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Scope-Maker and FDA Aware of “Superbug” Risk in 2013


April 22, 2015 — Olympus Corp. warned European hospitals about “superbug” infections from dirty medical scopes and recommended steps to reduce the risk nearly two years before issuing the same recommendations in the United States, according to the Los Angeles Times.

Olympus sent the first letter to European hospitals in January 2013, recommending the use of a special brush for the TJF-Q180V duodenoscope to help remove bodily fluids and debris from its complex mechanisms.

Olympus issued another letter in August 2014 after receiving reports of scopes that remained contaminated after proper cleaning procedures were followed.

Those same warnings were not issued in the United States until February 2015, when officials at UCLA’s Ronald Reagan Medical Center reported that a contaminated TJF-Q180V duodenoscope exposed 179 patients to an antibiotic-resistant “superbug.” At least seven patients were infected and two died.

Soon after that outbreak, the FDA issued a Safety Communication regarding the hard-to-clean scopes.

Olympus told hospitals in the United States to use the same cleaning brush that was recommended in Europe in 2013. Olympus also updated the cleaning protocol.

The FDA told the Times they were aware of the letters to European hospitals, but did not issue warnings in the United States because they were already working with Olympus to address the problem.

The TJF-Q180V duodenoscope has been on the market in the United States since 2010 without proper clearance from the FDA. In the last few years, Olympus has failed twice to provide the FDA with data proving their cleaning protocol can destroy 99.9999% of bacteria on the scope.


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