FDA official says Olympus never got permission to sell its endoscope
Medical device is connected to CRE outbreak in California that's left two people dead
CNN has learned that the manufacturer of the endoscope involved in two superbug deaths at UCLA never obtained permission to sell the device, according to an official at the Food and Drug Administration.
Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn’t notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market, according to Karen Riley, deputy director of strategy for the FDA’s Office of External Affairs.
“Why didn’t we notice it? I don’t know,” Riley said.
“Can you imagine a prescription drug getting out on the market that didn’t go through the approval process?” asked Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic, who’s testified to Congress about device safety problems. “Devices need to be regulated more vigorously. This is really disturbing.”
In a statement, Olympus said it didn’t think needed the FDA’s permission to sell the device, but now at the request of the agency, it has applied for that permission. That application is still pending.
Outbreak started at UCLA
Seven hospital patients at Ronald Reagan UCLA Medical Center were infected with the deadly superbug CRE – also known as carbapenem-resistant Enterobacteriaceae – from October to January, according to hospital officials. Two of those patients died.
The patients caught CRE after routine endoscopic treatments. Hospital officials believe two medical scopes that still carried the deadly bacteria even after disinfection guidelines were followed were the cause of the superbug outbreak.
The medical center has contacted 179 others who had endoscopic procedures between October and January and is offering them home tests to screen for the bacteria.
Four other patients at Cedars-Sinai Medical Center in Los Angeles have also been infected with the superbug linked to a contaminated duodenoscope, according to a statement released by the hospital. The medical scope was used in all four patients, between August and January 2015. Sixty-four other patients who had a duodenoscope procedure with that particular scope are being informed by mail, “out of an abundance of caution.”
According to FDA rules, a manufacturer must seek clearance for a new model if it includes changes that “could significantly affect the safety or effectiveness of the device.”