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Is this Medical Device Causing a Deadly Superbug?

infection-from-Duodenoscope-medical-deviceEver heard of the device called a duodenoscope? It’s a specialized endoscope, which is a device with a light attached that is inserted in the body for diagnostic reasons. A duodenoscope is threaded down a patient’s throat into the top of the small intestine for diagnostic and therapeutic reasons. Often it is used to treat gallstones, cancers, and other disorders associated with the digestive system. Sounds like a normal medical device, right? Well it’s now being linked to an outbreak of bacterial infections from “superbugs” at several hospitals throughout the U.S. According to the CDC, superbugs are often resistant to antibiotics.

What Happened?

Back in February 2015, the FDA issued a safety warning regarding the design of duodenoscopes. In the warning the FDA warned that patients who had undergone endoscopic retrograde cholangiopancreatography (ERCP) with re-sterilized duodenoscopes were at risk of contracting an infection (deadly for some). The FDA stated that “meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.” This warning occurred the same day that the New York Times reported that a large teaching hospital in L.A. informed patients that they may have been exposed to a drug-resistant bacterial “superbug” during endoscopy procedures, and that seven patients had been infected and two had died from the infection.

The NY Times’ article goes on to mention that the L.A. hospital had been sterilizing the devices, as required by manufacturer and national standards. However, after the outbreak they strengthened the process adding a second sterilization using a gas called ethylene oxide.

Another article from the NY Times claims that the FDA never previously reviewed data from manufacturers regarding the procedures for cleaning duodenoscopes. The article notes that FDA is now stepping in, asking that manufacturers provide evidence that the method they recommend for disinfecting the devices does in fact work. Yet, the article further discusses how duodenoscopes have been associated with similar outbreaks at other hospitals. For example, in 2013, 39 patients at a hospital in Illinois were infected with carbapenem-resistant Enterobacteriaceae (CRE), which is also the bacteria responsible for the infections in L.A. A CDC team investigated the outbreak in Illinois, and found that the duodenoscopes remained contaminated even after the proper cleaning process.

In more recent news regarding duodenoscopes, a woman filed a lawsuit in Washington against a hospital and Olympus Corp., a major manufacturer of duodenoscopes, after her husband died from a drug-resistant “superbug” he contracted from a contaminated scope. For reference, other major manufacturers of duodenoscopes are FujiFilm and Pentax. For more information on the lawsuit read the article from the New York Times here.

FDA Advises

A recent Wall Street Journal article discusses the FDA’s recommendation regarding the cleaning process for gastrointestinal medical devices like duodenoscopes. The FDA advisory panel members felt that duodenoscopes needed to undergo mandatory sterilization before reuse in a method of sterilization that uses ethylene oxide, which is both an expensive process and potentially toxic to workers, according to the WSJ. At this time the FDA has not recommended that hospitals stop using the medical scopes, even though bacteria is easily spread into a patient’s body.

To learn more about defective drugs and devices, please visit our resource website,

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