Released on Nov 26, 2019

GI Societies Advise FDA on Duodenoscope Reprocessing

Earlier this month, FDA’s Center for Devices and Radiological Health held a public advisory committee meeting to gather advice and recommendations on the risks of infection with reprocessed duodenoscopes.


ACG, AGA, ASGE and SAGES were represented by three physicians who made oral remarks to the panel: Dr. Michael Kochman, Wilmott Professor of Medicine and Surgery at the University of Pennsylvania; Dr. Bret Petersen, Professor of Medicine and advanced endoscopist at the Mayo Clinic in Rochester, MN; and Dr. Danielle Walsh, Associate Professor of Surgery at East Carolina University.

The GI societies’ goal is to ensure patient safety and ready access to clinically indicated procedures employing duodenoscopes and other elevator-channel endoscopes.

The panel discussed the adequacy/margin of safety for high-level disinfection, as well as the challenges and benefits of sterilization for routine duodenoscope reprocessing. The panel’s consensus was that cleaning is the most important step in duodenoscope reprocessing. The panel noted that in properly cleaned duodenoscopes, high-level disinfection is appropriate, however, panel members acknowledged that reports indicate that duodenoscopes are not properly cleaned. The panel also discussed the challenges of implementing sterilization of duodenoscopes, such as potential decreased patient access to ERCP procedures and increased costs.

The need for thorough training of those responsible for reprocessing resonated.

During remarks to the Panel, the GI societies proposed several overarching principles for the future evolution of our clinical practices focusing on patient safety and outcomes:

  1. We encourage embracing multiple solutions, using a measured step-wise approach to the transition with both iterative and novel devices and processes.  

    2.  We encourage data-based solutions addressing real-world efficacy while incorporating ongoing surveillance of processes and performance to ensure that early trouble signals are detected.

    3.  We believe that device or reprocessing transitions can be incorporated over the lifecycle of current instrumentation, to eliminate the potential for gaps in accessibility of care and to ensure that there is adequate efficacy and safety data to support the adoption of new technology.

    4.  We accept minimizing extensive premarket studies, while expecting vigilant post-market surveillance, for technologies or device changes made exclusively with intent to convert to conceptually more safe designs without significant changes in mechanism or function.

    5.  We support the addition of durability testing for devices undergoing both standard reprocessing and, in particular, those undergoing sterilization.

    6.  Our societies are prepared to support and participate in continued discussion regarding:
         a. Mandatory servicing and inspections.
         b. Mandatory device retirement for reusable devices.
         c. Assessment of the role and standards for third-party inspection and repair.

    7.  Our societies strongly support the importance and oversight of succinct, practical, reproducible, user-friendly guidance in manufacturers’ instructions for use (IFUs), which should incorporate post-market validation studies and updates.

    8.  We recommend that devices that incorporate programmable features (AERs, washers, sterilizers) should have lock-down mechanisms in place to prevent both user and manufacturer from deviating from the FDA cleared IFU parameters for the device.

    9.  Our societies, as well as numerous guidelines, include high-level disinfection as a currently acceptable option for endoscope reprocessing, assuming use of enhanced washing and drying standards of practice.

    10. Finally, we support the FDA in its efforts to convey to companies the necessary endpoints and goals for performance and expectations relative to post-market review and development of new data to ensure efficacy in the community.

Our societies appreciated this opportunity to comment on the complex and critical topic at hand. Our goal, as physicians, remains that of ensuring patient safety and ready access to clinically indicated procedures employing duodenoscopes and other elevator-channel endoscopes.


 

Thank you for your time. Please contact your GI Society with any questions:

American Society for Gastrointestinal Endoscopy
info@asge.org
(630) 570-5635
www.asge.org

American College of Gastroenterology
info@gi.org
(301) 263-9000
www.gi.org

American Gastroenterological Association
communications@gastro.org
(301) 654-2055
www.gastro.org

Society of American Gastrointestinal and Endoscopic Surgeons
webmaster@sages.org
(310) 437-0544
www.sages.org

 


 

ACG, AGA and ASGE and SAGES are committed to collaborate on issues of common interest to all members of the GI community, including public policy and regulatory challenges facing gastroenterologists. This message is being sent as a joint communication from the three societies and has been reviewed by each organization.
For more information: ACG websiteAGA websiteASGE websiteSAGES website


About Gastrointestinal Endoscopy
Gastrointestinal endoscopic procedures allow the gastroenterologist to visually inspect the upper gastrointestinal tract (esophagus, stomach and duodenum) and the lower bowel (colon and rectum) through an endoscope, a thin, flexible device with a lighted end and a powerful lens system. Endoscopy has been a major advance in the treatment of gastrointestinal diseases. For example, the use of endoscopes allows the detection of ulcers, cancers, polyps and sites of internal bleeding. Through endoscopy, tissue samples (biopsies) may be obtained, areas of blockage can be opened and active bleeding can be stopped. Polyps in the colon can be removed, which has been shown to prevent colon cancer.

About the American Society for Gastrointestinal Endoscopy
Since its founding in 1941, the American Society for Gastrointestinal Endoscopy (ASGE) has been dedicated to advancing patient care and digestive health by promoting excellence and innovation in gastrointestinal endoscopy. ASGE, with more than 15,000 members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit www.asge.org and www.screen4coloncancer.org for more information and to find a qualified doctor in your area.

American Society for Gastrointestinal Endoscopy
3300 Woodcreek Drive Downers Grove, IL 60515
P (630) 573-0600
F (630) 963-8332
 www.asge.org
 www.screen4coloncancer.org

Media Contact

Andrea Lee
Director of Marketing and Communications
630.570.5603
ALee@asge.org