|Olympus TJF-Q180V Duodenoscope--Courtesy of Olympus Australia|
Earlier this year, Olympus came under fire after its duodenoscope devices were implicated in superbug outbreaks at medical centers in the U.S. But the company's questionable practices regarding the products date further back, as Olympus played down an early report of a superbug outbreak linked to its device overseas.
Back in 2012, an investigator hired by Olympus and a hospital in the Netherlands found issues with the company's scope after 22 patients became ill, saying that the device's design could cause blood and tissue to become trapped and potentially spread bacteria from one patient to another, The Los Angeles Times reports. The investigator told Olympus to conduct a worldwide investigation and recall all of its scopes if it discovered similar problems.
But Olympus did not heed the investigator's warning. The company told European hospitals about the potential contamination, but it did not do the same across the pond. Instead, it swept the proverbial dirt under the rug and categorized each superbug outbreak at U.S. hospitals as an isolated incident. Olympus also continued to sell its products in the U.S., its biggest market for the devices.
"Olympus' silence on this important issue was unethical, irresponsible and dangerous," Dr. Andrew Ross, chief of gastroenterology at Seattle-based Virginia Mason Medical Center, one of the sites of the recent superbug outbreaks, told the LA Times.
The company also played down superbug outbreaks tied to its devices at U.S. hospitals. After the University of Pittsburgh Medical Center found out that many patients infected with the superbug known as CRE had undergone treatment with an Olympus scope, it pulled the devices and alerted the company.
An Olympus rep reviewed the hospital's test results for contaminated scopes and told doctors that the scopes might not be completely clean because the hospital was using the wrong type of washer, according to the LA Times story. The rep convinced the hospital to replace its cleaning machine with an Olympus model, which can run at about $25,000. But another scope at the medical center tested positive for bacteria even after it was cleaned with the new machine.
A similar story played out at Virginia Mason. In October 2013, patients who had operations with Olympus scopes at the hospital began developing serious infections, which in some cases led to death. An Olympus rep came to the medical center and watched hospital employees wash the scopes, but did not raise any concerns. The rep also did not tell the medical center about similar outbreaks in the Netherlands and Pittsburgh, Ross told the LA Times.
Now, Virginia Mason is suing the company for fraud, saying that it "deceptively concealed … the risks and flaws of the scopes," the company said, as quoted by the newspaper. But Olympus is standing by its practices, saying that the hospital failed to clean the scope correctly.
It took Olympus a while to come clean about some of the incidents related to its dirty duodenoscopes. The company revealed in February that it knew of 95 complaints linking its scope to patient infections. And a former top Olympus exec told the LA Times that previous models of the scope had fewer complaints than the latest iteration, TJF-Q180V, even though the company touts the newer model as safer and more time-efficient.
"This rash of incidents couldn't be explained away," the former official said on the condition of anonymity. "They should have pulled the scope."
Olympus has a lot on the line with its scopes. Medical devices make up about 75% of the Tokyo-based company's $7 billion in annual revenue, the LA Times points out, and sales of its scopes are surging.
The company is committed to resolving the recent safety issues, Olympus told the newspaper, saying that it will "work closely with the Food and Drug Administration in an effort to understand and address potential root causes" and that is has expressed "sympathy to patients and families who have experienced or have been affected with infections."
- read the LA Times story