Olympus, a major manufacturer of duodenoscopes that have been linked to the spread of infection, has issued a voluntary recall asking all organizations to return a certain style of duodenoscope for modifications.
The device manufacturer is contacting organizations with a TJF-Q180V duodenoscope and asking them to return the scope for revision. Olympus plans to replace the scope's forceps elevator mechanism with a new design.
Additionally, Olympus issued an updated operation manual and new reprocessing instructions for the TJF-Q180V scope. Updated reprocessing steps include using a certain disinfectant and an annual inspection by Olympus service staff.
Olympus urged organizations to start using the updated reprocessing procedures as soon as possible, but that the duodenoscopes can continue to be used until the forceps elevator mechanism is replaced.
The TJF-Q180V duodenoscopes have been on the market since 2010, but did not have 510(k) clearance for the device from the Food and Drug Administration. The FDA has now approved the TJF-Q180V's 510(k) with Olympus' modifications. New TJF-Q180V duodenoscopes will be made with the new forceps elevator.
The updates follow a Senate committee released a report saying Olympus had knowledge of lab reports finding closed-channel duodenoscopes could harbor and spread bacteria in early 2013, but "never brought this information to the FDA" or alert providers.
"Had Olympus initiated this recall sooner, numerous patients would not have been infected with antibiotic-resistant superbugs," Rep. Ted Lieu (D-Calif.) said, according to the Los Angeles Times. "Olympus' decision needs to be monitored to determine its effectiveness since previous claims of effectiveness by Olympus have proven not to work."
Rep. Lieu also called for Pentax and Fuji, the other two duodenoscope manufacturers, to recall their duodenoscopes.