Olympus Allegedly Neglected to Alert U.S. Users of Tainted Medical ScopesJul 26, 2016
As early as 2013, Japanese device giant Olympus Corporation was aware of superbug outbreaks in three counties and did not issue a warning to American hospitals about possible deadly infections from tainted medical scopes (duodenoscopes). Following two dozen infections reported in French and Dutch hospitals, Olympus alerted European customers that their medical scopes could become contaminated, reports the Los Angeles Times.
Concern grew when a similar outbreak occurred at a Pittsburgh hospital. The chief manager for market quality administration in Tokyo assured an executive in Center Valley, Pennsylvania that "It is not needed to communicate to all the users actively because a company assessment of the risk to patients found it to be "acceptable."
Over the next three years, outbreaks of infection at hospitals in Los Angeles, Milwaukee and Denver, as well as other cities, followed. At least 35 people at U.S. hospitals have died since 2013 after contracting infections from contaminated gastrointestinal scopes made by Olympus, report hospitals and public health officials.
Outbreaks and deaths may have been prevented but for the negligence as well as alleged inaction taken by Olympus. American patients and their families are filing lawsuits and federal prosecutors have investigated Olympus' handling of the infections. The company's internal emails reflected conflicts inside Olympus concerning their response to the growing threat to patient safety. The emails may become crucial evidence and were filed in a Pennsylvania court this month as part of a patient lawsuit.
The duodenoscope is a snake-like device put down a patient's throat to diagnose and treat problems in the individual in the case of cancers and blockages in the bile duct, reports the Los Angeles Times.
Olympus was already aware at the time of the safety alert in Europe, that flaws in the design could make it difficult to clean its duodenoscope for the next patient.