- Following superbug outbreaks in the U.S., France, and Netherlands tied to Olympus Corp.'s duodenoscopes, the Japan-based device manufacturer had sent internal emails to company executives in the U.S., asking them not to issue a broad warning to American hospitals regarding about the potentially deadly infections, according to a Kaiser Health News report.
- The emails were filed in one of several patient lawsuits arguing Olympus could have prevented hundreds of infections and 35 deaths since the outbreaks were first reported in 2013.
- "Olympus knew in 2012 that the design of its closed-channel duodenoscope could prevent effective cleaning," a Senate report from January 2016 stated.
Olympus' Laura Storms, vice president of regulatory and clinical affairs in Pennsylvania, became concerned about the company's involvement in an outbreak at the University of Pittsburgh Medical Center (UPMC) after two dozen infections reportedly occurred in Dutch and French hospitals in 2013.
European clients were alerted in January 2013 that the company's device could become contaminated, according to KHN. Roughly 85% of the duodenoscopes used in U.S. hospitals are manufactured by Olympus.
“Should [we] also be communicating to our users the information that [Olympus Europe] is communicating to their European users?” Storms said in an email to company headquarters in Tokyo.
Chief Manager for Market Quality Administration in Tokyo Susumu Nishina responded it is “not need[ed] to communicate to all the users actively,” Nishina wrote. Nishina argued the company had assessed the risk to patients and concluded it was “acceptable.”
Pasadena Public Health Department investigators linked 15 out of 16 patient deaths last month to an Olympus duodenoscope (model number TJF-160F). They also found the city's Huntington Hospital broke the law because it failed to report the outbreak.