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8.15.7 8.14.9 Resource Device - Mappings

Maturity Level : N/A
Responsible Owner: Orders and Observations icon Work Group Standards Status : Informative Security Category : Business Compartments : No defined compartments Device

Mappings:

FiveWs Pattern Mapping

Interface Pattern

RIM Mapping

UDI Mapping

ISO/IEEE 11073-10201: Domain Information Model

ISO/IEEE 11073-10206: Personal health device communication--Abstract content information model

ISO/IEEE 11073-10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication

Bluetooth Technology

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

8.15.7.1 8.14.9.1 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     additive FiveWs.source FiveWs.what[x]
    contact         type FiveWs.source FiveWs.what[x]
    location         quantity FiveWs.where[x] FiveWs.what[x]
    url     location FiveWs.where[x]

8.15.7.2 8.14.9.2 Interface Pattern ( http://hl7.org/fhir/interface icon )

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

8.15.7.3 8.14.9.3 RIM Mapping ( http://hl7.org/v3 icon )

.playedRole[typeCode=LOCE].scoper .telecom n/a
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     additive     contact .scopedRole[typeCode=CON].player Material
    location         type .code
    url         quantity .playedRole[classCode=CONT].quantity
    endpoint     location .playedRole[typeCode=LOCE].scoper
    note .text
    safety NA

8.15.7.4 8.14.9.4 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.
    displayName     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         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 A distinct identification code required by §1271.290(c), the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3. This may also be known as the donation identification number (DIN) or a value to trace the product's origin.
    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]
        display     additive
        type
    modelNumber         quantity
    contact
    partNumber     location
    note
    category     safety
    parent

8.14.9.5 ISO/IEEE 11073-10201: Domain Information Model ( urn:iso:std:iso:11073:10201 icon )

    type Device
    identifier system = IEEE EUI-64 or a local system
value = VMS::System-Id, MDS::Soft-ID
    definition
    version     udiCarrier
        deviceIdentifier VMS::Production-Specification[spec-type=device-identifier]::prod-spec
        deviceIdentifierSystem
        issuer VMS::Udi::udi-issuer
        jurisdiction VMS::Udi::udi-authority
        carrierAIDC
        carrierHRF VMS::Udi::udi-label
        entryType
    status
    availabilityStatus
    biologicalSourceEvent
    manufacturer VMS::System-Model::manufacturer, VMD::Vmd-Model::manufacturer
    manufactureDate VMS::Production-Specification[spec-type=manufacture-date]::prod-spec
    expirationDate VMS::Production-Specification[spec-type=expiry-date]::prod-spec
    lotNumber VMS::Production-Specification[spec-type=lot-number]::prod-spec
    serialNumber VMS::Production-Specification[spec-type=serial-number]::prod-spec
    name
        value
        type
        display
        component     modelNumber VMS::System-Model::model-number, VMD::Vmd-Model::model-number
    partNumber VMS::Production-Specification[spec-type=part-number]::prod-spec
    category
    type type = VMO::Type, VMS::System-Type
type.text = VMO::Label-String
    deviceVersion
        type VMS::Production-Specification[spec-type=xx-revision]::spec-type (with xx replaced by hw, sw or fw)
        component VMS::Production-Specification[spec-type=xx-revision]::component-id (with xx replaced by hw, sw or fw)
        installDate
        value VMS::Production-Specification[spec-type=xx-revision]::prod-spec (with xx replaced by hw, sw or fw)
    conformsTo
        category
        specification
        version
    property MDS::Clock::time-support attributes
        type
        value[x]
    additive
        type
        quantity
    contact
    location
    note
    safety
    parent

8.14.9.6 ISO/IEEE 11073-10206: Personal health device communication--Abstract content information model ( urn:iso:std:iso:11073:10206 icon )

Device
    identifier system = IEEE EUI-64 or similar
value = SystemInfo.system-identifier
    definition
    udiCarrier
        deviceIdentifier SystemInfo.udi.deviceIdentifier
        deviceIdentifierSystem
        issuer SystemInfo.udi.issuer
        jurisdiction SystemInfo.udi.authority
        carrierAIDC
        carrierHRF SystemInfo.udi.label
        entryType
    status
    availabilityStatus
    biologicalSourceEvent
    manufacturer SystemInfo.system-manufacturer
    manufactureDate
    expirationDate
    lotNumber
    serialNumber SystemInfo.serial-number
    name
        value
        type
    conformsTo         display
    modelNumber SystemInfo.system-model-number
    partNumber
        category     category
    type MDC_MOC_VMS_MDS_SIMP (fixed value for PHD)
    deviceVersion
        specification         type MDC code for a version (MDC_ID_PROD_SPEC_FW, MDC_ID_PROD_SPEC_HW, MDC_ID_PROD_SPEC_SW)
        component
        version         installDate
        value SystemInfo.firmware-, hardware-, software-revision
    conformsTo
        category communication (fixed value)
        specification SystemInfo.System-Type-Spec-List[i].type
        version SystemInfo.System-Type-Spec-List[i].version
    property clock attributes (as ASN1ToHL7 code)
        type
        value[x]
    additive
        type
        quantity
        value[x]     contact
    location
    mode     note
    safety
    cycle     parent

8.14.9.7 ISO/IEEE 11073-10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication ( urn:iso:std:iso:11073:10207 icon )

Device
    duration     identifier system = .../ProductionSpecification/ComponentId/Root
value = .../ProductionSpecification/ComponentId/Extension
    definition
    owner     udiCarrier
        deviceIdentifier MdsDescriptor/MetaData/UDI/DeviceIdentifier
        deviceIdentifierSystem
    contact         issuer MdsDescriptor/MetaData/UDI/Issuer
        jurisdiction MdsDescriptor/MetaData/UDI/Jurisdictions
        carrierAIDC
    location         carrierHRF MdsDescriptor/MetaData/UDI/HumanReadableForm
        entryType
    url     status
    availabilityStatus
    endpoint     biologicalSourceEvent
    manufacturer MdsDescriptor/MetaData/Manufacturer
    manufactureDate MdsDescriptor/MetaData/ManufactureDate
    gateway     expirationDate MdsDescriptor/MetaData/ExpirationDate
    lotNumber MdsDescriptor/MetaData/LotNumber
    serialNumber MdsDescriptor/MetaData/SerialNumber
    note     name
        value
        type
    safety         display
    modelNumber modelNumber = MdsDescriptor/MetaData/ModelNumber
name = MdsDescriptor/MetaData/ModelName
    partNumber MdsDescriptor/MetaData/PartNumber
    category
    type MdsDescriptor/Type, MdsDescriptor/Vmd/Type, MdsDescriptor/Vmd/Channel/Type
    deviceVersion
        type .../ProductionSpecification/SpecType
        component /ProductionSpecification/ComponentId
        installDate
        value .../ProductionSpecification/ProductionSpec
    conformsTo
        category
        specification
        version
    property MdsDescriptor/Clock/TimeProtocol, MdsDescriptor/Clock/Type
        type
        value[x]
    additive
        type
        quantity
    contact
    location
    note
    safety MdsDescriptor/Vmd/Channel/SafetyClassification
    parent

8.14.9.8 Bluetooth Technology ( https://www.bluetooth.com icon )

Device
    identifier system = urn:oid
value = DIS System ID characteristic value (8 octets hexadecimal string)
    definition
    udiCarrier DIS UDI for Medical Devices characteristic value fields - See Bluetooth GATT Specification Supplement (https://www.bluetooth.com/specifications/gss/) for details)
        deviceIdentifier Device Identifier field from DIS UDI for Medical Devices characteristic
        deviceIdentifierSystem
        issuer Issuer field from DIS UDI for Medical Devices characteristic
        jurisdiction Authority field from DIS UDI for Medical Devices characteristic
        carrierAIDC
        carrierHRF Label field from DIS UDI for Medical Devices characteristic
        entryType electronic-transmission
    status
    availabilityStatus
    biologicalSourceEvent
    manufacturer DIS Manufacturer Name String characteristic value
    manufactureDate
    expirationDate
    lotNumber
    serialNumber DIS Serial Number String characteristic value
    name
        value
        type
        display
    modelNumber DIS Model Number String characteristic value
    partNumber
    category
    type text = Appearance Value name or Primary Service name
coding = Appearance Value or Primary Service UUID
    deviceVersion
        type Bluetooth-UUID
        component
        installDate
        value DIS Firmware Revision characteristic value or DIS Hardware Revision characteristic value or DIS Software Revision characteristic value
    conformsTo
        category
        specification
        version
    property
        type
        value[x]
    additive
        type
        quantity
    contact
    location
    note
    safety
    parent