The US Food and Drug Administration (FDA) has proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.
The US Congress passed legislation in 2007 directing the FDA to develop such a UDI system, but the FDA is only now doing so.
The US Congress and Senate both just passed the “FDA Safety and Innovation Act” with near-unanimous bi-partisan support – a rare event when it comes to health care reform. The Act requires the FDA to enact the UDI system by the end of this year.
According to the FDA, “A UDI system has the potential to improve the quality of information in medical device adverse events reports.” The agency says a UDI system will help “identify product problems more quickly, better target recalls, and improve patient safety.”
A UDI would be a unique code identifying the device manufacturer and the type of device. It could also identify the device’s expiration date and batch or lot number.
This information would be stored in a public UDI database. Patients who receive such devices – and their lawyers – would be able to look them up in the database to learn more about them.
Benefits of a UDI system are expected to include:
- More accurate reporting of problems to and by the FDA
- Reduced errors by medical personnel
- Enhanced analysis of medical devices
- Better management of device recalls
The UDI system could also help prevent the use of dangerous counterfeit medical devices. For example, in 2010 counterfeit surgical mesh products were found in theUSmedical supply chain.
The European Commission is also preparing legislative proposals to improve controls of medical devices by the end of September, including a UDI system and database similar to the FDA’s.
These moves come in the wake of the scandal involving defective breast implants made by the French company Poly Implant Prothèse, and thousands of claims about other allegedly defective medical devices, including hip implants made by Johnson & Johnson’s DePuy unit and heart defibrillator leads manufactured by Medtronic.
Implementation of the final US UDI rule will take place in phases over seven years, and it is estimated that this will cost US companies about $550 million. The highest-risk devices are to be labeled first, and over-the-counter devices would be exempted.
The FDA is an agency within the US Department of Health and Human Services responsible for, among other things, assuring the safety, effectiveness, and security of drugs and medical devices.
About the Author: Nussin S. Fogel, Esq., has been practicing for over 25 years as a New York slip and fall lawyer. Mr. Fogel founded Fogel Law, a firm specializing in Slip and Fall Accidents, Motor Vehicle Injuries, and other areas of Personal Injury Law. He has published on various aspects of Personal Injury Law across the web.