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FDA Issues Warning about Duodenoscopes

FDA Issues Warning about Duodenoscopes

Duodenoscopes, which are used in a wide variety of surgeries and medical procedures, have been linked to so-called “superbugs” – aggressive bacterial infections that are very difficult to treat. Although the FDA has not recommended that doctors stop using these devices, it has issued a warning cautioning health professionals to use a specific type of sterilization procedure for all duodenoscopes.

What Is A Duodenoscope?

If you have ever had an endoscopy, your doctor may have used a duodenoscope. These devices are long, flexible tubes equipped with a light and, sometimes, a camera that can be threaded down a patient’s throat and into the small intestine. Doctors use them for both diagnostic and therapeutic reasons. Duodenscopes are used to diagnose and treat everything from gallstones and ulcers to cancer and problems in the bile ducts. According to the FDA, duodenoscopes are used in over 500,000 procedures every year.

Superbugs Associated With Duodenoscopes

Several recent incidents have linked duodenoscopes with superbug outbreaks. In a 2014 case, patients at a Los Angeles teaching hospital were infected with superbugs after undergoing endoscopies performed with a duodenoscope. In that incident, seven patients became ill and two died due to their infections. In response, the hospital began using a sterilization procedure that includes ethylene oxide, a powerful fumigant and disinfectant.

In 2013, duodenoscopes were responsible for another superbug outbreak at an Illinois hospital, when 39 patients contracted carbapenem-resistant Enterobacteriaceae (CRE). When the CDC investigated, it determined that the duodenoscopes used on infected patients were contaminated even though they had been sterilized.

For now, the FDA continues to review the link between duodenoscopes and drug-resistant bacteria. The agency has also released specific cleaning procedures for hospitals and physicians to use before reprocessing any duodenoscope.