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8.14.7 8.14.8 Resource Device - Mappings

Orders and Observations Work Group Maturity Level : N/A Standards Status : Informative Security Category : Business Compartments : Not linked to any defined compartments

Mappings:

FiveWs Pattern Mapping

Interface Pattern

RIM Mapping

UDI Mapping

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

8.14.7.1 8.14.8.1 FiveWs Pattern Mapping ( http://hl7.org/fhir/fivews )

Device
    identifier FiveWs.identifier
    udiCarrier FiveWs.identifier
        deviceIdentifier FiveWs.what[x]
    status FiveWs.status
    statusReason FiveWs.status
    distinctIdentifier FiveWs.what[x]
    manufacturer FiveWs.what[x]
    manufactureDate FiveWs.what[x]
    expirationDate FiveWs.what[x]
    lotNumber FiveWs.what[x]
    serialNumber FiveWs.what[x]
        type FiveWs.what[x]
    modelNumber FiveWs.what[x]
    partNumber FiveWs.what[x]
        version FiveWs.what[x]
        component FiveWs.what[x]
    patient FiveWs.subject[x]
    owner FiveWs.source
    contact FiveWs.source
    location FiveWs.where[x]
    url FiveWs.where[x]

8.14.8.2 Interface Pattern ( http://hl7.org/fhir/interface )

Device Participant
    identifier Participant.identifier
    status Participant.active
    deviceName Participant.name

8.14.7.2 8.14.8.3 RIM Mapping ( http://hl7.org/v3 )

Device Device
    identifier .id
    udiCarrier .id and .code
        deviceIdentifier Role.id.extension
        issuer Role.id.root
        jurisdiction Role.scoper
        carrierAIDC Role.id.extension
        carrierHRF Role.id.extension
        entryType NA
    status .statusCode
    distinctIdentifier .lotNumberText
    manufacturer .playedRole[typeCode=MANU].scoper.name
    manufactureDate .existenceTime.low
    expirationDate .expirationTime
    lotNumber .lotNumberText
    serialNumber .playedRole[typeCode=MANU].id
        type .playedRole[typeCode=MANU].code
    modelNumber .softwareName (included as part)
    partNumber .playedRole[typeCode=MANU].id
    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
    safety NA

8.14.7.3 8.14.8.4 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
    identifier The 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.
    definition
    udiCarrier
        deviceIdentifier The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
        issuer All 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
        jurisdiction
        carrierAIDC A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
        carrierHRF A unique device identifier (UDI) on a device label in plain text
        entryType
    status
    statusReason
    distinctIdentifier The 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.
    manufacturer N/A
    manufactureDate The 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”.
    expirationDate the 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”.
    lotNumber The 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.
    serialNumber
    deviceName
        name
        type
    modelNumber
    partNumber
    type
    specialization
        systemType
        version
    version
        type
        component
        value
    property
        type
        valueQuantity
        valueCode
    patient
    owner
    contact
    location
    url
    note
    safety
    parent