Report: Olympus knew about duodenoscope infection risks for three years

Patient Safety Monitor Insider

December 30, 2015

A new Los Angeles Times report alleges that device maker Olympus Corp. knew about the risk of infection in its duodenoscopes for three years before issuing an alert to its American hospital customers.

In April 2012, 22 Dutch patients were infected by a dirty duodenoscope made by the Olympus Corp. In response, the company hired a medical investigator in June of the same year. The investigator discovered the duodenoscopes design could allow blood and bacteria to become trapped inside even with proper cleaning, leading to infection. Warning Olympus of his findings, the investigator urged the company to conduct a worldwide study to see if a recall was needed.

Olympus didn’t.

While an alert was issued to European hospitals, Olympus didn’t issue any warnings in America, where the company controls 85% of the gastrointestinal scope market. Olympus even sent a second safety alert to European hospitals in 2014, still without notifying American health facilities. Whenever an infection related to its scopes was reported in the U.S., Olympus would blame the hospitals, claiming they weren’t cleaning the scopes properly, according to the Times. The company never told hospitals that other facilities were having the same problems and treated each case as an isolated incident.

This continued until April 2015, when the Food and Drug Administration (FDA) ruled that the basic design of Olympus endoscopes prevents them from being cleaned properly even if instructions were followed.
Since then, the FDA has linked Olympus products to seven out of 10 endoscopic infection outbreaks. Olympus duodenoscopes are now confirmed to have caused 21 deaths and at least 24 illnesses in Los Angeles, Pittsburgh, and Seattle since 2012. In November 2015, a wrongful death lawsuit was filed against Olympus for the death of Willie Warner Jr., who died of a Carbapenem-resistant Enterobacteriaceae (CRE) infection he contracted from an Olympus scope.

Several of the infections linked to Olympus duodenoscopes have involved CRE, a drug-resistant bacteria that can kill up to 50% of those it infects. CRE has appeared in the news recently because of a new mutation that allows it to share its drug immunity with other bacteria.