The Unique Device Identifier (UDI) Pattern provides the guidelines for exchanging UDI information associated with medical devices, initially implantable devices in patients. This document will not give implementation guidance for specific use cases and worfklows, but will set the overarching guidelines for all working groups that need to exchange the unique device identification on the fields and format intended for expressing UDI related data using V2, V3, and FHIR. The goal of the UDI Pattern is to enable semantic interoperability for recording UDI information on medical devices used on or implanted in patients regardless of the information exchange standard used to move the information across (e.g., HL7 Version 2.x, HL7 v3 messages or CDA, HL7 FHIR).
These are categories of potential users, implementers, or other interested parties such as those that are indicated on the Project Scope Statement under “Stakeholders/Vendors/Providers”. Select those that are applicable, or suggest others:
Clinical and Public Health Laboratories, Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors
EHR, PHR, Equipment, Health Care IT, HIS
Emergency ServicesLocal and State Departments of HealthMedical Imaging ServiceHealthcare Institutions (hospitals, long term care, home care, mental health)
- Creates clarity on where and how to document UDI related information in the base standards
- Enables implementation guides that require access and/or exchange of UDI related information to consistently define how to communicate it
54. Implementations/Case Studies
EHRs Certified to ONC’s 2015 Certification Edition
US FDA GUDID
IHE Patient Care Device Technical Framework
55. Development Background
The UDI Pattern was initially defined as a harmonization document. As the definitions solidified in the respective standard, the guidance was put in normative, cross-paradigm specification to ensure a higher degree of conformance.
With Release 2, updates resulting from HL7 v2.9 and HL7 FHIR R4 were included.