An investigator contracted by Olympus and a Netherlands hospital issued a report in June 2012 that the Scope’s design allows blood and tissue to be stuck, and this helps bacteria spread from one patient to another. This prompted the investigator to call for Olympus to make an in-depth investigation and replace scopes with similar problems.
A report issued by the Senate shows that the company knew about the superbug outbreaks which happened in the Netherlands, France, and Pittsburgh. The super infection affected 46 patients, and a European alert was issued in 2013.
Since then, numerous outbreaks in the States happened, and the emails from America to Japan reached to the highest level of the company.
Donny Shapiro, director of Olympus in San Jose, California, sent emails to Japan and to other employees, asking whether to recall the duodenoscope or not. He was concerned about the trouble in Europe and the results from a microbiology test, which concluded that the Olympus scopes had bacteria on them.
Shapiro asked colleagues why the recall only happened in Europe. However, because Olympus Japan decided no communications were to be made on the subject, the issue remained unsolved.
When asked about the possibility of bacteria remaining on the scopes, even after following the Olympus recommendations for cleaning procedures, the company replied that the hospitals were at fault for not cleaning the device properly, accusing them of “insufficient reprocessing.”
Lab tests were dismissed in the same manner by Olympus, as germs “could have gotten in during testing.” After each outbreak of antibiotic-resistant bacteria in the US, Olympus sent the same standard responses, blaming hospitals for not cleaning the equipment sufficiently.
Pressure mounted on the company when the American Society for Gastrointestinal Endoscopy noticed the problem and required Olympus to test the effectiveness of their product themselves.
Olympus is currently a market leader in America and Europe, in the duodenoscope device business.
After extensive testing, 40 percent of the devices were found to carry bacteria on them, even after following the cleaning procedures, as recommended by Olympus.
Overall, 350 patients all over the world were exposed to dirty scopes or even infected. Some of them made an association and decided to press charges against Olympus.
Image Source – Wikipedia