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FDA recommends moving to newer-design duodenoscopes

by Thomas Dworetzky, Contributing Reporter | August 29, 2019

At this time, there are two FDA-cleared, disposable-endcap duodenoscopes: the Fujifilm model ED-580XT (cleared under K181745), and the Pentax model ED34-i10T (cleared under K163614 and K181522).

In addition, the agency has ordered disposable-endcap-duodenoscope makers to do postmarket studies on contamination rates. When these studies are done, scope labeling would “be updated with contamination rate data,” it suggested.

This will allow informed decisions by both patients and healthcare professionals.

In other scope news, the FDA warned that some are assessing cleaning procedures with adenosine triphosphate, or ATP, test strips.

“These test strips claim to indicate the presence of live microbes inside of duodenoscopes,” warned the agency, noting that “to date, the FDA is not aware of any legally marketed ATP test strips cleared by the agency for this use, which means the FDA has not reviewed them for effectiveness in assessing reprocessing.”

In April, information from postmarket studies on contamination rates after cleaning and reprocessing of Olympus, Fujifilm and Pentax duodenoscopes revealed that “up to 5.4 percent of all properly collected samples tested positive for 'high concern' organisms, which is significantly higher than the earlier results,” Shuren said in a statement at the time.

In December 2018, the agency reported a three percent contamination rate for “high concern” organisms, such as E. coli or Staphylococcus aureus.

While recent actions to better reprocessing have “yielded improvements,” he added, “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.”

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