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. This testimony summarizes the June 2000 report, GAO/HEHS-00-123.

GAO noted that: (1) it is clear that some health care facilities have chosen to reprocess and reuse some kinds of SUDs, but 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) according to various surveys, approximately 20 to 30 percent of American hospitals reported that they reuse at least one type of SUD and at least one-third of the hospitals that do so contract with third-party reprocessing companies; (3) the results of clinical studies show that selected devices can be reprocessed safely if appropriate procedures are followed and closely monitored, a view shared by many professional organizations and infection control experts; (4) however, this does not mean that SUD reprocessing is always safe; (5) current medical device surveillance systems almost certainly do not detect all infections and injuries resulting from the use of reprocessed SUDs, or from the use of medical devices in general, and there is general agreement that many types of SUDs cannot be effectively cleaned and sterilized; (6) reprocessing SUDs can produce substantial cost savings, with independent reprocessing firms charging 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; (7) FDA is about to institute a new regulatory framework for SUD reprocessing that will require independent reprocessing firms and hospitals to obtain FDA's approval before they can reprocess many devices labelled for single use; (8) the framework will provide FDA with more information and strengthen its oversight of reprocessing; and (9) there are significant barriers to the framework's successful implementation.