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Medical Devices: Reprocessing and Reuse of Devices Labeled Single-Use

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Report Type Reports and Testimonies
Report Date June 27, 2000
Report No. T-HEHS-00-143
Subject
Summary:

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.

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