Healthcare Standards

UDI

UDI refers to a government initiative, a Unique Device Identifier system for medical devices. On September 27, 2007, the Food and Drug Administration (FDA) Amendments Act of 2007 was signed into law. This act includes language related to the establishment of a Unique Device Identification system. The new system when implemented will require:

  • the label of a device to bear a unique identifier, unless an alternative location is specified by FDA or unless an exception is made for a particular device or group of devices.
  • the unique identifier to be able to identify the device through distribution and use
  • the unique identifier to include the lot or serial number if specified by FDA

The FDA continues to explore how a national UDI system should be structured and how it will improve patient safety, reduce medical errors, facilitate device recalls and improve device adverse event reporting.

The FDA completed a pilot test of a prototype UDI Database (UDID). The purpose of the pilot was to better understand the data attributes and assess the feasibility and usability of the UDID. We were especially interested in manufacturer's ability to identify and organize the data and load it into the database as well as user’s ability to use, retrieve and export the information. The report is available here.

 

For additional information please read the following 2-part series on UDI:
From Information Silo to Bridge, Part 1: The State of UDI, Medical Device & Diagnostics Industry
From Information Silo to Bridge, Part 2: Creating a UDI System, Medical Device & Diagnostics Industry


Useful Links


Correspondence

AHRMM's correspondence to the FDA on the subject of Unique Device Identifiers


Advancing Patient Safety Coalition's (APSC) correspondence to the FDA

 

 
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