Healthcare Matters

It only took the better part of 5 years. The Food and Drug Administration (FDA) has finally released a proposed rule that most medical devices distributed in the United States carry a unique device identifier, or UDI. Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices.

The UDI system will enable all kinds of long overdue and important benefits for the industry. For starters, the system will improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.  In the absence of a national registry, this is the next best thing. The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to the public so that users of a medical device can easily look up information about the device. Neither the UDI nor the FDA database will contain any private patient information, but physicians and patients will be able to connect the most important dots without unreasonable effort.

When fully implemented, the UDI system should:

• 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.
• Enhance our analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post-market surveillance system can also be leveraged to support pre-market approval or clearance of new devices and new uses of currently marketed devices.
• 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.
• Lead to the development of a medical device identification system that is recognized around the world.

In developing the proposed rule, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies. Read the Unique Device Identifier Proposed Rule here. (Note: this document was sent to the Federal Register on 7/2/12 and will be published within the week.)

Source: FDA

The healthcare supply chain has finally standardized on a device level protocol. For obvious reasons, the news is being welcomed by all of the major medical product manufacturers, the market’s GPOs and distributors, the supply chain technology vendors and provider-side SCM professionals alike. Unique Device Identification will improve healthcare business processes –for everyone– and enhance patient safety. Although getting to a global system of standards requires investments by all healthcare stakeholders and is fundamental to enable an efficient and effective implementation of UDI, the good news is, most everyone “gets it” and can align with capable vendors anxious to deliver.

—Tom Finn