Benefits of Adding the UDI to the Item Master
Purpose of this Quick Start Guide
This guide provides fundamental knowledge and best practices for adding the Device Identifier (UDI-DI) segment of the Unique Device Identifier into the Item Master contained within the Enterprise Resource Planning (ERP) system.
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 manufacturer. 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 Adding the UDI-DI to the Item Master
- Including the UDI-DI in the ERP system is a precursor to utilizing the identifiers in supply chain operations and capturing the identifiers in electronic health records through barcode scanning at the point of care.
- Greater supply chain data standardization improves order accuracy, contract compliance, inventory management, and other supply chain functions.
For more information on the full array of benefits UDI usage enables see the Benefits of UDI quick start guide.
Getting Started
Identify and contact the individuals within your organization responsible for managing your Enterprise Resource Planning (ERP) and Electronic Health Record (EHR) systems. Work with those internal resources and ERP and EHR vendor representatives to answer the following questions:
- What are your ERP’s current capabilities for consuming and utilizing UDI-DIs?
- Can you hold UDIs in dedicated fields or do you need to maintain the data in an alternative field?
- Are there character length limitations?
- Can the software hold multiple UDIs for the same product?
- Is there a plan or work underway to replace the ERP?
- Is the ability to pull, store and transmit the UDI-DI and associated data fields an evaluation criterion?
- If you have chosen a new ERP, is there a plan to add UDIs for product data before implementation?
- Do you plan now or in the future to use barcode scanning to support inventory operations and/or at the point of care to populate your EHR? If so, the item master will need to include the UDI-DIs for all units of purchase and units of use.
- Are there other device-related attributes in the GUDID that you would like to populate in your ERP to support clinical work and enhance downstream analytics?
Once you understand your current and future 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 chosen source to create and implement a project plan to populate and maintain the data.
Obtaining UDI-DI master source data
There are 3 primary approaches to obtaining UDI-DI master source data and storing it in the ERP system:
- Work one-on-one with manufacturers to provide a list of the UDI-DIs for the products you purchase that can then be uploaded into the ERP.
- Pros: Good way to ensure the accuracy of that manufacturer’s data elements in your item master,
- Cons: Slow process and must create a plan for receiving UDI-DI change updates from the manufacturer for existing products and the UDI-Ds for any new products.
- Retrieve information from the GUDID via AccessGUDID (Download or API) to load data into the ERP.
- Pros: You can schedule regular updates
- Cons: Not all manufacturers include the catalog number in the GUDID making matching products difficult. Not all the data needed is in the GUDID (e.g. obsolete products, contact lenses, etc.)
- Use a group purchasing organization (GPO) or third-party data management company to update the item master via upload or APIs.
- Pros: Minimizes staff time requirements and generally includes data from both manufacturers and the FDA. GPOs and third parties also have processes for keeping information updated.
- Cons: There is a fee or subscription required.
Once the UDI-DIs are loaded into the ERP, a data governance and management plan will be required to keep the system up-to-date and handle UDI-DI changes and new products.
Who Should Be Involved
- Supply chain – purchasing, inventory management, master data management and analytics
- Internal resources responsible for the ERP and EHR
- ERP and EHR vendor representatives
- Clinical, Finance and IT representatives
- GPOs or third-party data management companies (If you decide to use an outside party for UDI-related data)