The FDA said it cleared the first fully disposable duodenoscope, made by Boston Scientific.
The EXALT Model D Single-Use Duodenoscope is designed for use in endoscopic retrograde cholangiopancreatography procedures. It is the first single-use duodenoscope on the market and was granted Breakthrough Device Designation.
“The availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices, which are used in more than 500,000 procedures in the U.S. each year. Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn’t need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing,” director of the FDA’s Center for Devices and Radiological Health Jeff Shuren said in a news 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, and the FDA continues to encourage innovative ways to improve the safety and effectiveness of these devices.”
Traditionally, duodenoscopes have been intended for use on multiple patients and required cleaning and disinfecting before each procedure. The devices are complex and can be difficult to clean because of its many small moving parts and can end up trapping contaminated tissue or fluid in its crevices. Duodenoscopes have sparked controversy in recent years because if not thoroughly cleaned, they can transmit infection-causing bacteria between patients, according to the FDA.
“The EXALT Model D Duodenoscope was developed to support clinicians in their mission to deliver the highest quality patient care,” senior VP and president of endoscopy at Boston Scientific Art Butcher said in a separate news release. “As a leading industry partner committed to advancing the care of pancreaticobiliary diseases for over 30 years, helping to ensure the integrity of ERCP is inherent in our mission to advance science for life and transform patient lives. This device, which was granted Breakthrough Device Designation by the FDA, builds on our legacy of delivering meaningful innovation that improves clinical outcomes.”
Boston Scientific plans to start a limited market release of the device in the U.S. in the first quarter of 2020.