FDA Issues Warning Regarding Reusable Duodenoscopes

The U.S. Food and Drug Administration (FDA) released warnings about the risk of infection associated with duodenoscopes. Duodenoscopes are long fiber-optic cameras that are inserted through the mouth to examine a patient’s duodenum, the top of the small intestine. Though they are designed to be used repeatedly on multiple patients, with a thorough cleaning process in between, recent findings show that they are not being properly sterilized between uses. Duodenoscopes have been linked to numerous disease outbreaks at hospitals.

Most hospitals currently use duodenoscopes with fixed endcaps, which are glued onto the end of the device to prevent injury to the patient during use. Hospitals reprocess the devices between patients by hand scrubbing each part and putting them through a cleaning cycle with special disinfecting chemicals. Bits of tissue or blood can get trapped in the tiny spaces under the endcaps, however, and allow germs to travel from one patient to another. An investigation by the FDA revealed that one in 20 devices was contaminated with microbes, even after they had been sterilized, and they may contribute to the spread of antibiotic-resistant infections.

The FDA acknowledged that the risk of infection caused by a contaminated duodenoscope is relatively low, and they advised patients not to cancel any exams or treatments that are currently scheduled without consulting their physician. However, the consistent levels of contamination found on duodenoscopes has them concerned about both the design of the product and the complicated nature of the cleaning process, which some health care facilities have a difficult time completing correctly. Additionally, many hospitals report using adenosine triphosphate (ATP) testing strips to check for microbes on reprocessed duodenoscopes, but the FDA has not approved them for this use.

Hospitals Should Plan Transition to Disposable Duodenoscopes

Duodenoscopes are used in approximately 500,000 procedures each year. They are critical for diagnosing and treating numerous conditions, especially those affecting the pancreas and bile duct. Some of these conditions are life-threatening, and hospitals will not be reducing their dependency on duodenoscopes anytime soon. For the time being, no duodenoscopes will be pulled from the market, but the FDA is encouraging hospitals to make the switch to single-use duodenoscopes as soon as possible.

While fully disposable duodenoscopes are not yet on the market, there are some available with disposable parts, including single-use endcaps. These products were approved and released without rigorous testing that other devices go through, because of their similarity to other products already on the market, but the FDA is now ordering manufacturers to conduct further testing to ensure that the disposable cap does not present the same contamination risk.

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