R6 Ballot (2nd Draft)

Publish-box (todo)

Orders and Observations icon Work GroupMaturity Level: N/AStandards Status: InformativeSecurity Category: Business Compartments: No defined compartments

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

Device administrative.device
    identifier FiveWs.identifier
    udiCarrier FiveWs.identifier
        deviceIdentifier FiveWs.what[x]
    status FiveWs.status
    availabilityStatus FiveWs.status
    biologicalSourceEvent 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]
        display FiveWs.status
    modelNumber FiveWs.what[x]
    partNumber FiveWs.what[x]
        component FiveWs.what[x]
        installDate FiveWs.what[x]
    owner FiveWs.source
    contact FiveWs.source
    location FiveWs.where[x]
    url FiveWs.where[x]
Device Participant
    identifier Participant.identifier
    status Participant.active
    name Participant.name
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
    manufacturer .playedRole[typeCode=MANU].scoper.name
    manufactureDate .existenceTime.low
    expirationDate .expirationTime
    lotNumber .lotNumberText
    serialNumber .playedRole[typeCode=MANU].id
        type .playedRole[typeCode=MANU].code
        display statusCode
    modelNumber .softwareName (included as part)
    partNumber .playedRole[typeCode=MANU].id
    owner .playedRole[typeCode=OWN].scoper
    contact .scopedRole[typeCode=CON].player
    location .playedRole[typeCode=LOCE].scoper
    url .telecom
    endpoint n/a
    note .text
    safety NA

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.
        deviceIdentifierSystem
        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
    availabilityStatus
    biologicalSourceEvent
    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
    name
        value
        type
        display
    modelNumber
    partNumber
    category
    type
    deviceVersion
        type
        component
        installDate
        value
    conformsTo
        category
        specification
        version
    property
        type
        value[x]
    mode
    cycle
    duration
    owner
    contact
    location
    url
    endpoint
    gateway
    note
    safety
    parent