U.S. Sen. Patty Murray has introduced a bill aimed at improving safety and oversight of medical devices such as the scopes tied to an outbreak of multidrug-resistant infections at Seattle’s Virginia Mason Medical Center.
In the wake of deadly infections tied to contaminated medical scopes that sickened at least 250 people in Seattle and around the world, U.S. Sen. Patty Murray introduced a bill Thursday aimed at improving the safety — and scrutiny — of the devices.
The proposed law, the “Preventing Superbugs and Protecting Patients Act,” would require manufacturers of reusable devices like duodenoscopes to submit cleaning instructions — and data that show the steps work — to the federal Food and Drug Administration (FDA) before putting the scopes on the market.
It would also give the FDA clear authority to refuse or deny clearance based on whether those instructions are adequate in real-world situations. It would also require the FDA to update guidelines about when manufacturers must seek the agency’s approval before marketing the devices.
The proposal follows an investigation launched by Murray after The Seattle Times revealed an outbreak of multidrug-resistant infections tied to contaminated scopes at Virginia Mason Medical Center. At least 39 people were sickened and 18 died between 2012 and 2014 after being infected with bacteria spread by the scopes, which could not be properly cleaned, even after following manufacturers’ directions.
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Murray’s investigation found the problem was far more widespread than previously known, with at least 250 people sickened by duodenoscopes worldwide, most at U.S. hospitals.
The scopes are medical devices snaked down the throat and into the gut to treat and diagnose problems with the pancreas and bile ducts. About 700,000 procedures, known as endoscopic retrograde cholangiopancreatography or ERCP, are performed in the U.S. each year.
Murray’s report also urged Congress to adopt unique device identifiers to track potential infections through insurance claims and urged the FDA to quickly evaluate scope design and implement a recall to fix or modify the tools.
Within days, the nation’s top manufacturer of duodenoscopes, Olympus Corp., said it would voluntarily recall and redesign the scopes implicated in the investigation.