FDA releases proposed UDI rule; reaction generally positive

The Food and Drug Administration (FDA) released Tuesday a proposed rule that most medical devices distributed in the United States carry a unique device identifier (UDI).

A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.

Congress passed legislation in 2007 directing the FDA to develop regulations establishing a UDI system for medical devices.

The system has the potential to 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, according to the proposed rule.

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. The UDI does not indicate, and FDA’s database will not contain, any information about who uses a device, including personal privacy information.

When fully implemented, the 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.
• Enhance 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 postmarket surveillance system can also be leveraged to support premarket 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 preparation for medical emergencies.
• Lead to the development of a medical device identification system that is recognized around the world.


Industry reaction to the proposed rule has generarly been positive.

“A robust UDI system will significantly enhance product identification, improve the device recall process and ensure the integrity of the product throughout the transportation process, and most importantly, advance and improve patient safety,” said Dan Sweeney, senior vice president of information and data services at Irving, Texas-based supply contracting firm Novation, in a written statement. “A UDI system also has the potential to generate significant savings for the healthcare industry through improved efficiencies and automated processes.”

Joe Pleasant, CIO of Charlotte, N.C.-based Premier healthcare alliance, told Healthcare Finance News that their members are excited that the proposed rule has been issued but most are disappointed by the seven-year timeframe for implementation.

“I think it’s too long,” said Pleasant. “We’ve been talking about this for five years.”

“I would say while I’ve been very disappointed in FDA taking as long as they have to make the ruling available, they have done a lot in last 3-5 years to talk to manufacturers, distributors and hospitals about what is needed… They should be applauded for the fact that they have done enough pilots and testing,” he said.

Pleasant expects the introduction of the UDI system to improve patient safety, noting it will make it easier to recall high risk products, identify patients who are using recalled products and compile electronic medical records for clinicians to know what devices patients have used or are currently using.

“It will also help reduce errors,” said Pleasant.

Additionally, the UDI system will create supply chain efficiencies, he said, adding, “If (providers) can depend upon the coding on the package, they can begin to eliminate internal barcoding and labeling and the costs associated with them.”

The FDA will accept comments on the rule for 120 days after it is published in the Federal Register.