R4 Ballot #1 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2

8.14.7 Resource Device - Mappings

Orders and Observations Work GroupMaturity Level: N/ABallot Status: Informative Compartments: Device

Mappings:

FiveWs Pattern

RIM Mapping

UDI Mapping

Mappings for the device resource (see Mappings to Other Standards for further information & status).

8.14.7.1 Mappings for FiveWs Pattern (http://hl7.org/fhir/fivews)

Device
    identifierFiveWs.identifier
    udiFiveWs.identifier
        deviceIdentifierFiveWs.what[x]
        nameFiveWs.what[x]
    statusFiveWs.status
    typeFiveWs.what[x]
    lotNumberFiveWs.what[x]
    manufacturerFiveWs.what[x]
    manufactureDateFiveWs.what[x]
    expirationDateFiveWs.what[x]
    modelFiveWs.what[x]
    versionFiveWs.what[x]
    patientFiveWs.subject[x]
    ownerFiveWs.source
    contactFiveWs.source
    locationFiveWs.where[x]
    urlFiveWs.where[x]

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

DeviceDevice
    identifier.id
    udi.id and .code
        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

8.14.7.3 Mappings for UDI Mapping (http://fda.gov/UDI)

UDI is a unique numeric or alphanumeric code that consists of two parts: (1) a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and (2) a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device: (2a) the lot or batch number within which a device was manufactured; (2b) the serial number of a specific device; (2c) the expiration date of a specific device; (2d) the date a specific device was manufactured; (2e) the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

Device
    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
        jurisdiction
        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
        entryType
    status
    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”.
    model
    version
    patient
    owner
    contact
    location
    url
    note
    safety