Legislation follows yearlong investigation into contaminated medical devices linked to outbreaks in Washington state and nationwide
Gives FDA authority to withhold approval of a device that lacks sufficient cleaning instructions, and will clarify clearance requirements for modified devices
Murray will continue pushing for more protections: “I’m committed to continued work to improve our medical device monitoring system and protect patients and families in Washington state and across the country.”
(Washington, D.C.) – Today, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) introduced new legislation, the Preventing Superbugs and Protecting Patients Act, to provide additional tools to review and ensure the safety of medical devices after contaminated devices known as duodenoscopes were linked to life-threatening, antibiotic-resistant infections. Outbreaks linked to duodenoscopes occurred in hospitals across the country, including Virginia Mason Medical Center in Washington state. Last month, an investigation led by Senator Murray showed that manufacturers knew the scopes could not be reliably cleaned, and could present a threat to patients’ lives.
“As my investigation made clear, there is much more we need to do to make sure that the medical devices patients rely on are safe and effective. This legislation would give the FDA some additional tools to review and ensure the safety of medical devices like duodenoscopes,” said Senator Murray. “There are additional steps we absolutely need to take as well, and I’m committed to continued work to improve our medical device monitoring system and protect patients and families in Washington state and across the country.”
Senator Murray’s legislation:
· Gives FDA clear authority to refuse or deny a 510(k) submission (required in order to sell certain devices) based on whether the manufacturer’s cleaning instructions work in real world conditions and whether the manufacturer can provide satisfactory data showing the device can be reliably decontaminated between uses. Senator Murray’s investigation found evidence that certain manufacturers of duodenoscopes failed to properly test whether the device could be reliably cleaned between uses.
· Requires the FDA to prioritize updates to its guidance that will clarify when manufacturers are required to seek clearance from FDA to market modified devices. The investigation found evidence that certain manufacturers of duodenoscopes failed to seek necessary FDA clearance before marketing devices with modifications that impacted the safety and effectiveness of the devices.
Find additional information about the bill here.
Following the January 2015 announcement of a tragic outbreak of antibiotic-resistant infections linked to contaminated duodenoscopes at Virginia Mason Medical Center in Seattle, Murray called for a full review of FDA practices surrounding duodenoscopes and other medical devices, urged the agency to provide health care professionals with updated guidance, and pressed scope manufacturers linked to the outbreaks for answers and accountability. Last month following the investigation that highlighted multiple weaknesses in the safety monitoring system for medical devices, Olympus recalled the medical scopes. The FDA then cleared a newly redesigned duodenoscope to improve patient safety.