FDA approved the first disposable duodenoscope: EXALT™ Model D Single-Use Duodenoscope from Boston Scientific.
Since FDA recommended in August that health care facilities gradually transition away from fixed endcap models to those with disposable components or use fully disposable duodenoscopes, it has approved five relevant devices.
Fully disposable scope
- Boston Scientific EXALT™ Model D
Reusable scopes with disposable parts
- FUJIFILM Duodenoscope Model ED-580XT (disposable endcap)
- PENTAX Medical ED3490TK/ED34-i10T Video Duodenoscope (disposable endcap)
- PENTAX Medical ED34-i10T2 Video Duodenoscope (disposable elevator component)
- GI Scientific, LLC ScopeSeal® Duodenoscope Protective Device, cleared for use on the Olympus TJF-Q180V duodenoscope
AGA believes that device or reprocessing transitions can be incorporated over the lifecycle of current instrumentation, to eliminate the potential for gaps in accessibility of care and to ensure that there is adequate efficacy and safety data to support the adoption of new technology.
Review the GI societies’ 10 principles to ensure patient safety and ready access to clinically indicated procedures employing duodenoscopes and other elevator-channel endoscopes.
AGA will continue to keep you apprised of new innovations in this space.