FDA issues proposed rule for unique device identifiers

Five years after a request from Congress, the Food and Drug Administration (FDA) has finally issued a proposed rule that would mandate the placement of unique device identifiers (UDI) on medical devices. Among other things, the use of UDIs will facilitate the reporting of adverse events related to these devices so that the FDA can more quickly address them and recall devices if necessary.

FDA has been testing UDIs since 2009. In July 2011, the agency sent its UDI proposal to the Office of Management and Budget (OMB), where it was stalled until recently. The new drug user fee legislation includes a provision requiring that FDA set a deadline for releasing the regulations; FDA acknowledged that it issued the notice of proposed rulemaking (NPRM) in response to the passage of that law.

After the NPRM is entered in the Federal Register, there will be a 120-day comment period before FDA writes the final regulations.

The proposal would require device makers to place UDIs on most medical devices distributed in the U.S. The exception would be those sold over the counter, which generally carry Universal Product Codes (UPCs).

The UDIs would have to include information about the type of device, its model number, manufacturer, expiration date, and lot number. UDIs would contain no patient identifying information, and would be recorded in a publicly available database.

Besides helping to identify adverse events, the FDA said, UDIs could be used to:

  • 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.

In an interview earlier this year with InformationWeek Healthcare, Karen Conway, executive director of government relations for Louisville, Colo.-based supply chain firm GHX, said that FDA has held conversations with the Office of the National Coordinator for Health IT (ONC) about including UDIs in Stage 3 of the Meaningful Use requirements for government electronic health record incentives.

Meanwhile, she said, device suppliers would like to see EHR vendors embed communication protocols in their software to allow UDIs to flow into EHRs.

To learn more:
- read the FDA announcement
- see the NPRM on the UDI regulation
- check out the InformationWeek Healthcare story