The FDA has cleared its first fully disposable duodenoscope, following years of reports of infections being transmitted between patients by the notoriously difficult-to-clean devices and efforts earlier this year to urge the industry to move toward safer designs.
Boston Scientific’s EXALT Model D is a single-use, sterile duodenoscope designed to access a patient’s upper gastrointestinal tract to allow physicians to visualize and diagnose bile duct disorders and other conditions in the same manner as a traditional endoscope.
“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,” said the FDA’s device center director, Jeff Shuren, in an agency statement. “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.”
Boston Scientific says the lightweight device mimics the controls of reusable duodenoscopes to be more familiar to physicians. The company plans to roll out the EXALT Model D, which previously received a breakthrough-device designation from the FDA, in a limited commercial release during the first quarter of 2020.
The FDA recently cleared Pentax Medical’s Video ED34-i10T2, its first duodenoscope with a fully disposable head piece—which typically houses intricate moving parts and tight crevices where biomatter and bacteria can survive disinfection processes. The device’s predecessor, the ED34-i10T, was the first OK’d by the agency to have a disposable plastic end-cap covering.
In October, the FDA greenlighted a disposable, sterile cover for duodenoscopes developed by GI Scientific. The ScopeSeal device fully encloses the front end and acts as a barrier for its inner working areas, preventing them from becoming soiled with biomatter during biopsy collection or when draining fluids.
“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,” Shuren said.
New data from FDA safety surveillance studies earlier this year tracking contamination rates from reprocessed duodenoscopes found up to 5.4% of samples taken from the reusable devices tested positive for “high concern” organisms—including Escherichia coli and Staphylococcus infections.
But in terms of overall infection rates, the FDA said it has seen dramatic declines, though patient deaths and disease outbreaks have been reported.