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FDA Recommends Disposability for Duodenoscopes

The Food and Drug Administration (FDA) recommends that health care facilities and duodenoscope manufacturers transition to using devices with disposable endcaps or to completely disposable devices to simplify cleaning and reduce contamination.

Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine in diagnostic and treatment procedures. Many duodenoscopes have a fixed plastic or rubber endcap to prevent tissue injury from the scopes’ metal ends; however, these fixed endcaps can limit the ability to clean the scopes’ crevices. Failure to process and sterilize a duodenoscope correctly could result in disease transmission.

FDA-required postmarket human factors studies show that users frequently struggled to understand and follow manufacturers’ reprocessing instructions. The agency will work with manufacturers to conduct additional testing and revise processing instructions.

In the interim, FDA recommends that health care facilities adopt duodenoscopes with disposable endcaps, such as the Fujifilm Corporation model ED-580XT and Pentax Medical model ED34-i10T. Other firms plan to develop fully disposable duodenoscopes in future.

The agency will convene a General Hospital and Personal Uses Devices Panel of the Medical Device Advisory Committee from Nov. 6–7 to discuss duodenoscope contamination rates, opportunities to improve reprocessing, options for new designs, and other responses to challenges. The agency will accept public comments on this meeting until Dec. 6; comments received by Oct. 21 will be shared with the Medical Device Advisory Committee.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Emily Schweich is a senior communications associate for America's Essential Hospitals.

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