Dive Brief:
- FDA has cleared two new single-use, disposable endoscopes, less than two months after again cautioning healthcare providers to be aware of contamination issues and infection risks tied to versions of the devices that require high-level disinfection or sterilization between procedures.
- Los Altos, California-based UroViu said it received clearance for its flexible single-use cystoscope that allows physicians to perform interventional and diagnostic urologic procedures without reprocessing.
- Separately, Chinese medical device manufacturer EndoFresh said it gained 510(k) clearance for its disposable endoscopy system for use in gastrointestinal procedures.
Dive Insight:
Persistent contamination concerns associated with reprocessed duodenoscopes used in multiple patients and disinfected between procedures have led FDA to recommend hospitals and endoscopy facilities transition to newer devices designed with disposable components to help improve cleaning, or move to use of fully disposable duodenoscopes when they become available.
The agency has also asked duodenoscope manufacturers, which include Ambu Innovation, Boston Scientific, Fujifilm, Olympus Medical Systems and Pentax Medical, to transition away from fixed endcap duodenoscopes to reduce risks of patient infection.
FDA has been monitoring infections tied to reprocessed duodenoscopes, a specialized form of endoscope, since becoming aware of a potential association between the devices and drug-resistant bacteria in 2013. In 2019, the agency said its analysis of medical device reports over a 5 1/2-month period through March of that year showed three reports of death, 45 reports of patient infection and 159 reports of device contamination tied to inadequate reprocessing of duodenoscopes used in procedures involving the pancreas and bile duct.
Last month, FDA said it was investigating more than 450 reports of contamination and patient infection over four years tied to reprocessed endopscopes used in urological procedures, including three deaths that occurred outside the United States.
Because the problems reported with urological endoscopes and duodenoscopes could apply to similar devices, the agency said it would review data on other types of endoscopes as well.
Manufacturers have been working to bring to market single-use endoscopes as well as duodenoscopes with disposable components. Olympus, Pentax and Fujifilm each sell disposable endcap duodenoscopes, and GI Scientific markets a shield that can be attached to a reusable duodenoscope to reduce contamination during procedures.
Boston Scientific received FDA 510(k) clearance in 2019 for the first fully disposable duodenoscope, called Exalt D. Cook Medical has a global distribution agreement with Ambu for the Danish medtech's single-use duodenoscope, which gained FDA clearance last year.
FDA's latest clearances, for UroViu and EndoFresh, introduce new disposable options to the market. UroViu said it will introduce its new device, called Uro-G, along with its full product line at the American Urological Association annual meeting this September in Las Vegas.
EndoFresh said its digestive endoscopy system includes a camera, disposable upper GI endoscope and disposable colonoscope.
