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  1. FHIR Specification Feedback
  2. FHIR-30669

This is conditional on other changes recommended to make the UDI requirements clear.

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    • Change Request
    • Status: Published (View Workflow)
    • Highest
    • Resolution: Persuasive
    • US Core (FHIR)
    • 3.1.1
    • Cross-Group Projects
    • US Core Implantable Device Profile
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      add suggested text to:

      Implantable medical devices that have UDI information SHALL represent this information in either carrierAIDC or carrierHRF.

      • UDI may not be present in all scenarios such as historical implantable devices, patient reported implant information, payer reported devices, or improperly documented implants. If UDI is not present and the manufacturer and model information is available, it SHOULD be included to support historical reports of implantable medical devices.
      • Although both are marked must support, servers are not required to support both udi_HRF and udi_AIDC but they SHALL support at least one of these elements
      Show
      add suggested text to: Implantable medical devices that have UDI information  SHALL  represent this information in either  carrierAIDC  or  carrierHRF . UDI may not be present in all scenarios such as historical implantable devices, patient reported implant information, payer reported devices, or improperly documented implants. If UDI is not present and the manufacturer and model information is available, it  SHOULD  be included to support historical reports of implantable medical devices . Although both are marked must support, servers are not required to support both udi_HRF and udi_AIDC but they SHALL support at least one of these elements
    • Marti Velezis/Gay Dolin:4-0-0
    • Enhancement
    • Non-substantive

    Description

      To support historical reports of implantable medical devices – manufacturer and model should be included in the US Core if that information is available.  Currently only the "type" is required – and may be augmented by manufacturer and model.

      (Comment 43 - imported by: Jean Duteau)

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              mrocca Mitra Rocca
              Mitra Rocca
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                Updated:
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