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EndoFresh gains FDA approval for Disposable Digestive Endoscopy System

Mon, 06/07/2021 - 12:07
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The FDA has approved EndoFresh’s Disposable Digestive Endoscopy System that 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 visualise, diagnose and operate gastrointestinal endoscopy.

According to the FDA, there have been reports of persistent cross-contamination issues being transmitted among multi-patients by the notoriously difficult-to-clean devices and efforts, and the agency has urged the industry to transform devices into safer design without reprocessing. For example, there were 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.

Compared with high acquisition and repair expenses, spending on washing equipment and cleaning personnel as well as multiple points of failure associated with improper high-level disinfection practices of reusable endoscope, the risk factor of disposable endoscope is much lower or even negligible, the company claimed. EndoFresh differentiates its devices from traditional reprocessing and time-consuming maintenance solutions, while also adhering to strict reliability and first-class quality standards and adapting to the fast-growing market demands for innovation and possessing greater potential to generate actual benefits in the near future.

According to EndoFresh, the Disposable Digestive Endoscopy System is indicated for gastrointestinal endoscopy, effectively helping physicians in ICU, ER, outpatient clinic, GI suite and bed-side treatment, especially during post-pandemic era.

"With this novel system, medical practitioners could offer patients a secure experience, which is available at anytime and anywhere. It helps to prevent the risk of cross-infection and minimize the workload in preoperative screening and postoperative disinfection," said EndoFresh CEO, Dr Lee.