US Core Implementation Guide (Release 1)

This page is part of the US Core (v1.0.0: STU1) based on FHIR R3. The current version which supercedes this version is 5.0.1. For a full list of available versions, see the Directory of published versions

D.4.1.4 StructureDefinition: US Core Device Profile - Mappings

Mappings for the StructureDefinition-us-core-device Profile.

Mappings for Argonaut DQ DSTU2 (http://unknown.org/Argonaut DQ DSTU2)

US Core Device Profile
Device (USCoreDevice)Device
   udiDevice.udi
      carrierHRFDevice.udi
      carrierAIDCNA (not Supoorted)
   typeDevice.type
   patientDevice.patient

Mappings for RIM Mapping (http://hl7.org/v3)

US Core Device Profile
Device (USCoreDevice)Entity. Role, or Act
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   identifier.id
   udi.id and .code
      idn/a
      extensionn/a
      modifierExtensionN/A
      deviceIdentifierRole.id.extension
      name.displayName
      jurisdictionRole.scoper
      carrierHRFRole.id.extension
      carrierAIDCRole.id.extension
      issuerRole.id.root
      entryTypeNA
   status.statusCode
   type.code
   lotNumber.lotNumberText
   manufacturer.playedRole[typeCode=MANU].scoper.name
   manufactureDate.existenceTime.low
   expirationDate.expirationTime
   model.playedRole[typeCode=MANU].code
   version.softwareName (included as part)
   patient.playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]
   owner.playedRole[typeCode=OWN].scoper
   contact.scopedRole[typeCode=CON].player
   location.playedRole[typeCode=LOCE].scoper
   url.telecom
   note.text
   safetyNA

Mappings for W5 Mapping (http://hl7.org/fhir/w5)

US Core Device Profile
Device (USCoreDevice)administrative.device
   identifierid
   udiid
      deviceIdentifierwhat
      namewhat
   statusstatus
   typewhat
   lotNumberwhat
   manufacturerwhat
   manufactureDatewhat
   expirationDatewhat
   modelwhat
   versionwhat
   patientwho.focus
   ownerwho.source
   contactwho.source
   locationwhere
   urlwhere

Mappings for UDI Mapping (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm)

US Core Device Profile
Device (USCoreDevice)
   identifierThe serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
   udi
      deviceIdentifierThe device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
      namePropietary/Trade Name of the medical Device as used in the labeling or catalog
      carrierHRFA unique device identifier (UDI) on a device label in plain text
      carrierAIDCA unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
      issuerAll UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
   typeType description using GMDN or other code system
   lotNumberThe lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
   manufacturerN/A
   manufactureDateThe date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
   expirationDatethe expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.