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Continued Risks Of Duodenoscopes Leads FDA To Recommend Disposable Cap Devices

After a study earlier this year found that fixed endcap duodenoscopes continued to pose a significant risk of infecting patients after being washed, the US agency is now urging providers to switch to newer-designed scopes that reduce or eliminate the risk from reprocessing, such as duodenoscopes that have interchangeable caps. The directive from the FDA is good news for Boston Scientific, which makes a disposable duodenoscope that is close to being approved by the agency.

Endoscopy. Doctor holding endoscope and lightig before colonoscopy - Video Duodenoscope - Image

The US Food and Drug Administration has issued a safety communication to hospitals and providers to transition from using fixed endcap duodenoscopes to ones where the cap can be switched out. The risk of infections from fixed duodenoscopes has led the agency to take a second look at the devices and find solutions to reduce harm to patients.

Duodenoscopes play a critical role in diagnosing diseases in the pancreas and bile ducts; they're used in more than half a million endoscopic retrograde cholangiopancreatography procedures annually. However, failure to properly clean the scopes has led to a number of significant adverse events, leading the FDA to issue the

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