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September 18, 2019

FDA transition to disposable component duodenoscopes — talking points for your patients

AGA has developed FAQs and talking points to help you explain the many benefits of ERCP procedures, which utilize duodenoscopes, and the low risk of infection in light of the recent FDA Safety Communication.
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The U.S. Food and Drug Administration (FDA) recently released a safety communication recommending duodenoscope manufacturers and health care facilities move 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. This announcement may have already produced some questions among your patients when it comes to their procedures that use a duodenoscope, such as endoscopic retrograde cholangiopancreatography (ERCP).

AGA has developed frequently asked questions and talking points below that can help you explain ERCP and infection risk when your patients come to you with questions.

Talking points:

Duodenoscopes are an important tool used during an ERCP to help localize and treat abnormal issues in your bile duct system and pancreas, and possibly help you avoid surgery. 

The complex design of duodenoscopes can sometimes result in bacteria remaining in a small portion of the duodenoscope (the “elevator channel”) even after careful cleaning according to approved instructions. However, getting an identified “superbug infection” with a duodenoscope is very low, currently estimated at 1 per 20,000 ERCPs performed in more than 650,000 ERCP procedures each year in the U.S. FDA continues to work with duodenoscope manufacturers to provide strict guidelines for cleaning and disinfection of these tools.

The switch to new duodenoscopes with disposable components will be slow and orderly to make sure that there are enough duodenoscopes to perform ERCPs so that patients who need this often life-saving procedure will still have access.

Do not cancel or delay any planned procedure without first discussing the benefits and risks with me or another health care provider, as delaying the procedure and alternatives like surgery or radiologic intervention may be riskier than a timely ERCP.

The esophagogastroduodenoscopy (EGD) procedure does not use the same tool that is used for ERCP. EGD uses a different endoscope than ERCP and has not been shown to have the same risk of infection because there is no “elevator channel.”

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