Report: Olympus may have known about duodenoscope problem

Patient Safety Monitor Insider

April 28, 2015

Olympus Corp., recently under pressure about improperly disinfected GI scopes that may have transmitted deadly infections, may have known about potential problems with cleaning its duodenoscopes nearly two years ago, according to a report in Outpatient Surgery Magazine.

According to the report, the Los Angeles Times claimed that Olympus sent two letters to hospitals in Europe, warning them of potential risks related to the scopes. Both letters sent by the company warned of the risks associated with improper reprocessing of the scopes. The first letter was sent in January 2013, when Olympus sent a safety alert to European hospitals with recommended cleaning practices to prevent contamination in their TJF-Q180V duodenoscopes.
The second letter came in August 2014 after Olympus received complaints that the scopes were still dirty despite cleaning efforts. The alert addressed the difficult elevator section of the scope, which the FDA has warned is a high-risk area for bacterial contamination, the report said.
Despite this, Olympus did not issue an alert in the U.S. until February, after an outbreak at the University of California’s Ronald Reagan Medical Center of carbapenem-resistant Enterobacteriaceae (CRE), which is highly resistant to antibiotics and can kill up to 50% of infected patients. In that outbreak, two patients died and nearly 180 more people may have been exposed to deadly bacteria.