FDA Announces Launch of Unique Identification Code System For Medical Devices
October 1, 2013
Each year, a large number of recipients of medical devices intended to help improve their quality of life suffer injuries as the result of defects in the product. The Defective Medical Device Lawyers with the law firm of Ferrer, Poirot & Wansbrough explain the U.S. Food and Drug Administration (FDA) is working to reduce this number and improve patient safety by requiring all such products to carry a unique device identification code (UDI).
According to an FDA Press Release, the codes will consist of a bar code made up of a selection of numbers and letters based on several aspects of the product. One part will be a required section of code consisting of information regarding the device’s label and model type. The second section of the code will consist of information regarding:
- Batch and Lot Numbers
- Serial Numbers
- Expiration Dates
- Manufacture Dates
- Identification Codes for Organic Devices
Experts say that the new UDI system will not only improve the quality of care and safety for patients, but will also create a more efficient system for targeting problem devices, identifying dangers, and initiating recalls. Implementation of the new system will begin in one year, but could take until 2020 to fully complete.
The law firm’s team of Hip Recall Lawyers applauds the efforts being made to reduce injuries and deaths caused by defective medical devices and are hopeful the new system is a success!