Nearly three years after Congress called for medical devices to be marked and tracked with unique identifiers, data on the tracked devices are now available to the public.
The goal of UDI was to provide a more effective means for consumers, healthcare providers and product manufacturers to identify and report adverse events from a device to more quickly manage a recall when warranted.
The system was established under a provision of the 2012 Food and Drug Administration Safety and Innovation Act. The FDA issued a final rule in 2013 outlining a phased implementation, beginning with requiring manufacturers of Class 3 devices such as implanted pacemakers and heart valves to include a UDI on their products. By 2020, all medical devices will be required to have one.
The agency estimates about 50,000 serious adverse events related to medical devices are reported each year, resulting in some 3,000 deaths.
But the system's implementation has come under criticism by some, including the CMS, who say the FDA's desire to include the identifiers in payment claims would be costly for providers who already face heavy administrative challenges associated with adopting electronic health records systems.
The FDA, though, counters that noting UDIs in claims would provide a much more comprehensive means of tracking devices and address the problem of sharing data across various systems.