FDA Proposes New System To Battle Problem Of Defective Medical Devices

by Staff Blogger | 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.

The FDA hopes the program will make gathering information about certain medical devices easier to find, as well as creating a more detailed and efficient reporting system for when a problem is discovered. The agency has already begun to introduce the system, which includes certain hip implant and transvaginal mesh models.

The California personal injury lawyers with Berg Injury Lawyers hope that the system will help to better protect patients from the dangers of defective medical devices and the injuries that they can inflict.