Handling Scanning Failures

  • 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

    The Purpose of this Quick Start Guide

    This guide will help users create a plan for addressing barcode scanning failures at the point of care or use.

    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 a Scan Failure Plan

    • Ensures continuity of operations in the event of a barcode scanning failure, including the ability to capture data manually to ensure compliance and accurate clinical documentation.
    • Reduces staff frustration.
    • Reduces likelihood of repeat scanning failures by identifying and proactively addressing the root cause.

    Who Should Be Involved in Plan Development:

    • Clinical staff from the area that will be scanning at the point of care
    • Supply Chain (purchasing, item master maintenance, and inventory management)
    • Information Technology
    • Party responsible for procuring and managing scanning technology

    Topic areas to be included in the Plan