FDA Says No More Reusable Duodenoscopes

After years of sterilization issues, the agency is urging device makers to transition to disposable duodenoscopes.

FDA / Image: FiercePharma
FDA / Image: FiercePharma

If you’re not familiar with duodenoscopes, they’re devices with cameras that are snaked through the mouth and stomach to the top of the small intestine, aka duodenum, to inspect a patient’s insides. This seems like something that should be a single-use device and promptly discarded once removed from a patient’s body. According to a recent FiercePharma article, the FDA now agrees. After years of issues related to sterilization and reuse, the FDA is now recommending the transition to duodenoscopes with disposable components to reduce the risk of transmitting infections between patients.

The new design includes a single-use cap that eliminates the need for reprocessing and allows access to the device’s interior for cleaning. There are currently two such models that have received clearance, one from Pentax and the other from Fujifilm. The transition to single-use caps won’t entirely eliminate contamination, but it should significantly decrease unnecessary infections in the 500,000 annual duodenoscope procedures that take place in the United States.

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