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MEDWATCH –
How to Report Problems With Manufacturers to the FDA
Press Release
Many of our members have complained, through the Discussion Forum and at IAHCSMM meetings, that they are having various problems with manufacturers. For instance, some manufacturers are not providing adequate instructions for cleaning and/or sterilization; some are calling for unusual cycles that are unavailable on standard hospital sterilizers; and the list goes on and on.
At our Fall conference, Larry Spears from the FDA reiterated that the only way the FDA can take any action is to receive complaints, and lots of them, properly filed on MEDWATCH Form 3500. To make the reporting easier for us, the FDA has provided a website that goes directly to the Form. They also made it easier for us by providing instructions on exactly how the Form should be completed.
The website is: https://www.accessdata.fda.gov/scripts/medwatch/
The suggested procedure to work your way through the form is:
- Click on "BEGIN" at the bottom of the first page.
- Click on "Next Section" at the bottom of the second page.
- This page is entitled "B. Adverse Event or
Product Problem"
• Fill in # 4 - "Date of this report"
• Fill in #5 - "Describe the event or problem"
• Click on "Next Section" at the bottom of the page. - Click on "Next Section" at the bottom of the page.
- Click on "Next Section at the bottom of the page.
- This page is entitled "E. Reporter"
• Provide all information requested
• Click "Confirm your submission" at the bottom of the page.
We thank the FDA for providing a simple process for the use of the form. Now it's up to us to do our part to bring the problems to the attention of the FDA.
Anne Cofiell
annecofiell@aol.com
