September 24th, 2012| September 24, 2012 With thousands of lawsuits and claims being filed because of serious or permanent injuries stemming from defective medical devices, the U.S. Food and Drug Administration (FDA) has submitted a new plan to help keep track of products on the market and reports of their adverse effects. According to the press release, the FDA hopes to one day have every medical device issued a unique code that would not only give information about the product and what it is used for, but also when and where it was manufactured. The agency hopes to accomplish this goal by implementing four major steps, including:
- Establish and promote the incorporation of a Unique Device Identification (UDI) system into the health industry.
- Create national and international registries for products selected to go to market in the United States.
- Update the Adverse Event Reporting and Analysis systems.
- Develop and utilize new methods for evidence generation, synthesis, and appraisal.