“Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented”, Sen.
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The devices are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures annually in the U.S. The procedure is a minimally invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions.
A spokesman for Olympus Corp., a manufacturer of the scopes, said in a statement to the press the company would “closely review” the report’s recommendations, which include a staggered recall of devices that pose a threat, according to Bloomberg; similarly, FDA Spokeswoman Deborah Kotz told Bloomberg the agency is already working to implement numerous recommendations.
The company, which sells about 85% of the duodenoscopes used in the United States, said it will redesign an internal mechanism in the device that had been nearly impossible to effectively disinfect.
Olympus, the world’s largest producer of the duodenoscopes, knew of concerns about the ability to properly sterilize the devices back in 2013, according to the Senate’s report, but “never brought this information to FDA, and did not alert hospitals, physicians or patients in the U.S.to the risk of infection until February 2015”. Patty Murray, D-Wash., after dozens of people became infected in a Seattle hospital in 2012.
Further, the report places some of the blame on the U.S. Food and Drug Administration, which it said used an “outmoded” and insufficient system to report potential device safety risks. The FDA notified Olympus in March 2014 that it would have to apply for approval of modifications it had made without first notifying the federal agency.
Olympus is just one of several duodenoscope manufacturers linked to bacteria transfers. The committee also said Congress should mandate unique medical device identifiers in insurance claims, electronic health records, and device registries, the AP reported.
The report – written by the by the minority staff of the Senate committee on health, education, labor and pensions and released Wednesday – cited repeated failures by manufacturers, regulators and hospitals to report outbreaks.
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Another recommendation submitted by the committee called for timely and routine reporting of incidents to be a requirement for hospitals to participate in Medicare.
