The U.S. Food and Drug Administration (FDA) has proposed rules that would require most medical devices to carry unique identifiers. According to the agency, the rule will make it easier to track adverse event reports, will boost recall efforts, and will improve patient safety.
The final rule will require many medical devices to carry two codes. One would be an alphanumeric code that identifies the device model. The other code would be a product identifier that contains specific product information such as serial numbers, batch or lot numbers, expiration dates, and other data.
The system is called the Unique Identifier System or UDI.
The FDA has been criticized for moving too slowly on product recalls. The Government Accountability Office (GAO) released a report last year that faulted the FDA for not having a comprehensive recall strategy. The report went on to say that the agency had consistently failed to efficiently regulate the medical device industry.
Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, told reporters in a phone interview that the proposal “outlines the cornerstone of a modern post-market surveillance system for medical devices.” He also added, “Once fully implemented, it will improve the quality of information in medical device adverse event reports, which will help us identify product problems more quickly and efficiently.”
The FDA has already invested time and money in four pilot programs to look into the logistics of implementing an identifier system. They will issue a final rule after a 120-day comment period.
The Tallahassee medical device injury attorneys at Farah & Farah support any regulations that will get unsafe medical devices off the market quickly and boost patient safety. If you believe a defective medical device has harmed you, contact our experienced legal team at (800) 533-3555. We can review your case and discuss your legal options.