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Three Endoscope-Makers Now Face Justice Dept. Investigation

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June 4, 2015 — USA Today reports that federal investigators have issued subpoenas asking for “thousands of pages” of documents from three endoscope-manufacturers and one hospital linked to a deadly outbreak of antibiotic-resistant “superbug” infections.

The manufacturers include Olympus Corp., Pentax Medical, and FujiFilm Holdings Corp., according to two unnamed sources close to the investigation.

The hospital is Virginia Mason Medical Center in Seattle, where at least 11 patients died after developing infections that were transmitted on dirty duodenoscopes.

Although Olympus reported the investigation last month in financial documents (PDF), the subpoenas to Virginia Mason, Pentax, and FujiFilm were not reported until now.

According to the Los Angeles Times, the Justice Department asked Virginia Mason for information and communications between the hospital and Olympus for several years.

Virginia Mason accuses Olympus of failing to provide adequate instructions for cleaning the scope. They have joined a lawsuit filed by a woman whose husband died from a “superbug” infection.

Earlier this year, the FDA warned that duodenoscopes have complex mechanisms that are extremely difficult to sterilize between uses. Virginia Mason has implemented far more rigorous cleaning procedures and has not had any new infection outbreaks on the scopes.

 

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