FDA

Prevention Challenges

FDA Updates Safety Communication on Duodenoscope Transition

The safety communication from the FDA follows a prior one issued in August 2019 calling for manufacturers and healthcare organizations to move to duodenoscopes that are partially or completely single-use.

The U.S. Food and Drug Administration has updated its recommendation that duodenoscope manufacturers and healthcare facilities transition to different types of duodenoscopes that may pose less risk to patient safety.

That includes not just duodenoscopes with disposable components, such as disposable endcaps, but scopes that are fully disposable. Ambu A/S and Boston Scientific Corp. have received FDA clearance for their single-use duodenoscopes and are cited by the regulatory agency as solutions that can reduce contamination and disease transmission.

The safety communication from the FDA follows a prior one issued in August 2019 calling for manufacturers and healthcare organizations to move to duodenoscopes that are partially or completely single-use. The FDA was spurred by ongoing challenges seen with reprocessing duodenoscopes for reuse and persistent high levels of contamination.

At that time, the agency recommended moving away from using duodenoscopes with fixed endcaps to those with disposable components that include disposable endcaps, or to fully disposable duodenoscopes when they become available.

Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination.

Duodenoscopes — flexible, lighted tubes that are threaded through the mouth, throat and stomach into the top of the small intestine (duodenum) — are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures a year in the U.S. This potentially life-saving procedure is critical to diagnosing and treating problems in the pancreas and bile ducts.

The challenge is that duodenoscopes have complex designs that include hard-to-clean reusable components. Human factors are also an issue – manufacturer cleaning specifications are complicated, prone to technician error, and often require staff retraining.

“Duodenoscopes remain critical to life-saving care for many patients in the U.S.,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, when the first safety communicated was issued. “While the risk of infection from inadequate reprocessing is relatively low, we are taking action because of continuing elevated levels of contamination in duodenoscopes.”

Interim results from the FDA's 522 postmarket surveillance studies of duodenoscope reprocessing indicated higher-than-expected contamination rates. This led to the recommendation to transition to duodenoscopes with innovative designs.

“We recognize that an immediate transition away from conventional duodenoscopes to the newer, innovative models will take time due to cost and market availability,” the FDA added in its latest communication. “We encourage health care facilities purchasing new duodenoscopes to begin developing a transition plan and work to replace their conventional duodenoscopes with newer models.”

The FDA has cleared six duodenoscopes with disposable components that facilitate reprocessing, including the single-use duodenoscope developed by Ambu A/S.

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