A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows

Area of Science:

• Biomedical Engineering
• Medical Imaging Informatics
• Health IT Standards

Background:

• Medical device imaging workflows require robust methods for linking Unique Device Identification (UDI) with Digital Imaging and Communications in Medicine (DICOM) metadata.
• Current systems lack a reproducible way to connect UDI with equipment metadata and external evidence like calibration records.

Purpose of the Study:

• To define a minimal, checkable profile for UDI-DICOM mapping that preserves full UDI information.
• To derive a device identifier suitable for registry lookup and link it to reviewable evidence.
• To develop a prototype validation artifact for UDI-DICOM data.

Main Methods:

• Derived a minimal UDI-DICOM mapping profile from IMDRF UDI guidance, DICOM provisions, and GUDID registry semantics.
• Developed a machine-readable manifest, explicit cross-layer validation rules, and a prototype validation artifact.
• The artifact performs presence, parseability, registry-resolution, cross-layer consistency, and evidence-link closure checking.

Main Results:

• The validation artifact successfully passed runs on an offline fixture, a live openFDA/GUDID lookup path, and a synthetic DICOM fixture.
• The artifact emits reviewable Markdown, JSON, and JSON Lines outputs.
• No real-device DICOM specimens have been validated yet.

Conclusions:

• The study contributes a bounded Methods Paper artifact for imaging informatics and biomedical engineering traceability.
• The developed profile and artifact offer a standards-oriented approach to workflow integration.
• Explicitly excluded are claims of clinical validation, regulatory approval, hospital-wide deployment, or universal interoperability.