September 4, 2019

FDA recommends transition to duodenoscopes with disposable components

By: Judy Mathias

Editor's Note

The Food & Drug Administration (FDA) on August 29 issued a News Release recommending that healthcare facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce the risk of patient infection.

The FDA also announced additional actions they have taken to help ensure the safety of patients having procedures with duodenoscopes.

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Those include:

  • ordering new postmarket surveillance studies on duodenoscopes with disposable endcaps
  • requesting the inclusion of real-world contamination rates in labeling
  • issuing letters to manufacturers of certain test strips used to assess cleanliness that have not been through proper FDA premarket review.

The FDA plans to convene a General Hospital and Personal Use Devices Panel of the Medical Device Advisory Committee in late 2019 to discuss these issues.


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