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.

Patty Murray

“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 new act would require manufacturers to submit proposed labeling and validated reprocessing data as part of a pre-market 510(k) submission to the FDA, and allows the agency to deny marketing clearance for submissions without this information. In addition, it would require that the FDA expeditiously 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 the 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.”

The proposed act received no contention from other legislators when opened to the committee, and was reported favorably in a unanimous vote. In a press statement released after the session, Murray applauded the committee’s decision to allow passage of the bill into the Senate for further approval.

“It is great news this important bill to give the FDA additional tools to review and ensure the safety of medical devices has passed out of committee,” Murray said. “There is much more to do as well to ensure the safety of medical devices like duodenoscopes, and I hope we can build on this step forward with additional efforts to ensure medical device safety for patients and families in Washington state and across the country.”

Jeffrey S. Duchin

In a statement on behalf of the Infectious Diseases Society of America, Jeffrey S. Duchin, MD, professor of medicine at the University of Washington School of Medicine, told Infectious Disease News that the proposed legislation would likely improve outcomes among patients who come in contact with the reusable medical devices affected by these guidelines.

“Requiring manufacturers to establish effective cleaning and maintenance guidance for users of reusable medical devices should lead to increased safety for patients undergoing procedures with these devices,” Duchin said. “It also makes good sense to have FDA review the need for any additional safety precautions before approving modifications of previously approved devices.”

Reference:

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 12, 2016.