Single-Use Medical Devices

Some single-use medical devices (SUD) can be safely reprocessed if appropriate cleaning, testing, and sterilization procedures are carefully followed. However, SUD reprocessing is not invariably safe, and relatively little is known about the practice of SUD reprocessing in health care institutions. The Food and Drug Administration has therefore taken steps to increase its oversight of SUD reprocessing. Nonetheless, the new framework does not treat all types of reprocessors consistently and will be difficult to implement. Because the demonstrated health risks from SUD reprocessing are small, it may also have only a limited effect on public health. GAO summarized this report in testimony before Congress; see: Medical Devices: Reprocessing and Reuse of Devices Labeled Single-Use, by Janet Heinrich, Associate Director of Health Financing and Public Health Issues, before the Senate Committee on Health, Education, Labor, and Pensions. GAO/T-HEHS-00-143, June 27 (nine pages).

GAO noted that: (1) while some health care institutions have chosen to reprocess and reuse some kinds of SUDs, accurate and comprehensive information about the number of facilities that use reprocessed SUDs and the types of SUDs that are reprocessed is not available; (2) surveys by professional associations and other groups have found that approximately 20 to 30 percent of American hospitals reported that they reuse at least one type of SUD and that at least one-third of the hospitals that do so contract with third-party reprocessing companies; (3) most hospitals using reprocessed SUDs reuse only a few types of devices; (4) it is likely that some hospitals do not report their use of reprocessed SUDs, and the estimates do not fully include ambulatory surgery centers or physicians' practices that also may reuse SUDs; (5) although SUD reprocessing does pose theoretical health risks, clinical evidence shows that certain devices can be reprocessed safely; (6) some infection control experts told GAO that the careful reprocessing of appropriate SUDs has not been demonstrated to be a public health risk; (7) GAO found that several reports of patient adverse events allegedly due to SUD reprocessing that GAO identified were inaccurate or not relevant to the debate; (8) however, this does not mean that SUD reprocessing is always safe; (9) current surveillance systems almost certainly do not detect all infections and injuries resulting from the use of reprocessed SUDs; (10) FDA, device manufacturers, and third-party reprocessors generally agree that many types of SUDs cannot be safely cleaned and sterilized, and even for devices that usually can be reprocessed, some models are impossible to clean and sterilize effectively; (11) substantial cost savings can be achieved by reprocessing SUDs; (12) independent reprocessing firms charge hospitals approximately one-half the price of a new device for a reprocessed device, while the in-house cost of reprocessing some devices can be less than 10 percent of the price of a new device; (13) under FDA's revised framework for SUD reprocessing, independent reprocessing firms and hospitals will have to obtain FDA's approval before they can reprocess many devices labelled for single-use; and (14) the revised regulatory framework will give FDA more information about SUD reprocessing and strengthen its oversight of reprocessing.