Japanese medical device maker Olympus knew in early 2013 that its duodenoscopes--used by 85% of the market in the United States--could be a source of bacterial infection even after the device was cleaned, according to a U.S. Senate report this week.
The devices, which are used to examine the small intestine, were found to be the source of infections in greater numbers than previously known, the report found, according to a story in the New York Times.
A cluster of infections in Seattle prompted investigators to look into the procedures to clean the "closed-channel" duodenoscopes, which are said to be difficult to clean, according to the report.
U.S. Food and Drug Administration (FDA) rules require manufacturers to report cases in which they have learned of information that suggests a device may have caused or contributed to a death, the report said. Senate investigators said Olympus knew of at least two investigations in the Netherlands in 2013 where its scopes were implicated in so-called "superbug" infections, but did not report those instances to the FDA until 2015.
An Olympus spokesman declined to comment on the findings of the Senate report, but told the NYT that it was "closely reviewing the recommendations in the report."
FDA officials also said they would "carefully consider the report's recommendations" that included mandating the FDA reevaluate the design of the scopes and issue a recall to force manufacturers to modify faulty devices. The report also called on Congress to require unique device ID tags be included in insurance claims and urged Congress to develop a national medical device evaluation system "rather than relying on adverse event reporting."
The devices made by Olympus were the focus of lawsuits in the United States in Los Angeles and Seattle where patients died after becoming infected. Hospital officials also criticized the company, with one calling the company's silence "unethical, irresponsible, and dangerous."
Part of the reason Olympus maintained its silence was that medical devices make up about 75% of the Tokyo-based company's $7 billion in annual revenue.
- here's the report from the NYT (sub. req.)