VA Health Care: Purchases of Safer Devices Should Be Based on Risk of Injury (Letter Report, 11/17/94, GAO/HEHS-95-12). Every day health care workers suffer cuts, punctures, nicks, and gashes from needles and other sharp instruments used in taking care of patients. These injuries can result in transmission of the hepatitis-B virus, human immunodeficiency virus (HIV), and other blood-borne diseases. Safer needles and sharp devices are being marketed by companies claiming that their products can reduce the number of accidental injuries. Such devices eliminate the need for a needle, maintain a protective cover over a needle, provide an alternative to resheathing a needle after use, or use some other safety mechanism. This report discusses (1) the incidence of needle and sharp instrument injuries among health care workers in the Department of Veterans Affairs (VA); (2) the extent to which VA health care workers have tested positive for hepatitis B or HIV after a needle or sharp instrument injury; (3) the safety procedures and devices now used to minimize these injuries; (4) the extent to which VA is adopting new, safer technologies to prevent needle and sharp instrument injuries; and (5) the cost of screening and treating personnel who have received needle and sharp instrument injuries. --------------------------- Indexing Terms ----------------------------- REPORTNUM: HEHS-95-12 TITLE: VA Health Care: Purchases of Safer Devices Should Be Based on Risk of Injury DATE: 11/17/94 SUBJECT: Medical equipment Veterans hospitals Accident prevention Occupational safety Health care personnel Infectious diseases Health resources utilization Information dissemination operations Safety standards Acquired immunodeficiency syndrome IDENTIFIER: VA 1992 Annual Infection Control Survey AIDS ************************************************************************** * This file contains an ASCII representation of the text of a GAO * * report. 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We are unable to accept electronic orders * * for printed documents at this time. * ************************************************************************** Cover ================================================================ COVER Report to the Chairman, Subcommittee on Regulation, Business Opportunities, and Technology, Committee on Small Business, House of Representatives November 1994 VA HEALTH CARE - PURCHASES OF SAFER DEVICES SHOULD BE BASED ON RISK OF INJURY GAO/HEHS-95-12 VA Health Care Abbreviations =============================================================== ABBREV AIDS - acquired immunodeficiency syndrome CDC - Centers for Disease Control and Prevention FDA - Food and Drug Administration HIV - human immunodeficiency virus IV - intravenous NCCC - National Center for Cost Containment OSHA - Occupational Safety and Health Administration SPD - Supply, Processing, and Distribution UD - University Drive VA - Department of Veterans Affairs Letter =============================================================== LETTER B-252786 November 17, 1994 The Honorable Ron Wyden Chairman, Subcommittee on Regulation, Business Opportunities, and Technology Committee on Small Business House of Representatives Dear Mr. Chairman: Each day health care workers suffer cuts, punctures, nicks, and gashes from needles and other sharp instruments they use in taking care of patients. These injuries can result in transmission of the hepatitis B virus,\1 human immunodeficiency virus (HIV),\2 and other bloodborne disease. Safer needle and sharps devices are being marketed by companies claiming that their products can reduce the number of accidental injuries. Such devices eliminate the need for a needle, maintain a protective cover over a needle, provide an alternative to resheathing a needle after use, or use some other safety mechanism. In February 1993, you asked us to determine the effect safer needle and sharps devices can have on the working environment of health care workers in the Department of Veterans Affairs (VA). You expressed specific interest in knowing (1) the incidence of needle and sharps injuries; (2) the extent to which VA health care workers have tested positive for hepatitis B or HIV after a needle or sharps injury; (3) the safety procedures and devices currently used to minimize these injuries; (4) the extent to which VA is adopting new, safer technologies to prevent needle and sharps injuries; and (5) the cost of screening and treating personnel who have received needle and sharps injuries. This report addresses each of your concerns. You also expressed concern that the Food and Drug Administration (FDA) may be taking too long to review and approve needle and sharps devices designed to protect health care workers from injury and exposure to bloodborne infections. In a February 2, 1994, letter, we discussed FDA's process for review and approval of such devices.\3 To learn how VA policies and procedures concerning needle and sharps injuries were being implemented, we visited VA's Central Office in Washington, D.C., and medical centers in Philadelphia and Coatesville, Pennsylvania; Chicago (Hines); and San Francisco. To determine how private hospitals dealt with needle and sharps injuries, we interviewed personnel at the Thomas Jefferson University Hospital in Philadelphia and the San Francisco General Hospital. We also discussed the importance of reducing the numbers of needle and sharps injuries with officials at the Department of Health and Human Services' Centers for Disease Control and Prevention (CDC), the National Institute of Occupational Safety and Health, the Service Employees International Union, and other health care experts around the country. We identified 41 safer needle and sharps devices that FDA approved from January 1, 1990, to May 31, 1993, for use in the United States and asked VA's Central Office to provide us with data on the extent to which each of these devices was procured in 1993 by VA medical centers. In conjunction with CDC, we established a method to determine the threat to VA health care workers of contracting a serious infection from a needle injury. This methodology is more fully discussed in appendix I. Our review was conducted from February 1993 through August 1994 in accordance with generally accepted government auditing standards. -------------------- \1 Hepatitis B is caused by a virus that can be transmitted through blood and other body fluids. It causes a number of conditions, ranging from fever and jaundice to more serious conditions such as inflammation of the liver, cirrhosis of the liver, and liver cancer. There are other forms of hepatitis such as hepatitis A and C. \2 HIV is a virus that attacks a certain type of white blood cell, the T-cell, which plays an important part in the body's immune system. As the virus slowly destroys the T-cells, the body becomes increasingly unable to fight the virus and other infections. HIV eventually leads to acquired immunodeficiency syndrome (AIDS) disease, which causes death. \3 FDA Safety Devices (GAO/HEHS-94-90R, Feb. 2, 1994). BACKGROUND ------------------------------------------------------------ Letter :1 VA employs over 238,337 health care workers in 158 medical centers.\4 During the course of performing their normal daily activities many of VA's health care workers come in contact with needles or sharps devices such as lancets, scalpels, and knives. Thus, the danger of receiving a percutaneous injury\5 while working with these devices is an ever-present occupational hazard. This is not unique to health care workers in VA. Health care workers in every hospital setting have always been subject to such an injury. However, with the rapid spread of HIV and hepatitis viruses, increasing attention is being paid to ways in which such injuries can be reduced and ultimately prevented. Until recently, hospitals have tried to reduce health care workers' percutaneous injuries through education. Now, the emphasis is on reducing percutaneous injuries using safer needle and sharps devices. -------------------- \4 VA has defined 130 of these medical centers as acute care centers. The remaining medical centers are psychiatric, long-term care, and nonacute general medical and surgical medical centers. \5 Percutaneous means effected or performed through the skin. Percutaneous injuries include needle and sharps injuries, and we will refer to both needle and sharps injuries as percutaneous injuries. Needle injuries are injuries caused by needled devices such as syringes or intravenous (IV) lines. Sharps injuries are caused by other sharp objects such as scalpels, lancets, and broken glass. RESULTS IN BRIEF ------------------------------------------------------------ Letter :2 VA medical centers are individually responsible for acquiring medical devices they need to perform their work, including safer needle and sharps devices. While some medical centers are acquiring safer devices, insufficient data are available within these centers to demonstrate (1) the extent to which safer devices are needed and (2) whether the devices will reduce the number of percutaneous injuries. In fiscal year 1993, VA's 130 acute care medical centers reported 4,791 needle injuries, about a 19-percent decrease from 5,933 in fiscal year 1992. VA officials do not know to what extent this decrease can be attributed to better use of universal precautions, safer devices, or underreporting of needle injuries. But infection control personnel in VA and clinical staff at the private hospitals we visited told us that percutaneous injuries regularly go unreported. In fact, medical research has found that percutaneous injuries in both public and private hospitals could be understated by as much as 75 percent because of underreporting. Health care workers are sometimes reluctant to report these injuries for a variety of reasons, including lack of severity (for example, if the needle was not contaminated by blood) and concern about maintaining confidentiality (for example, if a worker does not want it known that he or she was exposed to a potential infection). However, a current surveillance study conducted by three private hospitals and the VA medical center in San Francisco indicates that the reporting of percutaneous injuries can be substantially improved when immediate, confidential counseling and follow-up are available to the injured workers. VA health care workers are at risk of incurring life-threatening diseases from a percutaneous injury involving HIV- or hepatitis- infected blood from patients in VA medical centers. The risk of becoming HIV positive after a percutaneous injury is small, about one-third of 1 percent. In fact, as of September 1994, there were no documented cases of VA health care workers being infected with HIV as the result of such an injury. However, we estimated that in fiscal year 1993, VA health care workers had 71 injuries involving needles contaminated with HIV-infected blood. This number may, in fact, be understated because it is based on data of questionable accuracy. The risk of acquiring hepatitis B from a percutaneous injury is between 6 and 30 percent. However, VA's Central Office does not know how many of its health care workers have contracted hepatitis as a result of a percutaneous injury because no records are maintained on this type of occurrence. To combat the danger of infection, VA has implemented standards and procedures in each of its medical centers to protect health care workers from percutaneous injuries. It also conducts training programs that emphasize the importance of a safe work environment. However, acquisition of safer devices to prevent percutaneous injuries varies by medical center, and the type of information needed to make informed procurement decisions is not always available. In fiscal year 1993, 90 VA acute and nonacute medical centers spent about $1.1 million to purchase 33 types of new safer devices that FDA approved from January 1990 through May 1993 for marketing in the United States. The total dollar value of individual medical center purchases of these safer devices ranged from $10 to $103,000. Several of the medical centers that did not purchase safer devices are in areas with high numbers of people who are HIV positive or have already acquired AIDS. The VA medical centers that we visited did not have financial accounting systems that allow collection of precise information on the cost of screening and treating personnel who have received a percutaneous injury. As a result, we were only able to obtain estimates of such costs. VA NEEDLE INJURIES MAY BE UNDERSTATED ------------------------------------------------------------ Letter :3 The number of needle injuries that occur in VA medical centers may be understated because they are not being reported by health care workers. In fiscal year 1993, VA's 130 acute care medical centers reported 4,791 needle injuries, a 19-percent decrease from the 5,933 reported in fiscal year 1992. The number of needle injuries per medical center in fiscal year 1993 ranged from a low of 3 in Fort Harrison, Montana, to a high of 115 in Boston. (See app. II for a complete listing of needle injuries reported by acute care VA medical centers.) VA officials do not know to what extent the 19-percent decrease in the number of reported needle injuries is attributable to the better use of universal precautions, acquisition of safer devices, underreporting of injuries, or a combination of these factors. However, infection control personnel at two of the medical centers we visited told us that percutaneous injuries regularly go unreported. Furthermore, medical research has found that percutaneous injuries in both public and private hospitals could be understated by as much as 75 percent because of underreporting.\6 VA officials told us that the reasons percutaneous injuries go unreported include the lack of severity of the injury (for example, if the needle was not contaminated by blood), concern about maintaining confidentiality (for example, if a worker does not want it known that he or she was exposed to a potential infection), and the current lack of effective treatment for HIV. The threat of disciplinary action is also a deterrent to reporting injuries. For example, an official at one VA medical center said that a hospital service at the facility was telling employees that they would receive bad ratings if they had too many percutaneous injuries. VA's Central Office collects information on needle injuries for each medical center, but it does not collect similar information on sharps injuries although this information is available at some medical centers. Both of the two private hospitals we visited collected information on the number of percutaneous injuries to their employees. One of these hospitals had 219 needle injuries in fiscal year 1991/1992, 28 of which involved HIV-infected patients. The other hospital had 213 percutaneous injuries in 1992. But officials at both hospitals told us that their employees underreport such injuries. In December 1993, VA's National Center for Cost Containment (NCCC), at the Milwaukee VA medical center, initiated a project on the use of safer devices. In August 1994, at about the same time that a draft of this report was sent to VA for its comments, the results of this project were published. The study, Needle Stick Prevention in the Department of Veterans Affairs - Monograph I, concluded, among other things, that (1) needle injuries remain a prevalent problem for the VA health care system and (2) surveillance and tracking of needle injuries are not standardized throughout the VA system. Efforts are under way to improve the reporting of percutaneous injuries in both VA and private sector hospitals. For example, in January 1992, San Francisco VA medical center joined three private hospitals in a CDC-initiated percutaneous injury surveillance project. The project was designed to collect injury data in sufficient detail to isolate and understand problem situations, recommend solutions, and evaluate the effectiveness of prevention measures. A major part of the surveillance project is a confidential 24-hour telephone hot line that employees use to report percutaneous injuries as soon as they happen. The hot line has several benefits. Specifically, injured employees receive medical advice, counseling, and follow-up treatment immediately, and the hospital receives more accurate and complete reporting of percutaneous injuries. Before either employees or the patients whose blood contaminated the employees (source patients) are tested for HIV, however, VA is required to obtain written consent from the individuals being tested. Preliminary indications are that the project is effective. In the 12-month period after the San Francisco VA medical center implemented the 24-hour hot line, the number of reported percutaneous injuries nearly doubled from 43 in 1991 to 79 in 1992. An official at the medical center told us that, in his opinion, the increase was due to better reporting of injuries, not to a greater rate of injury. At two of the private hospitals involved in this study, the frequency of reporting percutaneous injuries increased by 54 percent and 60 percent. Project researchers found that while the hot line improved the reporting of injuries, the prevention measures instituted as a result of the hot line information failed to reduce the number of injuries. The project researchers concluded that for health care workers, behavioral changes alone are not a satisfactory solution. In their opinion, primary prevention of occupational exposures to blood must also embrace the industrial hygiene standard of work place safety, which emphasizes use of inherently safer devices, administrative controls, and personal protective equipment. Although the San Francisco VA medical center's 24-hour hot line program is currently in danger of being canceled for lack of funds, the Chief of Infectious Disease there told us that he will attempt to continue the hot line with a combination of hospital and research funding. The private hospitals participating in the project have integrated the hot line into their infection control programs and intend to continue it. -------------------- \6 Bruce H. Harmory, M.D., "Underreporting of needlestick injuries in a university hospital," American Journal of Infection Control, October 1983, Vol. 11, No. 5, pp. 174-77. VA DATA ON HEALTH CARE WORKERS WITH HIV/AIDS OR HEPATITIS B ARE INCOMPLETE ------------------------------------------------------------ Letter :4 As of September 1994, no VA health care worker had been reported to CDC as having acquired HIV or AIDS because of a percutaneous injury. However, VA's Central Office does not know the number of workers who may have acquired hepatitis B through work-related percutaneous injuries because it does not routinely collect those data. The Public Health Service Act authorizes CDC through the National Center for Health Statistics to collect information on AIDS cases in the United States.\7 Although there is no federal requirement that HIV or AIDS cases be reported to CDC, all states voluntarily report known AIDS cases and 36 states require reporting of known HIV cases to CDC. Also, all states report health care workers infected with HIV. CDC receives the AIDS and HIV information from state and local health departments. These departments reported that 40 health care workers were known to have acquired HIV infection in the performance of their occupational duties through December 1993. According to CDC, as of December 1993, 12 of the 40 health care workers had developed AIDS. In addition, 83 cases were reported to CDC in which health care workers were suspected of having acquired HIV from percutaneous injuries. Although no VA health care workers are known to have been infected on the job, the possibility of infection is very real. In fiscal year 1993, VA medical centers treated 16,749 patients with HIV or AIDS. We estimated that during 1993 at least 71 needle injuries to VA health care workers involved HIV-infected blood; and during 1992, at least 99 such injuries occurred.\8 We also estimated that every 5 years at least one VA employee will seroconvert\9 to HIV positive because of a needle injury.\10 (See app. I for the methodology we used.) Unless a cure is found, these HIV-positive health care workers will ultimately develop AIDS. Furthermore, given the fact that the data from which these calculations are made may be understated, HIV infection and seroconversion rates may be even higher. The fear of contracting AIDS has overshadowed the dangers of acquiring hepatitis B. According to CDC, about 12,000 health care workers contract the hepatitis B virus annually, and about 250 infected individuals die from the disease. The risk of acquiring hepatitis B from a percutaneous injury involving hepatitis B-infected blood is between 6 and 30 percent. By comparison, the risk of becoming HIV positive from a percutaneous injury is about one-third of 1 percent. Given that in 1992, 3,083 VA patients tested positive for hepatitis B and 6,613 tested positive for hepatitis C,\11 VA health care workers are at obvious risk of acquiring the disease. Although a vaccine is available that provides active immunization against hepatitis B infection, no such vaccine exists for hepatitis C. -------------------- \7 The Public Health Service Act, 42 U.S.C. 242b and 242k. \8 The decrease in estimated needle injuries involving HIV-infected blood reflects the decrease in reported needle injuries and the decrease in the estimated patient HIV seroprevalence percentage in fiscal year 1993. Seroprevalence means the number of cases of viral infection in a population. \9 Seroconvert means to indicate the development of antibodies in the blood in response to an infection. \10 These estimates were calculated only for VA medical centers. The methodology we used has not been applied to other federal or private sector medical facilities. \11 According to VA's 1992 Annual Infection Control Survey. VA HAS IMPLEMENTED SAFETY PROCEDURES AND ACTIVITIES DESIGNED TO PROTECT HEALTH CARE WORKERS ------------------------------------------------------------ Letter :5 VA has adopted and implemented CDC's recommended universal precautions that are designed to protect health care workers from accidental injury and infection. Under universal precautions, all health care workers are expected to use gloves, gowns, masks, and protective eyewear when exposure to blood and other potentially infectious body fluids is reasonably anticipated. These measures are also to be applied consistently for all patients no matter what the circumstances. Universal precautions also require disposal of needle and sharps devices in puncture-resistant containers located as close as possible to the use area to minimize the workers' exposure to injury. VA has also adopted the Occupational Safety and Health Administration's (OSHA) bloodborne pathogen standard. This standard, published in December 1991, requires health care institutions to provide adequate and appropriate protection for all health care workers potentially exposed to patient blood and body fluids. The standard is designed to minimize or eliminate percutaneous injuries by using a combination of engineering and work practice controls, personal protective clothing and equipment, training, medical surveillance, hepatitis B vaccination, signs, labels, and other provisions. A key provision of the standard is the requirement that all employers develop an exposure control plan that identifies individuals who will receive training, protective equipment, vaccinations, and other benefits. All of the VA medical centers we visited were implementing exposure control plans that follow the direction of the OSHA standard. In addition, for all health care workers who are exposed to HIV-infected blood, VA has established a policy for follow-up, treatment, and care. VA conducts training, education, and other activities to facilitate health care worker safety. Some labor-saving initiatives have also resulted in a safer work environment. For example, in an effort to reduce the workload of physician residents, VA encourages medical centers, where appropriate, to establish special teams of skilled staff to insert IV lines in patients. Intravenous teams can reduce the number of needle injuries because they are specially trained and are skilled in performing such procedures. Intravenous teams have been established in 57 VA medical centers, but VA does not know to what extent these teams have reduced needle injuries. Another approach taken by the Philadelphia and San Francisco VA medical centers is the use of phlebotomy teams. These teams are composed of members whose primary job is to draw blood from patients for testing and analysis. Medical center personnel at these facilities believe the introduction of phlebotomy teams has helped to decrease the incidence of needle injuries. Individual medical center personnel can also play a significant role in making the work environment safer. For example, the Supply, Processing, and Distribution (SPD) Chief at the Philadelphia VA medical center developed a bloodborne pathogen report using fiscal year 1991 and 1992 percutaneous injury information to determine who was injured and when and how the injuries occurred. This was a self-initiated report and not part of VA's standard reporting process. The SPD Chief estimated it took 500 to 800 hours to analyze the data and write the report. The report findings included the following: The nursing service was at the most risk for injuries. Syringes were involved in 49 percent of the injuries in fiscal year 1992. Lancets were the second leading cause of injury in both fiscal year 1991 and 1992. The SPD Chief recommended that the nursing service be targeted for all available safety training and devices, that a needleless IV system and safety lancets be procured, and that only phlebotomy and IV team personnel perform phlebotomies and IV insertions, respectively. In fiscal year 1993, the Philadelphia VA medical center implemented all the recommendations in the report. As a result, through July 1994, there were no IV injuries after the introduction of the needleless IV system in February 1994 and no lancet injuries after the introduction of the safety lancets in January 1993. The SPD Chief was waiting until the end of fiscal year 1994 to analyze the results of the implemented recommendations. MEDICAL CENTERS' ACQUISITION OF SAFER NEEDLE AND SHARPS DEVICES VARIES WIDELY ------------------------------------------------------------ Letter :6 VA medical center purchases of safer needle and sharps devices are not necessarily based on risk data. Under VA's decentralized management philosophy, VA medical centers decide when, and to what extent, they will acquire safer devices. However, we found that medical centers are purchasing safer devices, in varying degrees, without regard to data that can be collected at each of the medical centers on the extent and cause of percutaneous injuries. As a result, purchases of safer devices are being made, but they may not be resolving the injury problems. Conversely, some medical centers that should be considering acquisition of safer devices are not doing so. In fiscal year 1993, 90 VA medical centers spent between $10 and $103,000 to purchase safer devices that FDA approved from January 1990 through May 1993 for marketing in the United States. In total, these 90 medical centers spent about $1.1 million on 33 types of devices. (See app. III for purchases by individual medical centers in fiscal year 1993.) Whether these variations in procurement amounts are justified is unknown. However, of the top 10 VA medical center purchasers of safer devices in fiscal year 1993 2 medical centers (Portland, Oregon; and Cleveland) were among those with the highest needle injuries in fiscal year 1992; 4 medical centers (Miami; New York; Atlanta; and East Orange, New Jersey) had high patient HIV seroprevalence percentage estimates in fiscal year 1992; and 3 medical centers (Miami; Portland, Oregon; and Atlanta) had high health care worker HIV seroconversion estimates in fiscal year 1992. Conversely several medical centers (Los Angeles, San Diego, Puerto Rico) with high seroprevalence or seroconversion estimates in fiscal year 1992 purchased no safer devices in fiscal year 1993. Nonetheless, in each of these facilities, the number of reported needle injuries dropped from fiscal year 1992 to fiscal year 1993. Safer devices can be 2 to 3 times more expensive than their standard counterparts. For example, a safer 22-gauge, 1-inch, IV catheter costs approximately $1.76; the same standard IV catheter costs approximately 62 cents. Considering that a typical hospital could use hundreds of these and other safer devices in a year, the total annual cost differential could be substantial. Thus, the cost should be balanced against the safer devices' ability to reduce the number of percutaneous injuries. Table 1 shows the 10 VA medical centers that spent the most on safer devices in 1993, the number of needle injuries that occurred in each facility, and the facilities' relative ranking in terms of patient HIV seroprevalence percentage and health care worker HIV seroconversion estimates. The table is intended to show how additional pertinent information can be used to facilitate decisions on the acquisition of safer needle and sharps devices. For example, in fiscal year 1993, the Miami VA medical center spent more than any other medical center on the purchase of safer devices. Although it was 49th of the acute medical centers in terms of needle injuries in fiscal year 1992, the center was second in patient HIV seroprevalence percentage and third in health care worker HIV seroconversion at acute medical centers. These data indicate that careful consideration should be given to acquisition of safer devices which, in this instance, occurred. Table 1 Top 10 VA Purchasers of Safer Medical Devices and Pertinent Injury and Health Data