July 27, 2016 — Japanese executives at Olympus Corp. said there was no need to warn Americans about “superbug” infection outbreaks linked to their duodenoscopes, according to the LA Times.
In January 2013, Olympus sent European hospitals warnings about contamination of the TJF-Q180V duodenoscope after two outbreaks. In France, 16 patients developed infections in 2008-2009. In 2012, an outbreak infected 22 patients at one hospital in the Netherlands.
In company emails from February 2013, a senior executive at Olympus’ Tokyo headquarters told managers in the United States not to issue a broad warning to American hospitals.
Soon afterward, Virginia Mason Medical Center in Seattle discovered an outbreak involving contaminated TJF-Q180V scopes that infected 39 patients, 18 of whom died, between 2012 and 2014.
Olympus said the scopes were probably not being adequately cleaned between uses. However, a number of studies and the FDA have concluded that the cleaning instructions themselves were insufficient.
At least 35 people in the United States have died since 2013 after developing infections linked to contaminated duodenoscopes. Overall, the FDA estimates that 350 patients at 41 hospitals worldwide were infected or exposed from January 2010 through October 2015.
Olympus sells 85% of the duodenoscopes used in the United States. The scopes are inserted down the throat to access the upper part of the intestines (duodenum) to treat cancer, gallstones, and other common diseases.