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Olympus Did Not Tell U.S. Hospitals About Scope Infections

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July 27, 2017 — Top executives at Olympus Corp. decided not to warn American hospitals about “superbug” infection outbreaks linked to their scopes, according to the LA Times.

Olympus issued warnings in Europe after two infection outbreaks were linked to the TJF-Q180V duodenoscope. One outbreak in France infected 16 patients in 2008 and 2009. Another outbreak in the Netherlands infected 22 patients in January 2012.

In emails from February 2013, a manager in the United States asked executives in Japan if similar warnings should be issued. They said it was not necessary because the risk to patients was “acceptable.” The emails were unsealed as part of a lawsuit.

In September 2013, Virginia Mason Medical Center in Seattle reported an outbreak that infected 39 patients. Outbreaks also occurred at hospitals in Pittsburgh, Los Angeles, and other cities.

Olympus blamed the infections on inadequate reprocessing, but the FDA determined that the cleaning instructions provided by Olympus were inadequate. Olympus recalled the TJF-Q180V scope in January 2016 to fix the reprocessing instructions.

The FDA now estimates that 350 people at 41 hospitals worldwide have been infected or exposed from 2010-2015. Many were infected with the antibiotic-resistant “superbug” known as CRE.

Olympus supplies 85% of the duodenoscopes used in the United States. Hundreds of thousands of Americans undergo ERCP procedures every year. The scope is inserted down the throat to diagnose and treat diseases of the upper intestines, such as gallstones and cancer.

 

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