Olympus Corp. warned European hospitals about the risk of antibiotic-resistant bacterial infections associated with its gastrointestinal duodenoscopes two years before the deadly superbug outbreaks at UCLA Ronald Reagan Medical Center and Cedars-Sinai Medical Center in Los Angeles, the Los Angeles Times reported.
While the first of two European alerts came in January 2013, the U.S. never received a warning from Olympus. It was not until the day after the Los Angeles Times reported on Feb. 18 that 179 patients may have been exposed to the deadly carbapenem-resistant Enterobacteriaceae (CRE), a virulent type of bacteria that resists antibiotics and can kill up to 50 percent of the patients it infects.
The first “important safety advice” alert Olympus issued to European hospitals and regulators recommended that its TJF-Q180V duodenoscopes be cleaned with a specific type of brush to help prevent contamination.
Olympus issued a second European warning in August 2014 after it received complaints that the scopes harbored debris even after they were properly disinfected. In that warning, Olympus said it is “always very concerned about patient safety issues including the prevention of cross infection among patients through endoscopy.”
According to the Los Angeles Times, “Olympus considered the letter so important that it asked the European hospitals to fill out and return a form acknowledging they had shared it with relevant staff.”
In March, Olympus published new cleaning procedures for U.S. hospitals, calling for them to clean the duodenoscopes with the same brush it told European hospital to use two years ago.
Both warnings Olympus sent to European hospitals underscored the problems posed by cleaning the forceps elevator at the tip of its duodenoscope – a part of the device for special attachments containing crevices that can allow bacteria to survive cleaning and sterilization.
According to the Los Angeles Times, the U.S. Food and Drug Administration became aware of Olympus’ warnings in Europe last summer, but made no effort to share that information with hospitals.
Representative Ted Lieu (D-Los Angeles) said that Olympus’ failure to notify U.S. hospitals of the contamination risks shows that congressional hearings are needed.
“With every passing week, more information is coming out showing that the manufacturer and regulators had a lot of information about risks of superbug outbreaks from these scopes, and nothing much happened until press stories started coming out,” Lieu said.
“That is not how device makers should run their business. It’s clear Olympus knew something was not correct about its existing cleaning instructions,” he added.