Endoscope maker warned Europe years before U.S. superbug outbreaks

FDA learned of the warnings last summer

The maker of the medical endoscopes linked to superbug outbreaks at a handful of U.S. hospitals had warned European facilities about the risks associated with devices nearly two years before the recent cases, but U.S. hospitals did not receive such a warning.

Background on superbug outbreaks

As many as 179 patients could have been exposed to Carbapenem-Resistant Enterobacteriaceae after having an endoscopic retrograde cholangiopancreatography at UCLA's Ronald Reagan Medical Center between October 2014 and January 2015. Seven patients had been confirmed to have CRE infections, and two of those patients died.

Meanwhile, Cedars-Sinai Medical Center in Los Angeles in March reported that four patients had been infected with CRE and up to 67 more might have been exposed after being treated with the same type of scope, called a duodenoscope.

The devices at both hospitals were manufactured by Olympus Corporation.

Other hospitals—including one in Seattle earlier this year—have also report CRE infections linked to contaminated endoscopes.

FDA never approved scopes that have caused two types of superbug outbreaks

Details of warning

According to the Los Angeles Times, Olympus first warned European hospitals about the devices in January 2013, when it issued "important safety advice." In the alert, Olympus recommended that the hospitals use a specific cleaning brush to prevent contamination on a certain model of its scopes—the same model used in the Los Angeles cases.

In August 2014, Olympus issued a second European safety alert following complaints that the devices collected debris even after disinfection.

In that warning, Olympus said it "is always very concerned about patient safety issues including the prevention of cross infection among patients through endoscopy." The company also asked the European hospitals to submit forms acknowledging that they had shared the letter with relevant staff members.

The two alerts were published on the websites of regulatory agencies in Germany, Ireland, and other countries.

According to the Times, Olympus did not issue a U.S. warning about the devices until Feb. 19, a day after reports that 179 UCLA patients might have been exposed to the bacteria.

FDA response

According to the Times, FDA learned of Olympus' European warnings last summer but did not immediately alert U.S. hospitals. An FDA spokesperson said the agency delayed alerting hospitals because it already was working with the device maker to improve its cleaning protocols.

In October 2014, Olympus sent FDA a cleaning instructions proposal and test data, but the agency did not approve the initial recommendation and asked for more information.

FDA issues warning on endoscopes linked to superbug outbreaks

FDA in March reviewed the new instructions and data from Olympus' tests to prove they work. In a statement, FDA said the scopes can be adequately cleaned with "high-level disinfection" if hospitals follow the new instructions.

The company in March then issued updated guidance on how to disinfect its medical endoscopes (Petersen/Terhune, Los Angeles Times, 4/20).

The takeaway: European officials have been aware of issues with medical endoscopes that have been linked to recent superbug outbreak in the United States for nearly two years.


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