FDA Works To Reduce Dangers Posed By Defective Medical Device

by | October 4th, 2013

October 4, 2013

When a new medical device is brought to the market, the manufacturer has a responsibility to test the product to ensure its safety. Failure to identify any potential defects that lead to users being killed or injured can result in costly recalls and claims of liability. The Ohio Class Action Attorneys with Nurenberg, Paris, Heller & McCarthy explain the U.S. Food and Drug Administration is working to develop a system that could help identify such problems faster and, thus, improve patient safety.

According to a press release from the agency, the new system will require each medical device on the market be issued a Unique Device Identification (UDI) code. These codes will be made up of a series and numbers and letters that indicate specific characteristics of the device.

The codes will be made up of two sections. The first section will offer information on the make and model of the device, while the second section will indicate a product’s:

  • Batch and Lot Numbers
  • Serial Number
  • Expiration Date
  • Manufacturing Data
  • Identification Codes for Organic Devices

The agency is working to implement a similar system for devices used in other countries across the world.

The law firm’s team of Ohio Personal Injury Lawyers applauds the efforts being made to improve patient safety and is hopeful the new system will be successful in reducing the dangers posed by defective medical devices!