2015-08-04 21:12:33 UTC

New Guidance to Enhance Duodenoscope Reprocessing

Aug. 4, 2015

FDA encourages health-care facilities to go one step further to prevent infection transmission associated with duodenoscope use.

Today, FDA issued a safety communication to further help reduce the risk of infection transmission associated with duodenoscope use. In this communication, FDA recommends that hospitals and health-care facilities that utilize duodenoscopes, in addition to meticulously following manufacturer reprocessing instructions, take one or more of the following steps to further reduce the risk of infection and increase the safety of these medical devices:

  • Microbiological culturing
  • Ethylene oxide sterilization
  • Use of a liquid chemical sterilant processing system
  • Repeat high-level disinfection

This guidance is a result of an FDA-led expert panel meeting earlier this year, which AGA participated in. 

Both AGA and FDA recognize 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.

See the FDA Safety Communication for additional information.

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