FDA Unique Device Identification

The Food and Drug Administration (FDA) released a proposed the "unique device identifier" rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI.  A UDI system is designed to improve the quality of information in medical device adverse event reports.  This is intended to help the FDA identify product problems more quickly and allow better targeted recalls that will improve patient safety.

What is the Unique Device Identification - UDI?

  • A UDI is a unique numeric or alphanumeric code that includes:
    • A Device Identifier specific to device model
    • A Production Identifier
      • Current Production Information of a device
        • Lot or Batch Number
        • Serial Number and/or Expiration Data

The FDA is also creating a database containing a standard set of basic identifying elements for each UDI.  Most of this database will be available to the public allowing users of medical devices to look up information about any device. The FDA’s database will not contain any information about who uses a device or any personal privacy information.

FDA' Proposed Benefits of Fully Implemented Unique Device Identification:

  • More accurate reporting, reviewing and analyzing of adverse event reports
    • Problem devices can be identified and corrected more quickly
  • Reduce medical errors
    • Health care professionals more rapidly and precisely identify and obtain important 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 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 prepare for medical emergencies.
  • Lead to the development of a medical device identification system that is recognized around the world.

Reactions:

Industry reaction to the proposed rule has generally been positive

FDA medical device ID program: Purchasers pleased, industry wary

 

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