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Rules for Disinfecting Reusable Medical Devices Finalized by FDA

Friday, March 20, 2015   (0 Comments)
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The FDA announced the availability of a final guidance for industry entitled, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses.  

As noted in this press release, the final guidance document is intended to help device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection, and includes recommendations manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices. 

The scope of this guidance is limited to devices that fall into any of the four reprocessing situations:

  • Reusable medical devices initially supplied as sterile to the user and requiring the user to reprocess (i.e., clean and disinfect or sterilize) the device after initial use prior to the subsequent patient use.
  • Reusable medical devices initially supplied as non-sterile to the user and requiring the user to process (i.e., clean, clean and disinfect, or clean and sterilize) the device for initial use, as well as to reprocess the device after each use.
  • Reusable medical devices intended to be reused only by a single patient and intended to be reprocessed between each use.
  • Single-use medical devices initially supplied as non-sterile to the user, and requiring the user to process the device prior to its use.

In recent years, there has been an evolution towards more complex, reusable medical device designs that are more difficult to reprocess. In addition, there has been a significant advance in knowledge and technology involved in reprocessing reusable medical devices. This guidance reflects the scientific advances in these areas.


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