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FDA warns duodenoscope makers about failure to comply with requirements

by Thomas Dworetzky , Contributing Reporter
The U.S. Food and Drug Administration issued warning letters on Friday to all three duodenoscope manufacturers after the trio failed to comply with postmarket reprocessing surveillance studies.

The follow-ups were legally required of U.S. duodenoscope manufacturers Olympus, Fujifilm and Pentax in 2015, after inadequate reprocessing of the devices led to bacterial contamination causing illness and patient deaths.

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When the agency ordered the plans, the makers responded positively. A spokeswoman for Fujifilm said at that time that it "will continue to work with the agency to ensure the best long-term sustainable practices.”

A spokesman from Olympus stated that the issue was being taken "extremely seriously, and we intend to comply and provide the requested information." And a Pentax Medical representative said it "intends to cooperate fully with FDA to meet this request."

The approved study plans called for the manufacturers “to conduct a study to sample and culture reprocessed duodenoscopes that are in clinical use, to learn more about issues that contribute to contamination, as well as a human factors study to assess how well trained hospital staff are following the reprocessing instructions,” the agency noted it its recent letters.

So far, says the government, Olympus “has failed to commence data collection, and Pentax and Fujifilm have failed to provide sufficient data.”

Olympus and Pentax also failed to meet the requirements for human factors studies to see how well hospital staff are following reprocessing instructions. Fujifilm met those requirements.

“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real world clinical settings and whether we need to take additional action to further improve the safety of these devices,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said in the statement, adding that, “we expect these device manufacturers to meet their study obligations to ensure patient safety.”

In 2013, the agency discovered that there was a link between multi-drug-resistant bacteria and duodenoscopes – despite the fact that users were following the manufacturer-recommended cleaning procedures.
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