R6 Ballot (2nd Draft)

This page is part of the FHIR Specification v6.0.0-ballot2: Release 6 Ballot (2nd Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

8.15.7 Resource Device - Mappings

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

8.15.7.1 FiveWs Pattern Mapping (http://hl7.org/fhir/fivews icon)

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]

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

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

8.15.7.3 RIM Mapping (http://hl7.org/v3 icon)

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

8.15.7.4 UDI Mapping (http://fda.gov/UDI icon)

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