Stephen B. Hanauer, MD, FACG
Stephen B. Hanauer, MD, FACG

The FDA today announced supplemental measures to enhance duodenoscope reprocessing, including all Endoscopic Retrograde Cholangiopancreatography (ERCP) endoscopes.

The College recognizes that this important infection control issue remains largely unsettled, but since potentially lifesaving procedures cannot be sidelined, this FDA Safety Communication provides guidance to endoscopists to help reduce infection from duodenoscopes.

The FDA today recommended:Combined with strict adherence to the duodenoscope manufacturer’s reprocessing instructions, the following supplemental measures may further help reduce the risk of infection transmission associated with the use of duodenoscopes:

  • Microbiological Culturing
  • Ethylene Oxide Sterilization
  • Use of a Liquid Chemical Sterilant Processing System
  • Repeat High-Level Disinfection

See the FDA Safety Communication for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA safety communication, at:

Stephen D. Hanauer, MD, FACG, ACG President