Cath Lab Digest

In April of this year, and responding to requirements in legislation that passed Congress with broad bipartisan support, the FDA proposed that most medical devices distributed in the United States carry a unique device identifier (UDI). A UDI system has the potential to improve the quality of information in medical device adverse-event reporting, which will help the FDA identify product problems earlier and quicker, give better target recalls, and improve patient safety. The agency has apparently worked closely with industry, the clinical community, and patient and consumer groups to conduct 4 pilot studies in the development of this proposed rule. The FDA is seeking comment on the proposal for 120 days.

"The safety of medical devices is a top priority for the FDA, Congress, industry, and patients," said FDA Commissioner Margaret A. Hamburg, MD. "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."

Under the proposed rule, a UDI would include a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and a production identifier, which includes the current production information for a device.

The FDA is proposing a risk-based, phased-in approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The FDA is proposing to exempt over-the-counter devices sold at retail; these devices generally have UPC codes in place.

A UDI is a unique numeric or alphanumeric code that acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number. This information will be contained in a publicly available UDI database, and no identifying patient information will be stored in this device information center.

Potential benefits of the UDI system would include the following:

• Allow more accurate reporting, reviewing, and analyzing of adverse event reports so that problem devices can be identified and corrected quicker;
• Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device;
• Provide a consistent way to enter information about devices in electronic health records and clinical information systems;
• Provide a standardized identifier that will allow manufacturers, distributors, and healthcare facilities to more effectively manage medical device recalls
• Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion, and prepare for medical emergencies.