The U.S. Food and Drug Administration has updated a safety communication on duodenoscopes and is recommending that hospitals and endoscopy facilities “complete transition to innovative duodenoscope designs” due to concerns about reprocessing and patient cross-contamination.
The FDA previously said hospitals should consider using duodenoscopes with disposable components or adopt fully single-use models. The agency issued this new update in part because of new postmarket surveillance studies on fixed endcap design duodenoscopes that found 4.1 percent to 6.6 percent of samples tested positive with what the agency calls high-concern organisms.