Olympus Kept U.S. Hospitals in the Dark About the Risk of Infection from Endoscopes

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In April of 2015, attorney Brendan Lupetin reported about the case of a patient who contracted a deadly Carbapenem Resistant Enterobacteriacea (CRE) infection after undergoing an endoscopic procedure at Allegheny General Hospital.   We introduced recent evidence that protocols for cleaning the endoscope used during the procedure were inadequate to remove the “superbug” from the device.

This week, the LA Times released a series of Emails revealing the scope’s manufacturer, Olympus Corporation, kept U.S. hospitals and patients in the dark about the potential spread of antibiotic resistant bacteria through the use of their endoscopes.  The E-mails between Olympus Corporation in Japan and Olympus of America discuss concerns about the safety of the Olympus TJF-Q180V endoscope that were starting to emerge across the world by 2013.  The TJF-Q180V model scope is now believed responsible for exposing as many as 350 patients across the world to an antibiotic resistant superbug known as Klebsiella pneumoniae.   Worse, the spread of bacteria through the scope is linked to the deaths of 35 patients in the United States since 2013.

In January of 2013, following an outbreak of infections in French and Dutch hospitals, Olympus issued warnings to European hospitals about the risk of bacterial contamination related to use of their endoscope.  The warning letter included guidelines emphasizing the manufacturer’s recommendations for cleaning and reprocessing the scope in order to eliminate harmful bacteria from the components of the scope.  At around the same time, Olympus of America was investigating the link between the endoscope and spread of the superbug at a UPMC Hospital in Pittsburgh, Pennsylvania.

In an Email dated February 6, 2013, a representative of Olympus of America asked Olympus Corp. in Japan whether a warning similar to that issued in Europe should be issued to U.S. hospitals as well.   In response, Olympus Corp. told its American counterpart that it was not necessary to warn U.S. hospitals about the potential for its endoscope to spread deadly infections from patient to patient or provide hospitals with the recommended cleaning and reprocessing guidelines.  In his Email, the representative of Olympus in Japan described the risk of spreading the deadly carbapenem resistant infection via scope as “acceptable”.

The Emails the L.A Time obtained in collaboration with Kaiser Health News also reveal communications between Olympus of America and other groups across the United States who expressed concern about proper decontamination of the scopes.  Those groups include the American Society of Gastrointestinal Endoscopy, which requested support from Olympus for testing the adequacy of their procedures for cleaning and disinfecting the scope.

Also, William Rutala, Ph.D., M.P.H., Head of Epidemiology at UNC School of Medicine raised his own concerns in a March 31, 2014 Email to the head of infection control at Olympus of America.  In that Email, Dr. Rutala cited results from an internal investigation at his health center which found approximately 40% of the scopes tested contained bacterial microbes which could be passed from patient to patient in spite of the prevailing cleaning and reprocessing guidelines.

The released E-mails were filed as part of a lawsuit pending in a Pennsylvania court.  Today, the attorneys of Lupetin and Unatin are investigating the Emails and closely following new developments as part of their work in the previously mentioned lawsuit.   As it turns out, the endoscope in that case was used in the patient just days after the FDA released a February 2015 safety alert warning hospitals that patients could become infected by the scope in spite of adherence to Olympus’s cleaning and reprocessing instructions.   Regrettably, the warning came too late to prevent the patient from suffering contamination with the superbug.

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