Senate committee proposes updates to FDA application requirements for reusable devices

In a recent session, the Senate Committee on Health, Education, Labor and Pensions favorably reported a bill requiring manufacturers of reusable medical devices to submit cleaning instructions and validation data to the FDA before bringing these devices to market. The bill also would require the FDA to develop guidance on when manufacturers should seek clearance from the agency before marketing their products.The “Preventing Superbugs and Protecting Patients Act” (S. 2503), sponsored Sen. Patty Murray, D-Wash., references several incidents of drug-resistant infections related to closed-channel duodenoscopes brought to light in the past year. According to a recent investigation, also launched by Murray, there were 25 such incidents affecting 250 patients worldwide from 2013 to 2015. Along with identifying faults among device manufacturers and hospitals, the investigation found that the FDA’s surveillance system for ensuring medical device safety did not alert hospitals that scope designs hindered effective cleaning for nearly a year and a half.