Why UDI? Benefits and Opportunities

  • F1 Use Cases for UDI
  • F2 Uses of UDI Data
  • F3 IT Integration
  • F4 Selecting Scanners
  • F5 Regulatory Guide/Glossary

  • C1 Benefits of Scanning at POC
  • C2 Which Barcode to Scan
  • C3 Handling Scan Failures

  • SC1 Adding UDI to ERP
  • SC2 Using UDI in EDI
  • SC3 Managing UDI-DI Changes
  • SC4 Using UDI in Inventory Management
  • SC5 Using UDI in Contract Management

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    Description:

    This guide outlines typical and common use cases where the unique device identifier (UDI) improves patient safety and increases supply chain efficiency. With UDI-DI provided as a reference resource through the coordination of manufacturers, FDA GUDID system, third-party data management entities, and GPOs, this guide highlights how the UDI-DI can be used as the index, linking “key” key among disparate data systems to allow healthcare stakeholders the opportunity to combine supply chain and clinical information to improve patient safety, increase supply chain efficiency, enable device surveillance, and support medical research. Additionally, the guide highlights the critical role of the UDI-PI in comprehensive clinical documentation and the addressing of medical product expiration and recalls.

    Click here to listen to Jimmy Tcheng, MD, Professor of Medicine, Duke University School of Medicine share the benefits from scanning at the point of care.

    Terminology:

    See the “Glossary” Quick Start Guide for the definitions to any unfamiliar terms or acronyms.

    Principal UDI Use Scenarios:

    UDI Capture at the Point of Care:

    Automated capture (barcode scanning, optical readers, or RFID) of the UDI at the point of care (point of use) ensures that medical device usage is accurately documented in the patient record and provides the basis for subsequent clinical, operational, billing and coding, financial, research, public health, and other uses across a host of stakeholders. See the “Benefits of Barcode Scanning at the Point of Care” Quick Start Guide for a detailed description of the associated benefits.

    Supply Chain Operations:

    Use of the UDI to improve supply chain efficiency benefits all parties within the healthcare supply chain. For healthcare providers, the UDI-DI provides the common data link between internal systems such as the ERP, EHR, and inventory management systems. It also serves as the link between disparate supplier and provider systems and supports trading partner collaboration by providing consistent definitions and data that can be used to analyze current operations and plan future enhancements.

    Benefits and Opportunities:

    Clinical Documentation:

    • The UDI-DI is the link to information that manufacturers have populated in GUDID. The UDI-DI and the UDI-PI coupled with other data from GUDID can be brought into clinical documentation, improving device identification and increasing the accuracy of clinically relevant device information while reducing clinical burden.
    • By referencing the UDI-DI in AccessGUDID, critical medical device information such as MRI Safety, Contains Latex, and Human Cell, Tissue, Cellular or Tissue-Based Product (HTC/P) information can be quickly accessed. The LUC High Risk Implant workgroup found using the GMDN Term Definition found in the GUDID was one of the best ways to identify whether a medical device was considered an implant (insert Link to report). This information can be lifesaving in situations where emergency follow-up care is required.
    • UDI-DI can be used to standardize and improve the assignment of HCPCS, facilitating accurate capture of medical product usage and improving charge capture.

    Recalls and Adverse Event Reporting

    • Combining the scanning of the UDI with the inclusion of the UDI-DI and UDI-PI as fields in adverse event reports can lead to earlier detection of device-related issues, potentially reducing or preventing patient harm.
    • Using the UDI-DI to link information from 510(k) pre-market approval, adverse events and recall reports can lead to earlier detection of device-related issues by regulators and manufacturers.
    • Combining the scanning of the UDI with the inclusion of the UDI-DI and UDI-PI as fields in recall notices improves identification of recalled devices in inventory management systems and patient records. This speeds up the recall process, preventing recalled devices from being used on patients and facilitating the identification of specific patients who received a recalled device.
    • The inclusion of the UDI is particularly important for companies that assign more than one UDI-DI to their internal catalog (REF) number.

      • Medical Research:

      • UDI-DI can be linked to patient-specific data to provide real-world evidence about medical device effectiveness at the population level.
      • By facilitating device categorization, the UDI-DI can power comparative effectiveness of various methods of treatment for a given disorder (e.g., clips, coils, or shunts for brain bleeds). .
      • UDI-DI provides the index and UDI-PI provides specific lot and serial information for returning device performance data to product manufacturers for product development and improvement cycles. .

      Data Standardization, Product Substitutions and Analytics:

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      • The UDI-DI record in AccessGUDID contains the GMDN Term and Definition. This categorization provides a standard name and definition for device classification and assists with data analytics and with identifying potential product substitutions. It can also be used for assignment of UNSPSC codes or can be cross-referenced with the EMDN code which are other approaches to product categorization.
      • The UDI-DI allows the linkage of multiple databases with the goal of creating high quality, enriched data to improve device identification. Linking data contained in the AccessGUDID with other countries’ equivalent databases (e.g., Europe’s EUDAMED) can expand the information available to everyone.

      Supply Chain Operations:

      • Contract Management
        • Including UDI-DI in the contract/price file provides the foundational information to use the UDI-DI throughout all aspects of supply chain operations and point of care scanning.
      • Procure to Pay Process
        • Use of UDI-DI in EDI transaction sets reduces errors by more accurately identifying products and their associated unit of measurements. Link to UDI-DI in EDI QSG
      • Inventory Management:
        • The UDI-DI can be used as the data source for documenting the receipt, stocking, usage, and re-ordering of all supplies, products, and devices.
        • Some systems capture both UDI-DI and UDI-PI, improving expiry management and preventing use of expired or recalled medical devices at the point of care.

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