January 14, 2016 — A new Senate report (PDF) has found that Olympus Corp. waited three years to tell the FDA after learning that their medical scopes could transmit infections.
During a three-year stretch from 2012 to 2015, at least 250 people were infected with antibiotic-resistant infections in 25 separate outbreaks. The FDA learned about the problem in September 2013, but waited another 17 months to issue warnings. Meanwhile, at least 68 of infections occurred at seven hospitals.
About 85% of duodenoscopes used at hospitals in the United States are made by Olympus. The company learned that their scopes could harbor and transmit bacteria in May 2012. Later that year, an outbreak of antibiotic-resistant infections occurred at Virginia Mason in Seattle.
In early 2013, independent tests showed that two Olympus duodenoscopes remained contaminated even after meticulous cleaning. Olympus alerted some hospitals in Europe about the problem in 2013 and 2014. However, it was not until February 2015 that Olympus issued similar warnings in the United States.
Investigators also found that many hospitals where outbreaks occurred were sterilizing the scopes using machines made by Custom Ultrasonics. All of those machines were recalled in November 2015 because the manufacturer never validated that they actually worked.
Senate investigators said hospitals should share some of the blame. At least 16 hospitals traced infection outbreaks directly to procedures in which Olympus scopes were used. However, due to poor reporting, the FDA did not realize that hospital cleaning errors were not the source of the problem until recently.
Investigators asked the FDA to consider a recalling the scopes to force manufacturers to fix design flaws. The agency has already said it does not plan to pursue recalls because duodenoscopes are used in life-saving procedures and there is no alternative.
Ever year, duodenoscopes are used in about 500,000 procedures known as ERCP, usually to drain pancreatic or bile ducts that are blocked by cancer or gallstones. As medical technology has advanced, the design of the scope has become more complex. The problem is that intricate mechanisms in the tip of the scope are extremely difficult to sterilize between uses. Even so, the risk of disease-transmission is low — much lower than the risk of health problems from untreated cancer or gallstones.
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