April 7, 2022

FDA Safety Communication supports transition to disposable duodenoscopes

By: Judy Mathias

Editor's Note

In an April 5 Safety Communication, the Food and Drug Administration (FDA) provides new information supporting the use of fully disposable duodenoscopes and those with disposable components plus new information on 522 postmarket surveillance studies.

The FDA recommends that facilities transition to duodenoscope designs with disposable components, such as disposable endcaps, or to fully disposable duodenoscopes.

Duodenoscope manufacturers have developed transition programs, and the FDA has cleared seven new duodenoscopes that have disposable components (Fujifilm, Olympus, Pentax) or that are fully disposable (Ambu, Boston Scientific).

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