Unique Device Identifiers

Last week the FDA released a proposed rule, that if finalized would require all medical devices in the United States to bear a Unique Device Identifier (UDI). According to the FDA, the UDI system would allow the agency to better identify problem devices, properly target recalls and improve patient safety. According to the proposed rule, all UDIs 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 would implement UDIs in phases, beginning with the highest risk devices and exempting a few of the most low-risk devices, such as devices sold in retail stores with UPC codes. The “code” to the UDIs (which would include information about the manufacturer, batch and manufacturing date) would be maintained in a publicly accessible database.

According to the FDA, a UDI system can provide multiple benefits, including:

  • 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.

A copy of the proposed rule can be found here.