[Federal Register Volume 87, Number 250 (Friday, December 30, 2022)]
[Proposed Rules]
[Pages 80474-80479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28356]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[Docket No. PRM-35-22; NRC-2020-0141]
Reporting Nuclear Medicine Injection Extravasations as Medical
Events
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; consideration in the rulemaking
process.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) will consider in
its rulemaking process issues raised in a petition for rulemaking
(PRM), PRM-35-22, submitted by Ronald K. Lattanze on behalf of Lucerno
Dynamics, LLC. The petitioner requested that the NRC amend its
regulations to require reporting of certain nuclear medicine injection
extravasations as medical events.
DATES: The docket for the petition for rulemaking, PRM-35-22, is closed
on December 30, 2022.
ADDRESSES: Please refer to Docket ID NRC-2020-0141 when contacting the
NRC about the availability of information for this action. You may
obtain publicly available information related to this action by any of
the following methods:
Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2020-0141. Address
questions about NRC dockets to Dawn Forder; telephone: 301-415-3407; or
email: [email protected]. For technical questions, contact the
individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS
Search.'' For problems with ADAMS, please contact the NRC's Public
Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737,
or by email to [email protected]. For the convenience of the reader,
instructions about obtaining materials referenced in this document are
provided in the ``Availability of Documents'' section.
NRC's PDR: You may examine and purchase copies of public
documents, by appointment, at the NRC's Public Document Room (PDR),
Room P1 B35, One White Flint North, 11555 Rockville Pike, Rockville,
Maryland 20852. To make an appointment to visit the PDR, please send an
email to [email protected] or call 1-800-397-4209 or 301-415-4737,
between 8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except
Federal holidays.
FOR FURTHER INFORMATION CONTACT: Andrew Carrera, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001; telephone: 301-415-1078, email:
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. The Petition
A. Background
B. Issues Raised in the Petition
II. Public Comments on the Petition
A. Overview of Public Comments
B. Comments Received to Specific Questions in the Docketing
Request for Comment
C. NRC Response to Additional Public Comments
III. Reasons for Consideration
IV. Availability of Documents
V. Conclusion
I. The Petition
The NRC received and docketed a PRM (ADAMS Accession No.
ML20157A266) dated May 18, 2020, filed by Ronald K. Lattanze on behalf
of Lucerno Dynamics, LLC. On September 15, 2020, the NRC published a
notice of docketing and request for public comment on the petition (85
FR 57148). The petitioner requested that the NRC amend its regulations
in part 35 of title 10 of the Code of Federal Regulations (10 CFR),
``Medical Use of Byproduct Material,'' to require reporting of certain
nuclear medicine injection extravasations as medical events.
Extravasation is the infiltration of
[[Page 80475]]
injected fluid into the tissue surrounding a vein or artery.
Extravasation is not limited to the administration of
radiopharmaceuticals.
A. Background
In 1980, the Commission amended the medical use regulations in 10
CFR part 35 to require the reporting of medical misadministrations
(later renamed medical events) (45 FR 31701; May 14, 1980).
Misadministration reporting allowed the NRC to investigate
misadministrations for possible violations, evaluate licensee
corrective actions, inform other licensees of potential problems, and
take generic corrective actions. In this 1980 rulemaking, the
Commission stated in a comment response that it did not consider
extravasation to be a misadministration because extravasation
frequently occurs in otherwise normal intravenous or intraarterial
injections and that extravasations are virtually impossible to avoid.
The misadministration reporting requirements were updated in 1991
(56 FR 34104; July 25, 1991) with dose criteria based on the National
Council on Radiation Protection and Measurements dose levels. These
dose criteria were added to clarify the definition of misadministration
and to exclude events involving diagnostic procedures, which the
Commission considered low-risk. The next major update of 10 CFR part 35
was completed in 2002 (67 FR 20250; April 24, 2002). The term
``misadministration'' was replaced with ``medical event,'' the existing
dose reporting criteria for patient exposures from medical events was
retained, and a dose threshold of 0.5 Sv (50 rem) shallow dose
equivalent to the skin was added. The extravasation exemption was not
addressed.
B. Issues Raised in the Petition
The NRC identified two issues in the petition as follows:
Issue 1: The exemption of radiopharmaceutical extravasations from
medical event reporting is based on the incorrect assertion that
radiopharmaceutical extravasations are virtually impossible to avoid
and therefore does not protect the public from unsafe irradiation. The
petitioner requested that the NRC amend Sec. 35.2, ``Definitions,'' to
include a definition of ``extravasation'' as follows: ``Extravasation
means the inadvertent injection or infusion of some or all of a
radiopharmaceutical dosage into the tissue surrounding a vein or
artery.''
Issue 2: Exemption of extravasations from medical event reporting
requirements results in a lack of transparency to patients, the public,
and the NRC. The petitioner also requested that the NRC amend Sec.
35.3045(a)(1), ``Report and Notification of a Medical Event,'' by
adding a new paragraph (iv) as follows: ``(iv) An extravasation that
leads to an irradiation resulting in a localized dose equivalent
exceeding 0.5 Sieverts (Sv) (50 rem).''
II. Public Comments on the Petition
A. Overview of Public Comments
On September 15, 2020, the NRC requested comments from the public
on the petition and posed eight specific questions to gain information
on the scope of and basis for the issues raised by the petitioner. The
comment period closed on November 30, 2020. The NRC received 488 public
comment submissions, including late-filed submissions. All the comment
submissions received on this petition are available on https://www.regulations.gov under Docket ID NRC-2020-0141. A comment submission
is a communication or document submitted to the NRC by an individual or
entity, with one or more individual comments addressing a subject or
issue. Eighty-eight submissions (from the Association for Vascular
Access, Organization of Agreement States, congressional
representatives, and private citizens) generally supported the
petition, 396 submissions (from 11 medical communities and private
citizens) generally opposed the petition, and two submissions were
duplicates. The NRC reviewed and considered all comments in its
evaluation of the petition.
B. Comments Received in Response to Specific Questions in the Docketing
Request for Comment
The following is a summary of the feedback that the NRC received
from the public on the eight specific questions posed in the notice of
docketing and request for public comment on the petition.
Question 1: How frequently does radiopharmaceutical extravasation
occur?
Comments Received: Twenty-five comments provided at least one of
the following replies to the frequency of radiopharmaceutical
extravasations: (1) there is clinical evidence that extravasation rates
are greater than 1 percent of all administrations; (2) the frequency
rate is unknown because extravasations are not reported; or (3) some
groups are understating the frequency and potential harm to patients.
Four comments stated that the extravasation frequencies cited in
the petition--average of 15 percent and a range of 2 to 23 percent of
all administrations--are misleading and biased. Twenty-one additional
comments stated that the frequency of either therapeutic or diagnostic
extravasations is very rare, typically less than 1 percent of
injections. Some of the 21 comments stated that this information is
based on their own clinical observations, which these comments further
stated is consistent with the results from peer-reviewed manuscripts.
Question 2: Do you know of any extravasations that have resulted in
harm to patients? If so, what were the circumstances, the type of
effect or harm, and the impacts.
Comments Received: Thirty-nine comments provided at least one of
the following responses related to patient harm due to extravasations:
(1) it is difficult to know if extravasations have resulted in patient
harm because they are not tracked and rarely studied; (2) it can take
months or years for the effects to become evident; (3) there are over
50 peer-reviewed papers that list the following adverse biological
effects of extravasations--local pain, erythema, swelling, lesions, wet
and dry desquamation, severe tissue damage, and radiation necrosis; (4)
even diagnostic extravasations can lead to high radiation doses to
injection site tissue; and (5) extravasations can hinder the ability to
deliver therapeutic applications of nuclear medicine.
Forty-nine comments provided at least one of the following
responses related to patient harm due to extravasations: (1) despite
millions of nuclear medicine injections, there have been no serious
cases of patient harm; (2) no instances of patient harm have been
observed during decades on the job; and (3) there is a lack of clinical
and research studies demonstrating instances of harm.
Question 3: For medical use licensees, does your facility currently
monitor for radiopharmaceutical extravasations? If so, why and how do
you monitor? If not, why not?
Comments Received: Sixteen comments stated that they are currently
monitoring for extravasations through scans or other methods. Ten
comments stated they have capabilities to monitor for and minimize
extravasations but some clinics are doing a better job of monitoring
than others. The same ten comments stated that requiring monitoring of
extravasations would
[[Page 80476]]
hold all clinics to a higher bar and increase injection quality and
patient health. Four comments agreed that not all institutions monitor
extravasations probably because they do not need to report
extravasations.
Question 4: Do you expect that monitoring for extravasations and
reviewing the results would improve radiopharmaceutical administration
techniques at medical use licensee facilities? If so, how? If not, why
not?
Comments Received: Thirty-six comments stated that monitoring
extravasations would improve injection quality. The same comments
stated that tracking would lead to a better understanding of how often
extravasations occur, which would lead to better training to reduce the
frequency of occurrence. In addition, the same comments noted that
there is plenty of evidence in clinical observations and peer-reviewed
literature that the frequency of extravasations can be reduced.
Twelve comments stated that monitoring and reviewing extravasations
would not improve injection quality because highly trained
professionals are already doing their best to prevent extravasations
from occurring, so monitoring would only cause unnecessary burdens.
Three comments stated that monitoring extravasations would not improve
injection quality because extravasations occur largely as a result of
patients having poor vascular structure. In addition, the same comments
noted that, in particular, pediatric, geriatric, and chemotherapy
patients often have compromised vascularity.
Question 5: Do you believe an NRC regulatory action requiring
monitoring and review of extravasations would improve patient
radiological health and safety? If so, how? If not, why not?
Comments Received: Fourteen comments stated that they had concerns
about the health of patients for both therapeutic and diagnostic
extravasations. The same comments stated that reporting of
extravasations would lead to a better understanding of their frequency
and severity, which could reduce how often they occur and lead to
better patient health. One comment supported the petition because
extravasations then could be tracked and their frequencies reduced to
the benefit of patients.
Four comments stated that there would not be improvements to
patient health due to monitoring and reporting of extravasations
because they are not preventable. Seven comments stated that there
would be no health benefits but there would be additional burdens to
medical licensees. Two comments stated that monitoring for
extravasations would negatively impact patient health because any
manipulation of the injection site or addition of sensors could
decrease blood flow, resulting in radioactive material remaining in the
injection site for a longer period of time.
Question 6: Are there any benefits, not related to medical
techniques, to monitoring and reporting certain extravasations as
medical events? What would be the burden associated with monitoring for
and reporting certain extravasations as medical events?
Comments Received: Forty-two comments stated that there would be
considerable burdens to monitoring and reporting extravasations without
much, if any, benefit. One commenter provided the example that 14
million diagnostic procedures are performed annually and if there is a
1 percent extravasation rate, then the result would be 140,000 medical
events annually. The commenters stated that the main burdens they are
concerned about are (1) reporting with minimal or no benefit, (2)
considerable increase in paperwork, (3) considerable financial costs
for practitioners and the entire medical field--possibly hundreds of
millions of dollars, (4) the total time for extra monitoring and the
frequency of nuclear medicine injections would allow for fewer patients
to be seen, and (5) it may create false radiation safety concerns in
patients and increase public fear concerning nuclear medicine.
Eight comments listed the following benefits to monitoring and
reporting extravasations: (1) patients will know when an extravasation
occurs, (2) it will lead to better diagnostics, (3) it will lead to
better data for tracking, and (4) it will reduce medical workload and
costs. Ten comments stated that those in opposition are overstating the
burdens to the medical community. The comments also stated that the new
detection methods are more cost effective for detecting extravasations
than traditional computed tomography (CT) scans. Lastly, the comments
noted that while there could be additional costs, it would increase the
incentive to provide quality injections.
Question 7: If the NRC were to require that licensees report
certain extravasations as medical events, what reporting criteria
should be used to provide the NRC data that can be used to identify
problems, monitor trends, and ensure that all licensees take corrective
action(s)?
Comments Received: Nine comments were in favor of the petitioner's
proposed 0.5 Sv (50 rem) reporting level because it is consistent with
the level used for nuclear medicine both domestically and
internationally. In addition, the same comments stated that the
petitioner's proposed reporting level will lead to better monitoring
and reduce the frequency of extravasations.
Eight comments stated the following concerns with the petitioner's
proposed reporting level of 0.5 Sv (50 rem): (1) the criterion is
arbitrary and does not harm the skin or tissue; (2) it takes more than
2 Gray (Gy) (200 rad) to cause impacts to skin in fluoroscopy
procedures, which is much higher than the proposed criterion; and (3)
if an extravasation does occur, the nuclear agents end up in the
intended part of the body similar to a non-extravasated injection
(i.e., extravasations migrate from the lymphatic system and end up in
the venous system). Nine comments did not support the petitioner's
proposed criteria of 0.5 Sv (50 rem) because there is not a good or
technically sound way to evaluate the dose to the tissue. Two comments
stated that there should not be any criteria because there should be no
reporting of extravasation.
Question 8: If the NRC requires reporting of extravasations that
meet medical event reporting criteria, should a distinction be made
between reporting extravasations of diagnostic and therapeutic
radiopharmaceuticals? If so, why? If not, why not?
Comments Received: Eighteen comments stated that there should not
be a distinction between diagnostics and therapeutics for
classification of medical events because (1) if you exceed 0.5 Sv (50
rem), you could be causing harm regardless of the method, (2)
diagnostic extravasations can cause harm or compromise scans, and (3)
few facilities monitor diagnostic injections, but monitoring tools now
exist that could lead to a better understanding of the frequency and
help reduce the occurrence of extravasations. One comment supported the
classification of therapeutic injection extravasations as medical
events; explaining, however, that some diagnostic doses are used as
``test doses'' to determine injection quality; and stated that
classifying these ``test doses'' as extravasations would be
contradictory since they are meant to improve patient safety.
Twenty-five comments expressed concerns regarding classification of
diagnostic extravasations as medical events because they are of such
low dose that they do not cause harm or compromise scans. The same
comments also noted that while therapeutic extravasations can cause
tissue damage, they are extremely rare events that are dealt with under
existing regulations. Lastly, most of these 25 comments do
[[Page 80477]]
not support the classification of diagnostic or therapeutic
extravasations as medical events, with an especially strong position
against the classification of diagnostic extravasations as medical
events.
C. NRC Response to Additional Public Comments
The NRC received thirty-three additional comments related to the
petition that did not provide a direct response to the specific
questions in the notice of docketing and request for public comment on
the petition. In addition, the NRC received three comments that were
out of scope. The NRC has binned these additional comments related to
the petition into two categories. The following discussion provides a
summary of each category and the NRC's response to the grouped
comments, including--if appropriate--a summary of the basis for the
response.
1. Comments Supporting the Petition
Comment: The NRC received nine comments supporting the proposed
criteria of 0.5 Sv (50 rem) because the dose to the skin from
extravasation can be estimated and this limit is 500 times higher than
the dose from an ``ideal injection.''
NRC Response: The NRC disagrees with this comment. The NRC's
medical event reporting dose threshold criteria (0.05 Sv [5 rem]
effective dose equivalent, 0.5 Sv [50 rem] to an organ or tissue, or
0.5 Sv [50 rem] shallow dose equivalent to the skin) are conservative
dose levels that would not be expected to cause patient harm. The
criteria were implemented in part to screen out medical events
involving diagnostic procedures because, as stated by the Commission,
the NRC agrees that routine doses from diagnostic procedures represent
a small amount of risk to the patient. On the dose levels, the
Commission further commented that these levels correspond to a
threshold well below the onset of acute, clinically detectable adverse
effects that may be caused by exposure to ionizing radiation. Reporting
extravasations at 0.5 Sv (50 rem) would result in many extravasation
events of low radiation safety significance being reported. However,
the NRC agrees that the topic of extravasation is important and
therefore is considering the issues raised in the petition and
assessing a more risk-informed reporting requirement in the rulemaking
process.
Comment: The NRC received a comment stating that reporting
extravasations is within the purview of the NRC. While administration
of radiopharmaceuticals is a practice of medicine, misadministration of
radiopharmaceuticals should be reported and this will not intrude on
the practice of medicine.
NRC Response: The NRC agrees with this comment. Requiring medical
event reporting of radiation-safety-significant extravasations is
within the purview of the NRC's regulatory authority and supports the
NRC's public health and safety mission.
Comment: The NRC received one comment concerning the lack of
rationale explaining why extravasation of diagnostic injections should
be exempted from medical event reporting.
NRC Response: The NRC agrees with this comment. The NRC questions
whether excluding diagnostic administrations from an extravasation
reporting requirement is supportable. Due to the smaller amounts of
radioactivity used in diagnostic procedures, extravasation of
diagnostic radiopharmaceuticals would rarely be expected to result in
adverse tissue effects. However, while rare, significant extravasations
of diagnostic radiopharmaceuticals with longer half-lives (such as
thallium-201) could result in adverse tissue effects (Van der Pol et
al., 2017) and would be considered a safety-significant medical event.
2. Comments Opposing the Petition
Comment: The NRC received four comments stating that extravasation
is a generic medical issue outside the NRC's regulatory authority and
is best managed at the institutional level.
NRC Response: The NRC disagrees with this comment. The radiation
safety impact of some extravasations can be severe enough to warrant
regulatory action, and reporting and tracking these incidents is of
interest to the NRC.
Comment: The NRC received three comments concerning diagnostic
extravasations. The comments state that minor diagnostic extravasations
occur frequently but can be detected by scans and do not reduce scan
quality or affect patient health. The comments further state that
concerns regarding diagnostic extravasations are overstated and
extravasation should be managed at the institutional level.
NRC Response: The NRC partially disagrees with this comment. While
diagnostic extravasations of safety significance are rare, significant
extravasations of certain diagnostic radiopharmaceuticals can cause
adverse tissue effects, such as prolonged erythema and even skin
necrosis (Van der Pol et al., 2017). The NRC is interested in medical
event reporting of radiation-safety-significant extravasations,
regardless of whether they involve diagnostic or therapeutic
radiopharmaceuticals.
Comment: The NRC received 11 comments stating that the NRC's
extravasation exemption is outdated.
Response: The NRC agrees with this comment. In 1980 the use of
injectable radiopharmaceuticals involved diagnostic dosages of lower
energy gamma emitting radionuclides. Since then, nuclear medicine has
evolved to include use of higher energy positron-emitting diagnostic
radiopharmaceuticals (for positron emission tomography imaging) and
therapeutic radiopharmaceuticals, which use higher doses of
radioactivity to treat certain cancers and diseases. The NRC is
revisiting the exclusion of extravasation from medical event reporting
in light of intervening changes in radiopharmaceuticals in the
rulemaking process.
III. Reasons for Consideration
Although the petitioner requested that the NRC require the
reporting of radiopharmaceutical extravasations exceeding 0.5 Sv (50
rem) localized dose equivalent, the NRC considered the issue more
broadly and evaluated whether to require reporting of certain
radiopharmaceutical extravasations of radiation safety significance as
medical events. The NRC evaluated whether (1) the radiation safety risk
from extravasations merits medical event reporting, (2) extravasations
are preventable, (3) including extravasations in medical event
reporting would align with the objectives of the NRC's medical event
reporting regulations, and (4) regulating extravasations would align
with the NRC's Medical Use Policy Statement (65 FR 47654; August 3,
2000). The staff recommends further evaluating, within the NRC's
rulemaking process, medical event reporting of extravasations that
require medical attention for a suspected radiation injury. The
remaining paragraphs of Section III summarize the NRC's evaluation of
the two issues identified in the petition.
Evaluation of Petition Issues
Issue 1: The exemption of radiopharmaceutical extravasations from
medical event reporting is based on the incorrect assertion that
radiopharmaceutical extravasations are virtually impossible to avoid
and therefore does not protect the public from unsafe irradiation.
The petitioner stated that recent evidence demonstrates that
extravasations are avoidable, invalidating the NRC's 1980
[[Page 80478]]
determination and subsequent exemption of extravasations from medical
event reporting requirements. The petitioner asserted that reporting
extravasations as medical events would reduce the amount of
extravasations and protect patients from harmful injections. In
addition, the petitioner asserted that diagnostic and therapeutic
extravasations can result in significant radiation doses to injection
site tissue, potentially causing adverse tissue reactions and cancer.
The petitioner stated that diagnostic extravasations can also affect
the accuracy of imaging study results, affect the patient's care, and
may lead to unnecessary radiation dose due to repeat imaging studies.
Lastly, the petitioner asserted that, per the NRC's Medical Use Policy
Statement, the NRC has the obligation to regulate extravasations as
necessary to provide for the radiation safety of workers and the
general public.
NRC Evaluation: The NRC believes that the Commission's 1980
decision to exclude extravasations from medical event reporting should
be reconsidered in the rulemaking process given the evolution of
nuclear medicine since then. However, the NRC does not agree with the
petitioner that the 1980 decision is invalidated because extravasations
are avoidable. Although there have been many advancements in nuclear
medicine since 1980, there is still no technology or technique that can
fully prevent an extravasation. While monitoring technology could help
identify extravasations earlier and improvements in training, skill,
and tools could help reduce the prevalence of extravasations, there is
no way to fully prevent extravasations from occurring. Even the most
skilled clinician may infiltrate an injection due to many factors
outside of the control of the clinician. Patient anatomy, age, body
habitus, hydration, and prior medical treatment are all factors that
may impact an intravenous administration.
The NRC agrees with the petitioner that medical event reporting of
extravasations may focus some medical licensees on reducing their
extravasation rate through implementation of quality improvement
programs for intravenous administration of radiopharmaceuticals, and
reducing the extravasation rate would improve radiation safety for
patients.
The NRC agrees that certain extravasations can result in radiation-
safety-significant doses to the tissue around the administration site,
which could result in adverse tissue effects. However, published
studies (Van der Pol et al., 2017; Hall et al., 2006) and input from
the medical community and the Advisory Committee on the Medical Uses of
Isotopes (ACMUI) indicate that due to the smaller amounts of
radioactivity used in diagnostic procedures, extravasations of
diagnostic radiopharmaceuticals are typically of low radiation safety
significance and would rarely be expected to result in adverse tissue
effects. The NRC agrees that extravasations of therapeutic
radiopharmaceuticals, which deliver larger amounts of radioactivity to
treat cancer and other ailments by killing cells, may cause tissue
damage around the administration site (Van der Pol et al., 2017; Bonta
et al., 2011; Tylski et al., 2018; Benjegerdes et al., 2017).
The NRC's Medical Use Policy Statement says, in part, that the NRC
will not intrude into medical judgments affecting patients, except as
necessary to provide for the safety of workers and the general public.
The policy also states that the NRC will regulate radiation safety,
when justified by the risk to the patient, primarily to assure the use
of radionuclides is in accordance with the physician's directions. The
NRC agrees that medical event reporting of certain extravasations would
support these patient safety objectives of the Medical Use Policy
Statement by potentially reducing the occurrence of radiation-safety-
significant extravasations. Therefore, the NRC is considering the
issues raised by the petitioner in a rulemaking process that will
assess risk-informed reporting requirements for extravasations.
Issue 2: Exemption of extravasations from medical event reporting
requirements results in a lack of transparency to patients, the public,
and the NRC.
The petitioner asserted that the exemption of extravasations from
medical event reporting requirements results in a lack of transparency
to the patients, the public, and the NRC as the extravasation events
are not documented in the NRC's Nuclear Material Events Database
(NMED), which contains records of events involving nuclear material
reported to the NRC. The petitioner asserted that this may result in
patients and clinicians being unaware that the diagnostic image or
intended therapy may have been compromised, and the NRC remains unaware
when licensees misadminister radiopharmaceuticals resulting in doses
that exceed medical event reporting limits.
NRC Evaluation: Under the NRC's current practice of excluding
extravasations from medical event reporting, extravasations that result
in suspected radiation injury, or even those that meet the NRC's public
health and safety significance criteria for an abnormal occurrence, are
not required to be reported to the NRC. The NRC agrees that reporting
radiation-safety-significant extravasations would increase transparency
between patients, physicians, and the NRC. If certain extravasations
were required to be reported under Sec. 35.3045, this would enhance
transparency through medical event reporting requirements for notifying
the patient, referring physician, and the NRC within 24 hours of
discovering the event and through event notification reports published
by the NRC. These event notifications would be publicly available on
the NRC website. These extravasation events would be shared with and
evaluated by the ACMUI on an annual basis. Additionally, the reporting
and analysis of safety-significant extravasation events would allow the
NRC to identify similarities in reports from multiple facilities and
issue generic communications to share information that may help
licensees to reduce the occurrence of radiation-safety-significant
extravasations and mitigate their consequences.
IV. Availability of Documents
The documents identified in the following table are listed in the
order in which they are cited in this notice and are available to
interested persons through one or more of the following methods, as
indicated.
------------------------------------------------------------------------
ADAMS accession No./
Document web link/Federal
Register citation
------------------------------------------------------------------------
Petition for Rulemaking (PRM-35-22)--Lucerno ML20157A266.
Dynamics, LLC, Petition to Amend 10 CFR
35.3045, May 18, 2020.
Notice of Docketing and Request for Comment on 85 FR 57148.
Petition for Rulemaking, Reporting Nuclear
Medicine Injection Extravasations as Medical
Events, September 15, 2020.
Final Rule, Medical Use of Byproduct Material, 67 FR 20250.
April 24, 2002.
Final Rule, Quality Management Program and 56 FR 34104.
Misadministrations, July 25, 1991.
[[Page 80479]]
Final Rule, Misadministration Reporting 45 FR 31701.
Requirements, May 14, 1980.
Medical Use of Byproduct Material; Policy 65 FR 47654.
Statement, Revision, August 3, 2000.
Van der Pol, J., S. Voo S, J. Bucerius, and F.M. https://
Mottaghy, ``Consequences of Radiopharmaceutical pubmed.ncbi.nlm.nih.g
Extravasation and Therapeutic Interventions: A ov/28303300.
Systematic Review.'' European Journal of
Nuclear Medicine and Molecular Imaging, Vol.
44, No. 7, July 2017.
Hall, N., J. Zhang, R. Reid, D. Hurley, and M. https://
Knopp, ``Impact of FDG Extravasation on SUV jnm.snmjournals.org/
Measurements in Clinical PET/CT. Should we content/47/suppl_1/
routinely scan the injection site? '' The 115P.2.
Journal of Nuclear Medicine, Vol. 41,
Supplement 1, Pg. 115, May 2006.
Bonta, D.V., R.K. Halkar, and N. Alazraki, https://
``Extravasation of a Therapeutic Dose of 131I- pubmed.ncbi.nlm.nih.g
Metaiodobenzylguanidine: Prevention, Dosimetry, ov/21795365.
and Mitigation.'' The Journal of Nuclear
Medicine, Vol. 52, No. 9, September 2011.
Tylski, P., A. Vuillod, C. Goutain-Majorel, and https://doi.org/
P. Jalade, ``Dose Estimation for an 10.1016/
Extravasation in a Patient Treated with \177\ j.ejmp.2018.09.071.
Lu-DOTATATE.'' Journal of Medical Physics, Vol.
56, Supplement 1, December 2018.
Benjegerdes KE, Brown SC, Housewright CD, https://
``Focal Cutaneous Squamous Cell Carcinoma pubmed.ncbi.nlm.nih.g
Following Radium-223 Extravasation.'' Baylor ov/28127143.
University Medical Center Proceedings, Vol. 30,
No. 1, January 2017.
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V. Conclusion
For the reasons cited in this document, the NRC will consider the
issues raised in the petition in the rulemaking process. The NRC will
evaluate the current requirements and guidance for reporting of certain
nuclear medicine injection extravasations as medical events. The NRC
tracks the status of all rules and PRMs on its website at https://www.nrc.gov/about-nrc/regulatory/rulemaking/rules-petitions.html. The
public can monitor further NRC action on the rulemaking titled,
``Reporting Nuclear Medicine Injection Extravasations as Medical
Events,'' that will address the issues in this petition by searching
for Docket ID NRC-2022-0218 on the Federal rulemaking website, https://www.regulations.gov. In addition, the Federal rulemaking website allows
members of the public to receive alerts when changes or additions occur
in a docket folder. To subscribe: (1) navigate to the docket folder
(NRC-2022-0218); (2) click the ``Subscribe'' link; and (3) enter an
email address and click on the ``Subscribe'' link. Publication of this
document in the Federal Register closes Docket ID NRC-2020-0141 for
PRM-35-22.
Dated December 22, 2022.
For the Nuclear Regulatory Commission.
Brooke P. Clark,
Secretary of the Commission.
[FR Doc. 2022-28356 Filed 12-29-22; 8:45 am]
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