The U.S. FDA has greenlighted the EndoFresh Disposable Digestive Endoscopy System, following years of reports of persistent cross-contamination issues being transmitted among multiple patients by the notoriously difficult-to-clean reusable endoscopy devices and efforts earlier this year to urge the industry to redesign devices to be safer by eliminating reprocessing.
The EndoFresh Disposable Digestive Endoscopy System from Shenzhen, China-based EndoFresh features a camera system with innovative all-in-one design, disposable upper GI endoscope, and disposable colonoscope, which are used together with the medical display and other peripheral devices to allow physicians to visualize, diagnose, and operate gastrointestinal endoscopy.
Recently, the FDA has alerted healthcare providers to the risk of infections associated with reprocessed urological endoscopes, citing over 450 medical device reports since 2017, describing post-procedure patient infections or other possible contamination. According to the agency statement, the problems identified with reprocessed urological endoscopes and duodenoscopes may apply to similar devices. Therefore, the FDA has also been reviewing information on other types of reusable endoscopes.
Reusable endoscopes require high acquisition and repair expenses and costs to clean them, and there is the risk of multiple points of failure associated with improper high-level disinfection practices. The risk factor of disposable endoscopes is much lower or even negligible and EndoFresh devices do not require traditional reprocessing and time-consuming maintenance solutions.