The U.S. Food and Drug Administration (FDA) never approved the model of duodenoscope implicated in the recent superbug outbreak at Ronald Reagan UCLA Medical Center, CNN reports. Between October to January, the scopes spread the superbug carbapenem-resistant Enterobacteriaceae (CRE) to seven patients, two of whom died.
According to CNN, Olympus sold their TJF-Q180V in 2010 but never sought agency approval. Karen Riley, deputy director of strategy for the FDA’s Office of External Affairs said the agency did not realize that it was never cleared for the market until late 2013 or early 2014. “Why didn’t we notice it? I don’t know,” Riley said, according to CNN.
Manufacturers are required to submit an application for approval if a modification made to a device “could significantly affect the safety or effectiveness of the device.” In this case, Olympus sealed part of the elevator component of its TJF-Q180V in an effort to reduce infection. Riley commented that “The company clearly made these modifications to make the device safer, but it seems to be that it wasn’t safer,” according to CNN. The elevator component is the piece at issue with regards to the superbug infections.
“Can you imagine a prescription drug getting out on the market that didn’t go through the approval process?” said Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic commented according to CNN. “Devices need to be regulated more vigorously. This is really disturbing.” Dr. Nissen has previously testified about device safety problems in front of Congress.
Olympus stated that it was unaware that it needed approval to sell the scope. An application has now been submitted, and is pending.
Now FDA has now asked all three manufacturers of duodenoscopes to submit evidence showing that the scopes can be cleaned thoroughly. CNN reports that so far, results do not look promising. The FDA’s standard for disinfection is being able to eliminate 99.9999% of all microbes, but the data submitted by the companies has failed on this standard twice.
Riley said she is unsure whether the FDA will penalize Olympus for selling the scope without approval. Device safety expert Diana Zuckerman told CNN that they should. “It’s like with kids. How do you teach your children to behave if there are no consequences when they misbehave?” she said.
The infections at UCLA were caused by bacteria still living on the scopes despite following manufacturer’s instructions for sterilization; 179 patients who underwent the procedures with the scopes have been contacted. The hospital is offering home kits to screen for CRE.
Recently, another four patients at Cedars-Sinai Medical Center in Los Angeles were infected with scope-related CRE. All four patients underwent a procedure with the device between August 2014 and January 2015. The medical center contacted 64 other patients who had a procedure with the scope.