Canadian Baseline
1.1.0 - CI Build Canada flag

Canadian Baseline, published by HL7 Canada - FHIR Implementation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7-Canada/ca-baseline/ and changes regularly. See the Directory of published versions

Resource Profile: Device Profile (Implantable)

Official URL: http://hl7.org/fhir/ca/baseline/StructureDefinition/profile-device Version: 1.1.0
Draft as of 2024-11-15 Computable Name: DeviceProfile

Proposed constraints on the Device resource for the minimal set of data to query and retrieve a patient's implantable device.

CA Baseline Device (Implantable) Profile

This profile is seeking broader community and implementer feedback on this profile.

The clinical substream review of this profile is paused until a Subject Matter Expert can be found who can speak to the use of implantable device data in Canada. Due to a lack of current Canadian FHIR implementation guides that surface a device profile - this profile has not undergone a Due Diligence Review and should be treated with caution until more community feedback can be acquired. Simplifier issue log for this profile.

This profile sets minimum expectations for the Device resource to record, search, and fetch UDI information associated with a patient's implantable device(s). It identifies which core elements SHALL be present in the resource when using this profile.

This profile defines core localization concepts for use in the Canadian context.

Mandatory Data Elements

All elements or attributes within the FHIR specification have cardinality as part of their definition - a minimum number of required appearances and a maximum number of allowable appearances.

Most elements in the FHIR specification have a minimum cardinality of 0, so most elements are not required and subsequently they may be missing from a resource when it is exchanged between systems.

Required elements in the Device (Implantable) profile:

  • A Unique Device Identifier (UDI) numeric or alphanumeric code (Device.deviceIdentifier):
    • either as the Human Readable Form (HRF) string representation of the barcode (Device.carrierHRF)
    • or the Automatic Identification and Data Capture representation (Device.carrierAIDC)
  • The type of the device (Device.type)
  • A patient (Device.patient)

Must Support Data Elements

Some elements are marked as Must Support. This means that implementations generating, receiving, or otherwise using resources with Must Support elements SHALL provide support for those elements in some meaningful way (see Must Support definition).

The following elements are marked as Must Support in the Device (Implantable) profile:

Must Support elements:

  • Unique Device Identifier (UDI) Barcode string
  • distinct identification string
  • device manufacturer
  • expiration date/time of the device
  • lot number of manufacture
  • serial number assigned by the manufacturer
  • name of the device
  • type of the device
  • version of the device
  • patient

Usage Note

The following are example usage scenarios for the implantable Device profile:

  • Query for a patient's implantable devices
  • Record or update a patient implantable device information

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device C 0..* Device Device Profile
ca-device-1: Implantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
ca-device-2: For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
... udiCarrier S 1..1 BackboneElement Unique Device Identifier (UDI) Barcode string
.... deviceIdentifier S 1..1 string Mandatory fixed portion of UDI
.... carrierAIDC S 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF S 0..1 string UDI Human Readable Barcode String
... distinctIdentifier S 0..1 string The distinct identification string
... manufacturer S 0..1 string Name of device manufacturer
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices

... version S 0..* BackboneElement The actual design of the device or software version running on the device
... patient 1..1 Reference(Patient Profile) Patient to whom Device is affixed
... parent 0..1 Reference(Device Profile (Implantable)) The parent device

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ca-device-1warningDeviceImplantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
: udiCarrier.empty() or (udiCarrier.carrierAIDC.exists() or udiCarrier.carrierHRF.exists())
ca-device-2warningDeviceFor implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
: udiCarrier.empty() or (manufactureDate.exists() or expirationDate.exists() or lotNumber.exists() or serialNumber.exists() or distinctIdentifier.exists())
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device C 0..* Device Device Profile
ca-device-1: Implantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
ca-device-2: For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... udiCarrier SΣ 1..1 BackboneElement Unique Device Identifier (UDI) Barcode string
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 1..1 string Mandatory fixed portion of UDI
.... carrierAIDC SΣ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
... distinctIdentifier S 0..1 string The distinct identification string
... manufacturer S 0..1 string Name of device manufacturer
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.

... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices

... version S 0..* BackboneElement The actual design of the device or software version running on the device
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... value 1..1 string The version text
... patient 1..1 Reference(Patient Profile) Patient to whom Device is affixed
... parent 0..1 Reference(Device Profile (Implantable)) The parent device

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ca-device-1warningDeviceImplantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
: udiCarrier.empty() or (udiCarrier.carrierAIDC.exists() or udiCarrier.carrierHRF.exists())
ca-device-2warningDeviceFor implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
: udiCarrier.empty() or (manufactureDate.exists() or expirationDate.exists() or lotNumber.exists() or serialNumber.exists() or distinctIdentifier.exists())
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device C 0..* Device Device Profile
ca-device-1: Implantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
ca-device-2: For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Instance identifier
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier SΣ 1..1 BackboneElement Unique Device Identifier (UDI) Barcode string
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 1..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC SΣ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.


... distinctIdentifier S 0..1 string The distinct identification string
... manufacturer S 0..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.

... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices

... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version S 0..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient 1..1 Reference(Patient Profile) Patient to whom Device is affixed
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device Profile (Implantable)) The parent device

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Device.udiCarrier.entryTyperequiredUDIEntryType
http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.statusReasonextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ca-device-1warningDeviceImplantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
: udiCarrier.empty() or (udiCarrier.carrierAIDC.exists() or udiCarrier.carrierHRF.exists())
ca-device-2warningDeviceFor implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
: udiCarrier.empty() or (manufactureDate.exists() or expirationDate.exists() or lotNumber.exists() or serialNumber.exists() or distinctIdentifier.exists())
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Device

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device C 0..* Device Device Profile
ca-device-1: Implantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
ca-device-2: For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
... udiCarrier S 1..1 BackboneElement Unique Device Identifier (UDI) Barcode string
.... deviceIdentifier S 1..1 string Mandatory fixed portion of UDI
.... carrierAIDC S 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF S 0..1 string UDI Human Readable Barcode String
... distinctIdentifier S 0..1 string The distinct identification string
... manufacturer S 0..1 string Name of device manufacturer
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices

... version S 0..* BackboneElement The actual design of the device or software version running on the device
... patient 1..1 Reference(Patient Profile) Patient to whom Device is affixed
... parent 0..1 Reference(Device Profile (Implantable)) The parent device

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ca-device-1warningDeviceImplantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
: udiCarrier.empty() or (udiCarrier.carrierAIDC.exists() or udiCarrier.carrierHRF.exists())
ca-device-2warningDeviceFor implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
: udiCarrier.empty() or (manufactureDate.exists() or expirationDate.exists() or lotNumber.exists() or serialNumber.exists() or distinctIdentifier.exists())

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device C 0..* Device Device Profile
ca-device-1: Implantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
ca-device-2: For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... udiCarrier SΣ 1..1 BackboneElement Unique Device Identifier (UDI) Barcode string
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 1..1 string Mandatory fixed portion of UDI
.... carrierAIDC SΣ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
... distinctIdentifier S 0..1 string The distinct identification string
... manufacturer S 0..1 string Name of device manufacturer
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.

... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices

... version S 0..* BackboneElement The actual design of the device or software version running on the device
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... value 1..1 string The version text
... patient 1..1 Reference(Patient Profile) Patient to whom Device is affixed
... parent 0..1 Reference(Device Profile (Implantable)) The parent device

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ca-device-1warningDeviceImplantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
: udiCarrier.empty() or (udiCarrier.carrierAIDC.exists() or udiCarrier.carrierHRF.exists())
ca-device-2warningDeviceFor implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
: udiCarrier.empty() or (manufactureDate.exists() or expirationDate.exists() or lotNumber.exists() or serialNumber.exists() or distinctIdentifier.exists())
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device C 0..* Device Device Profile
ca-device-1: Implantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
ca-device-2: For implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Instance identifier
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier SΣ 1..1 BackboneElement Unique Device Identifier (UDI) Barcode string
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... deviceIdentifier SΣ 1..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC SΣ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.


... distinctIdentifier S 0..1 string The distinct identification string
... manufacturer S 0..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... deviceName S 0..* BackboneElement The name of the device as given by the manufacturer
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.

... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices

... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version S 0..* BackboneElement The actual design of the device or software version running on the device
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient 1..1 Reference(Patient Profile) Patient to whom Device is affixed
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device Profile (Implantable)) The parent device

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Device.udiCarrier.entryTyperequiredUDIEntryType
http://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1
from the FHIR Standard
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status|4.0.1
from the FHIR Standard
Device.statusReasonextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
from the FHIR Standard
Device.deviceName.typerequiredDeviceNameType
http://hl7.org/fhir/ValueSet/device-nametype|4.0.1
from the FHIR Standard
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
ca-device-1warningDeviceImplantable medical devices that have UDI information MAY represent this information in either carrierAIDC or carrierHRF.
: udiCarrier.empty() or (udiCarrier.carrierAIDC.exists() or udiCarrier.carrierHRF.exists())
ca-device-2warningDeviceFor implantable medical devices that have UDI information, at least one of the Production Identifiers (UDI-PI) MAY be present.
: udiCarrier.empty() or (manufactureDate.exists() or expirationDate.exists() or lotNumber.exists() or serialNumber.exists() or distinctIdentifier.exists())
dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceDeviceA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Device

 

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