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Home E-Weekly March 13, 2018

Why Did FDA Send Duodenoscope Manufacturers Warning Letters?

Published: March 13, 2018

Burning Time TOUGH TO CLEAN Bacteria can remain in duodenoscopes even if you follow the manufacturers' reprocessing directions to the letter.

The FDA has sent warning letters to all 3 duodenoscope manufacturers — Olympus, Fujifilm and Pentax — for failing to complete studies to determine if reprocessing staffs were able to properly clean and disinfect their duodenoscopes.

In 2015, after a series of deadly superbug outbreaks were linked to the difficult-to-clean devices, the FDA required the companies to conduct studies involving the sampling and culturing of reprocessed duodenoscopes. Concerns centered on bacteria that could remain in the scopes' elevator channels, even if staffs used proper cleaning and reprocessing instructions provided by the manufacturers.

According to the warning letters, the scope manufacturers have not completed the studies.

"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," says Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health. "We expect these device manufacturers to meet their study obligations to ensure patient safety."

All 3 companies tell us they intend to comply.

Daniel Cook

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