Olympus — one of three companies that manufacturers duodenoscopes linked to infection outbreaks — sold a specific model of the scope without obtaining clearance from the U.S. Food and Drug Administration, according to the FDA.
Olympus started selling the TJF-Q180V duodenoscope in 2010, but the FDA was not aware of it until late in 2013 or early in 2014, according to a CNN report. Olympus now has a pending 510(k) application for the device and continues to market the device.
The FDA is not taking action against Olympus currently because "based on the information currently available to the Agency, we believe that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States," an FDA statement reads.
The new model of duodenoscopes marketed by Olympus was modified to seal off the scope's elevator channel. "The company clearly made these modifications to make the device safer, but it seems to be that it wasn't safer," Karen Riley, deputy director of strategy for the FDA's Office of External Affairs, told CNN.
Olympus' duodenoscopes have been directly tied to at least one outbreak of "superbug" bacteria infections: Four patients at Cedars-Sinai Medical Center in Los Angeles contracted carbapenem-resistant Enterobacteriaceae infections after undergoing procedures using Olympus duodenoscopes. Even though the devices did not have FDA clearance, the "FDA has no evidence that the lack of a 510(k) clearance was associated with the infections," according to the statement, and the FDA says reported duodenoscope-associated infections have happened in patients who underwent procedures with scopes made by all three manufacturers (including Pentax and Fujifilm).
Despite recent reports of infections, the FDA does not recommend that healthcare providers stop offering endoscopic retrograde cholangiopancreatography procedures, which duodenoscopes are used for.