Olympus feels the heat on duodenoscopes reprocessing

Patient Safety Monitor Insider

July 22, 2015

In the months following the carbapenem-resistant enterobacteriaceae outbreak linked to duodenoscopes, medical device manufacturer has repeatedly come under fire for its response to the outbreak.

Recently, the Los Angeles Times reported that the company had warned hospitals in Europe about the risk of infections two years before the outbreak at Cedars-Sinai and UCLA. However, no warning were issued in the United States.

“That is not how device makers should run their business,” U.S. Rep. Ted Lieu (D-Los Angeles) told the Times. “It’s clear Olympus knew something was not correct about its existing cleaning instructions.”
A month after the news broke, an FDDA advisory panel concluded that duodenoscopes were unsafe as designed, but stopped short of advising the FDA to ban the equipment, according to the Times. The panel urged the FDA to do more to protect patients, and some experts criticized the manufacturer for remaining silent on the issue.

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