viernes, 13 de marzo de 2015

Announcing Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Final Guidance

Today, the FDA published a final guidance on reprocessing reusable medical devices. This guidance is a step toward further reducing the risk of patient infection by providing manufacturers with recommendations to validate their reprocessing instructions to ensure devices remain safe and effective for reuse.

This final guidance includes:
  • General considerations for reusable medical device design and reprocessing instructions in device labeling;
  • Six specific criteria that manufacturers should address in reprocessing instructions;
  • Recommended reprocessing validation methods designed to clean, disinfect and sterilize reusable medical devices; and
  • A subset of medical devices for which 510(k) submissions should include protocols and complete test reports of the validation of the reprocessing instructions to demonstrate that reprocessing methods and instructions are adequate. The Reprocessing of Reusable Medical Devices website has been updated to highlight this device subset.
We will discuss this final guidance document at a webinar scheduled for March 24, 2015. The webinar is intended to help manufacturers and other interested stakeholders understand the recommendations described in this final guidance document.  

Following a brief presentation, the FDA will respond to manufacturer’s questions regarding this guidance document.

Webinar details:
Registration is not necessary.
Date: Tuesday March 24, 2015
Time: 1:00 PM-2:30 PM, Eastern Time (please connect by 12:45 PM)

To hear the presentation and ask questions:
Dial: 888-324-3908; passcode: 7495402 | International: 1-312-470-7226; passcode: 7495402

To view the slide presentation during the webinar:

Following the webinar, a transcript, recording and slides will be available at: The slide presentation will be available at this site on the morning of the webinar.
If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health

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