FDA May Take Additional Regulatory Actions On Duodenoscopes, Shuren Says
The US FDA continues to find unacceptable levels of “high concern” disease-causing bacteria on duodenoscopes that have gone through cleaning and reprocessing steps, and is poised to take further action with three duodenoscope manufacturing firms to reduce patient risks.
You may also be interested in...
After a study earlier this year found that fixed endcap duodenoscopes continued to pose a significant risk of infecting patients after being washed, the US agency is now urging providers to switch to newer-designed scopes that reduce or eliminate the risk from reprocessing, such as duodenoscopes that have interchangeable caps. The directive from the FDA is good news for Boston Scientific, which makes a disposable duodenoscope that is close to being approved by the agency.
Two duodenoscope manufacturers – Olympus and Pentax – this week joined Fujifilm in saying they are aware of Senate HELP Committee ranking member Patty Murray’s concerns about recently released duodenoscope contamination levels and are working to complete postmarket surveillance studies of their devices, as required by the US FDA.
Sen. Patty Murray sent a letter this week to the three sole US duodenoscope-makers – Olympus, Fujifilm and Pentax – asking the firms to bring the contamination rates on their scopes down to between 0% and 1%. Murray's letter pointed to recent “troubling findings” from the FDA on rates of contamination from high-concern organisms.