FDA Clears First Completely Disposable Duodenoscope

A few years ago it was discovered that duodenoscopes, which are used in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) procedures, were bacterial vectors, spreading disease between patients and even causing multiple deaths. This was due to insufficient processing, so some manufacturers put out devices that are easier to clean, while others developed snap on covers to protect the working ends from infection, and yet others made those ends disposable.

Boston Scientific just won FDA clearance for its EXALT Model D duodenoscope that’s entirely disposable, alleviating all need for cleaning, processing, and handling between cases. Since the device is used only once, there’s no need to repair it as is common in frequently reused duodenoscopes.

The device works much like most existing duodenoscopes, so transitioning to this device shouldn’t be an issue for physicians. Having sterile and ready to go scopes at hand, without requiring equipment and manpower to process them, though, should be a big selling point for Boston Scientific.

“With the EXALT Model D Duodenoscope, I can perform the same high-quality ERCP procedure with the added benefit of using a brand-new sterile device for each patient,” said Dr. Raman Muthusamy, Medical Director of Endoscopy, Professor of Clinical Medicine, David Geffen School of Medicine at UCLA, in a Boston Scientific Press release. “I believe the development of this device is a significant advancement in the evolution of endoscopy.”

Product page: EXALT Model D Single-Use Duodenoscope

Flashbacks: PENTAX Medical’s DEC HD Partially Disposable Duodenoscope FDA Cleared; ScopeSeal, A Snap-on Shield to Keep Duodenoscopes Clean from Infections; FDA Clears First Duodenoscope with Disposable Business End; Pentax Unveils Easier to Clean Duodenoscopes Thanks to Disposable Business End;

Via: FDA and Boston Scientific