S1: Adding UDI Device Identifiers into an Item Master

  • 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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    This guide will provide fundamental knowledge and best practices to aid in adding the Device Identifier (UDI-DI) segment of the Unique Device Identifier into the Item Master contained within your Enterprise Resource Planning (ERP) system.

    Benefits

    • Including the UDI-DI in the ERP system is the first step required to utilize it in supply chain operations and integrate it into your downstream EHR to support barcode scanning at the point of care.
    • Obtaining the UDI-DI from master sources – such as manufacturers and FDA’s GUDID – and storing it in the ERP supports supply chain data standardization to improve contract compliance, inventory management, and other supply chain functions.

    Terminology:

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

    Getting Started:

    Contact the individuals within your organization responsible for managing your Enterprise Resource Planning (ERP) and Electronic Health Record (EHR) systems. Work with them and vendor representatives to answer questions such as:

    • What are your ERPs current capabilities for consuming and utilizing UDI-DIs?
    • If you have already begun to add some UDI-DIs to your ERP, are you leveraging UDI-DI fields that are available in the ERP or maintaining that attribute in an alternative field??
    • Is there a plan underway to replace the ERP? If so, are you using the ERP’s capability to pull, store, and transmit the UDI-DI and associated data fields as an evaluation criteria? Do you plan at some point to use scanning to support inventory operations and/or at the point of care to populate your EHR? If so, you will need to add the UDI-DIs for both unit of purchase and unit of use. ?
    • Are there other data elements in GUDID that you would like to populate in your ERP to enhance analytics and support device data capture in clinical areas?

    Once you understand your system capabilities and are ready to start adding UDI-DIs, break the process down into manageable segments. Choose from one or more of the following master sources of UDI-DI data and work with the appropriate source to set up a project plan.

    There are 3 primary approaches to obtaining UDI-DI master source data and storing it in the ERP system:

    • Work one-on-one with a manufacturer. The manufacturer will provide a list of the UDI-DIs for the products you purchase which can be uploaded into the ERP.
      • Pros: Good way to make sure al of that manufacturer’s data elements in your Item Master are accurate
      • Cons: Slow process and must create a plan for updates and UDI-DI changes with each manufacturer
    • Retrieve information from GUDID via AccessGUDID (Download or API) to load data into ERP
      • Pros: You can schedule regular updates
      • Cons: Not all manufacturers include the catalog number in GUDID making matching products difficult. Not all data is in GUDID (e.g. legacy data, contact lens, etc)
    • Use a GPO or third-party data management company to update the item master via upload or APIs.
      • Pros: Fast and generally, data from these sources should include and enhance regulatory and manufacturer data and have a process for keeping information updated.
      • Cons: There is a fee or subscription required

    Once the UDI-DIs are loaded into the ERP, a data management plan will be required to keep the system up to date and deal with UDI-DI changes and new products.

    Who Should be Involved:

    • Supply chain – purchasing, inventory management, master data management and analytics.
    • Internal ERP and EHR owner
    • ERP and EHR vendor representative
    • Clinical, Finance and IT representative
    • GPOs or third-party data management companies – if they are the source of the UDI-DI for your organization.

    RESOURCES

    Docs from GS1 and HIBCC for reading DI/PI elements in barcodes

    Access GUDID website

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