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July 22, 2019

How would FDA-mandated changes to scope technology impact you?

We’re collecting feedback to share with FDA on how the approval of disposable duodenoscopes and/or duodenoscopes with removable components would impact you, our members, and your patients.

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Over the past few years the AGA Center for GI Innovation and Technology has been working with FDA and other key stakeholders, including clinicians and industry, on potential infection control solutions around the design and cleaning of duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. Several potential innovations are under review by FDA and they have asked our help to obtain information from our members about how disposable duodenoscopes and/or duodenoscopes with removable components would be received by the field.

This is a critical topic as FDA’s decisions could ultimately change the way certain endoscopic procedures are performed in the future.

To understand potential concerns and barriers, such as cost, workflow, etc., we’re posting a series of questions in the AGA Community and encourage you to provide us with your honest and constructive feedback as it will help inform FDA and ensure your voice, as well as that of your patients, is represented.

The AGA Center for GI Innovation and Technology routinely engages with FDA on medical innovation developments — our goal is to provide clinically relevant input on topics they are working on to ensure the needs of gastroenterologists and patients are met with each new technology. Thank you in advance for your participation and engagement as the community works together to ultimately reach our shared goal of zero device-associated infections.

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