PACIO Personal Functioning and Engagement Implementation Guide, published by HL7 International / Patient Care. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-pacio-pfe/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pacio-pfe/StructureDefinition/pfe-device | Version: 2.0.0 | ||||
| Standards status: Trial-use | Maturity Level: 3 | Computable Name: PFEDevice | |||
The purpose of this profile is to facilitate exchange of information related to a device that will be used to support a patient’s personal functioning and engagement in a post-acute care (PAC) setting (e.g., skilled nursing facility). This profile is based on the US Core Device Profile version 6.1.0.
Example Usage Scenarios:
The following are example usage scenarios for this profile:
This profile was developed by the Personal Functioning and Engagement (PFE) subgroup of the Post-Acute Care InterOperability (PACIO) Project (pacioproject.org). PFE includes experts in: Assessing for and ordering devices (e.g., physical therapists, speech language pathologists), EHR implementation and interoperability (e.g., EHR vendors), HL7 FHIR, and user-centered design. PACIO is sponsored by the US Centers for Medicare and Medicaid Services (CMS) and convened by the MITRE Corporation. Contact the PACIO project at info@pacioproject.org for detailed information about the specific methods used to develop this profile.
The following data elements must always be present or must be supported if the data is present in the sending system (Must Support definition). They are presented below with a simple human-readable explanation. The Formal Profile Definition below provides the formal summary, definitions, and terminology requirements.
Each Personal Functioning and Engagement Device must have:
Each Personal Functioning and Engagement Device must support:
Implementations SHALL follow the US Core Device Profile UDI Specific Implementation Guidance when exchanging Unique Device Identifier (UDI) information.
Usages:
You can also check for usages in the FHIR IG Statistics
Description Differentials, Snapshots, and other representations.
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | USCoreImplantableDeviceProfile(6.1.0) | Item used in healthcare | |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 |
![]() ![]() |
SΣ | 0..1 | BackboneElement | (USCDI) Unique Device Identifier (UDI) Barcode string |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 |
![]() ![]() ![]() |
SΣ | 1..1 | string | (USCDI) Mandatory fixed portion of UDI |
![]() ![]() ![]() |
SΣ | 0..1 | string | (USCDI) UDI Human Readable Barcode String |
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. |
![]() ![]() |
S | 0..1 | string | (USCDI) The distinct identification string |
![]() ![]() |
S | 0..1 | dateTime | (USCDI) Date when the device was made |
![]() ![]() |
S | 0..1 | dateTime | (USCDI) Date and time of expiry of this device (if applicable) |
![]() ![]() |
S | 0..1 | string | (USCDI) Lot number of manufacture |
![]() ![]() |
S | 0..1 | string | (USCDI) Serial number assigned by the manufacturer |
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 |
![]() ![]() ![]() |
1..1 | string | The name of the device | |
![]() ![]() ![]() |
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. | |
![]() ![]() |
S | 1..1 | CodeableConcept | (USCDI) The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices |
![]() ![]() |
S | 1..1 | Reference(US Core Patient Profile(7.0.0)) | (USCDI) Patient to whom Device is affixed |
![]() ![]() |
S | 0..1 | Reference(Organization) | Organization responsible for device |
Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.deviceName.type | Base | required | DeviceNameType | 📍4.0.1 | FHIR Std. |
| Device.type | Base | extensible | FHIR Device Types | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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 | Device.implicitRules, Device.modifierExtension, Device.udiCarrier, Device.udiCarrier.modifierExtension, Device.udiCarrier.deviceIdentifier, Device.udiCarrier.carrierHRF, Device.status, Device.distinctIdentifier, Device.manufactureDate, Device.expirationDate, Device.lotNumber, Device.serialNumber, Device.deviceName, Device.deviceName.modifierExtension, Device.deviceName.name, Device.deviceName.type, Device.type, Device.patient, Device.owner | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | Device.modifierExtension, Device.udiCarrier.modifierExtension, Device.deviceName.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | USCoreImplantableDeviceProfile(6.1.0) | Item used in healthcare | |
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer |
![]() ![]() |
S | 0..1 | Reference(Organization) | Organization responsible for device |
Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
![]() |
0..* | USCoreImplantableDeviceProfile(6.1.0) | Item used in healthcare | |||||
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
![]() ![]() |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 | ||||
![]() ![]() |
0..* | Identifier | Instance identifier | |||||
![]() ![]() |
0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||
![]() ![]() |
SΣ | 0..1 | BackboneElement | (USCDI) Unique Device Identifier (UDI) Barcode string | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
![]() ![]() ![]() |
SΣ | 1..1 | string | (USCDI) Mandatory fixed portion of UDI | ||||
![]() ![]() ![]() |
0..1 | uri | UDI Issuing Organization | |||||
![]() ![]() ![]() |
0..1 | uri | Regional UDI authority | |||||
![]() ![]() ![]() |
Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | ||||
![]() ![]() ![]() |
SΣ | 0..1 | string | (USCDI) UDI Human Readable Barcode String | ||||
![]() ![]() ![]() |
0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ||||
![]() ![]() |
0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||
![]() ![]() |
S | 0..1 | string | (USCDI) The distinct identification string | ||||
![]() ![]() |
0..1 | string | Name of device manufacturer | |||||
![]() ![]() |
S | 0..1 | dateTime | (USCDI) Date when the device was made | ||||
![]() ![]() |
S | 0..1 | dateTime | (USCDI) Date and time of expiry of this device (if applicable) | ||||
![]() ![]() |
S | 0..1 | string | (USCDI) Lot number of manufacture | ||||
![]() ![]() |
S | 0..1 | string | (USCDI) Serial number assigned by the manufacturer | ||||
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
![]() ![]() ![]() |
1..1 | string | The name of the device | |||||
![]() ![]() ![]() |
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. | |||||
![]() ![]() |
0..1 | string | The model number for the device | |||||
![]() ![]() |
0..1 | string | The part number of the device | |||||
![]() ![]() |
S | 1..1 | CodeableConcept | (USCDI) The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices | ||||
![]() ![]() |
0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | |||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
![]() ![]() ![]() |
1..1 | CodeableConcept | The standard that is used to operate and communicate | |||||
![]() ![]() ![]() |
0..1 | string | The version of the standard that is used to operate and communicate | |||||
![]() ![]() |
0..* | BackboneElement | The actual design of the device or software version running on the device | |||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
![]() ![]() ![]() |
0..1 | CodeableConcept | The type of the device version | |||||
![]() ![]() ![]() |
0..1 | Identifier | A single component of the device version | |||||
![]() ![]() ![]() |
1..1 | string | The version text | |||||
![]() ![]() |
0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
![]() ![]() ![]() |
1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||
![]() ![]() ![]() |
0..* | Quantity | Property value as a quantity | |||||
![]() ![]() ![]() |
0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||
![]() ![]() |
S | 1..1 | Reference(US Core Patient Profile(7.0.0)) | (USCDI) Patient to whom Device is affixed | ||||
![]() ![]() |
S | 0..1 | Reference(Organization) | Organization responsible for device | ||||
![]() ![]() |
0..* | ContactPoint | Details for human/organization for support | |||||
![]() ![]() |
0..1 | Reference(Location) | Where the device is found | |||||
![]() ![]() |
0..1 | uri | Network address to contact device | |||||
![]() ![]() |
0..* | Annotation | Device notes and comments | |||||
![]() ![]() |
Σ | 0..* | CodeableConcept | Safety Characteristics of Device | ||||
![]() ![]() |
0..1 | Reference(Device) | The parent device | |||||
Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| Device.udiCarrier.entryType | Base | required | UDIEntryType | 📍4.0.1 | FHIR Std. |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.statusReason | Base | extensible | FHIRDeviceStatusReason | 📍4.0.1 | FHIR Std. |
| Device.deviceName.type | Base | required | DeviceNameType | 📍4.0.1 | FHIR Std. |
| Device.type | Base | extensible | FHIR Device Types | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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 | Device.meta, Device.implicitRules, Device.language, Device.text, Device.extension, Device.modifierExtension, Device.identifier, Device.definition, Device.udiCarrier, Device.udiCarrier.extension, Device.udiCarrier.modifierExtension, Device.udiCarrier.deviceIdentifier, Device.udiCarrier.issuer, Device.udiCarrier.jurisdiction, Device.udiCarrier.carrierAIDC, Device.udiCarrier.carrierHRF, Device.udiCarrier.entryType, Device.status, Device.statusReason, Device.distinctIdentifier, Device.manufacturer, Device.manufactureDate, Device.expirationDate, Device.lotNumber, Device.serialNumber, Device.deviceName, Device.deviceName.extension, Device.deviceName.modifierExtension, Device.deviceName.name, Device.deviceName.type, Device.modelNumber, Device.partNumber, Device.type, Device.specialization, Device.specialization.extension, Device.specialization.modifierExtension, Device.specialization.systemType, Device.specialization.version, Device.version, Device.version.extension, Device.version.modifierExtension, Device.version.type, Device.version.component, Device.version.value, Device.property, Device.property.extension, Device.property.modifierExtension, Device.property.type, Device.property.valueQuantity, Device.property.valueCode, Device.patient, Device.owner, Device.contact, Device.location, Device.url, Device.note, Device.safety, Device.parent | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | Device.extension, Device.modifierExtension, Device.udiCarrier.extension, Device.udiCarrier.modifierExtension, Device.deviceName.extension, Device.deviceName.modifierExtension, Device.specialization.extension, Device.specialization.modifierExtension, Device.version.extension, Device.version.modifierExtension, Device.property.extension, Device.property.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | USCoreImplantableDeviceProfile(6.1.0) | Item used in healthcare | |
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 |
![]() ![]() |
SΣ | 0..1 | BackboneElement | (USCDI) Unique Device Identifier (UDI) Barcode string |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 |
![]() ![]() ![]() |
SΣ | 1..1 | string | (USCDI) Mandatory fixed portion of UDI |
![]() ![]() ![]() |
SΣ | 0..1 | string | (USCDI) UDI Human Readable Barcode String |
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. |
![]() ![]() |
S | 0..1 | string | (USCDI) The distinct identification string |
![]() ![]() |
S | 0..1 | dateTime | (USCDI) Date when the device was made |
![]() ![]() |
S | 0..1 | dateTime | (USCDI) Date and time of expiry of this device (if applicable) |
![]() ![]() |
S | 0..1 | string | (USCDI) Lot number of manufacture |
![]() ![]() |
S | 0..1 | string | (USCDI) Serial number assigned by the manufacturer |
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer |
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 |
![]() ![]() ![]() |
1..1 | string | The name of the device | |
![]() ![]() ![]() |
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. | |
![]() ![]() |
S | 1..1 | CodeableConcept | (USCDI) The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices |
![]() ![]() |
S | 1..1 | Reference(US Core Patient Profile(7.0.0)) | (USCDI) Patient to whom Device is affixed |
![]() ![]() |
S | 0..1 | Reference(Organization) | Organization responsible for device |
Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.deviceName.type | Base | required | DeviceNameType | 📍4.0.1 | FHIR Std. |
| Device.type | Base | extensible | FHIR Device Types | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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 | Device.implicitRules, Device.modifierExtension, Device.udiCarrier, Device.udiCarrier.modifierExtension, Device.udiCarrier.deviceIdentifier, Device.udiCarrier.carrierHRF, Device.status, Device.distinctIdentifier, Device.manufactureDate, Device.expirationDate, Device.lotNumber, Device.serialNumber, Device.deviceName, Device.deviceName.modifierExtension, Device.deviceName.name, Device.deviceName.type, Device.type, Device.patient, Device.owner | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | Device.modifierExtension, Device.udiCarrier.modifierExtension, Device.deviceName.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Differential View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
|---|---|---|---|---|
![]() |
0..* | USCoreImplantableDeviceProfile(6.1.0) | Item used in healthcare | |
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer |
![]() ![]() |
S | 0..1 | Reference(Organization) | Organization responsible for device |
Documentation for this format | ||||
Snapshot ViewView
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
|---|---|---|---|---|---|---|---|---|
![]() |
0..* | USCoreImplantableDeviceProfile(6.1.0) | Item used in healthcare | |||||
![]() ![]() |
Σ | 0..1 | id | Logical id of this artifact | ||||
![]() ![]() |
Σ | 0..1 | Meta | Metadata about the resource | ||||
![]() ![]() |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
![]() ![]() |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
![]() ![]() |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
![]() ![]() |
0..* | Resource | Contained, inline Resources | |||||
![]() ![]() |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
![]() ![]() |
?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 | ||||
![]() ![]() |
0..* | Identifier | Instance identifier | |||||
![]() ![]() |
0..1 | Reference(DeviceDefinition) | The reference to the definition for the device | |||||
![]() ![]() |
SΣ | 0..1 | BackboneElement | (USCDI) Unique Device Identifier (UDI) Barcode string | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
![]() ![]() ![]() |
SΣ | 1..1 | string | (USCDI) Mandatory fixed portion of UDI | ||||
![]() ![]() ![]() |
0..1 | uri | UDI Issuing Organization | |||||
![]() ![]() ![]() |
0..1 | uri | Regional UDI authority | |||||
![]() ![]() ![]() |
Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String | ||||
![]() ![]() ![]() |
SΣ | 0..1 | string | (USCDI) UDI Human Readable Barcode String | ||||
![]() ![]() ![]() |
0..1 | code | barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered. | |||||
![]() ![]() |
?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device. | ||||
![]() ![]() |
0..* | CodeableConcept | online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device. | |||||
![]() ![]() |
S | 0..1 | string | (USCDI) The distinct identification string | ||||
![]() ![]() |
0..1 | string | Name of device manufacturer | |||||
![]() ![]() |
S | 0..1 | dateTime | (USCDI) Date when the device was made | ||||
![]() ![]() |
S | 0..1 | dateTime | (USCDI) Date and time of expiry of this device (if applicable) | ||||
![]() ![]() |
S | 0..1 | string | (USCDI) Lot number of manufacture | ||||
![]() ![]() |
S | 0..1 | string | (USCDI) Serial number assigned by the manufacturer | ||||
![]() ![]() |
S | 0..* | BackboneElement | The name of the device as given by the manufacturer | ||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
![]() ![]() ![]() |
1..1 | string | The name of the device | |||||
![]() ![]() ![]() |
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. | |||||
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0..1 | string | The model number for the device | |||||
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0..1 | string | The part number of the device | |||||
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S | 1..1 | CodeableConcept | (USCDI) The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices | ||||
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0..* | BackboneElement | The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
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1..1 | CodeableConcept | The standard that is used to operate and communicate | |||||
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0..1 | string | The version of the standard that is used to operate and communicate | |||||
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0..* | BackboneElement | The actual design of the device or software version running on the device | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
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0..1 | CodeableConcept | The type of the device version | |||||
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0..1 | Identifier | A single component of the device version | |||||
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1..1 | string | The version text | |||||
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0..* | BackboneElement | The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties | |||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
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1..1 | CodeableConcept | Code that specifies the property DeviceDefinitionPropetyCode (Extensible) | |||||
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0..* | Quantity | Property value as a quantity | |||||
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0..* | CodeableConcept | Property value as a code, e.g., NTP4 (synced to NTP) | |||||
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S | 1..1 | Reference(US Core Patient Profile(7.0.0)) | (USCDI) Patient to whom Device is affixed | ||||
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S | 0..1 | Reference(Organization) | Organization responsible for device | ||||
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0..* | ContactPoint | Details for human/organization for support | |||||
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0..1 | Reference(Location) | Where the device is found | |||||
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0..1 | uri | Network address to contact device | |||||
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0..* | Annotation | Device notes and comments | |||||
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Σ | 0..* | CodeableConcept | Safety Characteristics of Device | ||||
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0..1 | Reference(Device) | The parent device | |||||
Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Device.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| Device.udiCarrier.entryType | Base | required | UDIEntryType | 📍4.0.1 | FHIR Std. |
| Device.status | Base | required | FHIRDeviceStatus | 📍4.0.1 | FHIR Std. |
| Device.statusReason | Base | extensible | FHIRDeviceStatusReason | 📍4.0.1 | FHIR Std. |
| Device.deviceName.type | Base | required | DeviceNameType | 📍4.0.1 | FHIR Std. |
| Device.type | Base | extensible | FHIR Device Types | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| 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 | Device.meta, Device.implicitRules, Device.language, Device.text, Device.extension, Device.modifierExtension, Device.identifier, Device.definition, Device.udiCarrier, Device.udiCarrier.extension, Device.udiCarrier.modifierExtension, Device.udiCarrier.deviceIdentifier, Device.udiCarrier.issuer, Device.udiCarrier.jurisdiction, Device.udiCarrier.carrierAIDC, Device.udiCarrier.carrierHRF, Device.udiCarrier.entryType, Device.status, Device.statusReason, Device.distinctIdentifier, Device.manufacturer, Device.manufactureDate, Device.expirationDate, Device.lotNumber, Device.serialNumber, Device.deviceName, Device.deviceName.extension, Device.deviceName.modifierExtension, Device.deviceName.name, Device.deviceName.type, Device.modelNumber, Device.partNumber, Device.type, Device.specialization, Device.specialization.extension, Device.specialization.modifierExtension, Device.specialization.systemType, Device.specialization.version, Device.version, Device.version.extension, Device.version.modifierExtension, Device.version.type, Device.version.component, Device.version.value, Device.property, Device.property.extension, Device.property.modifierExtension, Device.property.type, Device.property.valueQuantity, Device.property.valueCode, Device.patient, Device.owner, Device.contact, Device.location, Device.url, Device.note, Device.safety, Device.parent | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | Device.extension, Device.modifierExtension, Device.udiCarrier.extension, Device.udiCarrier.modifierExtension, Device.deviceName.extension, Device.deviceName.modifierExtension, Device.specialization.extension, Device.specialization.modifierExtension, Device.version.extension, Device.version.modifierExtension, Device.property.extension, Device.property.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
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