Last week, the U.S. Food and Drug Administration (FDA) proposed rules regarding a Unique Device Identification (UDI) System. The rules will require medical device manufacturers to provide each item with a unique identifier in readable text, along with automatic identification and data capture (AIDC) technology. The technology must enable the number to be captured automatically. [1]
Medical device manufacturing and health care industries have 120 days to comment on the proposed rules.
According to Jay Crowley, a senior advisor to the FDA, the agency will have six months to issue the final rules once the 120-day period has passed. Following this, there will be a phased-in implementation.
A UDI system can provide multiple benefits, such as reducing medical errors, providing a consistency in entering information about devices in electronic health records and clinical information systems. The system also allows manufacturers, health care facilities and distributors to properly manage medical device recalls.
In addition, a UDI system will establish a global and secure distribution chain that can help address counterfeiting and diversion and prepare for medical emergencies. [2]
“The safety of medical devices is a top priority for the FDA, Congress, industry, and patients,” explained FDA Commissioner Margaret A. Hamburg, M.D. “The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.”
