By Rachel Fields, Becker’s Operating Room Clinical Quality and Infection Control

August 25, 2011

Ruth P. Shumaker, RN, BSN, CNOR, a healthcare management consultant who focuses on both ambulatory surgery centers and hospital settings, discusses 10 ways to develop a strong sterile processing program in a surgery center…

7. Never reprocess single-use devices. Reprocessing single-use devices should be strictly prohibited in a surgery center, Ms. Shumaker says. In Oct. 2002, the FDA Medical Device User Fee and Modernization Act was signed into law, imposing a number of requirements to regulate the reuse of single use devices. Reusable devices are those that include guidance on reuse from the original manufacturer. She says staff may be tempted to reprocess single-use devices because of inadequate instrumentation or devices, but this should not occur unless you have the manufacturer’s recommendation it can be reprocessed and how it should be cleaned and processed…

8. Investigate reprocessing facilities before using them. Many ASCs outsource reprocessing because they do not have the resources in-house. The Association of Medical Device Reprocessors is a trade-based association representing companies that are third-party reprocessors of single-use medical devices. Membership in this organization is voluntary, and members of AMDR agree to be registered with the FDA and comply with all FDA regulations…

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