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FDA MedWatch - Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing

MedWatch logoMedWatch - The FDA Safety Information and Adverse Event Reporting Program

Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing

Includes all Endoscopic Retrograde Cholangiopancreatography (ERCP) endoscopes (side-viewing duodenoscopes) 


AUDIENCE: Gastroenterology, Surgery, Biomedical Engineering, Infectious Disease, Nursing, Risk Manager

ISSUE: FDA is providing a detailed list of supplemental duodenoscope reprocessing measures that emerged from an agency-led expert panel meeting earlier this year. Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices.

FDA recognizes that not all health care facilities can implement one or more of these measures, which require specific resources, training, and expertise. Therefore, it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks. While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients.

BACKGROUND: Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices, and can result in infection transmission if reprocessing instructions are not followed in every step of the process. While there will always be a risk of infection transmission with devices used internally, it is important to take all possible steps to minimize that risk so that patients may realize the benefits of these devices.

RECOMMENDATION: 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: www.fda.gov/MedWatch/report
  • 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:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm457132.htm


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