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GAO evaluation of device reuse

This article was originally published in The Gray Sheet

Executive Summary

Senate Health, Education, Labor and Pensions Committee in July 26 letter to the General Accounting Office asks the investigative body to evaluate the appropriateness of FDA's current reprocessing policy, which "does not distinguish between different classes and types of medical devices (i.e., can some single-use devices be safely reprocessed but not others)." The committee members also ask GAO to analyze additional questions regarding reprocessing, such as the economic impact of reusing disposable products and the cost of requiring FDA to assure the safety and efficacy of reprocessed single-use devices for their intended use (1"The Gray Sheet" July 26, p. 7)

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