On Monday, the U.S. Food & Drug Administration approved a groundbreaking disposable duodenoscope, a device used in endoscopic retrograde cholangiopancreatography (ERCP).
Boston Scientific’s EXALT Model D single-use duodenoscope received Breakthrough Device designation from the FDA, according to a news release. It has several advantages over the reusable ones currently in circulation.
How Does the Device Work?
First, EXALT eliminates the need for repairs and reprocessing. Next, and more importantly, it permits providers to use a sterile, new device for each procedure. Last, it builds on the design of reusable duodenoscopes so there’s a minimal learning curve new users. In the U.S., providers perform more than 500,000 ERCP procedures each year with a duodenoscope.
Although reusable duodenoscopes go through an intensive disinfection process between uses, in a small number of cases, contaminated devices have transmitted infections between patients. Most procedures relying on these devices end safely, but infection can occur, even if providers follow established cleaning protocols, because duodenoscopes are complex and include many small parts.
What is the FDA doing about infections from duodenoscopes?
The FDA is trying to address this concern by working with duodenoscope manufacturers, medical societies, healthcare providers and other stakeholders, and has issued a recommendation that healthcare providers move toward using duodenoscopes that either have disposable components or are fully disposable.
In the fall of 2013, the Centers for Disease Control and Prevention (CDC) alerted the FDA about a potential link between duodenoscopes and multi-drug resistant bacteria. An investigation revealed that these cases of infection happened even though users correctly followed the instructions for cleaning, disinfection and sterilization of the units.
What does this mean for HCPs?
In August 2019, a Safety Communication from the FDA recommended that hospitals and endoscopy facilities start transitioning to duodenoscopes with innovative designs that either eliminate or facilitate the need for reprocessing. The Boston Scientific duodenoscope is expected to be in limited market release in the first quarter of 2020.
“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,” Raman Muthusamy, MD, medical director of endoscopy and professor of clinical medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, said in a news release. “I believe the development of this device is a significant advancement in the evolution of endoscopy.”
Infections Associated with Reprocessed Duodenoscopes, U.S. Food & Drug Administration.
The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication, U.S. Food & Drug Administration.