Medical Devices:

Reprocessing and Reuse of Devices Labeled Single-Use

T-HEHS-00-143: Published: Jun 27, 2000. Publicly Released: Jun 27, 2000.

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Pursuant to a congressional request, GAO discussed the reprocessing and reuse of medical devices marketed for single use, focusing on: (1) the extent of single-use devices (SUD) reprocessing; (2) the health risks associated with SUD reprocessing; (3) the cost savings from SUD reprocessing; and (4) the Food and Drug Administration's (FDA) oversight of SUD reprocessing.

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.

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