The Benefits of UDI
The Purpose of this Quick Start Guide
- This guide outlines many of the benefits and use cases for UDI across clinical, financial and supply chain operations. The UDI helps improve patient safety by improving clinical documentation accuracy, supporting a faster, more thorough medical device recall process, and enhancing post market surveillance. It delivers efficiencies and insights through the use of a standardized code that uniquely identifies medical devices across disparate technology systems, health care functions and organizations.
- While the scope of this document does not cover all use cases and benefits, it can be used to help multiple stakeholders build the collective business and clinical case for broad adoption and implementation in systems and processes.
Terminology
See the Glossary Quick Start Guide for the definitions for 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 and Use Cases
Linking information
A foundational benefit of the UDI is its ability to serve as a key that can be used to identify products and to link to information about those products across disparate technology systems, functions and processes and organizations. Information about the products can be at the macro level, (e.g., about all products of a particular type that are ordered, stored and used), or at the micro level, (e.g., about a serialized implant used in patient care). By linking data from different systems, health care professionals can gain a more comprehensive view of a product, relating clinical, financial and/or supply chain aspects for better analysis and decision making.
Recalls and Adverse Event Reporting
A primary objective of the UDI rule is its ability to improve recall and adverse event reporting, which supports both clinical quality and supply chain operations.
- Including the full UDI (UDI-DI + UDI-PI) as fields in adverse event reports can lead to earlier detection of device-related issues, potentially reducing or preventing patient harm.
- Using the UDI-DI to link information from 510(k) pre-market approvals, adverse events and recall reports can lead to earlier detection of device-related issues by regulators and manufacturers.
- Including the full UDI (UDI-DI+ UDI-PI) as fields in recall notices improves identification of recalled devices in inventory management systems and patient records. This speeds up the recall process, preventing recalled devices from being used on patients and facilitating the identification of specific patients who received recalled devices.
- The inclusion of the full UDI in recall notices is particularly important for companies that assign more than one UDI-DI to an internal catalog (REF) number.
Other Clinical benefits
- The UDI was mandated to better understand how medical devices perform in routine clinical practice. Use of the same identifier across health care can help identify patient safety issues faster and generate clinical evidence to guide appropriate product use and inform future product development.
- Linking the UDI-DI with other outcome data can power comparative effectiveness research related to various methods of treatment for a given disorder (e.g., use of clips, coils, or shunts for brain bleeds).
- The machine-readable format of the UDI on product labels facilitates scanning of products at the point of care (e.g., through barcode scanning, optical readers, RFID, etc.) to automate clinical documentation of product use, improving the accuracy and compliance of medical records and reducing the clerical burden on clinicians to capture that information. This information is also the basis for subsequent functions, such as billing and coding. See the Benefits of Barcode Scanning at the Point of Care Quick Start Guide.
- The GMDN Category (higher-level grouping) linked to the Term Definition found in the GUDID is one of the best ways to identify whether a medical device is considered an implant, according to the AHRMM Learning UDI Community (LUC) High Risk Implant workgroup. This information supports compliance with requirements to document implant use in EHRs using the UDI and proper assignment of charge codes.
- By referencing the UDI-DI for specific types of devices in AccessGUDID, clinicians can determine critical safety information, such as if a product impacts MRI Safety or contains latex.
- Using the UDI to document implant use also helps clinicians identify specific implants in the event an explant is required.
- For products containing a Human Cell, Tissue, Cellular or Tissue-Based Product (HTC/P), the UDI can also associate the device with the donor in the event there is a safety issue with the donated specimen.
Supply Chain Benefits
- Use of a standardized code to identify all products of a specific make or model and packaging quantity (unit of measure) can improve the accuracy of supply chain orders. See Quick Start Guide on UDI in transactions.
- Inventory Management: The UDI-DI can be used as the data source for documenting the receipt, stocking, usage, and re-ordering of all supplies, products, and devices. Systems that capture both the UDI-DI and UDI-PI improve expiry management and prevent the use of expired or recalled medical devices at the point of care. See Quick Start Guide on UDI in Inventory Management.
- Inclusion of the UDI-DI in the contract/price file can promote better price accuracy and serve as the foundation for use of UDI in other supply chain systems and functions. See Quick Start Guide on UDI in Contract Management.
- Use of the UDI as a link across technology systems and databases, (e.g., EDI transactions, contract/price files, and item masters), supports analytics to improve spend management, demand planning, inventory level optimization, and recall response through a more comprehensive view of products and their operational impacts.
- Use of the UDI-DI to access data in the GUDID also facilitates trading partner collaboration through the proliferation of more consistent and commonly used information about medical devices across supply chain functions and organizations.
Data Standardization, Product Substitutions and Analytics
- Using the same product identifiers across the supply chain can support more collaborative work to address shortages and improve resiliency by creating a common view of product availability and demand.
- The UDI-DI record in AccessGUDID contains the GMDN Term and Definition for each device. This categorization provides a standard name and definition for each device related to its approved use and can assist in identifying potential product substitutions.
- Regulatory bodies in other countries are also putting UDI regulations in place. The UDI-DI can support broader views into higher quality, enriched data on medical devices by linking data between the GUDID and other countries’ equivalent databases.
Financial Benefits
- UDI-DI can be used to standardize and improve the assignment of HCPCS codes, facilitating accurate capture of medical product usage, improving charge capture and billing and enhancing cost per procedure analysis.
- Linking data about the cost and quality of care can support better planning to optimize reimbursement and operating margins.
Click here to listen to Jimmy Tcheng, MD, Professor of Medicine, Duke University School of Medicine share the benefits from scanning at the point of care.
Resources
Playbook for Health System Unique Device Identifier Implementation at the Point of Care
Duke documents the value of UDI | HPN Online
How standards support supply continuity | HPN Online
How UDI supports innovation and safety | HPN Online
UDI, recalls and labor shortages – time for a reset? | HPN Online
GS1 Hospital Interactive Experience.
GS1 US: Implementation resources for Healthcare
Tackling the documentation burden among perioperative nurses