FDA 510(k) clearance of the EXALT Model D Single-Use duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. _ Boston Scientific

Boston Scientific Corporation announced FDA 510(k) clearance of the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D Duodenoscope is the first and only FDA cleared single-use (disposable) duodenoscope on the market and was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device.

Every year, more than 1.5 million ERCPs are performed worldwide using duodenoscopes to diagnose and treat various pancreatic and biliary conditions. Reusable duodenoscopes are put through a rigorous disinfection process between uses in different patients and the vast majority of procedures with these devices are carried out safely and effectively; however, there have been a small number of cases in which infections have been transmitted between patients via contaminated devices, despite adherence to established protocols. As a result, the FDA has been working with duodenoscope manufacturers, medical societies, physicians and other stakeholders to address this concern. The FDA recently issued a recommendation that healthcare providers transition to duodenoscopes with disposable components or fully disposable devices, when they are available, and held an advisory committee meeting to discuss this process and other issues related to reducing infection transmission by reusable duodenoscopes.

Comment:Although most postendoscopic retrograde cholangiopancreatography (ERCP) biliary tract infections are attributed to suboptimal ductal drainage, transmission of infection by contaminated reusable duodenoscopes has been reported. To overcome this limitation, a disposable duodenoscope has been recently developed. However, given the widespread use and large volume of ERCPs being performed worldwide, the financial viability of this novel concept is unclear.

See: "Concept of disposable duodenoscope: at what cost?"- Ji Young Bang, Bryce Sutton, Robert Hawes, Shyam Varadarajulu http://dx.doi.org/10.1136/gutjnl-2019-318227.