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.
In January 2015, Sen. Patty Murray, D-Wash., launched an investigation of these outbreaks, concluding that the device manufacturers, hospitals and the FDA were too slow to respond.
“While responsibility for the slow response is shared among Olympus and the other device manufacturers, hospitals and FDA, the investigation overall demonstrates that FDA’s device surveillance system is overly reliant on device manufacturers and user facilities to make quick and complete reporting of safety issues over their own competing priorities,” the committee wrote in its report.
The “Preventing Superbugs and Protecting Patients Act” (S. 2503) would require manufacturers to submit proposed labeling and validated reprocessing data as part of a pre-market 510(k) submission to the FDA, and would require that the agency finalize its guidelines on when manufacturers should seek FDA clearance before marketing modified devices.
“I asked my staff how the outbreaks could have occurred in the first place, and what Congress could do to protect patients and families going forward,” Murray said during an executive session. “So, I’m pleased to introduce a bill today that would take some initial steps to improve patient safety by giving the FDA additional tools to review and ensure the safety of medical devices. That yearlong investigation showed that we need to significantly [improve] our medical device surveillance system to ensure risks to patients are identified earlier.”
United States Senate: Health, Education, Labor, and Pensions Committee. Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients. http://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf. Accessed February 9, 2016.