FDA: Facilities Should Transition to Duodenoscopes With Disposable Parts


The U.S. Food and Drug Administration (FDA) has issued a safety communication advising hospitals and endoscopy facilities to transition away from fixed endcap duodenoscopes and begin using duodenoscopes with disposable components that help with or even eliminate the need for reprocessing.

In the communication, the FDA states it believes the most effective solution to reducing the risk of disease transmission by duodenoscopes is through "innovative device designs that make reprocessing easier, more effective or unnecessary." 

As an example, FDA highlights duodenoscopes that incorporate disposable components. Such components, FDA states, can "facilitate cleaning, reduce contamination and reduce disease transmission following reprocessing. Disposable designs may reduce between-patient duodenoscope contamination by half as compared to reusable, or fixed, endcaps."

To date, FDA has cleared two duodenoscopes with disposable endcaps that facilitate reprocessing: Fujifilm's duodenoscope model ED-580XT and Pentax Medical's duodenoscope model ED34-i10T.

FDA shared the following recommendations for hospitals and endoscopy facilities:

  • Use duodenoscopes that have disposable components, if available.

  • Ensure staff always follow reprocessing instructions.

  • Institute a quality control program that includes sampling, microbiological culturing and other monitoring methods.

  • Consider reprocessing with supplemental measures, such as sterilization or use of a liquid chemical sterilant processing system consistent with the device's labeling.

  • Monitor reprocessing procedures.

  • Develop schedules for routine inspection and periodic maintenance in accordance with duodenoscope manufacturer's instructions.

FDA acknowledged that transitioning to newer duodenoscope designs will take time due to cost and market availability challenges, stating, "We encourage healthcare facilities purchasing new duodenoscopes to begin developing a transition plan and work to replace their conventional duodenoscopes with newer models."

In the meantime, FDA noted it is encouraging and working with manufacturers to increase supply of disposable cap duodenoscopes and develop new designs that can further minimize or eliminate patient infection risk.

The safety communication comes just a few weeks after a New York Times article examined the difficulty providers face in properly sterilizing duodenoscopes. The article prompted multiple gastroenterology societies to issue a joint statement challenging points in the piece.