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U.S. Department of Health and Human Services

Medical Devices

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Executive Summary - Survey on the Reuse and Reprocessing of Single-Use Devices (SUDs) in U.S. Hospitals

As part of its study of the reuse and reprocessing of single-use-devices (SUDs), U.S. Food and Drug Administration (FDA) sponsored a telephone survey of all hospitals on SUD practices. FDA’s primary goal was to estimate the extent of hospital reprocessing (that is, the cleaning and resterilization, as appropriate) of SUDs that have been used on patients. Additionally, the survey provided data on the types of SUDs reprocessed and how FDA’s SUD enforcement guidance affected hospital activities. The survey was designed to help FDA develop cost-effective hospital inspection protocols and enforcement strategies. The survey was conducted between December 2001 and February 2002. The response rate for the survey was 79.1 percent, and included all for-profit, non-profit, and government hospitals, except Veterans Administration (VA) and Department of Defense (DoD) hospitals.

The survey indicated that 24.2 percent (after adjusting for nonresponse) of all US hospitals reuse SUDs that have been used on patients. The most commonly reused SUDs are sequential compression device (SCD) sleeves, which are reused by 15.8 percent of all hospitals. The next most commonly reused devices are “drill bits, saws, blades, or burrs” (7.3 percent), “biopsy forceps, snares” (6.2 percent), and “endoscopic/laparoscopic scissors, graspers, dissectors, or clamps” (6.1 percent). Finally, 3.9 percent of hospitals are estimated to reuse electrophysiology (EP) catheters. The survey did not cover the reprocessing of opened-but-unused SUDs, i.e., devices that have been opened, but which have not been used on patients.

Large hospitals are substantially more likely to be reusing SUDs. Nearly half (45.2 percent) of all hospitals with more than 250 beds reuse SUDs, compared to only 12.3 percent of hospitals with fewer than 50 beds. Of the hospitals reusing SUDs, the large majority (84.0 percent) use third-party reprocessors to reprocess these devices. The remaining 15.4 percent of hospitals reprocess at least some SUDs in house. Approximately 60 percent of the hospitals reprocessing SUDs in house are small (100 beds or fewer).

Limitations to the Study: FDA recognizes that there are limitations to this type of study. One limitation is that the person answering the survey may not have accurate information regarding reprocessing activities for that hospital. Although efforts were made to identify the best person to respond to the survey, this may not have happened in all cases. Also, the survey is an indication of what was happening at the time of the survey of the hospital. It does not reflect any changes in practices since that time.