By early 2013, the Japanese medical device manufacturer Olympus was already facing superbug outbreaks in three nations linked to their duodenoscopes. However, the company advised their U.S. executives against issuing warnings to hospitals about potentially contaminated scopes, according to information from internal emails relayed by the Los Angeles Times.
In the wake of two dozen infections in French and Dutch hospitals in 2013, Olympus notified European customers that their duodenoscopes could become contaminated. This spurred concern from Laura Storms, vice president of regulatory and clinical affairs at Olympus America in Center Valley, Pa., as a similar outbreak was under investigation at a Pittsburgh hospital.
On Jan. 31, 2013, Ms. Storms emailed Tokyo headquarters and asked, "Should [we] also be communicating to our users the information that [Olympus Europe] is communicating to their European users?"
On Feb. 6, 2013, Susumu Nishina, chief manager for market quality administration in Tokyo, responded, "[It is] not need[ed] to communicate to all the users actively." Mr. Nishina added that a company assessment determined that the risk to patients was acceptable, according to the LA Times.
However, during the safety alert in Europe, Olympus was already aware that design flaws in its duodenoscopes made it difficult to clean effectively. In December, the LA Times reported that the scope's design could allow blood and tissue to be trapped, spreading bacteria from one patient to another, according to findings in a June 2012 report from an independent expert. The expert had then called on Olympus to hold a global investigation on the scopes and recall all of them if similar problems continued to occur.
In total, 35 people died in U.S. hospitals, including Los Angeles-based Ronald Reagan Medical Center and Seattle's Virginia Mason Medical Center as a result of contaminated Olympus scopes.
The device manufacturer's internal emails, filed in a Pennsylvania court as a part of a patient lawsuit, expose a conflict between U.S. executives and those in Japan regarding the response to the adverse patient safety events. Olympus is the largest duodenoscope manufacturer in the world, controlling 85 percent of the gastrointestinal scope market in the U.S.
According to the LA Times, said the company said in a statement, "Patient safety is our top priority. The duodenoscope issue continues to receive the highest level of attention at Olympus, and we remain committed to working with the proper authorities and our stakeholders to understand and address the potential root causes."
Olympus declined to comment on why the company dissuaded U.S. execs from issuing warnings while their European counterparts were alerting hospitals.
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