FDA and CDC officials will meet in May to review the design and cleaning of endoscopes, a group of medical instruments which have been linked to bacterial infections. As many healthcare providers know, endoscopy helps to save lives by detecting, diagnosing, and even treating diseases of the colon, liver, bile ducts, and pancreas. Some endoscopes are difficult to clean, however, because these re-usable instruments feature narrow and intricate channels, rings, and moving parts.
According to the FDA, U.S. medical professionals perform more than 500,000 procedures each year with duodenoscopes, a class of endoscopes that are more complex (and therefore more difficult to clean and disinfect) than the instruments used for routine upper gastrointestinal endoscopy or colonoscopy. Although most duodenoscopy patients remain free from infection, the FDA cites reports of 135 infectious outbreaks linked to duodenoscopes in the last two years.
In a recent article in the Wall Street Journal, Thomas M. Burton examines a recent bacterial outbreak in Los Angeles where nearly 170 duodenoscopy patients may have been exposed to a “super bug” called carbapenem-resistant enterobacteriaceae (CRE). Similar infections linked to drug-resistant bacteria have been reported at hospitals in Seattle and suburban Chicago during the past several years.
Although the FDA doesn’t recommend that hospitals stop using duodenoscopes, the agency recommends that manufacturers assess their cleaning and disinfection instructions. Healthcare providers are encouraged to inform patients of the benefits and risks associated with these devices, which are also known as ERCP endocopes. Until the FDA and CDC meet in May, and possibly impose additional requirements, what should endoscopy providers tell their patients?