Olympus, the company that manufactured the duodenoscope implicated in the superbug outbreak at UCLA, never sought approval from the U.S. Food and Drug Administration (FDA) to sell the device. Tainted duodenoscopes caused seven patients to be infected with the superbug carbapenem-resistant Enterobacteriaceae (CRE) at Ronald Reagan UCLA Medical Center; two of these patients died.
According to CNN, all of these patients underwent a procedure with the Olympus TJF-Q180V duodenoscope. These specialized scopes are inserted down the throat in order to visualize the gastrointestinal tract and help diagnose diseases. Olympus sold the device in 2010 but never submitted an application for 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.
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.
It is mandatory for manufacturers to seek FDA approval when a change 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. This was done in attempt to reduce the risk infection, but this exact piece was still implicated in the outbreak. “The company clearly made these modifications to make the device safer, but it seems to be that it wasn’t safer,” Riley said.
“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. In a statement, Olympus claimed it did not know approval was needed to sell the scope, CNN reports. An application has now been submitted, and is pending.
The 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, things do not look promising. Data submitted by companies submitted data to the FDA has twice failed the agency’s standard of killing 99.9999% of all microbes on the scopes.
Riley said she is did not know whether the FDA would penalize Olympus for selling the scope without permission. 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.
Four patients at Cedars-Sinai Medical Center in Los Angeles were infected with CRE. All four patients underwent a procedure with a duodenoscope between August 2014 and January 2015. The medical center contacted 64 other patients who had a procedure with the scope.