Medical Device Maker Warns Europeans of Infection Risk, Waits Three Years To Warn Americans

By on July 25, 2016

The Los Angeles Times reported on July 24, 2016, that Japanese medical device company Olympus Corp. emails show that the company warned European hospitals that its medial scopes could be infected with drug-resistant bacteria while choosing not to issue similar warning in the United States.  In the three years since the European warnings, at least 35 died in U.S. hospitals.

In 2012-2013, dozens of patients became infected in French and Dutch hospitals after using gastrointestinal scopes manufactured by Olympus, which controls 85% of the U.S. market for GI scopes, which are inserted down a patient’s esophagus for diagnostic purposes.  A Dutch investigator concluded that the scope’s design could allow blood and tissue to become trapped on the scope, potentially shielding it from proper disinfection.   An alert to European hospitals was made in early 2013, but despite similar outbreaks in Pittsburgh and other American cities, Japanese executives instructed American executives to only disclose the issue if a healthcare provider specifically asks about known problems.

The emails were disclosed in lawsuits brought on behalf of infected patients.  In February 2015, after mounting outbreaks at U.S. hospitals, the U.S. Food and Drug Administration issued a safety alert warning that infections could occur even if Olympus’ disinfection instructions were followed.

Finally, 3 years after warning European hospitals, and after a critical Senate report was issued, Olympus recalled the scopes.

The L.A. Times article can be accessed at: