Manufacturers of specialized endoscopes, called duodenoscopes, and health care facilities that use them, should transition to duodenoscopes with disposable end caps – or to fully disposable duodenoscopes when they become available – to help reduce the risk of spreading life-threatening infections between patients, the Food and Drug Administration (FDA) advised in a Safety Communication.

Disposable components and fully disposable duodenoscopes simplify or eliminate the cleaning of the devices between uses, a process called reprocessing. While reprocessing is designed to clean and disinfect the devices, tiny crevasses in the duodenoscopes have made it difficult to ensure bacteria is completely removed. The specialized endoscopes have been blamed on numerous outbreaks of antibiotic-resistant infections at hospitals across the United States.

Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat and stomach into the top of the small intestines, or duodenum. They are used to diagnose and treat problems in the pancreas and bile ducts.

The FDA also rolled out results of postmarket human factors studies from each of the U.S. duodenoscope manufacturers (Fujifilm, Olympus, and Pentax) that the agency had previously required. The results suggest that users frequently had difficulty understanding and following manufacturers’ reprocessing instructions and were not able to successfully complete the reprocessing, which may have left the medical devices contaminated. The FDA said that while it is continuing to work with manufacturers to refine their reprocessing instructions, the best path to reducing the risk of disease transmission by duodenoscopes is through innovative device designs, such as those with disposable components, or those that are fully disposable.

The FDA also warned health care facilities from using adenosine triphosphate, or ATP, test strips to assess whether the devices are fully cleaned. “These test strips claim to indicate the presence of live microbes inside of duodenoscopes,” the FDA cautioned. “However, to date, the FDA is not aware of any legally marketed ATP test strips cleared by the agency for this use, which means the FDA has not reviewed them for effectiveness in assessing reprocessing.”

The FDA said it plans to convene a General Hospital and Personal Use Devices Panel of the Medical Device Advisory Committee late next year to discuss issues involving duodenoscopes.

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