What is a unique device identifier (UDI)?

June 30, 2020

3 minute read

Unique device identifiers (UDIs) were established by the FDA "to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.” Some hospitals might know UDIs by the organizations that issue them: GS1 (GTINs), HIBCC (UPNs), and ICCBBA (ISBT-128).

The FDA laid out eight specific benefits to creating the UDI system:

  • Reduce Medical Errors.
  • Simplify the Integration of Device Use Information Into Data Systems.
  • Provide for More Rapid Identification of Medical Devices With Adverse Events.
  • Provide for More Rapid Development of Solutions to Reported Problems.
  • Provide for More Rapid, More Efficient Resolution of Device Recalls.
  • Better Focused and More Effective FDA Safety Communication.
  • Standard Format for Dates Provided on a Device Label.
  • Additional Benefits, e.g. Inventory Management, UDI in EHR.
  • As such, UDI is intended to transform supply chain management at hospitals and health systems. For example, scanning at receipt and point of use can substantially improve inventory management. And if the UDI is auto-populated in the EHR while scanning a product at the point of use, providers can reduce input errors and improve recall management.

    What is a UDI?

    A UDI includes two components:

  • Device Identifier (UDI-DI): identifies labeler and device model/version.
  • Production Identifier (UDI-PI): includes device serial number, expiry, lot number, etc.
  • In addition to applying UDI to a device label, manufacturers are also required to submit the UDI-DI and associated fields to the FDA’s Global UDI Database (GUDID). There are a total of 63 fields, including: Manufacturer Name, Device Description, GMDN Code, Product Code, FDA Premarket Submission Number, Storage and Handling, and Unit of Measure (UOM) information. The UDI on the label must be present in both plain text and as a barcode on the label and packaging, enabling scanning.

    But UDI offers tangible benefits even prior to implementing scanning. UDI acts as a key data field to connect product data across datasets. For example, vendors have begun using the UDI to link product data reported in the GUDID with device adverse events and recalls, manufacturer details (including country of origin), and premarket approval information. As a result, the value of cleansing an item master with UDI information quickly moves beyond just understanding an item -- the UDI becomes a way to standardize and find substitutes as well, streamlining clinical integration.

    AccessGUDID is the public portal managed by the National Library of Medicine that allows access to data associated with the UDI-DI via search or API. Currently, over 2.5 million medical devices are present in AccessGUDID, with hundreds more added every month. As more medical devices are added to the database, the value of adopting UDI, scanning, and using GUDID data attributes will only continue to increase. In addition, the European Union, India, China and many others are in the process of implementing their own unique device identification systems. Providers who have already adopted UDI and built a data infrastructure to support its use in operations and purchasing stand to benefit from these additional regulations.

    If you have questions about adopting UDI, we’re happy to discuss the benefits and challenges in the context of your health system. Please reach out to us here.