An investigator hired by Olympus Corp.--which controls 85 percent of the U.S. market for gastrointestinal scopes--warned the device maker in 2012 about a design flaw in the equipment that trapped bacteria and could spread from patient to patient, the Los Angeles Times reported.
But the manufacturer ignored the investigator's recommendation to conduct a worldwide investigation and possibly recall its equipment. Although it alerted European hospitals about the possibility of contamination, it didn't issue a warning to U.S. hospitals, its biggest market, that the scopes were linked to deadly infections in the Netherlands, according to the newspaper. Instead it continued to see the equipment to U.S. hospitals.
The company also said nothing over the next three years when dozens of patients were sickened by the scopes in Pittsburgh, Seattle and Los Angeles and 21 people died, the LA Times reported.
The manufacturer instead blamed the hospitals for not properly cleaning the devices and didn't tell the organizations that other U.S. hospitals reported similar problems. Each case was treated as an isolated incident.
"Olympus' silence on this important issue was unethical, irresponsible and dangerous," Andrew Ross, M.D., chief of gastroenterology at Virginia Mason Medical Center in Seattle, where 18 patients died due to the contaminated scopes and 21 others became ill, told the LA Times.
It wasn't until the newspaper reported a superbug outbreak at the UCLA Ronald Reagan Medical Center in February that the Food and Drug Administration warned U.S. hospitals about the dangers of scope-related infections that were potentially caused by the design of the equipment.
The devices contribute to 75 percent of the company's $7 billion in annual revenue, the LA Times reported.
Olympus finally alerted customers in February 2015 that there were 95 complaints about infections linked to the scopes. A former Olympus executive told the newspaper that the company couldn't explain away the rash of incidents. "They should have pulled the scope," the unnamed executive said.
To learn more:
- read the LA Times report