Olympus Corp., which sells about 85 percent of the duodenoscopes used in the U.S., says it will recall and redesign a troubled medical scope linked to scores of “superbug” infections, including those at Seattle’s Virginia Mason Medical Center.
Olympus Corp. said it will voluntarily recall and redesign a troubled medical scope that has been linked to scores of potentially deadly patient infections around the world.
The company, which sells about 85 percent of the duodenoscopes used in the U.S., said it will redesign an internal mechanism that had been almost impossible to effectively disinfect.
The Food and Drug Administration (FDA) has approved the steps announced Friday, Olympus said.
A Senate report this week confirmed Olympus knew as early as 2012 that the scopes could harbor dangerous bacteria. The company didn’t warn U.S. hospitals for three years.
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The report also found the toll of potentially deadly infections tied to contaminated medical scopes — like those that sickened dozens at Seattle’s Virginia Mason Medical Center — was far higher than federal investigators previously estimated.
The devices were made by Olympus and two other manufacturers. It is unclear whether the other manufacturers will redesign their scopes.
From 2012-15, the Senate committee report said, at least 141 patients in nine U.S. cities were infected in at least 25 incidents of antibiotic-resistant infections linked to specialized duodenoscopes. At least 250 people were sickened worldwide.
The new figures included the outbreak at Virginia Mason, where at least 39 people were sickened and 18 died between 2012 and 2014 after being infected with multidrug-resistant infections spread by scopes that could not be properly cleaned, even after following manufacturers’ directions.
Sen. Patty Murray, D-Wash., who initiated the investigation and demanded internal company documents after the Virginia Mason news broke, praised the move Friday and urged further action.
“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,” Murray said in statement.
“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,” she said.
The devices are snaked down the throat and into the gut, where they’re used to diagnose and treat problems, including cancers and blockages in bile and pancreatic ducts. Tests by Virginia Mason and others found the closed channel at the end of the scopes retains bacteria, even after rigorous cleaning, and can spread germs among patients.
Olympus had redesigned its $40,000 duodenoscope in 2010 to seal a narrow internal channel and keep out blood and other infectious material. The change was intended to make the scope easier to clean.
The report — written by the minority staff of the Senate Committee on Health, Education, Labor and Pensions — cited repeated failures by manufacturers, regulators and hospitals to report outbreaks. That oversight allowed patients to remain at risk “with life-threatening consequences,” investigators determined.