FDA grants clearance to novel single-use cystoscope

The FDA has granted clearance to UroViu Corporation to market the Uro-G flexible, portable, single-use cystoscope, the company announced in a press release.1

The self-contained Uro-G device has a fully-deflectable tip, which offers urologists the flexibility to use the device for diagnostic or interventional procedures in any room in their clinic.

"Early adopters of UroViu's pioneering technology will value the practicality of this safe, user-friendly and effective option, both for practice and patients," Jed Kaminetsky, MD, clinical assistant professor of urology at the NYU Grossman School of Medicine and a medical director of Manhattan Medical Research, stated in a press release. "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."

UroViu also maintains that using the Uro-G single-use device typically translates to a lower cost per procedure versus reusable options.

"We are encouraged at the prospect of employing single-use devices that provide the same or better results for our patients without the heavy investment of time and capital in reprocessing,” Roger R. Dmochowski, MD, professor of urologic surgery at Vanderbilt University Medical Center, stated in the press release.

Safety issues with reusable cystoscopes

The Uro-G single-use device arrives at a time when the FDA is actively investigating reports of infections associated with reusable cystoscopes.2

The FDA announced in April 2021 that it had launched an investigation after receiving myriad medical device reportsproviding accounts of patient infections and other potential contamination problems related to the reprocessing of urological endoscopes, such as cystoscopes and ureteroscopes.

“The FDA is investigating potential causes and contributing factors associated with reported infections and contamination issues from reprocessed urological endoscopes. We are very concerned about the 3 reported deaths—outside of the United States—associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, stated in a press release.2

“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. 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. We take all reports of adverse events seriously, and we encourage prompt reporting to the FDA to help us identify and better understand the risks associated with reprocessed medical devices,” added Shuren.

References

1. FDA Clearance of the Uro-G Completes UroViu Corporation's Suite of Portable, Single-Use, Disposable Cystoscopes. Published online May 24, 2021. Accessed May 25, 2021. https://bit.ly/2SoZwsi.

2. FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes. US Food and Drug Administration. Published online April 1, 2021. Accessed May 25, 2021. https://bit.ly/3yBZxtf.