The U.S. Food & Drug Administration (FDA) has cleared the Olympus TJF-Q190V, a duodenoscope with a sterile, disposable distal endcap, the company announced.
This is the latest approval of a duodenoscope designed to improve the cleaning and reprocessing of the device, helping to reduce potential device contamination.
To date, the FDA has cleared five duodenoscopes with disposable components that facilitate reprocessing:
Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope (fully disposable duodenoscope)
Fujifilm Corporation, Duodenoscope model ED-580XT (disposable endcap duodenoscope)
Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V (disposable endcap duodenoscope)
Pentax Medical, Duodenoscope model ED34-i10T (disposable endcap duodenoscope)
Pentax Medical, Duodenoscope model ED34-i10T2 (disposable elevator duodenoscope)
As we previously noted, FDA has advised providers to transition away from fixed endcap — and more infection-prone — duodenoscopes and begin using duodenoscopes with disposable components that help with or even eliminate the need for reprocessing.
It is encouraging to finally see the development and approval of these devices. We drew attention to the challenges associated with the cleaning, disinfection and sterilization of duodenoscopes in a 2015 Special Report and recently included "endoscopes testing positive for bacteria after cleaning and disinfection" on our list of "10 of the Scariest Healthcare Infections and Threats."