Benefits of Incorporating UDI in EDI Transaction Sets

  • What is UDI?
  • The Benefits of UDI

  • UDI in Transaction Sets
  • UDI in Inventory Management
  • UDI in Contract Management

  • Benefits of Scanning the UDI at Point of Care
  • Knowing Which Right Barcode to Scan for the UDI
  • Handling Scanning Failures

  • Adding the UDI to the Item Master
  • Maintaining Data Quality

  • What is GUDID?
  • Glossary and Regulatory Guidance

    • Back to Introduction

    Purpose of this Quick Start Guide

    This guide outlines the benefits and provides a technical map for using the UDI in EDI transaction sets.

    Terminology

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

    What is UDI?

    The UDI is an FDA mandated code intended to improve patient safety by unambiguously identifying medical devices (from low to high-risk products) sold in the U.S. through distribution and use. Beyond patient safety, the UDI delivers a myriad of benefits across clinical, financial and supply chain functions. Manufacturers must obtain UDIs from one of three authorized issuing agencies for all of their products (unless specifically exempt) and label those products with the UDI in both human and machine-readable formats. The UDI consists of two parts: a device identifier (DI) that designates the specific make or model and packaging quantity (unit of measure) of a device and a production identifier (PI) that includes the information used by manufacturers to control production of the product, such as lot, batch or serial number, expiry date and date of manufacture. For medical devices including human cell, tissue, cellular or tissue-based products, the UDI-PI also includes a code that can associate the device with the donor. Manufacturers must also publish additional data about their products in the Global UDI Database (GUDID), most of which is publicly accessible through AccessGUDID.

    Under separate regulation from CMS and the ONC, health care providers are also required to use the UDI when documenting the use of implantable devices in electronic health records and in adverse event reports involving serious injury or death.

    For more information on the UDI, see the “What is UDI” Quick Start Guide.

    Benefits of Using UDIs in EDI Transaction Sets

    • By providing a common data link between disparate supplier and provider information systems, use of the UDI-DI in transactions can reduce order discrepancies, (e.g., wrong product identifiers, wrong unit of measure).
    • Reduces rework in the ordering, shipping, receiving, invoicing, and cash application processes.
    • Eliminates the need to create manufacturer specific unit of measure translation tables.
    • Eliminates the need to maintain crosswalks of manufacturer, distributor, and provider internal product numbers.
    • Using UDI-DI in the purchase order streamlines the shipping, receiving and put away process by synchronizing data between the ERP and inventory management systems.
    • For more information on the full array of benefits UDI usage enables see the Benefits of UDI quick start guide.

    Getting Started

    Internal Preparation

    Manufacturers and providers should each work internally first with the individuals in their respective organizations responsible for ERP and order management to answer the following questions:

    • Is your ERP capable of holding and transacting on UDIs?
    • When conducting transactions, do you only need the UDI-DI to identify the product and packaging level or do you also need to add the catalog (vendor reference) number?
    • In most cases only the UDI-DI (device identifier) will be used in EDI transaction sets, although some trading partners may decide to include some UDI-PI (production data).
    • In the case of ISBT128 transactions for human cell, tissue, cellular, or tissue-based products (HCT/P), some UDI-PI (production) data is required for traceability.
    • If you are in the process of standardizing to a single ERP system, can you leverage that work to support the use of UDI in transaction sets?
    • Set up your ERP to transact using the UDI-DI. Click here for the guide outlining transaction set maps for the purchase order (850), purchase order acknowledgement (855), advanced shipping notice (856) and invoice (810).

    Working with Trading Partners

    Identify a trading partner with which to pilot the process.

    • Start with trading partners with which you have an established trusted relationship.
      Find out if the trading partner is already using UDIs in transaction sets with other trading partners or ones that are interested and also have the necessary capabilities within their ERP and order management systems.
    • Your EDI vendor can be a resource for identifying trading partner capabilities and available data sets.
    • Make sure you have UDI-Dis loaded in your respective ERP systems for the products you plan to include in pilot transactions.
    • See the Adding the UDI to the Item Master in ERP systems quick start guide for more information.
    • Set up SMART goals for the pilot – specific, measurable, achievable, relevant and time-bound – to measure success.
    • Evaluate the competency of internal staff on technical aspects of EDI transmissions, especially those that include the UDI-DI. Provide training as needed.
    • Make sure all relevant parties at both trading partner organizations are aware of the pilot in advance and are expecting to see orders with the UDI-DI included.
    • Conduct a test with a limited number of items to ensure all data fields are operating correctly before expanding the process to additional products purchased from that vendor.
    • Expand the process to other capable trading partners.

    Who Should Be Involved

    • Supply chain – purchasing, inventory management, master data management and analytics.
      Internal ERP and EDI owners
    • ERP and EDI vendor representatives
    • Clinical and Finance and IT representatives

    Resources

    GS1 US: Healthcare – Implementing GTINs and GLNs in Order to Cash