Announcement follows Murray’s call for full review of scopes linked to infections in Washington state and nationwide
(Washington, D.C.) – Today, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-WA) released the following statement on the Food and Drug Administration’s marketing clearance of a newly redesigned duodenoscope that will improve patient safety. The manufacturer of the device, Olympus Corporation of the Americas, is voluntarily recalling duodenoscopes already on the market that have been linked to life-threatening, antibiotic-resistant infections among patients in a number of hospitals, including Virginia Mason Medical Center in Washington state. Olympus will repair the recalled devices, replacing the parts of the closed-channel tip of the duodenoscope to reduce the risk of bacterial infections. FDA has cleared this new design.
The actions follow a report released by Murray showing that the manufacturer knew the scopes could not be reliably cleaned, and could present a threat to patients’ lives. The report laid out recommendations to improve safety for patients, including asking the FDA to evaluate whether a redesign of duodenoscopes and a recall of duodenoscopes linked to infections would be appropriate.
“These devices exposed far too many patients and their families to unacceptable risks, and I am pleased to see that the FDA and manufacturers have taken additional actions to protect patients in the future,” said Senator Murray. “The steps taken today are important, but there is much more we need to do to make sure the FDA can respond quickly and appropriately when problems with medical devices occur. I have made it my priority to understand how these outbreaks could have happened, and how they can be prevented going forward—and I am going to keep fighting so that patients can trust that the devices used for their treatment are safe and effective.”
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.