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Senate proposes new safety requirements for reusable devices
The Senate Committee on Health, Education, Labor and Pensions today favorably reported a bill requiring manufacturers of reusable medical devices like duodenoscopes to submit cleaning instructions and validation data to the FDA before bringing these devices to market. The bill also seeks to clarify FDA guidance on when manufacturers should seek clearance from the agency before marketing their products.Between 2012 and 2015, there were 25 incidents of drug-resistant infections related to closed-channel duodenoscopes, affecting 250 patients worldwide, according to a recent report.