USFDA issues final guidance on "Reprocessing Medical Devices in Health Care Settings"

bio_subbu

bio_subbu

Super Moderator
Dear All

The US Food and Drug Administration (FDA) has published the final version of the guidance document titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”, The scope of this guidance is limited to devices that fall into any of the four reprocessing situations below.

1. 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.

2. 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.

3. Reusable medical devices intended to be reused only by a single patient and intended to be reprocessed between each use.

4. Single-use medical devices initially supplied as non-sterile to the user, and requiring the user to process the device prior to its use.

For more details, please refer the attached guidance document and press announcement.
 

Attachments

  • Reprocessing Medical Devices Guidance - FINAL 3.11.15.pdf
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Mark Meer

Trusted Information Resource
Re: USFDA issues final guidance on "Reprocessing Medical Devices in Health Care Setti

Well, this seems to clarify the question of "does reprocessing include cleaning and low-level disinfection" raised in previous threads.

Cleaning and low-level disinfection are both considered reprocessing according to this guidance.

My concern: so according to this guidance, cleaning instructions must be validated? In the section on "non-critical devices" it states:
"Devices that will likely not become contaminated with pathogens during use (e.g.,room vital signs monitor) may not require disinfection, and therefore may be suitable for use after cleaning only. "

I'm presuming that such "cleaning" described here is not in the scope of this guidance. It would seem ridiculous to validate the cleaning process for e.g. "wipe with a damp cloth", that would accompany many non-critical devices.
 
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