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FDA Issues Safety Communication to Enhance Duodenoscope Reprocessing


The FDA issued a safety communication last week to further help reduce the risk of infection transmission associated with duodenoscope use. In this communication, the FDA recommends health care facilities performing endoscopic retrograde cholangiopancreatography (ERCP) to evaluate whether they have the expertise, training and resources to implement supplemental measures discussed at May's Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee meeting. Hospitals and health care facilities that utilize duodenoscopes can, in addition to carefully 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.

Reprocessing is a detailed, multi-step 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.

Among the variety of infection mitigation strategies discussed at the Advisory Committee meeting, several specific supplemental measures have been implemented in individual health care facilities. 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

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.

Learn more about potential claims on our Defective Drug & Medical Device page.

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