In 2016, the conversation over the safety of duodenoscopes has continued to evolve. Here’s what you need to know:
1. On Jan. 15, 2016, FDA approved a modified version of Olympus’ duodenoscope (TJF-Q180V), which has been redesigned to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the scope’s closed elevator channel. The previous reprocessing instructions remain in place; FDA urges facilities to continue to follow the validated manual reprocessing procedures outlined in the March 26, 2015, Safety Communication when reprocessing Olympus TJF-Q180V duodenoscopes.
2. Following FDA’s approval of its redesign, Olympus announced that it would recall all 4,400 of its TJF-Q180V model duodenoscopes in use around the country and replace the existing elevator mechanism with one designed to be less vulnerable to contamination.
3. Meanwhile, Senate minority staff have issued a report highlighting the need for additional oversight of medical devices, noting that the outbreak of antibiotic-resistant infections from duodenoscopes demonstrates the importance of multiple checks.
4. FDA has developed a web page specifically highlighting automated endoscope reprocessors (AERs), which provides a list of the companies whose AERs have passed the agency’s validation testing for reprocessing and decontaminating duodenoscopes.
Michael L. Kochman, M.D., AGAF, FASGE, chair of the AGA Center for GI Innovation and Technology, offers his comments on this news: “The recent announcements from Congress, FDA, and Olympus are welcomed. These announcements demonstrate that “Getting to Zero” is a priority for all parties to ensure that we are using the safest possible devices for our patients. It is reassuring that modifications to existing devices are being developed and that the responsible agencies are proactively adjusting recommendations in view of new data and findings. We anticipate additional changes to the devices and reprocessing recommendations and our members should stay tuned and be vigilant.”
AGA will continue to keep you updated on this important issue. As always, our goal is to ensure patients continue to have access to this medically necessary procedure, while removing any risk of device-transmitted infections.
