FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Recommends Hospitals, Centers Move to Innovative Duodenoscopes

Sept. 4, 2019
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The FDA said hospitals and endoscopy centers should transition to duodenoscopes with newer design features that do away with reprocessing, citing safety concerns when reprocessing goes wrong.

Modernized fixed endcap duodenoscopes that simplify or remove the need for reprocessing should be used, as incorrect reprocessing “could result in tissue or fluid from one patient remaining in a duodenoscope when it is used on a subsequent patient,” the agency said.

The agency warned that in rare cases, incorrect reprocessing of a duodenoscope can lead to patient-to-patient disease transmission.

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