Olympus Corp. may have known about problems with cleaning its endoscopes nearly 2 years before superbug outbreaks hit UCLA and Cedars-Sinai, according to a new report.
Europe Warned of Scope Dangers in 2013, 2014
Olympus previously sent 2 letters to European hospitals warning them of potential risks associated with cleaning or ‘reprocessing’ their duodenoscopes, according to the Los Angeles Times. The finding raises questions as to why hospitals in the U.S. weren’t notified earlier.
“That is not how device makers should run their business. It’s clear Olympus knew something was not correct about its existing cleaning instructions,” Rep. Ted Lieu (D-Los Angeles) told the Times.
The first of the letters was a safety alert sent in Jan. 2013, when Olympus provided European hospitals with recommended cleaning practices to prevent bacterial contamination in their TJF-Q180V duodenoscopes.
The second letter came in Aug. 2014, after Olympus received reports that the scopes were still dirty despite the hospitals following their reprocessing protocol. The letter cited the hard-to-clean elevator section of the device, which the FDA has warned is a high-risk area for contamination. Both alerts were reportedly shared with hospital staff and posted on European regulatory agency websites.
Somehow, despite having knowledge of these risks and warning our European counterparts, Olympus did not issue an alert about its duodenoscopes in the U.S. until Feb. 2015, after an outbreak of the CRE superbug was reported at the Ronald Reagan UCLA Medical Center. At least 7 at the facility were infected, including 2 who died.
FDA Learned of European Scope Warnings, Took No Action
The U.S. Food & Drug Administration (FDA) learned of Olympus’ letters to Europe last summer, according to the Times, but it failed to issue a warning or identify any outside agencies. FDA has convened a panel meeting on May 14-15 to evaluate the devices.
“FDA is convening this committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information,” the agency said in its meeting notice.