The U.S. Food and Drug Administration has proposed that most medical devices distributed in the United States must carry a unique device identifier (UDI) as part of the effort to improve adverse events reporting.
A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety, officials say.
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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, say FDA officials, and no identifying patient information will be stored in this device's information center.
Having worked closely with the industry, the clinical community and patient and consumer groups, and having conducted four pilot studies in the development of this proposed rule, the FDA is now 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 generally 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 agency is proposing to exempt over-the-counter devices sold at retail, since these devices generally have UPC codes in place.
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The proposed rule reflects the considerable input the FDA received from the medical device industry, the clinical community, patients and industry experts. To minimize industry costs and expedite implementation, the proposed rule builds upon current standards and systems already in use by some companies.
Among its potential benefits, a UDI system can:
- 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 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.
For more information, click here (PDF).