FDA Proposes Unique Device Identification System

July 3, 2012—The US Food and Drug Administration announced a proposal that would require most medical devices distributed in the United States to carry a unique device identifier (UDI). The FDA noted that this proposal is in response to requirements in legislation that passed Congress with broad bipartisan support.

According to the FDA press release, a UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the agency identify product problems more quickly, better target recalls, and improve patient safety. The FDA stated that it has worked closely with industry, the clinical community, and patient and consumer groups, and conducted four 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,” commented 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.”

As outlined in the FDA announcement, under the proposed rule (with certain exemptions) 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 advised that it 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 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.

In its press release, the agency stated the proposed rule reflects the considerable input that the FDA received from the medical device industry, the clinical community, patients and consumers, and industry experts. To minimize industry costs and expedite implementation, the proposed rule builds on current standards and systems already in use by some companies. A UDI system may:

• Allow more accurate reporting, reviewing, and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.

• 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 health care 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.

For more information, a PDF of the 165-page Proposed Rule: Unique Identification System can be downloaded from the Medical Devices section of the FDA website.