To the Editor: The article “These Medical Devices Are Inserted Into 500,000 Patients Each Year — but Are Tough to Sterilize” by Roni Caryn Rabin largely understates the value of duodenoscopes and the procedure they are used for, endoscopic retrograde cholangiopancreatography (ERCP). This is a potentially life-saving procedure for hundreds of thousands of patients each year suffering from diseases of the pancreas, bile duct and gallbladder. When a doctor recommends ERCP, it often is because the patient is gravely ill and the benefits of the procedure far outweigh the risks. ERCPs also spare patients much more invasive and dangerous alternatives, including surgery. “Withdrawal” of these instruments from the marketplace is simply not feasible.
We agree that identifying safe and effective solutions that eliminate risk of infection transmission is a top priority. This cannot happen overnight: we cannot adopt a new technology such as disposable scopes without first understanding the new risks we may be introducing to our patients. Our medical societies have been working closely with FDA and industry to identify and properly vet potential solutions. At the same time, hospitals, medical societies and government agencies at all levels continue to pursue best practices to get infection rates as close to zero as possible. Vigilance has been raised and infection rates have improved. Patients who require ERCP should discuss with their physician the risks and benefits.
Hashem B. El-Serag, MD, MPH, AGAF
Sunanda V. Kane, MD, MSPH, FACG
John J. Vargo II, MD, MPH, FASGE
Lea Anne Myers MSN, RN, CGRN
AGA and its Center for GI Innovation and Technology are committed to working with FDA and industry to foster innovation and identify safe and efficacious alternatives for ERCP. If you are concerned about losing access to ERCP, a valuable procedure, please share your comments in the AGA Community. We will be sharing these comments with FDA to ensure their decisions reflect the needs of our members.