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Olympus hit with new superbug duodenoscope lawsuit

by Thomas Dworetzky, Contributing Reporter | July 01, 2015
Business Affairs Endoscopy Infection Control Medical Devices Risk Management
Olympus has again been sued over the superbug outbreak at Ronald Reagan UCLA Medical Center involving its duodenoscope that allegedly infected a woman and as many as six others, killing two.

The suit by Staci Simos against Olympus America Inc., claims that she caught the Carbapenem-resistant Enterobacteriaceae (CRE) superbug last October when UCLA doctors used the Q18OV scope on her during a procedure.

There have been a number of lawsuits against Olympus involving the superbug outbreak.

When reached by DOTmed News, Michael S. Levey, director of public relations & communications, Olympus Corporation of the Americas, stated that the duodenoscope issue "is receiving focused attention at the highest levels of Olympus."

He shared with DOTmed News a statement by Olympus spokesperson Mark Miller, which stressed that, "we are committed to working closely with the FDA, CDC, health care providers, and relevant medical societies to understand the causes of infections, to implement reprocessing improvements designed to reduce the risk of infections, and to educate health care professionals about the importance of adhering to the validated reprocessing instructions for Olympus duodenoscopes."

Olympus has issued cleaning procedures that were updated in May for the TJF-Q180V scope, which can be found here.

It also issued an "Urgent Device Safety Information" document on May 6, in which it alerted health care professionals that it was "replacing the previously distributed TJF-Q180V Reprocessing Manual with a new Reprocessing Manual and is providing a new cleaning brush for use in cleaning the elevator recess area" of the scope.

A lawyer for another plaintiff suing Olympus, Pete Kaufman, who had not returned calls from DOTmed News by deadline, explained in a February news report the issue in the case he is bringing on behalf of a different patient, Antonia Cerda, who died at the UCLA Medical Center.

"If you get sick with this [superbug] bacteria, you get infected with this bacteria, you could take every prescription antibiotic you have ever taken in your life and it would do nothing, and it would continue to get worse and worse and worse," he told ABC.

At issue, he said, is the lack of change in cleaning procedures after the scope design was changed.

"In June of 2014 they changed that scope physically but they didn't update the cleaning protocol. They never figured out if the old cleaning protocol worked, and they never took the time to develop a new cleaning protocol that would work," Kaufman stated.

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