable device. FDA is, in effect, creating a de facto
exemption from the premarket review requirements for most reprocessed
single use devices `` and in doing so, is violating its Congressional
mandate.
FDA's Disparate Treatment of OEMs and Reprocessors is Illogical
FDA acknowledges that it has not regulated OEMs, third-party
reprocessors, and health care facilities in the same manner with
respect to single use devices. For example, in order to market a single
use surgical stapler for use in multiple patients, an OEM must first
obtain clearance of a 510(k) from FDA. A reprocessor that wishes to
market that same stapler for use in multiple patients is currently free
to do so without a 510(k). Not only is this dichotomy arbitrary, it is
also illogical since only the OEM has full knowledge of the design
criteria and performance specifications of the device and thus is in a
far better position than the reprocessor to determine whether the
device can be reused.
In the FDA's November strategy, the agency lists the seven
requirements of the FDC Act to which OEMs must adhere: 1) registration
and listing; 2) premarket notification and approval requirements; 3)
submission of adverse event reports under the Medical Device Reporting
regulation; 4) manufacturing requirements under the Quality Systems
Regulation ; 5) labeling requirements; 6) Medical Device Tracking; and
7) Medical Device Corrections and Removals. Of these requirements, FDA
acknowledges that reprocessors have only been subject to four
``registration and listing, QSR, labeling requirements, and MDR
reporting requirements. This unequal treatment has no justification in
law.
Moreover, this unequal treatment also seriously compromises public
safety. Devices are being marketed that have not been demonstrated safe
and effective as required by law. FDA is effecting a double standard
that lowers the burden for reprocessors as compared to OEMs. The
protection of U.S. patients requires that FDA regulate all
manufacturers in the same manner, regardless of whether those
manufacturers are deemed OEMs or reprocessors.
Conclusion
FDA must quickly establish timelines for enforcement of the 510(k)
and PMA requirements on all reprocessed single use devices. The FDC Act
requires FDA to protect U.S. patients from unsafe and ineffective
medical devices before they cause patient injury. Such injury has
already been attributed to reprocessed single use medical devices.
Proper regulation of these devices, including enforcement of the
premarket submission requirements, will prevent further injury and
protect patients.
Mr. Upton. Thank you very much.
Dr. Grossman?
TESTIMONY OF PHILIP GROSSMAN
Mr. Grossman. Mr. Chairman, honorable committee members,
and guests, good morning. My name is doctor----
Mr. Upton. Good afternoon.
Mr. Grossman. You are right. Good evening, actually. My
name is Dr. Grossman. I am a practicing gastroenterologist in
Miami, Florida, a Clinical Associate Professor of
Gastroenterology, but I have spent my entire adult life as a
patient advocate. I want to thank both Chairman Bliley and
Upton for holding these hearings and for inviting me to
participate. Like many of you I am somewhat heartened by the
recent iteration of the FDA proposals because they address many
of our prior concerns, but they certainly do not go far enough
and in my opinion certainly do not get us there fast enough,
and I think the time is clearly now to act. I find myself
shaking my head in disbelief every day that this continues.
In simple terms let me explain to you what this is about.
Medicine has gone through an evolution to less invasive
procedures. There have been devices that have been designed,
created, and built to foster that improved healthcare and
perform a specific task. They were not built to achieve the
ability to reuse. They were built to achieve the ability to
take better care of patients. What are the implications? They
allow us to repair blocked coronary arteries without open heart
surgery. They allow us to remove benign and malignant polyps
without a laparotomy, and for the first time in our country
they allow for a national initiative to prevent colon cancer
using safe and effective techniques. But to achieve this
ability their very construction is somewhat unique. They have
sharp points, they have tightly coiled wires, and they have
very, very narrow lumen to permit the flexibility and mobility
required in many of these areas. This allows them to do the
job, but does not necessarily allow them to be cleaned.
Imagine being at home trying to clean the inside of a
swizzle stick and then using it again. What are the
consequences or the potential consequences of reuse? Infection,
major concern. Lost function. If I take one of these devices in
my hand to care for a patient and it fails in the middle of the
procedure, it is not a question of dollars and give me another
one. It may fail in a time and place that causes great harm to
that patient. There is risk from chemical toxic injury from the
reprocessing solution and finally, there is even a risk of
misdiagnosis. There is a case I am familiar with where a
patient underwent esophageal surgery for a diagnosis of
esophageal cancer, but at surgery there was no cancer. It was
believed that the tissue from which the diagnosis was made was
residual tissue left inside the tiny cup in the biopsy forceps,
and perhaps somebody could put a picture of the biopsy forceps
up.
In essence, if we permit what amounts to the recycling of
medical waste, these consequences will confront us day in and
day out. I implore you, do not be mislead by the proponents of
reuse who tell you there are no complications, there are no
problems, and there are no dead bodies. The reason is that
nobody is counting, and if you do not go looking and if you do
not count, you do not find it. There has never been a
prospective study investigating patients before procedures,
looking at their HIV status, their hepatitis status, and then
bringing them back every month for a year to determine if, in
fact, they have suffered a consequence. It is easy to say that
it is not there. We are creating a potential generation with
infectious time bombs. The incubation period for Hepatitis-C
alone is over 6 months. These patients are not followed during
that time. If you look at the biopsy forceps that is up there,
you can start to see why these problems occur. I agree with the
FDA that this is a high-risk device. My concern that the loop
hole for exemption may allow it to escape and go beyond the
protection that the law intended.
I would like to comment on informed consent for a moment,
and that is until the FDA actually embarks on device by device
review and approval, there will be two standards of care in
this country. I believe patients have a right to know. And if
the people who think that this is so safe really believe it, I
see no reason why they should not be bragging about it. In the
last group, your healthcare workers, the unsung heros who are
being exposed to unnecessary risk by handling these
contaminated devices. My conclusion would be and my hope for
this committee, the final answers may not be in, but if
reasonable doubt exists and reasonable doubt does exist, we
must err on the side of patient safety and patient well-being.
I thank you for your attention and particularly thank you for
your leadership.
[The prepared statement of Philip Grossman follows:]
Prepared Statement of Philip Grossman
introduction:
My name is Philip Grossman, MD., F.A.C.P., F.A.C.G., I am a
practicing Gastroenterologist in Miami, Florida, and Clinical Associate
Professor of Medicine and Gastroenterology at the University of Miami
School of Medicine. I am submitting this written testimony to address
the following subject not because of any titles, but primarily as a
family man and a concerned citizen. I feel very strongly about this
issue and have traveled from Florida to provide both written and oral
testimony. I applaud your efforts to protect United States citizens.
the problem:
The problem we are facing is the reuse of medical devices that were
designed, manufactured, tested, packaged, and labeled for the sole
purpose of a single use in a single patient. These are devices for
which the very approval from the FDA is contingent upon information
submitted, including the fact that these devices are to be disposed of
after a single use. Reprocessing refers to the cleaning, packaging, and
attempt at resterilization of a single-use medical device which was
used on a patient for its intended purpose and which will then be used
again on another patient.
Some single-use medical devices, for example, biopsy forceps, are
critical devices, which, according to the Spaulding Classification, are
those which routinely break the mucus membrane, thereby coming into
contact with sterile tissue or the vascular system. Critical devices
carry a much higher level of risk when reused than do non-critical or
semi-critical devices, which would include endoscopes--devices which in
themselves have been associated with disease transmission even in the
absence of sharp points and coiled wires. The core of this matter is
not the paperwork, labeling, or the official box these devices fit
into, although these factors are important as well. Rather, the core
issue is the actual reuse of single-use devices in real, live people--
husbands and wives, parents and children, brothers and sister.
The scope of this problem is broad. It encompasses a wide range of
devices in multiple specialties and includes biopsy devices, cardiac
catheters, and various access-related devices used in gastroenterology,
urology, and cardiology, as well as other specialties. This issue has
become increasingly controversial as more healthcare facilities
consider reuse of single-use devices as an attempted means of cost
containment. According to a survey published in 1997 by ECRI, a non-
profit health service research firm, approximately one-third of
healthcare facilities reused medical devices labeled for single use,
and 25% more were considering the practice (Costerton).
I must be clear though that I am discussing used single use devices
not single use devices that were opened prior to a procedure and then
not used. An unused single use device presents less risk to the next
patient. In a recent issue of OR Manager, 250 hospitals were surveyed
on this topic. Of the devices that were being reprocessed, 80% of them
were open but unused devices. Hospitals must look to the manufacturer's
instructions to determine if these devices can be resterilized. These
are not the devices that are being discussed here. I will focus my
comments on the reuse of used single use devices.
overview:
Devices are designed for single use only
No matter what the specialty--gastroenterology, cardiology, or
urology--single-use devices are specifically designed from inception
for safety and performance. Therefore, the very design structure did
not take into account the need to access all the nooks and crannies in
order to clean them. The research, development, and design of the
structure focused on a safe, effective product to be used once. An
analogy to this situation might be as follows: You are asked to design
a car to take a family of two adults three blocks from their home.
However, it is only later that you find out that this care needs to
transport eight schoolchildren fifteen miles away. But the car is six
seat belts short. As with the design of the car, the design and all of
the safety features of a single-use device make is totally suitable for
the purpose for which it was created but do not automatically apply
when the rules are changed. That's what this problem is about.
Proponents of reprocessing may maintain that reuse is safe and
vital as a measure to reduce healthcare costs; however, a preliminary
FDA study uncovered dozens of reports of infection, chemical injuries,
and mechanical failures associated with reusing equipment designed to
work just once. Although reprocessing single-use devices had been
widespread abroad; France has prohibited such reuse, and other
countries are looking at the issue.
Design features make cleaning/reprocessing a problem
Single-use devices have a number of common features:
1. They tend to be very small and intricate.
2. They typically have complex wiring systems, such as diagnostic
wiring that carries an electronic signal for measurement, or
mechanical wiring that operates the working portion of the
device much like a remote control tweezer or remote control
cane.
3. Because many of these devices are used for the purpose of removing
pieces of tissue or altering tissue during a procedure, they
typically have sharp points and sharp edges.
The problem is that the very structure just described that makes
the device work so safely and effectively in its intended use is the
same design that precludes the ability to access its nooks and crannies
and that encourages human debris to get caught in tightly woven wires
or on sharp points. In essence, the success of these devices is what
makes them such a risk in terms of the inability to clean them for
reuse. The basic tenet in the world of microbiology is: ``If you can't
clean it, you can't sterilize it!!!''
Devices designed to be reusable differ from reprocessed single-use
devices
Manufacturers are required to conduct additional testing for
devices that are intended to be reusable. They must meet FDA criteria
to validate that a device can be cleaned and resterilized multiple
times. Data supporting reuse must be submitted to the FDA through the
premarket notification process. FDA is not enforcing these same
regulations against reprocessors of used single use devices.
Many devices, whether labeled as single-use or reusable, may appear
identical. However, the devices may not include the same materials or
internal components. For a number of reasons, manufacturers may change
the materials used in production. Changes in materials may not be
obvious on visual inspection, but unless the devices is specifically
labeled ``reusable,'' the new materials may not be able to withstand
the heat or chemicals required for resterilization, particularly on a
repetitive basis.
Fallacies of cost savings with reprocessing
In an effort to control costs, some hospitals have taken the
position: ``If a device costs $50 and it is used just once, it costs
the full $50. If a devices costs $50 and is used ten times, it costs
only $5 per use.'' The two fallacies of this position are:
1. It reduces human risk solely into dollars per session; and
2. There are very real costs associated with processing a device for a
second or subsequent use. Devices are either reprocessed in-
house (at the hospital) or are outsourced to the new industry
of device reprocessors. Device reprocessors take the devices
from the hospital (much like dry cleaning) and later return
them, typically charging approximately 50% of the cost of a new
device. So, it's not an issue of $50 vs. $0. When you factor in
the cost of the reprocessor, as well as the hospital's cost of
labor in preliminary cleaning, nursing time, as well as plastic
bags, labeling, etc., the actual costs of reprocessing increase
significantly.
Devices being reused that are not intended for that function are in
fact being reused at risk to the patient--as a cost saving measure.
Because of the very nature of these devices, well meaning people
wanting to do a good job may still not be able to adequately make
single-use devices safe and appropriate for the next person.
Cost of failure
In addition to the issue of patient risk, there is a genuine cost,
both medical and economic, to a device which now performs at less than
the standard for which it was built. It may result in a delayed
procedure, damage to other medical devices, for example, endoscopes,
higher complications, and/or greater risk to the patient as well as the
medical personnel. In fact, the entire economic issue may become
lopsided beyond recognition when one actually weighs the economic cost
of an injured patient whether due to infection or device failure,
against the acquisition cost of single-use devices. It may take decades
to break even following such an adverse event.
disease transmission:
Reports document disease transmission
Extremely well documented reports and additional medical literature
confirm that diseases that have been transmitted from patient to
patient have been tied to improperly reprocessed medical scopes and
devices. Two reports documented the transmission of tuberculosis and
the transmission of hepatitis. Both of these studies were documented
with DNA fingerprinting--that is, researchers were able to actually
demonstrate that the exact DNA of the organism identified from patient
#1 was also found in patient #2--on whom the same scope had been used.
Scopes were implicated in these reports, and scopes do not have sharp
points. If you take a tweezer-like device with a tiny spike in it and
stab it into tissue, then reprocess the device and stab it into someone
else's tissue, it does not take a leap of the imagination to understand
why disease transmission is of great concern.
A fallacy: cleaned and sterilized equals safe
Some argue that because a device is cleaned and sterilized, it is
therefore safe. This view is faulty for the following reason: some
devices are constructed in a way that make it literally impossible to
properly clean. In order to clean in between wire segments, you would
have to literally unravel the device. An analogy would be: If in order
to get a pair of stretch pants properly cleaned, you have to remove the
elastic before taking them to the cleaners, thus rendering them useless
in the future.
When devices are reprocessed, whether in a hospital or by outside
contractors, there is a human chain of activity--that is, a series of
human events where people perform a variety of tasks. Even with well
meaning and competent people doing this task over and over, there is
still a possibility for human error, which magnifies as the number of
steps and number of people increase. When the task involved in the
process is repetitive, tedious and arduous, the likelihood of human
error along the way is further multiplied. Everyone agrees that any
human error, whether from inadequate cleaning, scrubbing, or delay,
makes it impossible to properly reprocess a device and may be the cause
of disease transmission. Compare that to the patient lucky enough to be
the recipient of a first-use device--where the device comes out of a
manufacturing plant which is inspected and whose processes are
regulated and monitored by the FDA, has an established Quality
Assurance process, and complies with stringent published standards for
microbiological testing. There is essentially no concern about the
possibility of error association with a repetitive human chain because,
compared to the alternative, the devices comes out assuredly sterile.
Devices may be pooled in reprocessing
If a hospital farms out its devices, hospital personnel are
supposed to do a preliminary cleaning. The devices are then placed in a
bag, picked up by the reprocessor, taken offsite for reprocessing, and
returned. It is not uncommon for reprocessors to return a similar but
not identical device. For example: You're a reprocessor. I give you
Catheter A from my hospital, and some time later you give me back a
ready-to-use Catheter A that came from a general pool of Catheter As
from various facilities. My staff, over whom I have control, may have
done a great job with the preliminary cleaning of our Catheter A
devices, but we got back someone else's catheters. Therefore our
staff's diligence might not be benefiting our patients.
Bacteria can become trapped
When human organic material--blood, stool, tissue, saliva--is
allowed to stand and crust, it forms a type of biofilm. The problem is
that, in many cases, devices sit for a period of time, waiting to be
picked up. A hospital being busy or any number of factors can result in
an initial delay in cleaning. This delay, as well as the possibility of
inadequate cleaning, enables the debris to form a resin that literally
seals in and therefore insulates the bacterial. (Picture the bacteria
going into a ``bomb shelter'' and reemerging when ``the coast is
clear.'') When the reprocessed device is returned to the hospital it
has allegedly been sterilized by the reprocessor. However, the bacteria
are not effected by the sterilization process because they've been
ensconced in this insulating shell. The problem gets worse. When the
reprocessed device is put into a patient, the shell, at body
temperature, and in the presence of body fluids, starts to degrade,
thereby releasing the bacteria into an innocent victim.
Devices are often used in contaminated areas of the body
In addition, the actual nature of reprocessed single-use devices
lends itself to disease transmission because: (a) the majority of
devices are used in the vascular system or in a contaminated area such
as the urological or gastrointestinal tract, and (b) most devices have
sharp points. All of the above factors contribute to disease
transmission in reprocessed devices and enormously raise the likelihood
that this is not a safe device when used under these circumstances.
public awareness
The reason the public is not up-in-arms about the use of
reprocessed devices is that people don't know enough about this issue,
which is why this hearing is so important. Reprocessing is not an issue
of greedy manufacturers; it is an issue that the public, when informed,
decries. The following data illustrate the issue of public awareness--
or lack thereof--and people's responses when they become aware.
1. In a study called The Medical Device Reuse Awareness Study for
Halsted Communications, conducted in October 1997, the
following question was posed to 501 participants from Los
Angeles, New York, Chicago, and Atlanta: How would you feel if
a device that by law was designed to be used once, was reused
on you or on someone you love? People responded as follows: 84%
stated they would be angry; 76% would demand an explanation;
69% would be frightened; and 59% would ask for a guarantee that
the person that the device was used on before was healthy.
Nineteen percent of the respondents from Los Angeles stated
that they would sue if they found out this happened.
2. Recently in Japan, a clinic initiated a policy in which patients
were told that there were two kinds of accessories they could
use in a procedure: single use or reprocessed. If they chose
the single-use device, however, they would have to pay an out-
of-pocket premium. Everyone chose to pay the premium.
3. Some time ago the television show ``Dateline'' did a piece on the
practice of reusing some dental material--braces in particular.
Following this program, there was a huge outcry. Again, it was
a case of the public initially not knowing, but voicing their
displeasure when they found out.
4. Many studies, commissioned by original manufacturers, have been
conducted by independent sterility testing labs. In these
studies, researchers took random samples of reprocessed medical
devices sitting on shelves in hospitals--ready for use in
patients. The reprocessed devices were then sent to the
independent lab for testing. In all the studies, a large number
of devices were found to be contaminated with blood, body
fluids, tissue, cleaning chemicals and bacteria. These studies
represented real situations, not just a theoretical concept. It
was not a case of ``What do you think would be used?'' Rather
it was a case of what would have been used, since these devices
were right there on the shelf awaiting the next patient.
5. At a symposium during a meeting of the Society for Gastrointestinal
Nurses and Associates, Inc. (SGNA) held in 1998, nurses were
asked the following question: ``If you were a patient, what
would you want used on you: single-use or reprocessed
devices?'' Unanimously, they did not want reprocessed devices.
Since then, the SGNA as an organization has published a
position paper speaking out against the practice of
reprocessing. It states, ``In the absence of clear regulatory
guidelines for reuse of single-use devices, based on current
scientifically based literature, and taking into consideration
concerns for patient safety and ethical practice, the Society
of Gastroenterology Nurses and Associates, Inc. supports the
position that critical medical devices labeled for single-use
should not be reused.''
informed consent and liability:
The outgrowth of the practice of reprocessing single-use devices
raises the issues of informed consent and liability. I believe that:
1. Ultimately the physician or physicians using the devices bear a
significant liability. They are the guardian of the patient. If
physicians have knowledge that the device handed to them in any
way might cause harm, they have accepted some responsibility.
2. If a hospital makes a choice to take a legally labeled single-use
device and use it contrary to the manufacturer's instructions,
the hospital also bears responsibility.
The patient's right to know
This also raises a question as to what the patient has the right to
know and do. Based on the above, it is my belief that, in addition to
telling the patient of the risks and benefits, potential complications,
and the names(s) of the physician(s), there should also be informed
consent. It would state: ``Devices that we use have been previously
used in other patients. Those patients may have had infectious
diseases, including AIDS and hepatitis. These devices are used contrary
to manufacturer' instruction.'' The patient would then have the
opportunity to say, ``Yes, I understand; go ahead and use the
reprocessed device.'' This, however, is obviously not being done. I
believe the practice of reprocessing of single-use devices is a
significant enough deviation that does warrant truly informed consent.
Why is information withheld?
Before conducting a procedure, I don't hesitate to tell my patients
that they have a one in ``x'' risk of perforation, the possibility of
hemorrhage, or even death. Clearly, it is not atypical to advise
patients of potentially serious or even possibly fatal events
associated with procedures. So why is it that we hide information about
the risks of reprocessed devices? The answer is that physicians and
hospitals are comfortable saying, ``The procedure we're doing is the
best available for your condition, while recognizing that no procedure
is perfect. Here is the scientific information to show why, given the
risk/benefit ratio, it is in your best interest.'' That is different
from trying to hide the fact that ``We paid $50 for a single-use,
disposable device, but by reusing it over and over, we will save the
hospital money.''
It is as though physicians and hospitals are not informing people
about using reprocessed devices and are not asking for consent because
they don't want people to know. If they are unwilling to ask for
informed consent, does that not tell the whole story?
Do patients get equal treatment?
A patient might rightfully question, ``Why do I go through life
living so carefully and avoiding risky behavior, then you expose me to
the risky behavior of someone else without telling me that the
motivation is to save money for the institution?'' Or, ``Why does
patient #1 get the benefit of a sterile, first-use device with no risk
of disease transmission while I, patient #2, get a reprocessed
device?'' There would be no justifiable answer.
in conclusion:
I have never in my own profession or in related specialties heard a
physician or hospital say, ``I think reprocessed single-use devices are
better.'' The only justification is that ``it helps control costs and I
think it's OK.'' Ardent supporters may say that they have conducted
many procedures safely with reprocessed single-use devices without
hearing about resulting deaths or diseases. But, you can't take a
device apart to ensure that it's sterile, and therefore, one doesn't
really know. We need to be open enough to state that we have seen
tremendous microbiological studies, including DNA fingerprinting, that
confirm that reprocessed devices can transmit disease. If we err on
this position, we should do so on the side of public protection. I
don't think the public is best served by waiting to form public policy
until enough victims are amassed.
You will hear from many people who will offer their legal,
microbiological, and engineering perspectives. The real message you
need to take away from me in my professional, life-long role as a
patient advocate is that, while not dismissing the hospital or its
association's role as the patient advocate, it is perhaps the physician
who has the major advocacy role and who ultimately drives the decision.
I understand cost containment, I am not a naive physician saying
that cost doesn't matter. In today's healthcare climate, we all must be
mindful of cost in order to be able to continue to deliver healthcare
to the populace. In fact, I currently sit on the board of directors of
a hospital and constantly deal with cost containment. However,
understanding the need to control health care costs and making
decisions for which current information tells us that our decisions may
be injurious to the patient, are hopefully--and should be--mutually
exclusive.
In closing, I'd like you to ask yourselves this question: Would you
want your loved ones who had the misfortune of being ill to be in the
care of a doctor or a hospital where you sat in the waiting room and
not only needed to worry about the disease that has afflicted them, but
also had to worry about the safety of the very device used to try to
bring about their wellness?
Mr. Upton. Thank you for your final answer.
Dr. Fielder?
TESTIMONY OF JOHN H. FIELDER
Mr. Fielder. Mr. Chairman, I am John Fielder. I am a
professor of Philosophy at Villanova University and I am here
not representing any group.
Risk is the probability of harm times the severity of harm.
We know that the severity of harm, potential harm is very
great. Hepatitis C, tuberculosis, and other diseases. What we
do not know is how large the probability of that harm is,
however, even if you have a low probability of harm, if the
severity of harm is high, you have a significant risk. Now, the
ethics of risk are clear and they are well established, both in
ethics and law. It is the patient's right to be informed of the
risk, informed of the benefits, the alternatives to treatment,
and to give consent. These principles are based on the
fundamental idea that persons are in charge of their lives and
it is the job of healthcare professionals to guide them in
making those decisions. Most patients are not informed that
they are being treated with devices that pose additional risk
to them over a single-use device.
Last fall I prudently got a flu shot, went down to the
infirmary at Villanova and they shot me, but I had to sign a
consent form first that told me the dangers, the benefits, and
the alternatives. So I signed it and I got my shot. And I was
thinking as I was walking back that if it is appropriate for me
to sign a consent form to get a flu shot like millions of other
Americans, I would sure like to sign a consent form if somebody
was going to put one of these things that had been in somebody
else into my body and to bite off a piece of me to bring back
for a sample. It is enlightening and constructive to try to
construct a consent form for a patient who is going to be
treated with a reused device. First the risk. Okay. We have
talked about the risks, we know that there is a potential of
transmission of disease, of functional degradation, and so
forth.
But what exactly are the benefits here to the patient? See,
this is where we hit the ethical brick wall. The patient is
getting no benefit by being treated with a reprocessed device.
They are getting additional risk, but they are not getting any
additional benefit. Now, you will be told that the savings from
these reprocessed device will be put back into patient services
and life will be better for patients and hospitals. This may be
true. But it is also true that money might go into the pockets
of investors or for-profit hospitals as well. Also, it seems to
me if this is a great benefit, put it down, let patients decide
if they want that benefit based on the risk that the device
poses.
I think the use of reprocessed devices in a present form is
really a kind of vast medical experiment that we are doing. We
do not really know the outcomes of using these extensively, we
do not really know how much disease is being transmitted, and
we are doing it without people's knowledge and consent. And
that is wrong. We should not be doing that. A couple of other
items. Fairness. I am pleased that the FDA is moving in the
direction to make the regulatory burden for the original
equipment manufacturers and the reprocessors more or less
equal. That seems to be appropriate. It is simply unfair to ask
one group to go through a complicated song and dance to get
their device approved and not the others. Another item I am
concerned about is labeling. Many times physicians do not know
that they are using a reprocessed device. They do not open it
in the operating room. Somebody else does and hands it to them.
So when they get the device, it says Cortis, or Boston
Scientific, or whatever, and they will think they are using an
original device. I think that is unfair to the original
equipment manufacturers because that is no longer their device
once it is reprocessed. And I would urge FDA and perhaps this
committee if it is appropriate, to make sure that this
information about the device is on the device so that people
who are using it can tell, and so that patients who may be
damaged can use that if they want to sue for damages.
Finally, as in all things, money is a big issue here. I
know that hospitals are under tremendous financial pressure.
Some of it from the Government, from HCFA and Medicare, some of
it from insurers. One of the reasons this kind of problem pops
up was that it is very hard to treat people in hospitals and
make money and to stay afloat. I am very concerned that we
create a system where hospitals start looking for places that
are ethically questionable to save money. I would much rather
have a system where they could do their work and have adequate
resources to do it, and not have to consider this kind of
practice. Thank you Mr. Chairman, I appreciate your holding
hearings on this important topic.
[The prepared statement of John H. Fielder follows:]
Prepared Statement of John H. Fielder, Villanova University
Introduction
The patient is the ethical center of health care. All who
participate in patient care, directly or indirectly, are ethically
obligated to provide adequate and appropriate care to patients and to
safeguard their right to make informed health care decisions. Patients
are ill, vulnerable, dependent, and usually ignorant of the nature of
their illnesses, their treatment options, and what they mean for them.
As a result, they require a greater degree of help and protection than
persons who are not ill.
Almost all health care procedures involve some risk to the patient.
It is a long-standing tradition in ethics and law that patients have
the right to decide what risks to take, and health care professionals
have the obligation to inform them of the risks and benefits of
alternative treatments, including nontreatment.\1\ Patients are in
charge of their lives, not doctors. The greater the risk, the greater
the patient protection that is needed. Formal biomedical research must
meet extensive requirements concerning maximizing benefits while
minimizing risks, independent review, and informed consent.\2\ The
concept of informed consent embodies the ethical principles of patient
autonomy and provider beneficence.
---------------------------------------------------------------------------
\1\ Beauchamp, Tom, and Childress, James, Principles of Biomedical
Ethics, Fourth Edition (1994), Oxford University Press, New York.
\2\ Faden, Ruth, and Beauchamp, Tom, A History and Theory of
Informed Consent (1986), Oxford University Press, New York.
---------------------------------------------------------------------------
Risk
From the patients' point of view, the primary question concerns the
risks posed by the reuse of medical devices approved by FDA only for a
single use. The devices in question are those that pose the greatest
risk to patients. No one worries about the reuse of single-use
compression sleeves or bedpans. It is the complex devices like cardiac
catheters, biopsy forceps, and similar devices that raise the most
serious questions of risk. These devices enter the patient's blood
stream, intestines, and major organs where disease organisms reside.
They also have tiny passages for guide wires which may be difficult to
clean and resterilize.
It is important to distinguish the two factors that are used to
determine risk. Risk is the product of the probability of harm and the
severity of harm. Thus, high risk could result from the high
probability of moderate harm as well as the low probability of very
serious harm. In assessing risk we must look at both the seriousness of
the potential harms as well as the likelihood of their occurrence.
In addition, we need to distinguish two kinds of harms that may
result from treatment with a reused single-use device. First, diseases
may be transmitted from previous patients to the patient being treated
through inadequate cleaning and resterilization. Second, devices may
have their functional characteristics changed as a result of cleaning,
so that patients may be injured or be given less than optimal
treatment. Thus we need to look at the probability and severity of harm
regarding both functional changes and disease transmission.
From my study of reuse of single-use devices, the following facts
emerge:
We know that studies of reprocessed single-use devices by FDA
and others show that some devices have debris left in them and
are contaminated with fungi, bacteria, or viruses. A study of
Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon
catheters found that some clean easily while others seemed to
regularly get clogged. About half the samples grew organisms in
the middle sections.\3\ Other studies report residual organic
debris that cannot be adequately eliminated.\4\ Company-
sponsored studies, some by independent laboratories, confirm
these results.\5\
---------------------------------------------------------------------------
\3\ Merritt, Katherine, Hitchins, Vicki, Woods, Terry, and Brown,
Stanley, ``Re-Use of Devices: Cleaning Issues,'' presentation at the
Association for Medical Instrumentation/FDA Conference, The Reuse of
Single-Use Devices: Practice, Patient Safety, and Regulation, Crystal
City, VA, May 6, 1999. This information was taken from a public
presentation; FDA has not made a report of this study publicly
available.
\4\ Yang M, Deng X, Zhang Z, Julien M, Pelletier F, Desaulniers D,
Cossette R, Teijeira FJ, Laroche G, Guidoin R, ``Are intraaortic
balloons suitable for Reuse? A survey of 112 used intraaortic
balloons.'' 1997 Artificial Organs 21(2) 121-130.
\5\ Two of the most extensive were conducted by Ethicon Endo-
Surgery, a Johnson and Johnson Company, ``Evaluation of Reprocessed
Ethicon Endo-Surgery, Inc. Single-Use Medical Devices,'' (1998) Ethicon
Endo-Surgery, Cinncinnati, OH, and Muradali, Kumaree, ``Report on Re-
furbished Single Use Devices,'' Cordis, a Johnson and Johnson Company,
Miami Lakes, FL.
---------------------------------------------------------------------------
We know that reprocessing devices can result in functional
changes. Another FDA study of PTCA balloon catheters found that
there were changes of up to 10% in balloon diameter after
reprocessing. Reprocessed balloons were also stickier that new
ones. The effects of cleaning agents on the various plastics
used in devices is materials-specific.\6\ The company-sponsored
study (see note 5) also found function changes in the devices
they studied.
---------------------------------------------------------------------------
\6\ Brown, Stanley, Merritt, Katherine, Hitchins, Vicki, and Woods,
Terry, ``Effect of Use and Simulated Reuse on Materials and PTCA
Balloons and Catheters,'' presentation at the Association for Medical
Instrumentation/FDA Conference, The Reuse of Single-Use Devices:
Practice, Patient Safety, and Regulation, Crystal City, VA, May 6,
1999. This information was taken from a public presentation; FDA has
not made a report of this study publicly available.
---------------------------------------------------------------------------
We know that devices approved for reprocessing have been
responsible for the transmission of TB and hepatitis C during
bronchoscopy and colonoscopy because of improper cleaning and
sterilization.\7\
---------------------------------------------------------------------------
\7\ Bronowicki JP, Venard V, Botte C, Monhoven N, Gatin I, Chone L,
Hudziak H, Rhin B, Delanoe C, LeFaou A, Bigard MA, and Gaucher P,
``Patient-to-Patient transmission of Hepatitis C Virus During
Colonoscopy,'' New England Journal of Medicine (1997) July 24; 337(4):
237-40. Michele TM, Cronin WA, Graham NM, Dwyer DM, Pope DS, Harrington
S, Chaisson RE, Bishai WR, ``Transmission of Mycobacterium Tuberculosis
by a Fiberoptic Bronchoscope. Identification by DNA Fingerprinting,''
Journal of the American Medical Association (1997) Oct. 1;
278(13):1093-5.
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We know that reprocessed devices can also transmit diseases.
Sixty percent of pediatric patients treated with reused
tracheostomy tubes contracted pneumonia compared to 25% treated
with new ones.\8\ We do not know if other diseases,
particularly hepatitis C, are being transmitted because no
studies have screened patients before treatment and tested them
later. A report by a well-regarded independent organization
concluded that ``there is no clear evidence that reuse of
single-use medical devices is either safe or unsafe for
patients.'' \9\
---------------------------------------------------------------------------
\8\ Bahng, Susanna, VanHaln, Sonja, Nelson, Virgina, Hurvits,
Edward, Roloff, Dietrich, Grady, Elizabeth, Lewis, Cathy, ``Parental
Report of Pediatric Tracheostomy Care,'' Archives of Physical Medicine
and Rehabilitation, (1998) Vol. 79; 1367-9.
\9\ ECRI Special Report, Reuse of Single-Use Devices: Making
Informed Decisions (1996). ECRI, Plymouth Meeting, PA., p. 1.
---------------------------------------------------------------------------
We know that reprocessed devices have failed and injured
patients. A patient undergoing cardiac catheterization for
coronary angiography reported a sudden loss of vision in his
right eye. The procedure was stopped and an examination of the
eye revealed a green crystalline foreign body within the
central retinal artery on the optic nerve head. The catheter,
approved only for a single use, was reautoclaved, making it
more friable. A fragment had broken off and traveled to the
central retinal artery, occluding blood flow. Treatment of the
injury was unsuccessful and the patient was left with only
light perception in his right eye.\10\ In another case the tip
of a reused cardiac catheter broke off and lodged in a
patient's atrium.\11\
---------------------------------------------------------------------------
\10\ Hallermann D, Singh G. ``Iatrogenic central retinal artery
embolization: a complication of cardiac catheterization.'' Annals of
Opthalmology 1984; 16:1025-27.
\11\ MedWatch report, 3/18/99. MedWatch is a voluntary reporting
system of FDA.
---------------------------------------------------------------------------
We know that a few studies in peer-reviewed journals show that
single-use and reprocessed devices have similar rates of in-
hospital adverse events. One study in this literature is a
double-blind, randomized control trial of 1,033 procedures, of
which 753 were reused PTCA balloon catheters. They found slight
differences in serious adverse complication rates, urgent
coronary artery bypass surgery, and abrupt vessel closure.\12\
---------------------------------------------------------------------------
\12\ Mak, Koon-Hou, Eisenberg, Mark, Plante, Sylvain, Strauss,
Bradley, Arheart, Kristopher, and Topol, Eric, ``Absence of Increased
In-Hospital Complications with Reused Balloon Catheters,'' The American
Journal of Cardiology (1996) Vol. 78; 717-9.
---------------------------------------------------------------------------
Several conclusions can be drawn from these facts.
Changes in Functional Characteristics
Severity of Harm: Reprocessed devices can fail and cause serious
injuries. Other changes in functional characteristics can result in
difficulties in treatment that may result in injuries or additional
exposure to risk.
Probability of Harm: There are only a few reports in the literature
of patients being harmed by failure of these devices, but it is likely
that device failures are underreported. Also, physicians may not
recognize problems caused by reprocessing. The probability of in-
hospital adverse events does not appear to be high, but more studies
need to be done to confirm this.
This analysis suggests that the probability of harm from functional
failure is likely to be low, although more good scientific evidence is
needed to establish this with reasonable certainty. I conclude that
patients who are treated with reprocessed single-use devices are being
subjected to a low risk of failure to function adequately.
Transmission of Disease
Severity of Harm: Reprocessed devices have the potential to
transmit deadly diseases; thus the severity of harm is high.
Probability of Harm: The probability of transmission of disease is
unknown but is certainly greater than zero. It also varies with the
type, brand, and model of device.
The real risk is not in functional failure but in the transmission
of disease. The severity of harm is great from TB and hepatitis C, and
we simply do not know much about the probability of this happening with
reprocessed single-use devices. We do know that improper cleaning and
resterilizing of used devices can transmit these diseases, and we know
that there is no manufacturer-developed and FDA-approved protocol for
cleaning them. Even if this is a low probability of harm, the severity
of the consequences creates a significant risk for patients.
Informed Consent
In cases where patients are exposed to a significant risk, ethics
requires that they be informed of the benefits of treatment, the risks,
and the alternatives. This is true even for common, low risk
procedures. Last October I got a flu shot at the Villanova University
Health Center. Vaccines have a small probability of triggering an
immune reaction that can cause serious illness or death. Because of
this I was asked to read and sign a consent form that informed me of
the benefits of the injection, the risks, and alternatives. The form is
appended to this document.
Since patients treated with reprocessed single use devices are also
exposed to a significant risk, it is enlightening to construct a
consent form for this procedure. Imagine that you are being asked to
consent to the use of a reprocessed device in your treatment instead of
an otherwise identical new, single-use device.
The form would have to state that the potential harms include the
possibility of transmission of TB and hepatitis C, very serious
diseases, and possible functional changes or failures. While some
studies suggest that the probability of these events occurring is low,
we do not really know how likely they are.
What are the benefits? None to you, the patient, only to the
hospital's finances. Note that the consent form may also have to
include the fact that the hospital has a significant financial interest
in treating patients with reprocessed devices.\13\
---------------------------------------------------------------------------
\13\ Moore v. Regents of the University of California, 51 Cal. 3d
120 (1990)
---------------------------------------------------------------------------
What are the alternatives? Besides nontreatment and any other less
invasive procedures, you could be treated with a new device at no extra
cost to you and avoid these potential complications. In effect, you are
being asked to take significant risks in your treatment for no
corresponding benefit to you but to contribute to the financial health
of the hospital.
To see how this works in practice, consider two patients, in 403A
and 403B, both scheduled for cardiac catheterization. The patient in
403A will be treated with a new, single-use device and will have no
risk of the infection being transmitted by the catheter, nor will that
patient or the physician have to worry about any functional changes
from previous uses. In contrast, the patient in 403B is put at risk,
without any corresponding therapeutic benefit, and without the
patient's knowledge or consent. This is simply ethically unacceptable.
You cannot put people at risk without their informed consent.
Patient Benefit
Proponents of reuse sometimes argue that savings will be passed on
to patients in the form of more and better services, but this is a weak
argument. First, in for-profit hospitals those savings will, in part,
be returned to investors as dividends. Second, it is not guaranteed
that any savings will directly affect the patients taking the risk,
because savings may well be applied to other hospital service areas.
Third, patients being treated with a reprocessed device may get some
indirect benefit from previous savings generated by reuse, but none
from their treatment with a reprocessed device. Fourth, if these are
patients' benefits, no matter how remote, shouldn't they have the right
to decide where they should be spent? The fact of the matter is that it
is the hospitals who benefit, and that benefit may have some indirect
beneficial impact on patient care. But this does not alter the fact
that any beneficial impact that accrues to a particular patient is
greatly out of proportion to the risks being taken.
Medical Experimentation
There are further ethical anomalies in the reuse of single-use
devices. When you take your flu shot, the probability of harm is
reasonably well established. When you are treated with a reprocessed
device, there are substantial unknowns, especially concerning disease
transmission. Consequently, the use of reprocessed devices is a form of
experimental treatment, providing an even stronger claim for the
traditional ethical protections, particularly informed consent.
The adequacy of consent to a pure experiment of to experimental
treatment raises more issues than consent to an established
therapy simply because less is known about the risks involved
in an experimental procedure . . . Therefore a prospective
subject must be aware that little is known about the possible
risks and consequences . . .\14\
---------------------------------------------------------------------------
\14\ Woltjen, Maria ``Regulation of Informed Consent to Human
Experimentation,'' Loyola University of Chicago Law Journal, Vol. 17
(1986), p. 313.
---------------------------------------------------------------------------
In the absence of adequate scientific evidence to establish the
probability of harm, particularly the transmission of disease, and in
the absence of FDA-approved, device-specific protocols for cleaning,
resterilizing and number of permitted uses, the continued use of
reprocessed medical devices is a large, ongoing medical experiment, but
one that lacks even the rudimentary protections to patients,
particularly the requirements that risk be proportional to patient
benefit and informed consent.
This raises further questions about the ethical responsibilities of
all who participate in this practice--hospitals, health care
professionals, and reprocessors. Because the use of reprocessed medical
devices is an unethical form of medical experimentation, then the
hospitals, physicians, and other health care professionals who take
part in it are also not meeting their obligations to put patient
interests first and to uphold their right to informed consent.
Other Ethical Issues
Regulatory Fairness: Risk and patient protection are the primary
ethical issues, but there are others that need to be mentioned.
Original equipment manufacturers (OEM's) who wish to market a reusable
device must submit a validated protocol to FDA for approval. The
protocol must include scientific evidence to show that it can be
properly cleaned and resterilized, the effect of cleaning an
resterilization on the materials, functionality, and safety of the
device, and the number of times it can be reprocessed without loss of
safety and effectiveness. No such regulatory burden falls on the
reprocessor, who must, at most, meet good manufacturing and quality
control standards. This is an unequal burden for which there is no
adequate justification. Thus the present arrangements are unfair to
OEM's. However, FDA has recently taken significant steps to bring
reprocessed devices under greater regulatory scrutiny.
Labeling: Reprocessed devices still bear the name of the OEM on the
device, but in a real sense it is no longer theirs, since they can no
longer vouch for their safety and effectiveness. Unless there is clear
information in the labeling of the reprocessed device, there is the
misleading suggestion that the device has the assurance of quality,
safety, and effectiveness associated with the OEM, or that any failure
is to be attributed to the OEM.
OEM's and Reprocessors: Are OEM's unethical for failing to produce
reusable catheters? Critics have charged that what were once reusable
devices were simply relabeled for single use. Is this practice wrong?
The FDA does not have the authority to determine what products
companies may develop or what they charge for them. It is a basic
principle of our economic system that producers have a right to decide
what products they wish to market as long as they meet all legal and
regulatory requirements. Unless there is some strong reason to think
otherwise, OEM's and reprocessors are not ethically obligated to make
or withhold particular products.
Conclusion
Hospitals are under severe financial pressure from payers,
including Medicare and HCFA. They are, understandably, looking for ways
to cut costs and using reprocessed devices is one of them. However,
this practice is, at present, ethically unacceptable because of the
severity of potential harm to patients, the lack of knowledge about the
probability of disease transmission, and the absence of device-specific
FDA standards for cleaning and resterilizing. It amounts to an
extensive medical experiment without patient benefit, knowledge, or
consent.
It may be useful to end with the observation that it is the problem
of costs that is driving the issue of reuse of single-use medical
devices. The present arrangements encourage ethically questionable
arrangements because of the pressure to cut costs of services.
Mr. Upton. Thank you very much.
Dr. Maurer, welcome.
TESTIMONY OF WALTER G. MAURER
Mr. Maurer. Thank you. Mr. Chairman, members of the
committee, I am Dr. Walter Maurer, Director of Quality
Management at the Cleveland Clinic Foundation in Cleveland,
Ohio. I am here today on behalf of the American hospital
Association. In addition to being Board Certified and
practicing in both the areas of internal medicine and
anesthesiology, I serve as Medical Director of the Office of
Quality Management. With approximately 50,000 surgeries and
more than 1.5 million outpatient visits yearly, it is my
responsibility to guide and direct our quality management team
in ensuring the highest level of patient care is provided. I
also chair the Quality Council, the Safety Coordinating
Committee, and the Joint Commission Preparation Team.
The term reuse and reprocess can encompass numerous
scenarios and they take place in multiple locations: In
hospitals, ambulatory surgical centers, and physician offices.
Some hospitals utilize the services of third party reprocessors
while others reprocess within their own facilities. In some
cases, the device never touches a patient. For example, almost
every day at the Cleveland Clinic we have a surgery cancelled
or postponed, sometimes after the operating room has been
prepped for the procedure. That preparation may include
assembling customized procedure trays that contain many open
single-use devices, such as needles, scalpels, and syringes. I
have with me here today what we term our total hip pack. This
total hip pack costs us $236. I just spent $236. This is
medical trash. Right now this is all thrown away. This is gone.
Another common scenario is the use of a low risk device,
one that does not penetrate a sterile tissue plane or mucus
membrane during use, but may simply contact the patient's skin.
For instance, the device put on a patient's leg to promote
circulation comprised largely of plastic and fitting like a
sleeve over a patient's leg. Hospitals routinely clean,
sterilize, inspect, and repackage these types of devices.
Ironically the most controversial reprocessing practice is
probably the least common for hospitals, that of cleaning,
sterilizing, and repackaging a single-use, critical device
after it has been used on a patient. With constrained
healthcare resources and a heightened commitment to the
environment, reprocessing does makes sense.
I need only reiterate the slogans we now teach our
children, the three Rs of reduce, reuse, and recycle. AHA
members are committed to being better stewards of the
environment by pledging to reduce, not increase waste. The AHA
strongly supports the FDA's plan to develop a research program
to help bridge the data gap between the perceived and actual
safety risks associated with the reuse of single-use devices.
We must move away from anecdotal reports although they are
important to look at. Research should be directed at more
complex or high-risk devices and be peer reviewed and published
for credibility. This will provide device specific scientific
evidence regarding patient safety. We applaud the FDA's plan to
develop consensus standards for the reprocessing of single-use
devices. The FDA should include all stakeholders,
manufacturers, third party reprocessors, healthcare facilities,
physicians, and members of the public in developing the
consensus standards.
At the Cleveland Clinic, for example, our cardiology
electrophysiology laboratory reprocesses diagnostic heart
catheters. These are solid tubes without hollow lumens. Each
catheter is limited to five uses. First it is thoroughly
cleaned by professionals in sterile processing. It is then
tested after each and every use for electrical and mechanical
safety and function and only then re-sterilized. Each year
standard operating procedures are reviewed and patient outcomes
are assessed. The sterilization practices are regularly
reviewed and staff competency assessed. Since 1993 our lab has
had a continuous quality improvement project on any infections
caused by any procedures done in that lab. Infection cases are
then reviewed with the Infectious Disease Department.
Additional oversight is provided through existing Federal
and State agencies charged with ensuring safe quality patient
care. We must restore the meaning to the term single-use.
Original equipment manufacturers have little to no incentive to
label their devices as reusable, and, in fact, have financial
incentives to self-designate devices as single-use. In the last
2 years we have observed products that have been historically
labeled as reusable arriving with the single-use label with no
observable change in the product. These are orthopedic saw
blades. Stainless steel. There are no small lumens in these.
This is reusable. This is not. The ones that we have started to
use reprocessors of, I found out, are marked when they come
back. So we know which ones are reusable and how many times
they have been reused.
The FDA should begin to regulate the use of single-use only
labels and require manufacturers to both justify labeling a
device as single-use and provide scientific data specifying any
re-sterilization or reprocessing techniques that may compromise
the integrity of the device. In conclusion, Mr. Chairman,
patient safety is the first and foremost concern of all
hospitals and health systems. The AHA believes that the FDA's
proposed strategy on the reuse of single-use devices represents
a thoughtful approach to a complex issue. And we are pleased
that the FDA has been consulting with front-line caregivers and
other experts in its effort to make the standards even more
meaningful. We further believe that the additional legislation
is unnecessary at this time and would only undermine the
progress that the FDA has already made. We welcome the
opportunity to work with the FDA to ensure the best practices
are universally used. Thank you.
[The prepared statement of Walter G. Maurer follows:]
Prepared Statement of Walter Maurer, Cleveland Clinic Foundation, on
Behalf of the American Hospital Association
Mr. Chairman, I am Walter Maurer, M.D., director of quality
management at the Cleveland Clinic Foundation in Cleveland, Ohio. I am
here today on behalf of the American Hospital Association's (AHA)
nearly 5,000 hospital, health system, network, and other health care
provider members. We are pleased to have the opportunity to testify on
the long-standing practice of reprocessing medical devices.
The Cleveland Clinic Foundation, founded in 1921, integrates
clinical and hospital care with research and education in a private,
non-profit group practice. Last year at the Cleveland Clinic and
Cleveland Clinic Florida, more than 850 physicians representing 100
medical specialties and subspecialties provided care for more than 1
million outpatient visits and close to 50,000 hospital admissions.
I have spent most of my career as a private practice internal
medicine specialist and anesthesiologist at the Cleveland Clinic with a
focus on outpatient, pediatric, and ear, nose and throat anesthesia. I
also have been involved in resident education, quality assurance and
preoperative testing. Currently, I serve as the medical director of the
Office of Quality Management. The role encompasses the hospital, its
ambulatory settings including community health centers, and a long-term
care facility. With approximately 50,000 surgeries and more than 1.5
million outpatient visits yearly, it is my responsibility to guide and
direct our quality management team in ensuring the highest level of
patient care is provided. I also chair the Quality Council, the Safety
Coordinating Committee and the Joint Commission Preparation Team.
background
The term ``reuse'' and ``reprocess'' can encompass numerous
scenarios, and they take place in multiple locations, in hospitals,
ambulatory surgical centers and physician offices. Some hospitals
utilize the services of third-party reprocessors while others reprocess
within their own facilities. In some cases, the device never touches a
patient. For example, almost every day at the Cleveland Clinic we have
a surgery cancelled or postponed, sometimes after the operating room
has been prepped for the procedure. That preparation may include
assembling customized procedure trays that contain many open single-use
devices (SUDs), such as needles, scalpels, sponges and syringes. What
becomes of these devices when the surgery is cancelled? Most of it
would be unfortunately wasted as ``medical trash'', but because of
increased environmental concerns and cost reduction initiatives, we
have found that we can safely sterilize, inspect and repackage many
devices for later use.
In another scenario, often a manufacturer will ship SUDs to
hospitals with separate sterilization instructions, if the manufacturer
is experiencing a period of high demand and has not had time to
sterilize the SUDs prior to shipment. Hospitals sterilize, inspect and
repackage these devices too.
Another common scenario is the reuse of a non-critical device-one
that does not penetrate a sterile tissue plane or mucus membrane during
use, but may contact the patient's skin. For instance, a sequential
compression device, which is used on the patient's leg to promote
circulation and avoid deep vein thrombosis, is comprised largely of
plastics and fits like a sleeve over a patient's leg. Hospitals
routinely sterilize, inspect and repackage these types of devices.
Ironically, the most discussed reprocessing practice is probably
the least common for hospitals: that of cleaning, sterilizing and
repackaging a single-use, critical device after it has been used on a
patient so it can be used again on another patient.
reprocessing makes sense
Many medical products can be safely reused. The AHA is unaware of
any evidence to demonstrate a problem with reprocessed SUDs. With
constrained health care resources and a heightened commitment to the
environment, reprocessing makes sense. I need only reiterated the
slogans we now teach our children--that's the three R's--reduce, reuse,
and recycle. AHA members are committed to being better stewards of the
environment by pledging to reduce, not increase waste. In 1998, the AHA
and the Environmental Protection Agency initiated a joint-partnership
to reduce hospitals' total waste volume by 50 percent by 2010.
Responsible waste management and recent cost reduction initiatives have
resulted in the discovery that hospitals can safely sterilize, inspect,
and repackage many devices for later use.
The AHA is encouraged by the Food and Drug Administration's (FDA)
decision to provide guidance in this area to ensure and enhance patient
safety, which is the first and foremost concern of AHA members. AHA
members have a great deal of experience with reprocessed medical
devices and have been working closely with the FDA as it refines its
strategy. We believe that the agency's Proposed Strategy represents a
thoughtful approach to a complex issue; it both echoes and furthers the
goals of patient safety, which we share.
The potential for device malfunctions, patient injuries, or
infections related to the reprocessing and reuse of single-use devices
is a matter of great concern to hospitals and health systems. The AHA
strongly supports the FDA's plan to develop a research program to help
bridge the data gap between the perceived and actual safety risks
associated with reuse of SUDs. Such research should be directed at the
more complex or highrisk devices and be peer reviewed and published for
credibility. This will provide device-specific scientific evidence
regarding patient safety.
The AHA also is encouraged by the FDA's proposal to categorize SUDs
into risk categories, and we agree that the level of regulation for a
device correspond to the level of risk to a patient.
Furthermore, the AHA applauds the FDA's plan to develop consensus
standards for the reprocessing of SUDs. These kinds of standards would
go a long way toward addressing the safety, and effectiveness of
reprocessing. The FDA should use a ``community best practices''
approach for low-risk devices and a more formal FDA interdisciplinary
advisory panel for high-risk devices. The FDA should include all
stakeholders--manufacturers, third-party reprocessors, health care
facilities, physicians and members of the public--in developing the
consensus standards.
oversight of reprocessing
Hospitals are subject to significant regulatory and accreditation
oversight by entities such as the Health Care Financing Administration,
the Joint Commission on Accreditation of Healthcare Organizations
(JCAHO), state licensing authorities, and other county and city
agencies, particularly with respect to patient safety and quality of
care. By contrast, only one outside source--the FDA, regulates
manufacturers and third-party reprocessors.
Hospital reprocessing activities are marked by a high degree of
physician involvement, supervision and control. In many cases, a multi-
disciplinary committee, such as the infection control committee,
consisting of clinical staff (physicians and nurses) and operational
staff (sterile processing, risk management, and materials management)
oversees the reprocessing activities of health care facilities. This
committee monitors reprocessing quality assurance and improvement
activities, recommends strategies for improving performance, and
reports such findings and recommendations to the facility's performance
improvement oversight committee, medical staff and governing body.
Through its membership, activities and reporting structure, this
type of multi-disciplinary committee meets the requirements of numerous
JCAHO standards, including those for surveillance, prevention and
control of infection, etc. Naturally, medical professionals and the
health care facilities in which they practice have as their primary
mission quality patient care, and have in place standards, policies and
procedures for reprocessing.
At the Cleveland Clinic, for example, our cardiology
electrophysiology laboratory reprocesses both non-lumen diagnostic
electrophysiology catheters and non-lumen radiofrequency ablation
catheters. Each catheter is used five times or less. It is tested after
each use for electrical and mechanical safety and function, and then
resterilized. Each year, standard operating procedures are reviewed and
patient outcomes are assessed. The sterilization practices are
regularly reviewed and staff competency assessed. Since 1993 our lab
has had a continuous quality improvement project on any infections
caused by any procedures done in the lab. Infection cases are then
reviewed with the Infectious Disease Department.
Reprocessing standards, policies and procedures, in conjunction
with the quality improvement program, are designed specifically to
protect the well-being of hospital patients. Existing nonFDA regulatory
oversight, which the AHA believes includes the components necessary to
address and satisfy the FDA's concerns in this area, has resulted in
the development of these processes.
For instance, JCAHO, during its announced and unannounced surveys,
focuses heavily on patient safety. In addition to visiting patient care
and reprocessing areas to observe infection control practices, JCAHO
reviews the minutes of the infection control committee, the medical
staff executive committee, the performance improvement oversight
committee and the governing body. The inspectors look for evidence of
sufficient reporting of performance improvement information and for
action on performance improvement recommendations. Failure to
adequately demonstrate compliance in these areas would result in
substantial findings of noncompliance for the facility.
restore meaning to the term ``single use''
Original equipment manufacturers have little incentive to label
devices as reusable, and, in fact, have financial incentives to self-
designate devices as ``single use.'' Manufacturers appear to use the
term ``single use only'' as part of their labeling without justifying
whether, in fact, the device can be safely reprocessed for subsequent
use. In the last two years, we have observed products that have been
historically labeled as reusable, arriving with the ``single use only''
label with no observable change in the product.
We must ensure that the label ``single use only'' is meaningful and
not simply an attempt to increase device sales. Currently, device
manufacturers determine whether a device is labeled ``single use.''
However, the FDA should begin to regulate the use of the ``single use
only'' label and require manufacturers to both justify labeling a
device as ``single use'' and provide scientific data specifying any
resterilization or reprocessing techniques that compromise the
integrity of the device. Manufacturers are the repository for data on
the functional specifications of their devices and know the most about
the ability of their devices to hold up to repeated cleanings and
sterilizations. They should share that information with those of us who
use the devices, and be actively involved in developing consensus
standards.
opened but unused devices deserve special treatment
As discussed earlier, it is common practice for hospitals to
reprocess open, but unused, SUDs. Many SUDs are routinely opened prior
to use and are assembled as part of customized procedure trays that
contain several devices. Sterile processing professionals assemble,
wrap and sterilize these trays, which may consist of single-use and
disposable items. It is essential that hospitals be permitted to open
singleuse devices, combine them with other devices as needed for each
medical procedure, and resterilize the entire tray. The creation of
these trays in advance of surgeries and other procedures is designed to
avoid delays in the surgical suite, create efficiencies, and prevent
subsequent infection during the procedure. Treating this process as a
``reprocessing'' activity impedes these efforts.
As I stated earlier, any regulation should reflect the relative
risk of the device involved. Reprocessed devices that have been opened,
but not used on a patient, do not need to be part of the FDA's
guidance. Resterilization and repackaging of such devices pose
virtually no risk for patients.
There are three general areas of risk associated with reprocessing:
1. contamination of the device, if it is not properly cleaned and
sterilized, could lead to infection; 2. the cleaning and/or
sterilization process could harm the integrity of the device; and 3.
the repeated use of the device in subsequent procedures could harm the
integrity of the device.
With respect to unused devices, the third risk is eliminated
entirely. A major component of the first risk, patient
crosscontamination, is also eliminated. The only possible risks,
therefore, are whether the device can be adequately resterilized and if
the process of resterilization somehow harms the device. Hospitals have
a great deal of experience in sterilization of medical devices as
sterilization is routinely performed on many types of devices. In fact,
as mentioned earlier, it is not uncommon for manufacturers to ship SUDs
to hospitals with separate sterilization instructions. Therefore, many
providers suspect that the ``single use only'' label and ``do not
resterilize'' instructions are not based on reliable scientific
evidence.
conclusion
Mr. Chairman, as we have already noted, patient safety is the first
and foremost concern of all hospitals and health systems. The AHA
believes that the FDA's proposed strategy on the reuse of SUDs
represents a thoughtful approach to a complex issue, and we are pleased
that the FDA has been consulting with front-line caregivers and other
experts in its effort to make the standards even more meaningful. This
is an important step towards the goal of assuring patient safety. For
the sake of all concerned, we commend the FDA's efforts to move
forward, with all deliberate speed, to finalize its strategy. We
further believe that additional legislation is unnecessary at this time
and would only undermine the progress that FDA has already made towards
developing a balanced and reasonable regulatory structure. We welcome
the opportunity to work with the FDA to ensure best practices are
universally used.
Mr. Upton. Thank you very much.
Mr. Feltner?
TESTIMONY OF VERN FELTNER
Mr. Feltner. Good afternoon. The Association of Medical
Device Reprocessors appreciates the opportunity to present
testimony regarding the reprocessing of medical devices labeled
as single-use. My name is Vern Feltner. I am President of
Alliance Medical Corporation. We are a member of AMDR. AMDR is
a trade association representing the legal and regulatory
interests of third party reprocessors of medical devices
labeled as single-use. It is estimated that AMDR members
perform approximately 80 percent of the third party
reprocessing done in the United States. AMDR is not here today
seeking exemption from regulation and oversight. In fact, just
to the contrary. AMDR believes that a strong, rational, FDA
regulatory regime is critical to ensuring the safety of
reprocessed devices. FDA currently imposes a number of
regulatory controls on third-party reprocessors, and membership
in AMDR requires compliance with all applicable FDA
requirements. In AMDR's view, protecting the patient must be of
the highest priority, and accordingly FDA regulation of
reprocessing must be based on demonstrated patient safety risk
and not on hypothetical risk designed to provoke public alarm.
Unfortunately much of the opposition of reprocessing comes
from original device manufacturers who view reprocessing as an
economic threat, and who stand to reap enormous financial gains
by eliminating reprocessing as an option for hospitals. Their
strategy has been to portray reprocessing as unsafe, but the
facts simply do not support their claim. The truth is that the
safety record of reprocessing is excellent. As you will hear,
reprocessing enjoys the support of major hospital and physician
groups, and the safety of reprocessing has been demonstrated in
numerous peer review studies and scientific studies. AMDR
companies, themselves, have reprocessed over 9 million devices
with very few problems. In order to ensure the safety of their
devices, AMDR members adhere to several important safety
principles, including testing every single device before it is
returned to the hospital that requested that reprocess.
The reality is that proper reprocessing of certain medical
devices labeled for single-use is absolutely safe.
Manufacturers label devices as single-use, not because FDA
requires a single-use designation, but because the manufacturer
chooses that label. And what we have seen again and again is a
single-use label being used for economic reasons as a way to
sell more devices, and not out of a concern for patient safety.
Hospitals that discard devices that could easily be
reprocessed, are wasting resources that could be directed
toward improvement in patient access and medical technology.
Mr. Chairman, as I listened to the testimony being given I
would like to take the rest of my short period of time and set
the record straight on a couple issues that I believe are very
important. First, there seems to be a gross impression that the
industry is not regulated. Nothing could be farther from the
truth. Reprocessors must comply with FDA QSRs just like
manufacturers. The fact is that FDA does not regulate all
medical companies in exactly the same way. There is a whole
industry known as device servicers and refurbishers. FDA
considers these companies to be manufacturers, but pre-market
review and compliance with QSRs are not required. Second, an
issue I believe that is most important and certainly of highest
concern to everyone here and that is patient safety.
This is a hard one to say, but there have been documents
distributed, even to members of this committee that at best are
misleading and disingenuous. At worst blatant untruths. There
have been articles commissioned and published insinuating that
multitudes of patient injuries due to the use of reprocessed
devices are labeled as single-use, and that patient safety lies
in using only the new devices. Facts are stubborn things, and
the facts expose the disingenuous nature of these accusations.
Public records solidly promote the efficacy and safety of
commercially reprocessed devices. As a matter of comparison
between AMDR companies and just four device manufacturers, the
four that happen to be so strongly fighting our industry, the
facts state this. In the reporting period from January 1997 to
March 1999, 27 months, there were three medical device reports
filed concerning devices reprocessed by AMDR companies. In the
same reporting period for just these four device manufacturers,
there were in excess of 16,000 medical device reports filed,
11,827 product malfunctions reported, 2,508 patient injuries
recorded, and a very unfortunate number of 163 deaths
associated with the new products. Now, everyone knows that the
delivery of healthcare is not risk free. Not for one moment am
I suggesting that any of these companies market inherently
unsafe products. These are good companies, good histories, made
up on the most part of good and caring people. But the facts
remain that in the 12 year history of the reprocessing
industry, there shows an excellent record, whether you judge it
on its own or whether you compare it to the OEM industry
segment. I thank you for your time.
[The prepared statement of Vern Feltner follows:]
Prepared Statement of the Association of Medical Device Reprocessors
The Association of Medical Device Reprocessors (AMDR) appreciates
the opportunity to present testimony regarding the reprocessing of
medical devices labeled for single-use. My name is Vern Feltner, and I
am President of Alliance Medical Corporation. AMDR is a trade
association representing the legal and regulatory interests of third-
party reprocessors of medical devices labeled for single-use. It is
estimated that AMDR members perform approximately 80 percent of the
third-party reprocessing done in the United States. Members of AMDR
serve a nationwide customer base of hospitals and outpatient surgery
centers, and reprocess a limited set of devices in several clinical
areas, including perioperative, cardiology, orthopedics, patient floor,
and respiratory therapy. AMDR companies contract with hospitals in all
50 states, and reprocessing takes place in many of the elite hospitals
of our nation.1 AMDR companies very likely work with
hospitals in the districts of many Subcommittee members.
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\1\ See ``America's Best Hospitals,'' U.S. News & World Report,
July 19, 1999, at 61.
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AMDR is not here today seeking exemption from regulation and
oversight. To the contrary, AMDR and the reprocessing industry can only
survive in a clear, rational regulatory scheme. It is important,
however, that any regulatory scheme be based on demonstrated public
safety risks and not on hypothetical risks designed to provoke public
alarm. This industry is made up of people who are doctors, nurses,
parents, husbands, and wives. Our families are the very ones on whom
reprocessed devices will be used. If there was truly a question of
increased risk to patients and, therefore, to our families, we would
not be in this business. The hospitals we serve are populated by
doctors who live and work under the Hypocratic Oath, which is based
upon the premise that patient safety must come first. In fact, the
reprocessing industry came to be as a direct result of doctors who saw
the need for reprocessing. Yes, we are a business, and yes, hospitals
have bottom-lines, but that does not mean that our motives are suspect
or that reprocessed devices are inherently unsafe. All businesses have
bottom lines. AMDR members stand committed to complying with all Food
and Drug Administration (FDA) requirements applicable to third-party
reprocessing. It is in AMDR's best interest to ensure that reprocessing
is a safe, rationally regulated practice that hospitals can utilize to
conserve health care resources without compromising patient care.
i. history and background
Over Two Decades of Successful Reprocessing. From the recent press
and congressional interest, one might believe that reprocessing of
medical devices labeled for single-use is new, uncharted territory. One
might also assume that reprocessing is a haphazard practice applied
indiscriminately to a garden variety of medical devices. In fact, these
assumptions are entirely false. The reprocessing of certain medical
devices labeled for single-use has taken place for over two decades.
The American Hospital Association (AHA) calls reprocessing of ``single-
use'' devices ``a safe and standard medical practice'' that hospitals
have used ``for years with excellent success.'' The American College of
Cardiology wrote to Congress that ``there are cardiovascular
specialists who have been using reprocessed catheters in their labs for
more than 20 years and cannot cite a single instance where a
reprocessed catheter has broke[n] or caused infection.'' And the Mayo
Clinic states that ``for more than 20 years, the catheters used in
electrophysiology procedures have been reprocessed at Mayo and have
continued to function normally without any evidence of infection.''
2
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\2\ See Attachment A for these letters.
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Hospitals originally began to reprocess for two reasons: 1) certain
devices initially labeled ``reusable'' were switched to ``single-use''
without any structural change in the device; and 2) doctors and nurses
recognized the inherent waste in discarding certain devices after one
use. The single-use designation is not based on a determination by FDA.
To the contrary, the single-use label is chosen by the original
equipment manufacturers (OEMs), and, for many devices, the single-use
designation is a marketing decision, not a safety decision. AMDR
believes that much of the attack on the reprocessing industry is also
based on marketing concerns, not true safety concerns. The math is
easy--the more devices that are reprocessed, the fewer brand-new
devices are purchased, and that much less money is made by
manufacturers.
Making the Decision to Reprocess. Hospitals do not reach the
decision to reprocess lightly. Rather, they rely on committees made up
of physicians, nurses, sterile processing professionals, infection
control specialists, risk managers, and hospital lawyers to determine
whether a specific device can and should be reprocessed. At each AMDR
company, the specific devices are carefully scrutinized in order to
determine whether they can be safely and effectively reprocessed.
Because of this rigorous selection process utilized by hospitals and
third-party reprocessors, only a small percentage of the thousands of
medical devices used by hospitals are actually reprocessed.
ii. third-party reprocessing is an fda-regulated industry
In the past, manufacturers have claimed that third-party
reprocessing is an ``unregulated'' industry. The fact is that third-
party reprocessors are currently required to comply with a number of
FDA regulatory requirements, the most significant of which is the
Quality System Regulation. The Quality System Regulation is an
extensive set of quality assurance provisions governing every aspect of
a reprocessor's operations, including production and process controls,
process validation, control of non-conforming product, and finished
device acceptance. Pursuant to these Quality System Regulation
requirements, third-party reprocessors must: (1) control and monitor
production processes to ensure that a device conforms to its
specifications; (2) validate with a high degree of assurance that their
reprocessing processes ensure that specified requirements are met; and
(3) establish and maintain procedures for reprocessed device acceptance
to ensure that each production run, lot, or batch meets acceptance
criteria. See 21 C.F.R. Part 820. In other words, reprocessors must
document that they have developed comprehensive systems to assure that
a reprocessed device is clean, sterile, and able to perform its
originally intended clinical function. The functional testing step of
reprocessing differs significantly from the testing performed by device
manufacturers: AMDR companies functionally test every single
reprocessed device before sending it back to a hospital, whereas device
manufacturers test only a small sampling of their finished devices.
Third-party reprocessors must make all required Quality System
Regulation information and data available for FDA inspection
3, and firms that fail to comply with these requirements are
subject to agency enforcement action. In addition to complying with
Quality System Regulation requirements, third-party reprocessors also
are required to: (1) register with the agency; (2) comply with FDA
labeling controls; (3) and adhere to Medical Device Reporting (MDR)
regulation requirements. Pursuant to MDR requirements, third-party
reprocessors must report to FDA certain device malfunctions and device-
related patient adverse events.
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\3\ All AMDR companies have been inspected by FDA in the last 12
months.
---------------------------------------------------------------------------
AMDR members reprocess three broad categories of medical devices
labeled for single-use: 1) opened devices that have never been used; 2)
unopened devices whose expiration date has passed; and 3) previously
utilized devices. All three of these categories are reprocessed in
compliance with the rigorous quality assurance requirements contained
in FDA's Quality System Regulation.
iii. the manufacturers' allegations are based on one overriding
concern: economics
Manufacturers Want to Erect Economic and Regulatory Barriers to
Market Competition. In AMDR's view, there exists little, if any,
factual basis for the vast majority of objections to third-party
reprocessing. The major medical device manufacturers have embarked on a
crusade at the federal and state level to eliminate third-party
reprocessing. This is not a surprise. Hospitals are fully aware that
the ``single-use'' label on a medical device does not necessarily mean
that it should be discarded after one use. As the AHA noted, ``In our
view, the real issue is not whether reuse is appropriate, but whether
the single-use label is a complete and accurate representation of the
device.'' 4 For hospitals, proper reprocessing offers a way
to maintain the highest quality patient care, while also achieving
significant cost savings.
---------------------------------------------------------------------------
\4\ See Attachment A.
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Reprocessed Devices are More Affordable, and Market Competition
Exerts Downward Pressure on the Price of New Devices. It is clear that
third-party reprocessing represents a potentially formidable economic
threat to manufacturers. A future where hospitals no longer needlessly
discard certain devices labeled for single-use could, ultimately, mean
a future of lower profits for manufacturers. The fact is that
reprocessing has already had a substantial impact on the sales and
profits of device manufacturers. Indeed, every time a hospital chooses
to reprocess a device rather than purchase a new device, that means a
lost sale for manufacturers. In addition, in an effort to persuade
their customers not to reprocess, manufacturers have lowered the price
of their devices. Lower prices generally mean lower profits.
The experience of one hospital that utilizes third-party
reprocessing services is particularly telling. EP Technologies, Inc., a
division of Boston Scientific Corporation, informed the hospital that
it
would be willing to supply [the hospital] with new catheters at
the price of each returned catheter, if I (the hospital's Chief
of Infection Control Service) would stop reprocessing . . .
Being dumbfounded with this offer for cutting the price in half
for each new catheter, I immediately asked her (the E.P.
Technologies representative) where her integrity was with
keeping the price so high all this time? She had no
answers.5
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\5\ Letter from Dana Gruber, Chief, Infection Control Service,
Brooke Army Medical Center, to William B. Stoermer, Jr., Executive Vice
President, Alliance Medical Corporation (December 29, 1999). See
Attachment B.
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Not surprisingly, the device manufacturers fail to acknowledge that
their opposition to third-party reprocessing is rooted in economics.
Rather, they repeatedly assert that their primary motivation is patient
safety. While emotionally appealing, the manufacturers' professed
interest in patient safety is disingenuous at best, misleading at
worst. As set out below, third-party reprocessing is a safe, federally-
regulated industry. When performed properly, third-party reprocessing
poses no threat to patient safety.
A. Manufacturers Frequently Designate a Device As ``Single-Use'' For
Economic Reasons, Rather Than Out Of Concern For Patient Safety
FDA does not require manufacturers to designate certain devices as
``single-use'' only. There are no FDA regulations or formal standards
distinguishing the quality or functionality of reusable devices from
single-use devices. The discretion to label a device as single-use lies
solely with the device manufacturer.
The ``Single-Use'' Label Provides Little Indication of the
Product's Useful Life. The device manufacturers have repeatedly
contended that devices labeled for single-use must be discarded after
one use because they are manufactured in such a way that makes reuse
prohibitive. As a practical matter, however, it is nearly impossible to
manufacture a medical device for ``one use and only one use.'' For
example, a surgical instrument labeled for single-use does not ``wear
out'' simply because it was used in a surgical case that took three
hours rather than two hours. Likewise, it is absurd to suggest that if
a scissor labeled for single-use is utilized to snip only once in a
surgical case, then its entire useful life has been exhausted. In
reality, a manufacturer's ``single-use'' designation on a medical
device provides little indication of the product's useful life. The
``single-use'' designation more often than not reflects a
manufacturer's decision to market a product that will lead to a
needless waste of scarce health care resources. The key issue should be
the device's functionality. If a device labeled for single-use can be
properly cleaned, packaged, and sterilized without negatively affecting
its functionality, it can, and should, be used again.
Evidence that manufacturers often designate devices as single-use
for economic reasons, rather than out of a concern for patient safety,
is abundant. For example, the December 11, 1998, episode of NBC's
``Dateline'' exposed Johnson & Johnson's practice of labeling as
``single-use'' contact lenses 6 that were virtually
identical to the lenses that the company had been marketing as
reusable. Thus, consumers were needlessly discarding lenses after one
use. When asked why it had designated the lenses as single-use, Johnson
& Johnson stated: ``If we had changed the label and marketed for
general use, then we couldn't advertise and create this single-use,
daily disposable category. We made that decision because we felt it was
a good business decision to do it that way.'' 7
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\6\ AMDR members do not reprocess contact lenses.
\7\ Transcript of December 11, 1998, Dateline episode at 5
(emphasis added).
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Another example is a letter written by USCI Cardiology & Radiology
Products (USCI) to a hospital explaining that, although USCI had
decided to change the label on a particular device from reusable to
single-use, it had made no structural changes to the device.
Specifically, USCI stated: ``[O]ur manufacturing processes of Woven
Dacron Intracardiac Electrodes have not changed. These electrodes are
made with the same materials and in the same manner they have been in
the past.'' 8 In another example, Microvasive, a division of
Boston Scientific Corporation, advised hospitals that, although
Microvasive's hemostatic probes are labeled for single-use only, they
may be reused under certain circumstances. Specifically, the
Microvasive notice states: ``BICAP' Hemostatic Probes are
recommended for single-use only. However, this recommendation does not
prohibit reuse under certain specific conditions . . .'' 9
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\8\ See Attachment C.
\9\ See Attachment D.
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In light of the above evidence, the manufacturers' protestations
that the single-use designation on a device is never arbitrary, and
that ``economics must be subordinate to this concern for proper
health'' 10 ring hollow. The reality is that some devices
that carry a single-use label are suitable for reprocessing, and many
are not. Every product--whether it is labeled ``single-use'' or
``reusable''-- must be assessed individually to determine whether it
can be cleaned, packaged, and sterilized without impairing
functionality. Hospitals, and their doctors and nurses, should not be
forced to needlessly discard devices labeled for single-use that could
be safely reprocessed. Hospitals should be free to redirect their
limited resources where they are truly needed--toward improvements in
patient access and medical care.
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\10\ Josephine Torrente, President, Association of Disposable
Device Manufacturers, testimony to Illinois State Board of Health Board
Meeting and Public Hearing Regarding the Reprocessing of Medical
Devices Labeled for Single-Use, December 10, 1998.
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B. When Done Properly, Third-Party Reprocessing Is Safe
The most frequently levied allegation in the manufacturers' arsenal
of scare tactics is that third-party reprocessing is unsafe. There
simply is no factual basis for this claim. The manufacturers cling
desperately to this argument as a way to disguise what is, for them, an
economic issue. The facts are as follows: AMDR member companies have
collectively reprocessed over 9 million devices labeled for single-use
with very few problems.
Indeed, FDA itself recently stated that it ``has been unable to
find clear evidence of adverse patient outcomes associated with the
reuse of a single-use device from any source.'' 11
Similarly, a physician with the Centers for Disease Control and
Prevention remarked that he ``would just be absolutely amazed if
[reprocessing] is a major health problem and the [leading hospitals]
have failed to realize it.'' 12
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\11\ Letter from David W. Feigal, Director, Center for Devices and
Radiological Health, FDA, to Larry R. Pilot, McKenna & Cuneo. See
Attachment E.
\12\ Lauran Neergaard, Debate on Reuse of Medical Devices,
Associated Press, August 13, 1999.
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1. The Safety Record Of Reprocessed Devices Is Excellent--As
Demonstrated By The Handful Of MDRs And As Compared To The OEM
Record
Based on FDA's own database of device-related patient adverse
events, the safety record of reprocessing is excellent. Pursuant to the
agency's MDR regulation, hospitals must notify FDA when they learn that
a device may have caused or contributed to a patient death or serious
injury. 21 C.F.R. Sec. 803.30. Every year, FDA receives over 100,000
MDR reports. Significantly, there have been only a handful of MDR
reports associated with reprocessed devices. Indeed, FDA itself
recently remarked that the number of MDR reports involving reprocessed
devices is ``tiny'' compared with other problems.13
Furthermore, the incidents reported in the few MDRs involving
reprocessed devices are identical to problems that have occurred in new
devices. Thus, it is not at all clear that these incidents were caused
by reprocessing.14
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\13\ Device & Diagnostics Letter, Vol. 26, No. 48 (Dec. 17, 1999)
at 1.
\14\ As one example, an MDR report was submitted to FDA concerning
a reprocessed electrophysiology (EP) catheter whose tip became
detached. MDR Report Number 1062310-1999-00001. See Attachment F.
However, the identical incident has been reported for new EP catheters.
MDR Report Numbers 4501350000-1995-0088 and 6000087-1998-00002. See
Attachment G.
---------------------------------------------------------------------------
There are Thousands of MDR Reports on Brand New Devices Each Year.
The OEMs have made much noise about the handful of MDRs on reprocessed
devices. Attached to my testimony is a chart of some of the MDRs for
the few companies leading the attack on reprocessing. From January 1997
to March 1999, a 27-month period, Boston Scientific companies had a
total of 2,396 MDRs. This number includes 874 injuries and 50 deaths.
Johnson & Johnson companies had 11,327 MDRs, including 1,239 injuries
and 58 deaths. Mallinckrodt companies had 1,755 MDRs, including 90
injuries and 47 deaths. Tyco companies had 552 MDRs, including 305
injuries and 8 deaths.15
---------------------------------------------------------------------------
\15\ See Attachment H.
---------------------------------------------------------------------------
As you can see, there are numerous examples of medical devices
causing patient injury during their first use. For example, a 1994
outbreak of post-surgical infections has been attributed to bacteria-
contaminated sutures manufactured by Ethicon, Inc. (Ethicon), a
division of Johnson & Johnson. The contamination allegedly resulted
from a malfunction in Ethicon's sterilization system.16
Ethicon ultimately recalled 3.6 million packages of
sutures.17 As another example, FDA recently found that an
improperly functioning coronary stent system manufactured by Boston
Scientific Corporation had caused 26 patient injuries, and may have
been a factor in the death of one individual. Boston Scientific
Corporation is engaged in a recall of the defective
stents.18 We cite these examples to show that the use of
medical devices is not and will likely never be 100% problem-free. That
said, the reprocessing industry believes that having one injury is
still one injury too many, and we will continue to strive to make our
services as safe as possible.
---------------------------------------------------------------------------
\16\ See, e.g., Lance Williams, ``Common thread in illnesses:
sutures lawsuits blame postsurgical infections on a single source,''
San Francisco Examiner (Feb. 21, 1999); Lance Williams, ``Patients
wounded by infections across the country, lives have been torn by post-
op complications,'' San Francisco Examiner (Feb. 21, 1999); Lance
Williams, ``How suture maker kept lid on infection suits despite
recall, Ethicon said product was harmless,'' San Francisco Examiner
(Feb. 22, 1999); Lance Williams, ``Patients who suffered,'' San
Francisco Examiner (Feb. 22, 1999).
\17\ See, e.g., FDA Enforcement Reports 94-43 & 95-08.
\18\ See, e.g., Ronald Rosenberg, ``Boston Scientific, FDA spar
over stent,'' The Boston Globe (October 10, 1998).
---------------------------------------------------------------------------
2. The Warning Letters Received By Certain Third-Party Reprocessors Do
Not Constitute Evidence That Third-Party Reprocessing Is Unsafe
The device manufacturers also cite FDA Warning Letters received by
certain third-party reprocessors as evidence that third-party
reprocessing is unsafe. Once again, the manufacturers are not applying
their own logic to themselves. While it is true that some third-party
reprocessors have been issued FDA Warning Letters, most, if not all
manufacturers have also received FDA Warning Letters. Indeed, FDA often
issues Warning Letters to device manufacturers.19
---------------------------------------------------------------------------
\19\ FDA's Center for Devices and Radiological Health issued 303
Warning Letters in 1999. See www.fda.gov/foi/warning.htm and
Thompson.com, an FDA Warning Letter Monitor.
---------------------------------------------------------------------------
By way of background, a Warning Letter is based upon an FDA
inspector's inspectional observations and is not independently
verifiable by a court or other impartial finder of fact. A Warning
Letter is informal and advisory, and constitutes only an FDA
communication that the Agency considers a violation to
exist.20 Typically, the company in question addresses the
concerns raised in the Warning Letter, and FDA re-inspects the facility
to ensure that any necessary changes have been made.21
---------------------------------------------------------------------------
\20\ See Regulatory Procedures Manual at Ch. 4; FDA Office of
Regulatory Affairs Warning Letter Reference Guide (October 4, 1994) at
p.14.
\21\ As an example, we are including an FDA letter issued to an
AMDR member company indicating that, in FDA's view, the concerns raised
in the Agency's Warning Letter had been adequately addressed. See
Attachment I.
---------------------------------------------------------------------------
By failing to frame FDA Warning Letters in their proper
perspective, and by choosing not to disclose that manufacturers
themselves often receive Warning Letters, the manufacturers clearly
hope to create the impression that FDA has singled out third-party
reprocessors for some sort of special scrutiny. This is not the case.
Actually, a discussion of our receipt of Warning Letters helps prove
our case--that reprocessors are subject to FDA oversight, that
oversight is active even as we sit here. Also, what is important is
that the Warning Letter recipient take the appropriate steps to address
the agency's concerns. While AMDR members have full confidence in the
safety and efficacy of their operations, they recognize that there is
always room for improvement, and they welcome FDA's input in this
regard. But, if the suggestion that receipt of Warning Letters means
that reprocessed devices are inherently unsafe, then brand new devices
should also be considered inherently unsafe. We do not believe this
line of thinking is logical and urge the manufacturers to be consistent
in their application of the facts.
3. A Substantial Body Of Peer-Reviewed Scientific Literature
Demonstrates The Safety Of Reprocessing
Physician and hospital groups have articulated strong support for
reprocessing. There is also a significant body of independent, peer-
reviewed scientific literature confirming the medical community's
confidence in the safety of reprocessing devices labeled as single-use.
Indeed, studies demonstrating the safety and efficacy of reprocessing
have been published in a number of highly esteemed medical journals,
including Gastrointestinal Endoscopy, The American Journal of
Gastroenterology, Journal of the American College of Cardiology,
Journal of Thoracic Cardiovascular Surgery, Pacing and Clinical
Electrophysiology (PACE), American Journal of Cardiology, Medical
Journal of Australia, Canadian Journal of Surgery, and Canadian Journal
of Cardiology.22
---------------------------------------------------------------------------
\22\ See Attachment J for a bibliography and summary of these
studies.
---------------------------------------------------------------------------
As one example, Dr. Richard Kozarek, Chief of Gastroenterology at
the Virginia Mason Medical Center in Seattle, Washington, and former
President of the American Society for Gastrointestinal Endoscopy, has
conducted a number of independent studies demonstrating the reusability
of certain endoscopic accessories. In the area of sphincterotomes
labeled as single-use, for instance, Dr. Kozarek found that ``[d]ouble
channel sphincterotomes marketed as one-time-use items can be reused
safely when properly cleaned.'' 23 Likewise, with respect to
argon beam plasma coagulation (APC) probes labeled for single-use, Dr.
Kozarek concluded:
---------------------------------------------------------------------------
\23\ R.A. Kozarek, M.D., S.L. Raltz, R.N., M.S.N., T.J. Ball, M.D.,
J.J. Brandabur, M.D., ``Reuse of disposable sphincterotomes for
diagnostic and therapeutic ERCP; a one-year prospective study.''
Gastrointestinal Endoscopy, Vol. 49 (1999) at 39.
---------------------------------------------------------------------------
The combination of manual cleaning and ETO sterilization
consistently cleaned APC probes. Ninety percent of the probes
showed no sign of physical deterioration and 100% maintained
their electrical activity after 10 uses. APC probes can
potentially be safely and effectively reused up to 10 times,
and a significant procedural savings is possible with reuse.''
24
---------------------------------------------------------------------------
\24\ S.K. Roach, R.A. Kozarek, M.D., S.L. Raltz, R.N., M.S.N., and
S.E. Sumida, Ph.D., ``In Vitro Evaluation of Integrity and
Sterilization of Single-Use Argon Beam Plasma Coagulation Probes,'' The
American Journal of Gastroenterology, Vol. 94 (1999) at 139.
---------------------------------------------------------------------------
As another example, Dr. Edward V. Platia, a nationally recognized
electrophysiologist at the Washington Hospital Center in Washington,
D.C., conducted an extensive multi-center study of the reuse of
electrophysiology (EP) catheters, involving 14,640 EP cases and 48,075
catheter uses. Dr. Platia concluded that:
the sterilization and reuse of non-lumen, woven Dacron pacing
catheters is safe, and does not appear to result in any
increase in the risk of infection. The catheters are
sufficiently durable to allow them to be reused well in excess
of five times. One-time use of such catheters appears to be an
unnecessary and expensive policy.25
---------------------------------------------------------------------------
\25\ E.V. Platia, M.D., S. O'Donoghue, ``Reuse of Pacing Catheters:
a Survey of Safety and Efficacy,'' PACE, Vol. 11 (Sept. 1988) at 1280.
---------------------------------------------------------------------------
What is, perhaps, most striking about the rigorous body of
scientific evidence supporting the safety and efficacy of reprocessed
devices is its dramatically superior quality, as compared to the
``studies'' offered by the OEMs that oppose reprocessing. Indeed, most
of the ``scientific evidence'' submitted by the opponents of
reprocessing should be disregarded, as: (i) much of it was conducted by
the OEMs themselves, rather than independent entities, and, as such, is
tainted by the OEMs' clear economic incentive to portray reprocessing
in a negative light; and (ii) much of it is plagued by fundamental
scientific deficiencies, such as lack of an adequate sample size, and,
as a result, cannot serve as a basis for any conclusions about the
safety of reprocessed devices.
4. Tracking And Tracing Systems For Reprocessed Devices Help Ensure
Accountability And Safety
Third-party reprocessing is not conducted in a black hole where no
one is accountable. There are several steps taken to ensure appropriate
tracking and tracing of each device. Once a hospital makes a
determination that a specific type of device can be reprocessed, AMDR
members pick up a batch of the devices from the hospital, reprocess
those devices, and return the same devices to the hospital. AMDR
members also ensure that there are numerous ways to determine whether a
device was reprocessed and to identify who the reprocessor was. For
example, some reprocessors employ bar code tracking systems, which
allow devices to be tracked back to the reprocessor. Likewise, some
reprocessors provide hospitals with ``peel-off'' labels, which can be
placed in a patient's record to identify where the device was
reprocessed. Therefore, it is quite easy for a doctor and a hospital to
know if a reprocessed device was used and to identify who the third-
party reprocessor was.
5. Proper Reprocessing Does Not Require Access To The Manufacturer's
Specifications
One the most misleading arguments made by the manufacturers is that
third-party reprocessors are incapable of safely reprocessing devices
labeled for single-use because they lack access to the original
manufacturer's specifications. The assertion that the manufacturer's
specifications are required to reprocess most devices is misleading.
Access to manufacturers' specifications is unnecessary because
third-party reprocessors employ a variety of techniques to equip
themselves with intimate knowledge about the workings of every device
they reprocess. For example, in addition to utilizing every publicly
available source of product-related information, e.g., product
labeling, marketing materials, AMDR members also use independent
laboratories to ``reverse engineer'' certain devices. In addition, AMDR
member companies are engaged in an ongoing dialogue with the clinical
users themselves, i.e., the hospitals and physicians, in order to
understand the performance requirements for each device they reprocess.
More importantly, AMDR member companies have developed validated
protocols to ensure that every device they reprocess is safe and
effective for its intended use. If an AMDR member lacks sufficient
information about a device in order to safely reprocess it, then that
device will not be reprocessed. Furthermore, as described above, AMDR
members--unlike manufacturers--perform functionality testing on every
single device that they reprocess. Thus, the manufacturers' argument
that access to the original specifications is necessary to safely
reprocess devices labeled for single-use is without merit. Indeed, if
the manufacturers were correct in this claim--and they are not--it
certainly is difficult to understand why so many hospitals and doctors'
groups have endorsed the use of reprocessing.
iv. the manufacturers' call for ``informed consent'' is simply another
prong of their economic argument
As part of their campaign to create an ``aura'' of suspicion around
third-party reprocessing, the manufacturers argue that the very doctors
committed to treating and curing the sick are keeping patients ``in the
dark'' about the alleged hazards of third-party reprocessing. Indeed,
the manufacturers advocate vociferously for mandatory ``informed
consent'' regarding the use of reprocessed devices.
Although dressed up in the garb of patient safety, the
manufacturers' informed consent argument is merely another prong of
their economic agenda. Medical ethicists state that the objective of
informed consent is to arm patients with sufficient information to make
a prudent judgment about their medical care. If a physician believes
that the use of a certain device or procedure will increase a patient's
risk, then the physician should disclose this to the patient. Properly
done, third-party reprocessing presents no additional risk to patients.
Because properly reprocessed devices are as safe and effective as new
devices, there is no ethical basis for requiring informed consent
before the use of reprocessed devices.
Should There be Informed Consent for New Devices? It is striking
that, although they push vigorously for informed consent with respect
to the reprocessing of devices labeled for single-use, the
manufacturers conspicuously avoid the obvious implications of their own
argument. According to the manufacturers' thinking, a physician should
tell a patient before using any device that has been the subject of an
MDR report, Warning Letter, or recall. Similarly, it seems only logical
that the manufacturers would demand informed consent with respect to
the ``second use'' of devices that are labeled reusable. The
manufacturers do not make these arguments because they realize that
informed consent regarding MDR reports, Warning Letters, and recalls
would be detrimental to their own economic interests.
v. conclusion
As we have demonstrated, when performed properly third-party
reprocessing is safe. Third-party reprocessors are required to comply
with a host of FDA requirements. Hospitals that take advantage of the
benefits of third-party reprocessing can maintain the highest quality
patient care, while also achieving significant cost savings. Resources
saved through third-party reprocessing can be redirected toward
improvements in patient access and medical technology. We believe that
patient safety is of utmost concern, but health care cost containment
is also of extreme importance. In this age of rising health care costs,
reprocessing is one of the few technologies that offers a solution.
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Mr. Upton. Thank you.
Dr. Trotter?
TESTIMONY OF C. GRIFFIN TROTTER
Mr. Trotter. Thank you. I am Griffin Trotter. I am an
Assistant Professor of Ethics and an Assistant Professor of
Surgery at Saint Louis University, Sciences Center. As a matter
of record, I am not representing any particular organization
and have not received an honorarium for this appearance.
However, the Association of Medical Device Reprocessors has
covered my travel and my lodging expenses. As an emergency
physician and medical ethicist, my expertise is in general
ethical and clinical considerations. I am not an expert in the
reprocessing of medical devices, and hence will confine my
comments about safety issues to general remarks concerning
clinical risks and the moral requirement for informed consent.
In clinical medicine, healthcare providers are morally
obliged to disclose significant risks pertaining to any
treatment, test, or procedure that they have recommended or
intend to undertake. Determining which risks count as
significant for the purposes of disclosure is an important
clinical challenge that is widely addressed by the use of a
material risks standard. Risks are material when they are
likely to be relevant to the decisions of reasonable patients.
When risks are very remote, disclosure is not required and, in
fact, may even detract from informed consent by inducing
unreasonable fears. Physicians or other clinicians are
generally the individuals who bear the task of disclosing
risks. However, in an age of managed care, many decisions
governing the practice of medicine and its attendant risks, are
determined at an institutional level. In such instances, the
moral obligation for obtaining informed consent may shift away
from the individual clinician to the institutional provider.
For example, an institution that reprocesses the contents
of its suture kits may have a moral responsibility to inform
clients of thispractice, if, indeed, it was determined that the
use of these kits poses a significant risk. One problem is that
it is not clear whether the material risk standard applies or
even makes sense at this level. Informed consent in this
context pertains not so much to decisions about specific
treatments or procedures, but to patient's decisions about
whether or not they want to subscribe to a given healthcare
plan. The likely risk pertaining to the use of a reprocessed
single-use medical device will vary depending on the nature of
the device, the previous use of the device, the reprocessing
method, and the proposed manner in which the device will be
reused. These variations, along with the aforementioned
intricacies that pertain to the material risk standard, make it
very difficult to articulate a uniformed requirement for
informed consent. However, if standards for reprocessing
medical devices are sufficiently rigorous to ensure that these
devices may be used safely, then there is no more requirement
for informed consent.
My opinion is that if the use of reprocessed single-use
medical devices is not safe, then these devices simply should
not be used. Ensuring that the devices are safe is a far better
strategy than legislating burdensome requirements for informed
consent that would amount to one more bureaucratic obstacle to
the provision of a swift, efficient, and effective response to
our patients' needs. Thank you.
[The prepared statement of C. Griffin Trotter follows:]
Prepared Statement of C. Griffin Trotter, Center for Health Care
Ethics, Saint Louis University
summary
In clinical medicine, health care providers are morally obliged to
disclose significant risks pertaining to any treatment, test or
procedure that they have recommended or intend to undertake. The
determination of which risks count as ``significant'' for the purposes
of disclosure is an important clinical challenge that is widely
addressed by the use of a ``material risks'' standard. Risks are
material when they are likely to be relevant to the decisions of
reasonable patients. Physicians or other clinicians generally disclose
these risks. However, in some cases it may be more appropriate if
institutions obtain informed consent. If use of reprocessed single-use
medical devices was shown to be risky, then hospitals or other
corporate providers who systematically use these devices have a moral
obligation to inform their clients of this practice. On the other hand,
when risks are very remote, disclosure is not required and, in fact,
may even detract from informed consent by inducing unreasonable fears.
The likely risks pertaining to the use of a reprocessed single-use
medical device will vary, depending on the nature of the device, the
previous use of the device, the reprocessing method and the proposed
manner in which the device will be reused. These variations make it
difficult to articulate a uniform requirement for informed consent.
However, if standards for reprocessing medical devices are sufficiently
rigorous to ensure that these devices may be used safely, then there is
no moral requirement for informed consent.
In assessing the relevant scientific data pertaining to the reuse
of single-use devices, objective sources (such as the FDA and the CDC)
are preferred over other sources (such as original equipment
manufacturers, reprocessors and even the news media) that have
important financial interests hinging on the interpretation of this
data.
Health care policy concerning the use of reprocessed single-use
devices should be guided by the Principle of Subsidiarity, which
implies that regulatory authority and action should be concentrated at
the lowest hierarchical level of government where there is sufficient
competence. This principle points, once again, to the importance of
garnering advice from important regulatory agencies such as the FDA.
written statement
Mr. Slobodin has asked me to testify about safety and policy issues
associated with the use of reprocessed single-use medical devices
(abbreviated ``RSUDs'' in subsequent text). As a physician and medical
ethicist, my expertise is in general ethical and clinical
considerations that may pertain to the use of these devices. I am not
an expert in the reprocessing of medical devices and, hence, will
confine my comments about safety issues to general remarks concerning
clinical risks and the moral requirement for informed consent.
Valid informed consent consists of three elements: disclosure,
understanding and voluntariness. Disclosure involves the relay of
relevant information (risks, anticipated benefits, costs and
alternatives) about recommended medical interventions to medical
decision-makers (i.e., patients or patients' proxies). Understanding
involves the ability of medical decision-makers to grasp the disclosed
medical information and to deliberate about choices in a manner that
integrates this information with the patient's goals and values.
Voluntariness is freedom from undue constraint. Undue constraints
include various forms of coercion, as well as emotional and social
constraints that hinder reasonable decisions.
If the proposed use of a RSUD bodes a significant risk, then this
risk should be disclosed to patients. Various standards for what ought
to count as a ``significant risk,'' requiring disclosure, have been
offered. In a landmark 1972 U.S. Circuit Court decision, Judge
Spotswood G. Robinson articulated the ``material risk'' standard.
According to this standard (which is now widely accepted) all material
risks should be disclosed. A risk is material ``when a reasonable
person, in what the physician knows or should know to be the patient's
position, would be likely to attach significance to the risk or cluster
of risks in deciding whether or not to forgo the proposed therapy.''
Robinson held that serious complications that occurred in less than 1%
of cases were generally not material risks.
Robinson's 1% standard probably does not apply for risks that could
be easily avoided. Hence, even a 0.2% additional risk posed through the
use of reprocessed medical devices may be material if the complications
in question are serious and new devices are readily available and
affordable. The rationale for requiring a higher standard of disclosure
in such instances would be that the risks are clinically unnecessary.
Where to draw the line for disclosing such risks is debatable, and our
ultimate decision will of necessity be somewhat arbitrary (just as the
standards of statistical significance that we use in estimating risk
are themselves somewhat arbitrary).
Saving money is not an adequate reason for foregoing disclosure,
unless there is an agreement (tacit or explicit) between patient and
provider that the provider may pursue cost savings whenever the risks
do not exceed a certain (more generous) threshold. The degree to which
such tacit understandings operate in a managed care environment is
debatable. Physicians and/or corporate health care providers often are
not expected or required to disclose risks that may pertain when they
employ cost-saving medical technologies or protocols that are less than
the best available. For instance, hospitals with a policy of not
providing pelvic ultrasounds after radiologists' office hours are not
required to post a warning on the emergency department doorway that
announces this policy to patients. As another example, physicians
generally are not expected to disclose whether the lab is measuring
cardiac enzymes by the traditional chromatography method or with the
newer, more effective mass spectrometry method. As a practicing
clinician and patient advocate, I am more worried about these practices
than I am about not disclosing the use of reprocessed medical devices,
since I believe the potential risks are generally less serious in the
latter instance.
If it is determined that risks of using reprocessed medical devices
are minimal, then the process of trying to disclose these risks could
actually hinder the integrity of informed consent by promoting
irrational concerns (thus constraining understanding and
voluntariness). Two pitfalls pertain.
1. Patients do not generally reason statistically. Even when a risk
is statistically very remote, most patients will assume that if you
mention it, then it is a clinically significant risk. I often
illustrate this point to medical students by noting that if one pointed
out the known risks of taking a bath (e.g., possible traumatic brain
hemorrhage, drowning, and broken bones), then most patients unfamiliar
with the process of bathing would refuse the procedure outright, even
if you explained that the cumulative serious risks were less than one
in fifty thousand.
2. Patients often maintain un-warranted superstitions about the
hazards of contact with others' bodies. Members of the media who hope
to turn the use of reprocessed medical devices into a high-profile
health care scandal have used these superstitions as emotional
leverage. Magic Johnson's decision to quit professional basketball is
an example of how concern about the transmission of AIDS is sometimes
overwrought. Even health care workers tend to be irrational about the
issue of AIDS transmission. A number of health professionals have
expressed concern about occupational AIDS transmission and hope that
their occupational risks can be minimized through the development of an
effective AIDS vaccine. However, many of these same health care
professionals have failed to obtain immunization against hepatitis B,
despite data showing that the occupational risk of dying from hepatitis
B is far greater than it is for AIDS.
In an age of managed care, issues about the context of informed
consent emerge. Often, decisions governing the practice of medicine--
and its attendant risks--are determined at an institutional level. In
such instances, the moral obligation for obtaining informed consent may
shift away from the individual clinician to the institutional provider.
For example, an institution that reprocesses the contents of its suture
kits may bear a moral responsibility for informing clients of this
practice (if it was determined that the use of these kits poses a
significant risk). One problem is that it is not clear whether or not
the material risk standard applies, or even makes sense, at this level.
Informed consent, in this context, pertains not so much to decisions
about specific treatments or procedures, but to patients' decisions
about whether or not they want to subscribe to a given health care
plan.
Several public policy implications follow from these considerations
about informed consent. First, the problem of determining the risks of
using RSUDs is crucial. The likely risks pertaining to the use of a
reprocessed single-use medical device will vary, depending on the
nature of the device, the previous use of the device, the reprocessing
method and the proposed manner in which the device will be reused.
These variations make it difficult to articulate a uniform requirement
for informed consent.
Second, if standards for reprocessing medical devices are
sufficiently rigorous to ensure that these devices may be used safely,
then there is no moral requirement for informed consent. One exception
might be in unusual cases where patients could be expected to have
religious or other doctrinal objections to any reuse of specific
devices. But this sort of consideration applies to any device, drug or
procedure, and is best handled at a clinical level rather than through
government regulations. If significant dangers pertain despite adequate
regulation, then informed consent may be morally obligatory. It will be
important to ensure that the standards of disclosure in such cases are
neither too rigorous nor too lax. Overly rigorous requirements would
result in irrational fears based on the disclosure of clinically
insignificant risks. It is also likely that overly rigorous disclosure
requirements would place a bureaucratic obligation on clinicians that
would impede patient care. Overly lax requirements would result in
violations of the moral requirement for informed consent--in effect,
exposing patients unwittingly to dangers that reasonable persons might
not approve.
Third, regulatory requirements for informed consent for the use of
RSUDs should be responsive to the context in which specific RSUDs are
employed. In some instances, consent should be obtained by clinicians,
in other instances the obligation should lie with hospitals or other
corporate providers.
There are also ethical issues that pertain--apart from the
Principle of Informed Consent--to the proper interpretation of risks
and to the proper level of government intervention. If the risks of
using various RSUDs are to be interpreted accurately, it is important
that we obtain the best possible scientific data. Objective sources
(such as the FDA) are to be preferred over sources that have important
financial interests that hinge on the interpretation of this data. Even
the news media is suspect in this regard, since they are exposed to
financial incentives to find newsworthy scandals that will arouse an
emotional response from the general public. Hence, they will be prone
to exaggerate the dangers of RSUD use and to rely on anecdotal reports
of untoward effects.
Finally, health care policy concerning informed consent for the use
of RSUDs should be guided by the Principle of Subsidiarity, which
implies that regulatory authority should be concentrated at the lowest
hierarchical level where there is sufficient competence. This
consideration enhances the rationale for looking to the FDA for input
and guidance about risks and about necessary policy adjustments.
Assuming that the FDA is properly motivated to represent patients'
safety interests, the cumulative training and expertise of FDA
officials is an important asset that should be maximally utilized.
I suspect, when all is said and done, that it will not be possible
to articulate and legislate a uniform standard for obtaining informed
consent for the use of RSUDs that is more effective or useful than
general legal standards that already pertain in clinical medicine. A
more promising avenue would be to rely on the enforcement of effective
safety regulations, which would render informed consent into a moot
issue. The best available scientific evidence should guide the
development of safety standards. This hearing attests to the serious
efforts that are being taken in order to garner such evidence.
Mr. Upton. You get a bonus.
Mr. Lindsay?
TESTIMONY OF BRUCE D. LINDSAY
Mr. Lindsay. Mr. Chairman and members of the subcommittee,
I am Dr. Bruce Lindsay, a cardiologist and a member of the
American College of Cardiology and the North American Society
of Electrophysiology. And these organizations represent about
24,000 board certified cardiologist in the United States. I
thank you for the opportunity to testify about the safety and
efficacy of reusing electrophysiology catheters in patients who
undergo procedures for the diagnosis and treatment of heart
rhythm disorders. I have about 15 years of experience in
electrophysiology and I direct the Cardiac Electrophysiology
Laboratory at Washington University in St. Louis, where more
than 1,500 diagnostic and therapeutic procedures are performed
each year. In all my years of practice I have never encountered
a complication related to the reuse of an electrophysiology
catheter.
Furthermore, in my conversations with professional
colleagues at other major medical institutions, I have never
heard any of them describe this problem. I would like to
emphasize that neither I nor the organizations that I represent
have any direct or indirect financial interest in the reuse of
electrophysiology catheters. Our position is rooted in
scientific evidence and puts concern for patient safety as its
first priority. The standard electrophysiology catheters that
we use have several electrodes used for recording electrical
signals. They cost about $500 each. In fact, some of the newer
and more advanced catheters cost $2,000 or $3,000 each. The
cost of a reprocessed catheter is generally about half the cost
of a new catheter. The first electrophysiology procedures were
performed more than 30 years ago. Experience over the years has
shown that electrophysiology catheters are durable and can be
re-sterilized for reuse. The obvious motives were to reduce
costs and eliminate waste. Clearly there are ethical, medical,
and legal reasons for physicians to avoid any practices that we
feel would add material risk to a procedure.
Sometimes several catheters are tried during a procedure
before an optimal catheter is identified. Sometimes a catheter,
whether it is new or reprocessed, does not have the right
configuration to reach a specific target in the heart, or may
become less maneuverable over a period of time. You can see how
the cost of a procedure would escalate if we had to take
catheters out and reuse them, meaning try other catheters and
change the models that we are using. The costs begin to add up.
Medicare and other third-party payers do not increase their
reimbursement irrespective of whether we use one catheters,
three catheters, or six catheters. Reprocessing is a way to
help reduce the fiscal implications of using several catheters
during a single procedure. I must point out that there are
studies that have evaluated the safety of reusing
electrophysiology catheters, and these studies have involved
more than 15,000 patients. And in these studies the sterility
of reprocessed catheters was not a concern, nor was the
incidence of infection increased. Moreover, several studies
have demonstrated that the catheters are durable enough to be
reused in excess of five times. The conclusions from these
studies are that the catheters appear to be stable for reuse,
that this can be done provided that they are carefully examined
and that the quality assurance standards are observed. It is an
expensive policy to preclude reuse of these catheters.
You are also aware that adverse events stemming from the
reuse of medical devices are reported to the FDA. We have
already heard today that some of these reports involve not just
reprocessed catheters, but new catheters. So I think it is
appropriate to emphasize that despite the reuse of hundreds of
thousands of catheters, only a few instances have been cited in
which they have proved to be faulty. We conclude that the risk
to patients associated with reusing electrophysiology catheters
is very, very small relative to the overall risk of the
procedure. The risk, in fact, is so low that it is difficult to
quantify. Policies that prohibit the reuse of electrophysiology
catheters will not have an appreciable impact on risk, but they
will most certainly increase costs. In a major medical center,
the cost for example just of reusing electrophysiology
catheters, the savings from that are in the range of $250,000
to $400,000. Both the American College of Cardiology and the
North American Society of Pacing and Electrophysiology are
working with the FDA to refine additional risk adjusted
standards that can be applied to reprocessing medical devices
and to clarify the criteria for single-use labels. We urge
Congress to defer to the FDA is it perfects a regulatory
strategy for the reuse of medical devices that is based on
science and emphasizes the public safety as a first priority.
Mr. Chairman, I appreciate the opportunity to speak before the
committee. Thank you.
[The prepared statement of Bruce D. Lindsay follows:]
Prepared Statement of Bruce Lindsay, Associate Professor of Medicine,
Director, Clinical EP Laboratory, Washington University School of
Medicine, on Behalf of the American College of Cardiology
introduction
Mr. Chairman and members of the subcommittee, I am Dr. Bruce
Lindsay, a cardiologist and member of both the American College of
Cardiology (ACC) and the North American Society of Pacing and
Electrophysiology (NASPE). I thank you for the opportunity to testify
before you today about the safety and efficacy of reusing
electrophysiology (EP) catheters in patients who undergo EP studies for
the diagnosis or treatment of heart rhythm disorders.
Over the past several months there has been much discussion, and
unfortunately much factual distortion, about the reuse of certain
medical devices. My testimony pertains to the reuse of EP catheters and
is based on more than 15 years of experience in the field of clinical
EP. I direct the cardiac electrophysiology laboratory at Washington
University in St. Louis, where more than 1,500 diagnostic and
therapeutic procedures are performed each year. During all these years,
I have never encountered a complication related to the reuse of an EP
catheter. Moreover, in my conversations with professional colleagues at
other major medical centers, I have never heard any of them describe
this problem.
The ACC and NASPE share several common objectives that promote
optimal patient care, research, and education. These organizations also
provide leadership in the development of standards and guidelines and
the formulation of health care policy. The interest of these two
organizations in the medical reuse debate grows out of concern for
patient safety and the promotion of quality cardiovascular care for
patients. Neither I, nor the organizations that I am representing
today, have any direct or indirect financial interest in the reuse of
EP catheters. The involvement of the ACC and NASPE in this issue is
rooted in scientific evidence. The ACC and NASPE have been working with
the Food and Drug Administration (FDA) and believe that it has also
taken an approach to the issue of medical device reuse that is based in
science out of concern for patient safety.
Electrophysiology Procedures
Clinical cardiac EP studies are performed to diagnose and treat
abnormal heart rhythms referred to as arrhythmias. Typically, three to
six catheters are used during these procedures. Each catheter
incorporates four to 20 platinum electrodes to record electrical
signals or pace the heart. The standard EP catheters are solid
nonluminal designs, which means they do not have a hollow inner core.
Some catheters have special mechanisms used to deflect the tip to help
guide the catheter to a specific target. Catheters with these
deflection mechanisms are often used to deliver radiofrequency energy--
a high frequency electrical current--to destroy a small amount of
tissue on the lining of the heart that has been identified as the cause
of a patient's abnormal heart rhythm. This curative technique is
referred to as an arrhythmia ablation procedure.
The cost of catheters used to perform EP studies varies depending
on the number of electrodes, steering mechanisms, or materials used for
the particular model. Diagnostic catheters range in cost from $100 to
more than $1,000. Deflectable catheters used for ablation of abnormal
heart rhythms generally cost $400 to $800. Some advanced designs that
provide feedback about the position and orientation of the catheter
cost $2,000 to $3,000.
The first EP procedures were performed more than 30 years ago. The
early experience showed that EP catheters were quite durable and could
be sterilized for reuse, as has been the practice for many surgical
instruments. The obvious motives were to reduce cost and eliminate the
waste of catheters that could be reused without compromising patient
safety. The physicians who perform these studies have no direct or
indirect personal financial incentives to reuse catheters, and there
are ethical, medical, and legal reasons to avoid any practices that
would add material risk to EP studies. The cost of medical supplies is
the responsibility of the hospital where the procedure is performed;
however, physicians often consider it their responsibility to work with
hospitals to make efficient use of supplies and reduce operating costs.
Arrhythmia ablation procedures typically take three to five hours
to perform. In order to advance the EP catheters to the heart, tube-
like sheaths are inserted into the arteries and veins to provide
vascular access for EP catheters. The catheters are then inserted
through the sheaths and advanced to the heart. The sheaths allow
cardiovascular specialists to remove, exchange, or reinsert the EP
catheters as needed during the procedure. Sometimes catheters--new or
reprocessed--must be exchanged because they do not have the necessary
configuration to reach a specific target in the heart, or because they
have become less maneuverable during the course of the procedure.
Sometimes several catheters are tried during a procedure before the
optimal catheter is identified. Reprocessing allows the flexibility to
use several catheters during an EP study safely and free of fiscal
concerns.
In some cases the catheter is easily positioned at the target site
and is subjected to very little manipulation. In more difficult cases a
catheter may be removed and reinserted several times during the course
of a procedure and is subjected to considerably more stress when
extensive efforts are required to reach the target. Because the
stresses that can be imposed on an individual catheter can vary
considerably during a study, EP catheters are manufactured to be very
durable. It is their durability which makes them reprocessable.
Regardless of the amount of stress imposed on a catheter during a
study, each one is carefully evaluated by the reprocessor to determine
whether it is suitable for reuse.
The number of catheters used during an EP study can have a
substantial impact on the cost of performing the study, but it does not
change the level of reimbursement from Medicare or other insurance
companies. When the cost of catheters exceeds the level of
reimbursement, hospitals bear the loss.
Review of Published Clinical Studies
There are studies, all of which have been published in peer-
reviewed scientific medical journals, which have evaluated the safety
of reusing catheters for EP studies. All have found no evidence that
the sterility of reprocessed catheters is a concern or that the
incidence of infection is increased. The results of four clinical
studies are summarized:
1. The results of a study of 12 medical centers were published in
the medical journal Pacing and Clinical Electrophysiology in 1988. The
study looked at the safety of reusing catheters. The incidence of
infection related to a total of 14,640 EP procedures involving 48,075
catheter uses was reported. At three centers, catheters were
automatically discarded after a single use. These centers carried out
1,245 EP procedures using 3,125 catheters. At the other nine centers,
catheters were sterilized for reuse. There were 13,395 procedures using
44,950 catheters in the reuse group. The incidence of bacteremia (blood
borne infection) and superficial skin infection at the site of catheter
insertion is shown below.
Table 1: Incidence of Infection During EP Studies.
------------------------------------------------------------------------
Superficial
Group Bacteremia Skin
------------------------------------------------------------------------
Single Use Catheters.......................... 1 (0.03%) 1 (0.03%)
1,245 studies
3,125 catheters
Reused Catheters.............................. 8 (0.018%) 1 (0.002%)
13,395 studies
44,950 catheters
------------------------------------------------------------------------
The authors of the study concluded that sterilization and reuse of
the catheters employed in this study did not result in any increase in
the risk of infection. They felt the catheters were sufficiently
durable to be reused well in excess of five times, and that one-time
use of such catheters appeared to be a medically unnecessary and
expensive policy to adopt.
2. Similar results in a prospective study were published in the
Journal of the American College of Cardiology in 1987. The study
evaluated catheter reuse over a five-year period during which 178
catheters were used 1,576 times for 847 EP procedures. Detailed records
of catheter testing and use were maintained. No complications were
encountered during the study period. All reused catheters functioned
for cardiac pacing and recording of cardiac electrical signals.
Surveillance cultures and biologic indicators revealed that adequate
sterilization procedures were used. The authors concluded that EP
catheters may be safely reused provided a thorough cleaning, testing
and record-keeping system is instituted. They also concluded that the
practice of reusing catheters would result in substantial cost savings
to hospitals.
3. The studies mentioned above were conducted in patients
undergoing diagnostic EP studies before the advent of deflectable
catheters and arrhythmia ablation procedures. A study published in the
Journal of the American College of Cardiology in 1993 prospectively
investigated the time course of electrical, physical and mechanical
changes in ablation catheters to determine the affect of reuse on
safety and efficacy. The study included 69 ablation catheters made by a
single manufacturer that were used in 336 procedures. Testing of
physical integrity consisted of visual and stereoscopic (X30
magnification) examination of handle function, catheter shaft and the
deflectable tip. Specific attention was paid to the ablation electrode
attachment to the catheter shaft, and the ablation tip electrode was
scrutinized for pitting. The electrical integrity of the catheters was
measured by electrical resistance from the handle connector to the
recording rings and to the tip electrode. Deflection and torque
measurements were made to assess mechanical integrity.
During the course of this study 36 catheters (52 percent) were
rejected at some point because of mechanical or electrical failure.
Eighteen catheters were repeatedly sterilized and eleven of the
catheters were used 10 or more times. The most common reasons for
catheter rejection were tip electrode glue separation after an average
of 4.3 uses and loss of deflection after an average of five uses.
Electrical discontinuity was observed after an average of 10 uses.
There was no significant decrease in catheter torquing ability that
determines the steering responsiveness of the catheter. The medical
records of 140 patients who had arrhythymia ablation procedures in this
study revealed only one case (0.7 percent) of local infection at the
insertion site that was treated effectively by antibiotics. There were
no other complications.
The authors of the study concluded that the catheter model used in
this study could be reused an average of five times. They recommended
that after each use catheters be carefully examined under magnification
with special attention to the tip electrode. They also recommended that
the catheters be tested for deflection and electrical integrity after
each use.
4. Another study published in the American Journal of Cardiology in
1994 looked at the effects of reprocessing on mechanical integrity,
sterility, and chemical residuals. The study was part of an internal
quality review process conducted by a hospital to establish and
validate an institutional policy for reuse. A total of 12 commercially
available catheters from two manufacturers were analyzed. Eleven of the
catheters were randomly selected from the catheter inventory of the
clinical EP laboratory after being used one to four times. They were
manually cleaned, repackaged, and gas sterilized with ethylene oxide.
To assess the sterility of reused catheters, three were cut into two-
inch segments, placed in bacterial culture media, and incubated for
five days. Six of the catheters were analyzed for chemical residuals
after gas sterilization. Two catheters were examined for evidence of
component failure. Visual inspection and microscopy were used to
determine mechanical integrity of the catheter surface, and x-ray
inspection was performed to assess interior structures.
The results showed no bacterial growth detected on any of the
cultures. which indicated that reprocessed EP catheters are effectively
sterilized. The chemical analysis demonstrated that the concentrations
of ethylene oxide detected in extraction liquid exceeded standards
established by the FDA. Microscopic examination of reprocessed
catheters demonstrated inconsequential metal and fiber particulates on
the catheter surface and at some electrode-catheter interfaces. The
shaft of the catheters and the electrodes remained intact. There was no
evidence of electrical discontinuity, and the integrity of internal
structures was confirmed by x-ray inspection.
The authors concluded that, with sterilization techniques
frequently used by hospitals, the potential for chemical residual
contamination might exist after sterilization with ethylene oxide.
Based on these results the hospital changed its policy to single use.
It should be noted that the hospital subsequently resumed multiple use
of catheters that were reprocessed by a commercial vendor whose
chemical residuals after reprocessing met FDA standards.
Medical Device Reports
Medical Device Reports (MDRs) submitted to the FDA contain
information about three cases involving EP catheters. One case involved
a reprocessed catheter. The other two occurred with new single-use
catheters. It is appropriate to emphasize that despite the reuse of
hundreds of thousands of catheters, only one MDR has been submitted to
the FDA that involved a reused catheter. The reports are summarized
below:
A new deflectable ablation catheter was being positioned in
the right atrium when the catheter tip was noted to be detached
and wedged in the coronary sinus. The patient was observed
overnight and discharged the following day without any reported
symptoms.
A small fragment of the distal tip in proximity to the
electrode side of a new catheter broke away and the fragment
could not be located. Further details are not available.
A reprocessed orthogonal EP catheter was used without incident
until it was removed from the heart. The physician felt some
resistance during removal of the catheter. A subsequent x-ray
showed a small electrode fragment lodged in the wall of the
right atrium. It was presumed that a single platinum electrode
mounted on the surface of the catheter might have been
compromised during reprocessing. The surgical consultant
decided that removal of the fragment was not indicated and the
patient remained free of symptoms.
Impact of Reuse Policies on Physicians, Hospitals, and Patients
Most EP laboratories are staffed and administered by hospital
employees. The cost of supplies and maintenance for EP laboratories is
also paid from hospital budgets. The physicians' motive to reuse EP
catheters has arisen from their experience that the catheters are
durable and can be safely used for several procedures without posing an
increased risk to the patient. As such, it would be a waste to discard
EP catheters after a single use.
The risk to patients associated with reusing EP catheters is
inconsequential relative to the overall risk of these procedures. The
risk is, in fact, so low that it is difficult to quantify. Policies
that prohibit the reuse of EP catheters will not have an appreciable
impact on the risks of these procedures, but they will certainly
increase the costs.
The cost savings realized by hospitals that reuse EP catheters
depend on the volume of procedures and whether catheters are
reprocessed internally or through a commercial reprocessing company. As
a general rule, reprocessing companies charge 50 percent of the
original cost of the catheter each time the catheter is reprocessed.
Allowing for an 85 to 90 percent pass rate for each reprocessing cycle
for a maximum of six uses per catheter (resterilized a maximum of five
times), hospitals can reduce their catheter costs by about 35 percent.
At large medical centers these measures may lead to cost savings in the
range of $250,000 to $400,000. At smaller medical centers the total
savings would be substantially less, but for both large and small
hospitals this practice is a significant cost-reducing measure at a
time of escalating costs and declining reimbursement.
Development of Policies For Reuse of Medical Devices
The FDA has proposed a strategy to address the reuse of medical
devices currently labeled for single use. This policy was developed in
response to the concern that a device's performance, safety,
specifications, or intended use might be compromised during
reprocessing procedures. The policy would be applicable to both
commercial reprocessors and hospitals that engage in these activities.
The FDA's strategy categorizes levels of risk presented by reprocessing
and reusing single-use devices. Factors that would influence the risk
category of a specific device include the complexity of procedures
associated with reprocessing, the actual and potential risk for
infection should the device be reused, and the quality and extent of
published data on reprocessing for that device. The agency would
consider ``high-risk'' devices to be products that may pose significant
public heath risk to patients and users after reprocessing. It is
anticipated that the FDA would enforce all of the agency's regulatory
requirements, including premarket requirements, for high-risk devices.
The FDA has indicated that it would also enforce applicable premarket
requirements for ``moderate-risk'' devices to ensure that the
reprocessed device remains as safe and effective as a device that has
never been used.
The FDA is examining the criteria used to label a device as
``single-use.'' The new policy would potentially clarify or justify
manufacturers' need for ``single-use'' labels.
The FDA has also questioned the need for informed consent when it
is anticipated that reprocessed devices might be used during a
procedure.
Summary
The ACC and NASPE support the position that reuse of EP catheters
is a safe and cost-effective practice provided that these devices are
meticulously cleaned, sterilized, and inspected in accordance with
accepted standards of practice. Both organizations are working with the
FDA to refine additional risk adjusted standards that can be applied to
reprocessing medical devices and to clarify the criteria for single-use
labels. We urge Congress to defer to the FDA as it perfects a
regulatory strategy for the reuse of medical devices that is based on
science and emphasizes public safety as the first priority. We firmly
believe that no further congressional action is required at this time.
Mr. Upton. Well, thank you all very much for your testimony
and as folks could tell we wanted a diverse range of opinions
and we got them. I compliment the staff, Mr. Ford and Mr.
Slobodin. A couple of things. This is an enormously complex
issue and Dr. Ganske, as an example, will be able to come back
to discuss. He is one of the physicians that serves on this
subcommittee. I know that the FDA regulations that they put out
for comment only really came out this week. There has been a
lot of talk about them in recent days, weeks. And Ms. Eshoo's
bill has been out there for a little while as well.
I am wondering if any of you at the table have actually
looked at the regulations that came out earlier this week, and
might make some comment or indicate whether you are going to
comment on them. And if so, maybe give us an advance in terms
of where you think they are strong enough, where you think they
may be too weak. Or maybe you do not think we need them at all
or whether this is exactly the right direction that we are
going to head. And I will just start, Mr. Lindsay. And if you
have not had a chance to see them, I certainly understand. We
understand. I appreciate your comments maybe in writing at some
point if you, in fact, you do make those comments known.
Mr. Lindsay. I just received the documents yesterday and
was taking care of patients until late in the day, so I have
not reviewed them. But I have spoken to people at the FDA this
week, and we have talked about some of the common ground that
as a professional organization we feel that we have with the
FDA in trying to address this problem. Physicians have no
reason to use devices that are unsafe. It just makes our lives
miserable and it is not why we went into medicine. Our interest
is in protecting patients and in trying to help them, and we
would like to work with the FDA to tackle this in a responsible
way.
Mr. Upton. So, you do not have a verdict yet whether or not
it is the right course?
Mr. Lindsay. From what I have read I think that it is a
workable solution and one that will protect the public
interest. I think it is one that would prohibit the recycling
of certain devices that are not safe to reuse. I think it would
permit the reuse of devices that can be safely reprocessed, and
I think that is a reasonable approach to take.
Mr. Upton. Dr. Trotter?
Mr. Trotter. I too have not been able to review the written
revisions by the FDA. I do think that it is important that we
focus on the FDA recommendations. One of the things I
appreciate about all the attention that was given to the FDA
today is I consider them to be a relatively objective source. I
think some of the other parties involved on both sides may have
financial conflicts of interests that could implicitly or
explicitly affect their testimony. I think there is less of
that then on the FDA.
Mr. Upton. You want to stay on the topic. The clock is
ticking on me, too.
Mr. Trotter. Okay.
Mr. Upton. Mr. Feltner.
Mr. Feltner. Yes. It is AMDR's view that FDA regulation of
reprocessing is necessary, critical to ensuring the safety of
reprocessed devices, and the patients. We believe that the
current FDA regulatory regime which emphasizes compliance with
QSRs is well-suited to meeting public health. We do not really
believe that the pre-market review scheme proposed is
necessary, but if there is a reason, and there is an
assessment, and there are relevant facts that determine a pre-
market review is necessary, we support it and we are willing to
work and look forward to working with FDA on any path that it
chooses.
Mr. Upton. Dr. Maurer, and actually before you answer, I
would just like to know what the difference was. You showed
those saw blades that you said were recyclable. What was the
other device that looked like a----
Mr. Maurer. Both of these are saw blades.
Mr. Upton. Oh, they are? Okay. I did not see the other end
of it.
Mr. Maurer. It has been coming for years and years.
Mr. Upton. You had it covered up with your thumb.
Mr. Maurer. And it shows up on our door----
Mr. Upton. I just saw the wrench.
Mr. Maurer. [continuing] you could be paralyzed. Same
blade.
Mr. Upton. Okay. Okay. I just saw the wrench at the other
end when you----
Mr. Maurer. Put it with the other saws.
Mr. Upton. So that is--all right. All right. Go ahead and
answer the----
Mr. Maurer. Well again, we have not had much time to look
at it. I looked at it briefly. I think the major thing that
comes out of it, just on a cursory review, is it's got to be
the same across the board. I think when you first read it, it
looks like it is directed purely at hospitals and reprocessors.
We have free standing inventory, surgery centers, we have
physician offices, we have a lot of people that are going to
reuse these devices, and it has got to be a level playing field
or we are going to have patient problems.
Mr. Upton. Do you all at the Cleveland Clinic, actually
keep track then of the number of times that things are
reprocessed?
Mr. Maurer. Absolutely. You would have to be or we would
not be able to limit it to five and those that come back from
the reprocessor have a mark on them. Half of the ones we sent
out, they threw away because after they looked at them they
felt they were unacceptable and we do not get charged for that
when they throw them away.
Mr. Upton. Dr. Fielder.
Mr. Fielder. I very much like the direction that the FDA is
moving. I did have a chance to look at the documents, but not
terribly carefully. One of the things that, from an ethical
standpoint, is important about their proposal is that they are
going to have patient assurance that these devices can be
cleaned and sterilized that is based upon an objective third
party review rather than simply on what the manufacturers say,
or on GMPs and quality assurance. And that is very important
for patients.
Mr. Upton. Dr. Grossman.
Mr. Grossman. Yes. I'm sorry. I have had a chance to review
them and have four specific areas. First, I think they are very
commendable in that they do level the playing field and for the
first time will force the production of reliable data, and that
should be commended. Some of the specific devices, I think,
probably should be in higher categories and I think that will
probably evolve under their scheme up. The exemption issue
concerns me because the very biopsy device I showed, although I
am not an attorney, clearly, the reason for it in the past
would be to allow similar devices. But in fact, if it would
allow that kind of device with a sharp point to skate through
and bypass the safeguards, clearly that would need to be
tightened up. My last comment is again, the plea. This issue
has been alive for longer than today. My concern is I start to
see 6 months to 12 months to 18 months, a notice period. I do
not know how much more it could be tightened, but that would
clearly be a plea.
Mr. Upton. Mr. O'Holla?
Mr. O'Holla. Yes. I have also had an opportunity to read
them in between everything else I was doing this week, and I
think FDA has come a long way, certainly from where they were
18 months ago. Certainly where they were even in November, and
I would like to thank this committee and its members because I
think it is a result of the attention you have paid to that
issue that has caused some of that movement. I do, however,
think there is one problem area where we need to talk with FDA
a little more, and that is the area of exemptions raised by Dr.
Grossman. The exemptions currently for medical devices did not
take into consideration the risks associated with reuse and
cleaning. I think, therefore, those exemptions should not stand
for a prolonged period of time. We are going to have to figure
out how can we deal with that issue and make sense out of the
scheme. But I think we are headed in the right direction. I
think the nice part is, nobody has to believe me and nobody has
to believe them. We will have a referee.
Mr. Upton. Ms. West.
Ms. West. I think the recommendation certainly show
progress. My concern is that it does not cover staff
incompetence and question how they would be able to implement
that without having someone on the floor continually for
quality assurance.
Mr. Upton. Thank you. Mr. Stupak, you ready or do you want
me to come back to you?
Mr. Stupak. Thank you Mr. Chairman. Dr. Lindsay, if the FDA
is going to set a standard for a number of times the device is
reused, how do you establish this number? Is there a community
or an acceptable medical practice standard for a device
established by ACC or NASPE or would it vary from hospital to
hospital? Would the standard include a level of device
integrity below which the catheter is discarded? How do you
track and account for the number of times that the individual
catheter has been reused? What happens if the numbers exceed
it? I know there are a lot of questions there, but I am just
trying to get it on the record.
Mr. Lindsay. First of all the tracking is easy in that any
catheter that is reused has a tag on it. It is a serial number
and it is tracked by the reprocessor. So that there are limits
that are set on that. Many hospitals with regard to
electrophysiology catheters have set a limit of five reuses
based on some information that is available from the
literature. In some cases catheters in these studies have been
used 10 or 15 times, but we do not want to push it to its limit
because at that point I think you could have a greater risk for
a breakdown. But certainly somewhere in the maximum of five
seems reasonable. Now, having said that let me make it clear
that not all catheters make it to five.
Each cycle, at least with our reprocessor, each cycle about
80 percent, 85 percent of the catheters will make it through
that cycle and the others do not. They do not make the cut. So,
I think that the criteria that are used has to be the same at
each hospital or at each reprocessor. We cannot have divergent
criteria.
Mr. Stupak. So whether a catheter makes the cut, that is up
to the reprocessor?
Mr. Lindsay. That depends on the inspection and the testing
that is done. So they examine it for nicks and electrical
integrity, things that might potentially compromise it. Now,
the other part of that question is that as catheter designs
evolve, and the catheters we use today are different than they
were say 10 or 15 years ago. It may be that with the newer
designs, some of the designs will not be suitable for
reprocessing. They may have sensors in them that would preclude
reprocessing. We have that, for example, for some of the
catheters that cost $2,000 or $3,000. They have sensors built
into them that cannot be reprocessed. In other cases they may
have mechanisms that may not lend themselves to reprocessing.
So I think that one of the challenges before us is to identify
these catheters, to look at their mechanisms, to look at the
materials that they are made of, and decide whether they can
safely be reprocessed and used in patients in such a way that
nobody has any question whatsoever about the integrity of that
product.
Mr. Stupak. Thank you. Dr. Maurer, in keeping with that
same line of thought, in your testimony you talked about the
fact there is a five time use limit for reprocessed non-
aluminum diagnostic electrophysiology catheters. Would you
outline for the committee how the clinic tracks the five times
use to assure that is not exceeded? What mechanisms are in
place that you use? Should it be accidentally exceeded? And is
this a model for tracking limited reuse utilized on a hospital
wide basis?
Mr. Maurer. Well, it is important to understand there is
very little of this done. I mean, more sterile processing and
so forth, I mean, 99.9 percent is with reusables. Scissors and
clamps in ORs. So we are not, you know, just striking out on
this.
Mr. Stupak. True.
Mr. Maurer. This is a very small amount. I would echo what
Dr. Lindsay says. We follow the same things. These are
nationally published studies that are peer reviewed and have
been around for years. We track them by serial numbers, there
is a log kept, we have continuous quality improvement and
statistical process control that is applied to these entire
departments, not just in the reprocessing of catheters. It
looks at all their infections, and all staff competency, and
the review that has to occur on a regular basis. We are
required to do this for Joint Commission. Believe me, when they
come they bare down on this and if there is any problem, there
is a root cause analysis done by us before Joint Commission
does come and we have to show them that root cause analysis. So
it is very stringent. I mean, you have got to understand, we
physicians do not get any money from this. Can you imagine what
it takes for us to grab a reprocessed device. We require that
there be good quality control before we touch that and stick it
in a patient.
Mr. Stupak. Sure, but then a question I asked earlier about
DRGs. I mean, DRGs source will only pay so much for a
procedure. Now, if I can use a reprocessed catheter I am going
to save some money, and the pressure on the hospitals, and
clinics, and everyone else to keep within that amount, I mean,
you know, we talk about these things, but there is also a
responsibility here for the rest of us up on this side of the
dias when we start putting on these standards or what we are
saying has to be done. DRGs limited amount payment leads to
this reuse.
Mr. Maurer. Yes. We charge less, and we so note that in the
record that it is a reused device. I do.
Mr. Stupak. But if it is a DRG, I mean, you get paid the
same for the DRG whether you use reprocessed or not.
Mr. Maurer. That's true. That's true. But that charging
less than when the DRG gets reevaluated by HCFA they will note
that. And if it has become a standard thing that everyone
reprocesses it, then they feel within their rights in terms of
being budget neutral to cut back on that where they want to
give money elsewhere.
Mr. Stupak. I do not have any more for now.
Mr. Upton. You are out of time.
Mr. Stupak. Okay. Thanks.
Mr. Upton. We are going to have another round though, I
promise. Mr. Bryant.
Mr. Bryant. Thank you Mr. Chairman. Dr. Trotter, on the
issue of informed consent I kind of, first of all I want to
apologize for being late. We have been in a prescription drug
meeting right next door, and I missed, I think, the first four
or five panelists testimony. But I did come in and Dr. Trotter
you had mentioned something in your testimony about informed
consent and when it would be appropriate. And as I recall it
was based on, I think, the degree of risk involved, that being
determined by I assume a physician, would determine whether or
not the patient ought to be informed. And if I hear what you
are saying that overall the gist of your testimony is that for
a reprocessed medical equipment there should not be an informed
consent by the patient?
Mr. Trotter. That would be the end result that I would
recommend. My opinion was that we ought to ensure that these
reprocessed single-use devices are safe, safe enough so that
there would not be a significant risk, and therefore informed
consent would be a moot point.
Mr. Bryant. And how do you do that? How do you ensure that
they are that safe? You as a physician cannot do it, can you?
Mr. Trotter. No. No, I cannot do it as a physician. I did
read H.R. 3148 and I noticed though that many of the devices
that I use I guess I count as the reprocessor. For instance, a
stethoscope would count as a critical Class I device since I
put it in unsterile areas of the body like the oscula and the
inframamillary fold every time I examine a patient. So if
something like a stethoscope, if that sort of risk was
something where we required informed consent, then I guess, you
know, I would need to be more involved in that sort of manner.
But in fact, the specific requirements for ensuring the safety
of some of these more complicated devices are far beyond my
scope.
Mr. Bryant. Yes. That should be at least the FDA's
responsibilities?
Mr. Trotter. Yes.
Mr. Bryant. Okay. Dr. Lindsay, on reviewing some of the
information here I find that the Association for Operating Room
Nurses has developed a different policy from the one you
expressed and the one that is endorsed by your American College
of Cardiology and that is that in essence that unless the
hospital can demonstrate the patient's safety and the medical
devices effectiveness and integrity are not compromised, that
reprocessing is not recommended by that Operating Room Nurses'
Association. Do you have any comments on that?
Mr. Lindsay. I think some of this may reflect the different
types of devices that are reused. The American College of
Cardiology and NASPE are not advocating that all devices be
reused, and some of it may depend on what kind of things they
come in contact with. That is a different group than nurses,
for example, that work in cardiac catheterization and
electrophysiology laboratories. I do not know that a lot of
these devices clearly should not be used. I think there are
some things in gastroenterology that probably should not be
reused. And there may be some areas in cardiology that we have
touched on today that they should not be reused. But that is
what we have to examine carefully.
Mr. Bryant. I would like to just throw this question open
to anyone who would like to answer. I think some of you have
touched on this already in other questions, but my question
would be what more, beyond these two letters that the FDA has
sent out, what more can they do now to advise and instruct or
anything else the FDA can do to help ensure the safety of
patients in this area of using reprocessed, I almost said
repossessed, reprocessed medical equipment.
Mr. Upton. You are thinking of NAPA auto parts.
Mr. Bryant. We were talking about body parts a minute ago.
Yes, doctor.
Mr. Maurer. Well, I think they have already done quite a
bit. I have looked at their conferences that many on this
committee have attended and given their views to, and they have
taken views from everyone. I just think they need to continue
to collect data, now that it is time to get the studies of
large groups of patients that are peer reviewed and published,
that have the chance of appropriate criticism of the design of
the study and the results, and we get the data out in the open
and let the public know that we are doing our job at looking at
this on a scientific basis.
Mr. Upton. Very quickly, one more.
Mr. O'Holla?
Mr. O'Holla. Yes. I think the FDA has done a great job in
getting everybody's comments together and looking at the
available data. You know, peer review is not the standard that
FDA uses to establish safety and efficacy. I think it is time
for FDA to act. They have already said that this is a device by
device decision. The big studies are not necessary to make the
device decisions. They need to act. They may need to act more
quickly than they have published this week and start looking at
the applications that show the particular device that the
surgeon is grabbing tomorrow is safe.
Mr. Bryant. Anyone else? I thought I saw a hand go up.
Okay. Well, thank you very much, and I yield back the balance
of my time.
Mr. Upton. Thank you. I wish all members were able to spend
the time like you have, Ms. Eshoo. Maybe you should think about
getting off one of those other subcommittees and we will find a
vacancy over here.
Ms. Eshoo. There are several people here that would not
want me to.
Mr. Upton. Go ahead.
Ms. Eshoo. Thank you very much, Mr. Chairman. I want to
make a couple of observations before I ask questions of this
very distinguished panel. A few barbs have been thrown around
that the effort underway to take an even closer look at
reprocessing, what that means relative to the public health and
whether we have policies in place that speak to the best of
what we could do. These are all very legitimate questions that
are being asked. And I think that the, I know that the intent
here, my intent of submitting the legislation was not to favor
one group or another. Now, around here, you know, you punch the
pillow, you put a dent in it, but there is always something
else that pops up. I remember going back to FDA reform where
medical device manufacturers were not happy with what I placed
on the table because it was very stringent and it did not
always meet with what they wanted to do. There were some people
involved in that debate that wanted to destroy the FDA. They
did not want an FDA around. Now today I hear so many
complimentary things said about the FDA and I welcome that.
I think it is important to the American people, and I
reminded my colleagues during that debate that if they were to
say otherwise they were frightening the American people. The
American people want an Agency that is going to be a top
watchdog that will step between whatever interests are out
there and their interests. I think today by the questions that
have been asked by my colleagues on both sides of the aisle,
that you have all figured out that we are here for the public
interest. So, you know, always in all of these issues someone's
ox seems to be gored or the perception is that. I am here for
the public interest and I think everyone here on the committee
is as well. So I would hope that you would keep that in mind. I
really want to work with everyone.
I really believe that the reason that all of these proposed
guidelines were bragged about today, and I think it is terrific
that they have proposed guidelines, is because we have pushed,
and pushed, and pushed. That is what my colleagues and I are
supposed to do. Because every 2 years our constituents hold us
responsible for what we have done or have not done. So I think
it is a very important background for each one of the people
that comprise this very distinguished panel. Just one more
observation, and that is in all of the research we did before
we ever thought of writing legislation, yes each side has some
studies, but the FDA does not on behalf of the public which
raises another question. Of course an organization is going to
bring information forward that is going to be favorable to what
they do. I would be all over you, questioning you, why you had
not done that. But the fact of the matter is, is that the
public agency that is supposed to be guarding the best
interests of the public health has not done that. Nor do the
regulations, so to speak, or the guidelines, or whatever they
have in place do not bring that about.
That is a big, deep, dark hole as far as I am concerned
because we have to have a public yardstick by which we measure
these things. I think it is important for organizations to do
it. Certainly I will take that into consideration, but I want
you to know that I think that at the top the absence of that
kind of information, I think, is somewhat alarming and we need
to do something about that. Now, I would like to go to Dr.
Maurer, thank you for being here representing the American
Hospital Association. I am very familiar with the Joint
Commission standards because I chaired a hospital board of
directors. So I know what those standards are, but I also know
that as someone at this end of the table said that there really
is a patchwork quilt throughout the country of what some
hospitals may do, what some other hospitals may not. My
question to you is do you pass the savings on of the reuse of a
single-use device onto the patient or to Medicare?
Mr. Maurer. Well, like I said we charge less. It all
depends on whether the patient----
Ms. Eshoo. Where does the savings go though? Does it go to
the patient or does it go--if it is a HCFA issue----
Mr. Maurer. Whoever is paying the bill. If Medicare is
paying the bill on a Medicare patient, the savings goes to
Medicare.
Ms. Eshoo. Then it goes to Medicare.
Mr. Maurer. If the patient does not pay anything, we cannot
impart savings to him.
Ms. Eshoo. If it is a private insurance, do you pass it up
to the private insurers?
Mr. Maurer. Yes. Yes. The charge is made.
Ms. Eshoo. You do? And that is a consistent standard across
the country or is it just where you are?
Mr. Maurer. That I do not know. I can only speak for what I
do.
Ms. Eshoo. All right.
Mr. Maurer. And what my hospital does.
Ms. Eshoo. Well, I think the committee members need to keep
that in mind. In your testimony you said, to go with the FDA's
proposed guidelines, you have not read them thoroughly, but you
said we do not need the bill. Have you read the bill?
Mr. Maurer. I have read the bill.
Ms. Eshoo. All right. Now, if you have not read the others
and you compare and contrast the two, how can you come to that
conclusion? I mean, I have said to the American Hospital
Association, California Hospital Association, I stand ready to
work with you. So it is a little disturbing to me because you
have been my partner in so many things, and I have a deep
regard for what you do and fought very hard, by the way, for
the BBA refinements to take place because hospitals were really
getting it across the country. Why would you say in your
testimony not having read one, but read the other, to go with
the one that you really have not read but disregard the one
that you had.
Mr. Maurer. No. What I meant was, I have read the bill. I
think the bill actually does exactly what you said it did. It
is a wake-up call. This needs to be looked at. But all the bill
can do is one thing. The FDA has a continuous regulatory
process which they are putting in place. Which conceptually as
we have heard today I fully agree with. In a cursory review of
what I got less than 12 hours ago I have some concerns, but
that is the regulatory process which will go on and on years
and years after you and I are doing something else.
Ms. Eshoo. Well, good laws do too as well.
Mr. Maurer. Exactly.
Ms. Eshoo. So thank you very much. To--let's see who it
was. I do not have a name. Is it Dr. Trotter? I think if you
read page four again of the bill's language, it really applies
to devices that are inserted into the body. And to take that,
to pull that out of context I think is, well, I mean as the
author of the legislation I can say it is somewhat unfair. If
we need to go back and say that in a better way we will do
that. But it was never intended, you know. I am a legislator, I
am a politician. I do not consider myself a fool. I simply
would not do that legislatively, because it is not necessary.
So I just want to correct that.
Let me ask one more question and that is to Mr. O'Holla,
and I want to thank you. Even though I am not asking all of you
questions, I would like to thank you all for what you have
brought forward today. In your view should any single-use
device be reprocessed without a 510(k)? This has gone on back
and forth today and, you know, I think that I would like to
have this set down for the record. For instance, if a new
device is exempt, it is all around these exemptions and the
consistency. Now, I heard Dr. Feigal say that under the
proposed guidelines that there would be total consistency, and
yet I do not hear a consistency of comments from the varying
views that are a part of this panel in agreement that there
will be consistency. So would you comment on that where a new
device is exempt from pre-market requirements, should not the
reprocessed one be exempt as well?
Let me just add a little asterisk to this. For those of you
that cannot stand what I am doing, you must think that I am
regulation happy. I am not. But I do think and if anyone ever
wanted to go back and track this and we have talked about
tracking today, in all of the years of my public service, both
in County government and now here in the House of
Representatives, there are two places where I think, regardless
of what level of government we are at, that we have to have
absolutely the highest standards when it comes to public safety
and when it comes to public health. People cannot do these
things for themselves. They simply cannot. They are reliant
upon either very sound regulations and laws that are put into
place. So, would you comment on this.
Mr. O'Holla. I am glad you asked that question, because I
also got confused this morning, but I have worked it out in my
mind and I hope I can clarify it for the members here. There
are exemptions for new devices in two categories. There are
exemptions for the disposable devices, and there are exemptions
for reusable devices. For certain kinds of devices both of
those are lumped together. So we have three different kinds. If
a disposable device has been exempted, it has never been taken
into consideration the risks associated with the reuse of that
disposable device. That exemption does not address those risks
and should not hold. If an exemption holds for a reusable
device, it has been exempted based upon the fact that the
device was designed to be reusable. It still does not take into
consideration the risks associated with reusing a single-use
device. So, my comment to the committee would be, be very
careful about these exemptions. They have not taken the risks
into consideration. They should not stand.
Ms. Eshoo. Thank you.
Mr. O'Holla. Does that help?
Ms. Eshoo. It does help. Thank you.
Mr. O'Holla. Okay.
Ms. Eshoo. It is clarifying and it is an important part of
the record. Thank you to all of you and to Mr. Chairman.
Mr. Upton. Thank you. I have got a number of questions left
and I know Mr. Stupak is back and so I would expect the same as
well. What is the number of single-use devices that are
reprocessed about, percentage wise? Mr. O'Holla? Mr. Maurer, at
the Cleveland Clinic?
Mr. Maurer. I can comment at our institution. We have just
done a recent review of that. It is very hard to give an exact
percentage, but of all devices that go through sterile
processing, and that is what we are talking about. I think, you
know, Ms. Eshoo's comment is: Let us get away from this reuse
of single-use devices. We are talking about sterile processing
of devices, period. It is less than 1 percent, maybe even less
than \1/10\th of a percent.
Mr. Upton. Mr. Feltner?
Mr. Feltner. Yes. Overall it is very small. In fact, on the
list that FDA published of commonly reprocessed devices, AMDR
members do not do half of them.
Mr. Upton. Well, that is my other question. In fact, I was
going to ask Dr. Maurer, you know, as I look at--and you are a
terrific witness. The Cleveland Clinic is up at the very top,
so we are glad that you are here and I know my hospitals of
Michigan are very good as well, and I am anxious to see exactly
what they are doing. But of the devices that you watch over,
how many of them will be sent out to one of the AMDR member
versus what you do in-house?
Mr. Maurer. Most of the reprocessing is in-house. When it
gets down to a critical device, the saw blades like I showed
you, we send out. Now, the electrophysiology catheters, what if
you were better at that. They are contained within the
department of electrophysiology, there are trained people
there, we have looked at them, we have continuous process
control upon them. You have got to remember in terms of sterile
processing, hospitals have done that ever since they opened
their doors hundreds of years ago and, you know, Halsted
decided that things should be sterile. That we should wear
gloves. Hospitals do that, they are professionals in that. The
people are trained. You cannot walk into those areas unless you
are supposed to be there.
Mr. Upton. And Mr. Feltner, as your organization brings
things in, and obviously some things fail, what percentage of
that? I mean, obviously if the average of----
Mr. Feltner. It varies by product as you--I mean, saw
blades, for instance. I mean, you cannot drop one and break it
generally, but other products you could. So I would say we have
some products as high as 60 percent rejection. Other products
as low as 10 percent rejection. But I think there is something
here that I am not comfortable that we are all speaking in the
same language, because here is the thing.
Mr. Upton. I know there are a lots of oranges and apples
here.
Mr. Feltner. Yes. One thing though that is very important
that we have common language on. I am hearing a lot of concern
that these devices that we are talking about I could not
possibly think of having a device put in my body that was in
the body of a previous person. Well, then you better never go
to a hospital because every procedure that I have ever seen,
someplace in that procedure is a product, whether it is
reprocessed, or reusable, or new, that has been used on another
patient. So what we are really saying is oops, I did not mean
to say that I meant to say if it is single-use.
Mr. Upton. Well, this happened. Yes.
Mr. Feltner. Now, what we are saying then is we have two
different standards of sterility. We have two different
standards of cleanliness. One for a product marked single-use,
and one for a product marked reusable. Well, that does not make
any sense because the standard for validating the sterility of
either product is the same. So, I think we have to look at
this. Once a product is out of the package it has to meet the
same standard. We were talking about which one would be exempt.
The example just talked about. One of Dr. Maurer's saw blades
would be exempt and one would not. Why? Because the
manufacturer chose to label one single-use. It just so happened
he sold the same one as reusable last week. Which one do you
exempt?
Mr. Upton. When an AMDR member rejects a product, is there
some reporting of that? Do they go back to the OEM?
Mr. Feltner. We manifest everything that we must turn that
into medical waste or hazardous waste.
Mr. Upton. Right. Right. But do you report back to the
original manufacturer or to the FDA?
Mr. Feltner. Oh, yes. Sure. Well, not back to the
manufacturer. No. We report back to the hospital who sent it to
us. See, that is another thing I want to make sure we
understand. Hospitals who send products to us only get their
products back. These are never owned by us. We do not sell
products.
Mr. Upton. Right. I understand.
Mr. Feltner. So when they send us 50 saw blades and we
reject five, they know that. We send them back and say we
rejected five of these. We are shipping you 45 back.
Mr. Upton. Well, what happens with devices that are used on
someone with a disease like Hepatitis or HIV, what happens to
those--are those automatically out of the stream? Are they
reprocessed still? What type of----
Mr. Maurer. Well, I can tell you, we have a policy in terms
of sterilization that is the same for everything, because you
do not know who has the Hepatitis.
Mr. Upton. Right.
Mr. Maurer. It was spoke about here that it may take 6
months to develop.
Mr. Upton. But what if you do know that somebody has that?
What if you do know that somebody has HIV, are any of those
products that might have been used in that individual's body?
Are they still processed with maybe more care? I mean, what
happens?
Mr. Maurer. The processing is the same. The processing will
kill HIV. It has got to because you do not know if they have
it. It has got to. Now, to be frank, when I am in an operating
room and I know the patient has got HIV, yes. I double glove
and, you know, obviously that is just normal. But we cannot
rely on that, so our processing has to be enough to kill that
bug, no matter if we knew it or not.
Mr. Upton. As I go back to, and I am going to use, you
know, one of Mr. O'Holla's, I guess it is the lower picture
there which is the tip of a catheter, is that what that is?
Mr. O'Holla. Ablation catheter, yes.
Mr. Upton. Ablation residue, and I presume that this device
that you came back to get had been reprocessed, right?
Mr. O'Holla. Yes, it had.
Mr. Upton. So it was not perfect.
Mr. O'Holla. That is right.
Mr. Upton. And if that individual whose residue is still
there, in fact, had HIV or something else infection like that,
it would be more than trouble?
Mr. O'Holla. I would think so.
Mr. Maurer. Two things. You have got to look at what the
process is that delivered that to the physician. You know, it
is probably not a good process. You also have to remember that
residue does not always equal infection as was shown in some of
the studies.
Mr. O'Holla. Right.
Mr. Maurer. Now, it is yucky. I agree and it should not be
there and I would not want it in me. Okay. Absolutely. But you
have got to look at the process. That is a good quality
control. If that is coming out, the process needs to be looked
at. The process needs to be improved, but do not throw out the
baby with the bath water. We are not going to throw out
reprocessing because the process is bad. That is where the data
needs to come from, from the FDA, and that the processes are
certified as not producing that product.
Mr. Upton. Well, I guess as us novices sit up here on this
dais, we want something that is going to work so that that does
not happen.
Mr. Maurer. That is true.
Mr. Upton. And we want some good housekeeping seal or
something along those lines to ensure the safety to the
patients, as well as to the hospital workers that are using
those particular products. My time has expired here so I guess
I go to Mr. Stupak.
Mr. Stupak. Thank you Mr. Chairman. Dr. Fielder, in
delineating patient alternatives, you used the example of
offering a patient the choice between a used or reprocessed SUD
with no difference in the cost to the patient. Would it follow
then that a patient should be offered the same choice in a
situation of two brand new devices, or one that costs the
hospital less and at a smaller potential risk?
Mr. Fielder. If I was a patient and they came at me and I
had a choice between a new single-use device and a reprocessed
one, I would take the new one, sure.
Mr. Stupak. Sure. But I am saying should they be offered
that choice?
Mr. Fielder. Yes, they should.
Mr. Stupak. Okay.
Mr. Fielder. Because it is an alternative treatment.
Mr. Stupak. But on two new ones, where one would cost less,
both new, if there is one cost----
Mr. Fielder. If there is no significant difference in risk,
then that is the choice of the physician and the hospital. In
the case of reprocessed devices, there is a significant risk.
That crud that you see on the ablation catheter could be
Hepatitis C that you are going to put into somebody else, so
that is a risk. We do not know how high the risk is, but it is
a risk.
Mr. Stupak. If you have two new devices, brand new, and the
question assumes a small potential risk with using one or the
other, the patient should be made aware of that, right?
Mr. Fielder. Not necessarily. I mean, there has to be some
kind of, I mean, there is some risk in everything.
Mr. Stupak. Sure.
Mr. Fielder. And there is some level, as Dr. Trotter was
saying, that the Courts have used the idea that material risk,
is this something that the patient would want to know as part
of his or her decision to have this treatment? So there is a
kind of floor or level beyond which the risks are so remote
that that does not really matter and people need not to be
informed. They need to be informed if this is part of their
decision in their lives and in their healthcare. And I think
the fact that we do not have a well controlled cleaning and
sterilization process that has been approved by FDA, means that
there is a significant risk that people ought to know about so
they can decide if they want to go along.
Mr. Upton. Mr. Feltner?
Mr. Feltner. Yes. That is not entirely correct because all
of the processes in commercial reprocessing are validated and
the FDA has standards for sterilization validation. Now, if we
ask or have the doctor get patient consent for every product
that has been used, are we going to get patient consent for
every reusable product? Every product has a life. We just do
not happen to know what it is. I have seen $4,000 instruments
sold as reusable break on the first case. They were not meant
to be disposable. They just happened to be that time. So we
never know. Well, we say oh, take this out of circulation
because next time it is going to break. We do not know that. So
all of these products that are being reprocessed should they
have patient consent as well?
Mr. Stupak. Well, should a patient be asked their consent
on whether they want a new one or reprocessed one?
Mr. Feltner. If we do that we will run out of money by 7
this evening.
Mr. Maurer. Let me explain a little bit about patient
consent because I do it every day. Every day I do anesthesia on
somebody, I have to consent that patient. Okay. These people
are very nervous. They are coming in for surgery on their
bodies. Okay. What they want is quality care delivered to them
in a safe environment. That is all our jobs here is to make
sure that the regulatory, that the laws, that the FDA, that the
licensing to be a physician, is done properly. Okay. I consent
them for the serious parts of their procedure that they need to
consent to. Okay. I tell you, to shirk our duties and think
that somehow the consent issue is the primary one and that is
going to solve this, is not going to work. Okay. We should
consent patients. We should inform them, but when the risk is
very low, and that is the thing that we are arguing here on
either side, is how high is the risk. When the risk is very low
and that risk is documented by valid data, then let us not
confuse the issue with consent.
Ms. West. Excuse me. I want to know if there is a reused
device going to be put into my body. I have suffered for 17
years because a C-arm was reused when they originally did the
surgery on my head. And whether we run out of money or not,
then we need to find another way to do that. But as a patient,
I want to know if I am being given a reused or a clean device.
And then in addition to that, I need to ask to be excused as I
am supposed to be over at the Senate at 3 and I apologize for
this, but my opinion is that I want to know. And I have many
years of experience because I was not told, I was not given the
option and everybody should be given the option.
Mr. Stupak. Dr. Maurer, if I may, just a point of
clarification on a question and answer with Ms. Eshoo. Maybe I
misunderstood it. But I understand that, Ms. West, you can go.
Right, Mr. Chairman, she can go?
Mr. Upton. Yes.
Mr. Stupak. I understand that the Cleveland Clinic passes
along savings of reprocessing to the government and the
patient, but where does the Cleveland Clinic reduce cost by
reprocessing? I got the impression that there was a reduced
cost that was passed on to the patient and the Government, so
where does the Cleveland Clinic reduce the cost by
reprocessing?
Mr. Maurer. Well, if you reduce the cost and you deliver
the same quality, you increase your value. And that is
reflected in your market share because you then, the patients
come to you more because you are delivering better value. So
that is where the advantage is.
Mr. Stupak. Okay. So it is not, that is value to the
Cleveland Clinic then?
Mr. Maurer. That is right. Now in some instances, in terms
of going out in the marketplace and then negotiating a managed
care contract, if we can do it at a lower cost, we offer a
lower managed care contract, as long as we deliver the same
quality and can certify that quality to the people that are
paying us, and we get the contract.
Mr. Stupak. Okay.
Mr. Upton. Dr. Ganske.
Mr. Ganske. Thanks Mr. Chairman. I want to go back to a
question I asked Dr. Feigal, and it looks to me like we have a
cardiologist on this panel, and I apologize for not being here
earlier, but I had some other meetings I had to be at. We have
somebody from the reprocessors, and the manufacturers. And now
Dr. Maurer, are you representing the American Hospital
Association?
Mr. Maurer. I have been asked to come here on their behalf,
yes.
Mr. Ganske. Okay. Let us go to this situation where we have
a catheter used for balloon angioplasty to crack open a
stenosis in a coronary artery. That little balloon, you know,
is made of an inflatable material. It is manufactured, in my
understanding to under a certain pressure go to a certain size,
there are different techniques for sterilization, one of which
though is a heat sterilization. The other would be a gas, but
then you are also dependent on very meticulous cleansing,
manual cleansing. I want to know specifically, does this panel
think that the average hospital, I am not saying some hospitals
cannot, but the average hospital, can they re-sterilize those
catheters, and I am not talking about the reprocessors. I will
get to that in a minute. But the average hospital, can they re-
sterilizing that balloon catheter, with a proper
sophistication, to be able to certify that after multiple uses
this catheter is up to par.
Mr. Maurer. Well, I can tell you that I cannot comment
nationally, and I do not have the data on it, but in my hands,
when I open a Swan-Ganz catheter with a balloon on it, even if
I do not put it into the patient it goes in the trash. We do
not even re-sterilize those that are open and not used because
we have that concern.
Mr. Ganske. So it is a Swan-Ganz?
Mr. Maurer. Well, it has got a balloon on it. That is what
I have in my hands.
Mr. Ganske. All right. I am talking about are balloon
angioplasty catheters reuse?
Mr. Maurer. We do not reuse those at the Cleveland Clinic,
no.
Mr. Ganske. Are they reused, do you think they are reused
anywhere?
Mr. Maurer. You can ask our cardiologist.
Mr. Ganske. Yes.
Mr. Lindsay. I'm Dr. Lindsay. There are some hospitals that
reuse these catheters. My hospital does not, and I have some
reservations about whether the data would support reusing
those. I think there are some of these devices that probably
should not be used. And I think as the FDA looks at them, that
is one of the devices that I have questions about.
Mr. Ganske. Mr. Feltner, what would your response on that
be?
Mr. Feltner. Some AMDR members reprocess balloon catheters,
and when they do they use FDA published guidelines that assure
bio-compatibility and physical testing. One company I know that
is an AMDR member, they tested over 8,000 balloon catheters
before they ever shipped their first one back to the hospital.
And I am told now that they have processed over 3,000 without
an incident. This----
Mr. Ganske. Does this require some special type of
technology and expertise to do that?
Mr. Feltner. Oh, yes. It will require special technology,
special equipment, but I think here what we are really getting
to though----
Mr. Ganske. Let me just ask you.
Mr. Feltner. Yes.
Mr. Ganske. Do you think the average hospital has that type
of technology or equipment to do?
Mr. Feltner. I would not think, and I use the word think, I
would not think that today many hospitals would have all that
equipment, but this is where we really need to zero in on the
answer here. And the answer is process. Validation. I am aware
of a major institution reprocessing in-house pace makers from
cadavers. Now, that sends a little hair up my back when I first
heard that and I heard no. If the process is right, if the
cleaning is validated, if the sterilization is validated, and
the functional testing is to a standard that could be
validated, the process is good. Now, many companies may chose,
or many hospitals may chose not to reprocess a product simply
because of our litigious society. There are certain products
that maybe the risk of a legal problem is greater than the
possible return of the market.
Mr. Ganske. Okay. Well, let me just follow this. I want an
answer from everyone on the panel on this. Is the panel in
consensus that at least for some types of single-use products
that the re-sterilization should be done, not by hospitals, but
only by certifiable reprocessors?
Mr. Maurer. The hospitals could get certified if they had
enough volume to get all the same equipment.
Mr. Ganske. Okay. But they would have to go through a--that
for some types of single-use products they ought to go through
FDA certification process. Is there any disagreement with that
on this panel?
Mr. Grossman. I would disagree because I think that the FDA
themselves are saying that what they are going to finally focus
on is the data that not what the process might have led to, but
what actually happened. Because that is the burden they put
when these products are originally created. The Office of
Science and Technology recently did a study they presented
publicly in May looking at the kind of catheters to which you
refer. Took them from Walter Reed instead of discarding them in
the garbage and performed functional testing and showed that
they were a disaster. They were a disaster. The balloons
changed compliance, changed shape, became sticky, so I think
since----
Mr. Ganske. So, you are agreeing with me?
Mr. Grossman. Well, I am saying I do not think the process
will protect it by saying you have handled it well. I think the
FDA then needs to actually go to the device and say now that it
has been processed, we are going to say that it is safe and
effective just like we did when it was new.
Mr. Ganske. Well, right. I am assuming that if it is
processed----
Mr. Grossman. Oh, okay.
Mr. Ganske. That if it is processed that the process
certification says that it works, not that you can just have a
sterile one--but now it inflates to 3 millimeters instead of
2.5. Okay.
Mr. Grossman. Yes.
Mr. Ganske. So, at least the entire panel is in consensus
that there are probably some sophisticated devices that are in
use that it would be inappropriate for a hospital to be
reprocessing and sterilizing themselves unless they have some
extraordinary reprocessing/processing capability, and that
these are items that could be identified by the FDA. Is that
fair?
Mr. Maurer. It out to be a functional definition. I worry
about location because things change over time. You know, so I
think it is a functional definition. If you cannot meet the
standard, then you should not be doing it no matter who you
are.
Mr. Ganske. Yes.
Mr. O'Holla. Congressman Ganske, I do not know if FDA can
actually identify those a priority. I know that FDA can make a
judgment about those if the person who wanted to do the act
came to FDA and said I am going to reprocess this particular
device this way and here is the data that shows it is safe and
effective. I think they can evaluate that. I think you may be
asking them to do an impossible task to identify a priority
which devices can and cannot be done, because they do not know
what people will be doing to them.
Mr. Ganske. Okay. Let me get to my second question. And you
know, pictures like this are disturbing to all of us, but
matters of thoroughness, of cleansing can vary between let's
say hospitals and professional reprocessors. Is there anyone
that would disagree with that?
Mr. Maurer. Well, I think it can vary hospital to hospital.
It can vary reprocessor to reprocessor.
Mr. Ganske. Right. But how many reprocessors are there in
the country?
Ms. Eshoo. They do not know.
Mr. Feltner. I cannot really say. I hear some stories that
are amazing. I do not know if they are--somebody said there are
23. If there are, I do not know who they are. There are three
major processors that are members of AMDR. I think that as FDA
implements the proposed guidelines, they would all have to
register, and then we would definitely know who they were. We
have cooperated with FDA in giving them all the companies that
we know of.
Mr. Ganske. Well, are were talking about less than 20?
Mr. Feltner. Oh, yes. Yes. Yes.
Mr. Ganske. Okay. And how many hospitals are there in the
country?
Mr. Feltner. Six thousand, roughly.
Mr. Ganske. It would be a lot easier to oversee whether
less than 20 reprocessors are doing their job properly than to
be thinking about looking at, for single-use devices,
particularly the ones that can be identified as problematic,
6,000 hospitals. Does not that seem reasonable?
Mr. Maurer. On the surface, yes. Okay. But you have got to
watch because, you know, hospitals have very good sterile
processing departments and quality control systems in place,
and those are well set up. They are supervised by Joint
Commission and State health boards, and it is not just the FDA
that is getting in on this. You know, processing and sterile
processing has been around for years.
Mr. Ganske. I understand. I am a surgeon. I have worked
with instruments all my life.
Mr. Maurer. You know what I am talking about. We have got
to look at those ones which are borderline, and we do not have
the data on, and if they require functionally specialized
techniques and the hospital cannot deliver that specialized
technique, then a specialized person needs to do it. And if
that is a reprocessor, then so be it.
Mr. Ganske. I agree. Thank you. Thank you Mr. Chairman.
Mr. Upton. Thank you. Ms. Eshoo, do you have additional
questions?
Ms. Eshoo. Yes. Mr. Chairman, I would like to make a
request and that is that if Dr. Maurer for the committee's
record could submit to us copies of the hospital's billings
that show the rates that are billed to HCFA when a reused
device is used versus the other. Because I think it will show,
you know, it is a demonstration and an example of the billing.
And I also think that when we look at these things that are
submitted for the record that we understand that while you may
be doing that at your hospital, we do not know what is
happening at others.
Mr. Maurer. We can do that.
[The following was received for the record:]
[GRAPHIC] [TIFF OMITTED] T2970.074
Ms. Eshoo. And I think that this patchwork quilt of issues
has really been nailed down with me today. That we have some
reprocessors that are absolutely terrific. The gentlemen that
represents them as a trade association cannot tell us how many
there are in the country. We do not know how many hospitals
adhere to the high standards that Dr. Maurer has talked about,
nor do we have information and data that has been collected by
the FDA, not the associations and the groups around all of
this. They simply have not tracked and collected the data that
we could weigh and measure in a hearing like this. So, it is a
patchwork quilt. I think that there are some problems out
there. We do not know in the reuse of these devices if, in
fact, the record that we know about anecdotally is the best
record of all. I mean, maybe that is the perfect good news. It
is not perfect, but there is a lot of good news in it because
people with legitimacy can say well, we do not have that many
problems in the country. But do we really know that? So I think
that this hearing was designed, or really offered us, what
Congressional investigation and oversight is really meant to
be. It has answered some questions, it has raised others, and
because of each one of you I think that we are going to move on
and keep examining this, at least I will. So thank you very
much. And thank you again, Mr. Chairman, for allowing me to be
here today and for the legislative courtesies that have been
extended to me, and your patience as well. Thank you.
Mr. Upton. Thank you. Again, I appreciate all of your
testimony and your answers. We would be most interested in the
future as you comment back to the FDA with regard to the
regulations that they put out. You have done a fine job today
and you are formerly now excused. Thank you.
[Whereupon, at 2:58 p.m., the subcommittee was adjourned,
to reconvene at the call of the Chair.]
[Additional material submitted for the record follows:]
Prepared Statement of National Consumers League
The National Consumers League is a national, nonprofit consumer
advocacy organization founded in 1899 to represent consumers in the
marketplace and workplace. NCL commends the Subcommittee on Oversight
and Investigations for holding this hearing. As you examine the complex
issue of medical device reprocessing, we want to bring to your
attention important consumer implications of this issue.
NCL believes that Congress must do all that it can to assure that
the Food and Drug Administration is doing its job to protect public
health. We believe that the Commerce Committee is moving in the right
direction as it investigates and oversees FDA's regulation of medical
device reprocessing. The safety of medical device reprocessing must be
the overriding concern of Congress, the FDA, hospitals, and physicians.
Clearly, no amount of health care cost savings can be justified if
safety is compromised.
In our view, the medical device reprocessing debate concerns two
very different interests: the interests of consumers who expect safe
health care practices and the interests of the medical device
manufacturers who are working very hard to eliminate competition.
First and foremost are the interests of consumers. Through
appropriate regulation, FDA must assure that medical device
reprocessing is safe. Consumers must have confidence that when a
reprocessed medical device is used in a procedure, it will perform as
safely and effectively as it would on its first use. Consumers should
be assured that they will not experience an infection or health
complication because a device was reprocessed.
Once it is determined, through sound science, that medical device
reprocessing can be safely performed and is adequately regulated, then
and only then should the cost savings that such a practice provides be
considered. Faced with overwhelming cost pressures, hospitals are
increasingly reducing staff and scaling back on the procedures they
will perform. For many consumers, the result has been lower quality and
less affordable health care. Measures that can help control health care
costs must be encouraged but should never be considered if patient care
is compromised.
As you know, medical device reprocessing is a practice aimed at
reducing costs associated with medical devices labeled as ``single
use'' or ``disposable'' by the manufacturer. We understand that many
hospitals have been reprocessing ``single use'' devices for years and
that a number of hospital and physician groups have sent letters to
Congress expressing confidence in the safety and effectiveness of
reprocessed devices.
FDA has a strong tradition of protecting the public health based on
sound science. As FDA reviews its regulatory approach for medical
device reprocessing, we expect the agency to continue this tradition.
Even though there has not been any significant evidence of a public
health hazard to date, FDA should be thorough and vigilant in its
regulation of device reprocessing and should take a strong regulatory
posture that is systematic, based on science and based on risk. If
effectively enforced, FDA's current regulatory regime affords consumers
appropriate protection. FDA's Quality System Regulation, which governs
the reprocessing of medical devices by third parties, is similar to
good manufacturing practice regulations and sets forth requirements
designed to assure that reprocessed medical devices are clean, sterile,
and functional. Through inspection, FDA must assure compliance with all
of the QSR requirements, including process validation, acceptance
activities, internal audits, personnel training, storage, and complaint
handling. By requiring those engaged in the reprocessing of medical
devices to withstand the scrutiny of FDA inspection, consumers can have
assurance that reprocessed medical devices are clean, sterile, and
functional.
We understand that FDA is reviewing its policy to require premarket
review of reprocessed medical devices. To date, the agency has not
believed premarket review is necessary to protect the public health. If
risk warrants premarket review for certain device reprocessing, FDA
should require it. NCL also believes consumers deserve more information
about the risks and benefits with all health practices, including
procedures that involve using all devices. FDA should work with
consumer and patient advocates to ensure that the messages patients
receive are accurate and thorough. To that end, statutory requirements
for informed consent--in consumer friendly language to assure that the
consumer understands--should be more broadly applied so that consumers
may assess the relative risks of a procedure or a particular device.
The FDA should require that all significant risks trigger an informed
consent requirement. In this way, consumers will receive relevant
information, communicated both orally and in writing in consumer
friendly language, and the information that they receive will be put in
the proper context with respect to their own health care regimen.
As mentioned, the issue of medical device reprocessing touches on
two different interests: the interests of consumers and the interests
of the medical device manufacturers. As the Subcommittee studies the
safety of medical device reprocessing, we urge you to take note of the
strong opposition to reprocessing voiced by the manufacturers of
``single use'' devices. You should be aware that the term ``single
use'' is a term that is chosen by the manufacturer of the device; it is
not required by the FDA. There is a clear economic incentive to label
devices as ``single use'' in order to sell more devices.
As Congress considers the issue of medical device reprocessing, it
should make sure that FDA has a sound science-based regulatory
procedure for medical device reprocessing in place that will protect
the public health and assure consumers that the devices used for their
health care are safe and effective.