Knowing Which Barcode to Scan to Capture the UDI

  • 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 helps users identify the barcode that contains the UDI on medical device packages that have multiple barcodes.

    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), which 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 Knowing which Barcode to Scan

    • Improved documentation accuracy and completeness
    • Less time required to document device usage
    • Reduced staff frustration.

    For more information on the full array of benefits UDI usage enables see the Benefits of UDI quick start guide.

    Foundational Steps

    • Ensure that staff understand the benefits of capturing the UDI at the point of care through barcode scanning. See Quick Start Guide on Benefits of UDI.
    • Understand barcode scanning capabilities, (e.g., can your existing technology scan both linear and 2D matrix barcodes?). Test to make sure they are configured correctly.
    • Develop/update and educate your staff on your organization’s process for capturing and documenting UDIs at the point of care, especially for non-sterile implants.
    • Develop a process and educate staff on what to do when barcode scanning fails:
      1. How to identify key data in human readable barcodes
      2. Which internal and external parties to notify and how

    See Quick Start Guide on Managing Barcode Scan Failures

    How to Identify the Right Barcode

    • The UDI barcode contains both human and machine-readable data, the latter of which can be captured using automated information data capture (AIDC) scanning technology.
    • To identify the barcode containing the UDI, look for the human readable numeric or alphanumeric information under the barcode. The barcodes provided by the three authorized issuing agencies use specific qualifiers in the human readable formats to identify the information that follows.
      1. GS1 barcodes containing the UDI begin with (01)
      2. HIBCC barcodes start with +
      3. ICCBBA barcodes start with =/

    Click here to see examples of different barcode formats (linear, data matrix) from each of the issuing agencies and the different identifying qualifiers.

    • Examine the medical device package to see if it contains the ISO UDI symbol. The symbol is a rectangle with the letters “UDI” inside. It will be placed adjacent to the barcode that contains the UDI information.
    • Consider upgrading scanning technology. More sophisticated optical character recognition devices with matching algorithms can take a picture of the label and automatically populate the UDI into the correct fields. This eliminates the need for the person scanning to know which barcode contains the UDI. However, it is important for staff to be able to identify the barcode containing the UDI in the event manual documentation backup systems are required.

    Click here to see Sarah Scott, Registered Nurse at Duke Raleigh Hospital explain which barcode to scan.

    Resources

    Not Scanning UDI: What Are You Missing? | HPN Online

    The Barcode Dilemna