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FDA recommends moving to newer-design duodenoscopes

por Thomas Dworetzky, Contributing Reporter | August 29, 2019
In the latest move to improve duodenoscope safety, the FDA has recommended transitioning from fixed endcap duodenoscopes to those with replaceable endcaps — or other newer designs.

“The FDA believes the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary,” it said in a statement.

At the same time the agency acknowledged that such a shift will not happen overnight.

"We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all healthcare facilities due to cost and market availability," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. "This is why we're communicating with healthcare facilities now — so they can begin developing a transition plan to replace conventional duodenoscopes, and those facilities that are purchasing duodenoscopes with fixed endcaps can invest in the newer, innovative models. We are also encouraging the manufacturers of these duodenoscope models to assist health care facilities with their transition plans.”

The newer-design endcaps aim to improve cleaning. With fixed-endcap duodenoscopes, a plastic or rubber cap is glued to the metal edges around the distal end and may prevent tissue damage but also limits accessibility for cleaning.

“We continue to address challenges with current reprocessing methods and support expanding the types of validated methods available to reprocess duodenoscopes,” the agency stated, while calling the infection risk from inadequate reprocessing “relatively low.”

It provided guidelines for clinicians and facilities, including:

– Consider using duodenoscopes that have disposable components, if available at your facility.
– Make sure reprocessing instructions are “meticulously” followed.
– Ensure that standard quality control programs also include regular sampling and microbiological culturing.
– Consider adding extra steps to reprocessing, including sterilization or use of a liquid chemical sterilant processing system in line with device labeling.
– Implement routine inspection and periodic maintenance along the lines of scope maker instructions.

These steps are warranted, because despite all ongoing efforts, field-monitoring studies by makers Fujifilm, Olympus, and Pentax “continue to show elevated rates of contamination, including the presence of high-concern organisms, defined as organisms that are more often associated with disease transmission, such as E. coli and Pseudomonas aeruginosa,” the agency warned.

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