FDA Issues Final Guidance on Reusable Medical Devices

Endoscopes Linked to “Superbugs” Lead to New FDA Guidance for Reusable Medical Devices

The FDA has released the slides from their presentation on Reprocessing Medical Devices. Get the slides here.

In light of the fatal “superbugs” that have been plaguing hospitals after using endoscopes, the FDA has released new guidance for reusable medical devices. While the risk of getting an infection of this type is low, there is still a risk. With that in mind, the FDA has updated their thinking with the release of Reprocessing Medical Devices in Health Care Settings.

The FDA is also intending on putting together an advisory panel to review and discuss the transmission of “superbug” infections via endoscopy procedures. The purpose of the panel is to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information. The committee will make recommendations on:

  • The effectiveness of cleaning, high level disinfection, and sterilization methods;
  • the amount and type of premarket validation data and information needed to support labeling claims and technical instructions;
  • the appropriate use of other risk mitigations, such as surveillance cultures;
  • best practices and guidelines for 3 reprocessing duodenoscopes and endoscopes at user facilities to minimize the transmission of infections; and
  • recommended approaches for ensuring patient safety during ERCP procedures, including a discussion of appropriate patient selection.

It will be interesting to note how the regulations will adapt to meet the needs of patients with the increase in antibiotic-resistant bacteria.

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