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CHANGE: Used to only apply to implantable medical devices, now broadened to apply to ALL devices used in medical care
Specific ask: Feedback on whether Unique Device Identifier (UDI) should be one or two data elements (Unique Device Identifier—Implantable and Unique Device Identifier—Non-implantable). Is there an impact on standards development or information exchange to use one data element, Unique Device Identifier, to include both implantable and non-implantable devices?
Notes:
previoulsy rejected additional data element for test kit and instrument identifiers can now be covered by this
CHANGE: identifies LOINC as the standard to use - version 2.78
Notes:
Performance Time (under Procedure):
CHANGE: Definition is now
Notes:
CHANGE: Definition is now: Unit of measurement to report quantitative laboratory test results
Notes:
Was called out as having updated definition, but definition remained unchanged, but UCUM updated from 2.1 to 2.2
Updated versions of referenced code systems for these elements in the Laboratory Class:
Laboratory Class - Tests → LOINC version 2.78
Laboratory Class - Values/Results → SNOMED US Edition September 2024
Laboratory Class - Specimen Type → SNOMED US Edition September 2024
Laboratory Class - Specimen source site → SNOMED US Edition September 2024
Laboratory Class - Result Unit of Measure → UCUM 2.2
Laboratory Class - Reference Range → UCUM 2.2
Laboratory Class - Specimen Condition Acceptability → SNOMED US Edition September 2024
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