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FDA Hopes to Curb Infection Risks with New Endoscope Clearances.

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The federal agency gave out nods to EndoFresh and UroViu for endoscopes.

FDA has recently cleared two endoscopes from device-makers that could cut down on some of the contamination problems.

The federal agency cleared EndoFresh’s disposable-digestive endoscopy system and a portable cystoscope from UroViu.

EndoFresh Disposable Digestive Endoscopy System 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.

UroViu’s device has a fully deflectable tip that enables physicians to perform interventional and diagnostic urologic procedures in their clinics conveniently in any room, anytime, without reprocessing. This allows for practices to expand their cystoscopic capabilities and throughput without capital investments or service contracts. Typically, the per-procedure cost of owning and using a UroViu device is lower than for traditional reusable platforms.

"Early adopters of UroViu's pioneering technology will value the practicality of this safe, user-friendly and effective option, both for practice and patients," said Jed Kaminetsky M.D., clinical assistant professor of urology at the NYU Grossman School of Medicine and a medical director of Manhattan Medical Research. "In particular, we find the off-the-shelf availability of Uro-G to be extremely efficient and convenient in performing outpatient diagnostic procedures and stent  removals."

The clearances came about a month after FDA announced it was investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes and cystourethroscopes.

“While some reports indicate the potential causes could be inadequate reprocessing or device maintenance issues, we’re also evaluating other possibilities, including device design or the reprocessing instructions in the labeling,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “Although we believe that the risk of infection is low based on available data, we’re reminding health care providers how important it is to follow the labeling and reprocessing instructions to properly clean and reprocess the devices, including accessory components.”

The agency cited more than 450 medical device reports since 2017, describing post-procedure patient infections or other possible contamination. 

 

 

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