Canadian Baseline
1.1.0 - CI Build
Canadian Baseline
1.1.0 - CI Build
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
| 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.
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.
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:
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:
The following are example usage scenarios for the implantable Device profile:
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Device
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  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 |
| 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 |
| 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 | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Device.type | extensible | FHIRDeviceTypeshttp://hl7.org/fhir/ValueSet/device-kindfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| ca-device-1 | warning | Device | Implantable 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-2 | warning | Device | For 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()) |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Device |
C | 0..* | Device | Device Profile dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management 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 ele-1: All FHIR elements must have a @value or children |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
 udiCarrier |
SΣ | 1..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| deviceIdentifier |
SΣ | 1..1 | string | Mandatory fixed portion of UDI ele-1: All FHIR elements must have a @value or children |
| carrierAIDC |
SΣ | 0..1 | base64Binary | UDI Machine Readable Barcode String ele-1: All FHIR elements must have a @value or children |
| carrierHRF |
SΣ | 0..1 | string | UDI Human Readable Barcode String ele-1: All FHIR elements must have a @value or children |
| status |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. ele-1: All FHIR elements must have a @value or children |
| distinctIdentifier |
S | 0..1 | string | The distinct identification string ele-1: All FHIR elements must have a @value or children |
| manufacturer |
S | 0..1 | string | Name of device manufacturer ele-1: All FHIR elements must have a @value or children |
| expirationDate |
S | 0..1 | dateTime | Date and time of expiry of this device (if applicable) ele-1: All FHIR elements must have a @value or children |
| lotNumber |
S | 0..1 | string | Lot number of manufacture ele-1: All FHIR elements must have a @value or children |
| serialNumber |
S | 0..1 | string | Serial number assigned by the manufacturer ele-1: All FHIR elements must have a @value or children |
| deviceName |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| name |
1..1 | string | The name of the device ele-1: All FHIR elements must have a @value or children | |
| 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. ele-1: All FHIR elements must have a @value or children | |
| type |
S | 1..1 | CodeableConcept | The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices ele-1: All FHIR elements must have a @value or children |
| version |
S | 0..* | BackboneElement | The actual design of the device or software version running on the device ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| value |
1..1 | string | The version text ele-1: All FHIR elements must have a @value or children | |
| patient |
1..1 | Reference(Patient Profile) | Patient to whom Device is affixed ele-1: All FHIR elements must have a @value or children | |
| parent |
0..1 | Reference(Device Profile (Implantable)) | The parent device ele-1: All FHIR elements must have a @value or children | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | |
| Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1from the FHIR Standard | |
| Device.type | extensible | FHIRDeviceTypeshttp://hl7.org/fhir/ValueSet/device-kindfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| ca-device-1 | warning | Device | Implantable 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-2 | warning | Device | For 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-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Device | If 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-4 | error | Device | If 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-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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.
| |||||
| 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 | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI | |||
| Device.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard
| ||||
| Device.udiCarrier.entryType | required | UDIEntryTypehttp://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1from the FHIR Standard | ||||
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | ||||
| Device.statusReason | extensible | FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reasonfrom the FHIR Standard | ||||
| Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1from the FHIR Standard | ||||
| Device.type | extensible | FHIRDeviceTypeshttp://hl7.org/fhir/ValueSet/device-kindfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| ca-device-1 | warning | Device | Implantable 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-2 | warning | Device | For 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-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Device | If 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-4 | error | Device | If 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-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must 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
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Device.type | extensible | FHIRDeviceTypeshttp://hl7.org/fhir/ValueSet/device-kindfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| ca-device-1 | warning | Device | Implantable 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-2 | warning | Device | For 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
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Device |
C | 0..* | Device | Device Profile dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated dom-5: If a resource is contained in another resource, it SHALL NOT have a security label dom-6: A resource should have narrative for robust management 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 ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| udiCarrier |
SΣ | 1..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| deviceIdentifier |
SΣ | 1..1 | string | Mandatory fixed portion of UDI ele-1: All FHIR elements must have a @value or children |
| carrierAIDC |
SΣ | 0..1 | base64Binary | UDI Machine Readable Barcode String ele-1: All FHIR elements must have a @value or children |
| carrierHRF |
SΣ | 0..1 | string | UDI Human Readable Barcode String ele-1: All FHIR elements must have a @value or children |
| status |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. ele-1: All FHIR elements must have a @value or children |
| distinctIdentifier |
S | 0..1 | string | The distinct identification string ele-1: All FHIR elements must have a @value or children |
| manufacturer |
S | 0..1 | string | Name of device manufacturer ele-1: All FHIR elements must have a @value or children |
| expirationDate |
S | 0..1 | dateTime | Date and time of expiry of this device (if applicable) ele-1: All FHIR elements must have a @value or children |
| lotNumber |
S | 0..1 | string | Lot number of manufacture ele-1: All FHIR elements must have a @value or children |
| serialNumber |
S | 0..1 | string | Serial number assigned by the manufacturer ele-1: All FHIR elements must have a @value or children |
| deviceName |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| name |
1..1 | string | The name of the device ele-1: All FHIR elements must have a @value or children | |
| 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. ele-1: All FHIR elements must have a @value or children | |
| type |
S | 1..1 | CodeableConcept | The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices ele-1: All FHIR elements must have a @value or children |
| version |
S | 0..* | BackboneElement | The actual design of the device or software version running on the device ele-1: All FHIR elements must have a @value or children |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both |
| value |
1..1 | string | The version text ele-1: All FHIR elements must have a @value or children | |
| patient |
1..1 | Reference(Patient Profile) | Patient to whom Device is affixed ele-1: All FHIR elements must have a @value or children | |
| parent |
0..1 | Reference(Device Profile (Implantable)) | The parent device ele-1: All FHIR elements must have a @value or children | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | |
| Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1from the FHIR Standard | |
| Device.type | extensible | FHIRDeviceTypeshttp://hl7.org/fhir/ValueSet/device-kindfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| ca-device-1 | warning | Device | Implantable 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-2 | warning | Device | For 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-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Device | If 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-4 | error | Device | If 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-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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.
| |||||
| 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 | |||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet | URI | |||
| Device.language | preferred | CommonLanguageshttp://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard
| ||||
| Device.udiCarrier.entryType | required | UDIEntryTypehttp://hl7.org/fhir/ValueSet/udi-entry-type|4.0.1from the FHIR Standard | ||||
| Device.status | required | FHIRDeviceStatushttp://hl7.org/fhir/ValueSet/device-status|4.0.1from the FHIR Standard | ||||
| Device.statusReason | extensible | FHIRDeviceStatusReasonhttp://hl7.org/fhir/ValueSet/device-status-reasonfrom the FHIR Standard | ||||
| Device.deviceName.type | required | DeviceNameTypehttp://hl7.org/fhir/ValueSet/device-nametype|4.0.1from the FHIR Standard | ||||
| Device.type | extensible | FHIRDeviceTypeshttp://hl7.org/fhir/ValueSet/device-kindfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| ca-device-1 | warning | Device | Implantable 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-2 | warning | Device | For 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-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | Device | If 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-4 | error | Device | If 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-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | Device | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from Device
Other representations of profile: CSV, Excel, Schematron