FDA Clears First Duodenoscope with Disposable Business End

Pentax Medical won FDA clearance for its ED34-i10T2 duodenoscope that features a disposable elevator end piece, making it easier to guarantee that the scope is properly sterilized between patients. This is the first scope of its kind, although we recently covered the clearance of ScopeSeal, a disposable device that snaps over a scope’s business end to keep it clean.

Thanks to a disposable end piece, there are fewer parts to process when sterilizing the new ED34-i10T2 duodenoscope. A few years ago it was discovered that duodenoscopes are carriers of infections, because of design flaws and insufficient processing, causing multiple deaths as well as a shock to the scope industry. According to Pentax, with the new device there’s a “35% reduction in distal end reprocessing due to better access for cleaning and disinfection as well as disposability of the elevator”.

“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a press release. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S. We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess. Today’s clearance is another step in the FDA’s ongoing effort to advance the development and availability of safer duodenoscopes.”

As the following dramatic video portrayal demonstrates, the new duodenoscope was developed using alien rocket technology:

” alt=””/>

Flashbacks: ScopeSeal, A Snap-on Shield to Keep Duodenoscopes Clean from Infections; Pentax Unveils Easier to Clean Duodenoscopes Thanks to Disposable Business End

Product page: Video Duodenoscope ED34‑i10T2

Via: FDA

Medgadget Editors

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.