FDA, NIH, CDC -- there are many acronyms that we use to describe a federal agency or organization. As part of my ONS Annual Congress experience in Washington, DC, I signed up to take a tour and visit the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) Clinical Center on Wednesday, April 24, 2013.
I wanted to share and highlight a voluntary program offered by the FDA that can save lives. There are approximately 40 nurses who work at the FDA, all with diverse backgrounds such as biology, public health, advanced practice nurses, and clinical trials. The FDA is committed to protecting and promoting the public's health, and one way is the reporting of adverse events.
In your workplace, have you noticed defective or malfunctioning medical products or inaccurate product labeling? If so, have you shared your concern with nursing leadership? In addition to sharing these concerns with nursing leadership, it is strongly encouraged to report it to the FDA Safety Information and Adverse Event Reporting Program, known as MedWatch.
This is a voluntary program for reporting a serious adverse event, product quality problem, or product use error that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device or dietary supplement.1
The FDA provides ongoing updated information if you are interested in joining the MedWatch e-list, or even if you would like quick access to adverse event reporting forms -- please share this information with your colleagues, nursing leadership, and staff.
Have you used MedWatch before? How can we encourage nurses to report concerns or defective devices? What are the barriers to reporting?