January 14, 2016 — Olympus Corp. knew their duodenoscopes could transmit infections in 2012 but did not warn doctors or the FDA for nearly three years, according to a Senate Health Committee report (PDF).
Olympus manufactures 85% of the duodenoscopes used in the United States. In May 2012, the company learned that a scope used at Virginia Mason Medical Center in Seattle could harbor and spread bacteria even after proper cleaning.
Later that year, the scope was linked to several outbreaks of antibiotic-resistant “superbug” infections. In early 2013, tests on at least two scopes showed the devices remained contaminated even after careful, repeated cleaning.
Despite the events, Olympus issued no warnings in the United States until February 2015, nearly three years after discovering the problem. In comparison, Olympus sent hospitals in Europe two separate alerts in 2013 and 2014.
Meanwhile, the FDA was informed about problem in September 2013, but waited 17 months to warn doctors, hospitals, and the public. The report found that at least 68 patients in 7 hospitals were infected during that time.
In a three-year stretch from 2012 to 2015, duodenoscopes were linked to 25 separate outbreaks of antibiotic-resistant infections that sickened at least 250 people in the United States and Europe, the investigators found.
Investigators also found that many hospitals with duodenoscope-linked infection outbreaks used an automated endoscope reprocessor (AER) made by Custom Ultrasonics. In November 2015, all of the machines were recalled because the manufacturer never verified they could actually sterilize a duodenoscope.
Failures by the FDA and manufacturers are not the only problem. Investigators found that at least 16 hospitals traced antibiotic-resistant infections directly to duodenoscope procedures. However, due to poor reporting by hospitals, it took the FDA a long time to realize that scope infections were the result of design — not hospital cleaning errors.
Investigators asked the FDA to evaluate whether a recall is necessary to get manufacturers to repair the scopes. The agency previously said it will not recall the scopes because they are used in life-saving procedures, there is no alternative, and the risk of disease-transmission is low.
Duodenoscopes are used in more than 500,000 procedures annually in the United States, often to drain digestive fluids when ducts are blocked by gallstones or tumors. The scope is a flexible tube that is inserted down a patient’s throat to access the upper part of the intestine. The problem is that the tip of the scope has a complex “elevator” mechanism that is extremely difficult to sterilize due to intricate moving parts.