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This is an excerpt from a member-only article. To read the article in its entirety, please login or subscribe.

FDA: Problems persist with duodenoscope reprocessing

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July 1, 2019

By Jay Kumar (jkumar@blr.com)

Despite progress made with the reprocessing of duodenoscopes over the last few years, the FDA says continued improvement is necessary.

“A recent analysis of medical device reports submitted to the FDA indicates that the number of reports associated with patient infections peaked in 2015 at 250 reports and has declined by 62% to fewer than 100 reports per year in 2017 and 2018,” said Jeff Shuren, MD, director of the Center for Devices and Radiological Health, in a release. “Our recent actions have yielded improvements, but we also received reports of three deaths of U.S. patients in 2018 that were related to infections associated with duodenoscopes. That’s three deaths too many.”

Despite progress made with the reprocessing of duodenoscopes over the last few years, the FDA says continued improvement is necessary.



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