A Bounded Public DICOM Metadata Audit for UDI-DICOM Evidence Readiness in Medical Imaging Workflows

Area of Science:

• Medical Imaging Informatics
• Health Data Standards
• Regulatory Science

Background:

• Digital Imaging and Communications in Medicine (DICOM) archives are crucial for medical data sharing.
• Unique Device Identification (UDI) is essential for medical device traceability and regulatory compliance.
• Assessing the presence of UDI metadata in public DICOM archives is vital for evidence-readiness.

Purpose of the Study:

• To evaluate if selected public DICOM archive series contain equipment-identity and UDI-related metadata.
• To determine the readiness of UDI-DICOM data for evidence-based workflows.
• To identify gaps in UDI metadata within public medical imaging datasets.

Main Methods:

• Performed a metadata-only audit of DICOM headers from Imaging Data Commons (IDC) and The Cancer Imaging Archive (TCIA) datasets.
• Analyzed 442 instances across 12 IDC series and 49 instances from one TCIA series.
• Utilized synthetic controls and local Orthanc/DICOMweb/FHIR systems to test data retrieval and UDI pattern detection.

Main Results:

• No standardized UDI-related signal was found in 0/12 IDC series and 0/1 TCIA series at the selected-series level.
• Manufacturer and model information were present in all records, but serial numbers were missing in 246/442 IDC and all TCIA records.
• Unique Device Identifier (UDI) Sequence and contributing-equipment UDI signals were entirely absent in both IDC and TCIA samples.

Conclusions:

• Selected public DICOM archives lack essential UDI metadata required for robust evidence-readiness workflows.
• The absence of UDI signals may stem from de-identification, export, curation, or acquisition-era practices.
• Further standardization and implementation are needed to embed UDI metadata within medical imaging archives for regulatory and clinical utility.