Medical Devices

Reporting Problems with Reusable Medical Devices or Reprocessing

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

If you suspect a problem with a reusable medical device or reprocessing procedures for a reusable medical device, we encourage you to file a report with the FDA.

Health Care Professionals and Consumers:

We encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

User Facilities:

Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Device Manufacturers:

Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

What to Include in a Report:

To help us learn as much as possible about the adverse events or problems associated with reusable medical devices or reusable medical device reprocessing, please include the following information, if available, in your reports:

  • Details surrounding the event including, but not limited to:
    • Make and model of device
    • Any additional identifying information including catalog and serial number
    • A complete description of the event including patient outcome
    • The health care provider's description of the event and their thoughts on how the device contributed to the event
    • Device design or labeling that may have contributed to the event
    • Patient exposure to retained debris
    • Disclosure to patient including infection control input
  • Whether or not the device has been evaluated, including the evaluation results, if available.

If You Have Questions about the Medical Device Reporting (MDR) Regulation, Including Interpretation of MDR Policy:

  • Email: MDRPolicy@fda.hhs.gov
  • Call: (301) 796-6670 (voice)
  • Or write to: Food and Drug Administration
    Center for Devices and Radiological Health
    MDR Policy Branch
    10903 New Hampshire Avenue
    WO Bldg. 66, Room 3217
    Silver Spring, MD 20993-0002

 

Page Last Updated: 06/30/2014
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