International Patient Summary Implementation Guide
1.1.0 - STU 1 Update 1 International flag

This page is part of the International Patient Summary Implementation Guide (v1.1.0: STU 1) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: Device (IPS)

Official URL: http://hl7.org/fhir/uv/ips/StructureDefinition/Device-uv-ips Version: 1.1.0
Standards status: Trial-use Maturity Level: 2 Computable Name: DeviceUvIps

This profile represents the constraints applied to the Device resource by the International Patient Summary (IPS) FHIR Implementation Guide, based on FHIR R4. A device used by or implanted on the patient is described in the patient summary as an instance of a Device resource constrained by this profile.

This profile constrains the representation of a medical device used by or impanted on the patient, in the context of the international patient summary as specified by the IPS project of HL7 International.

Usage:

  • Refer to this Resource Profile:

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 0..*DeviceItem used in healthcare
... type S0..1CodeableConceptIPSType of device. Preferably valued by using SNOMED CT. The absence of information, or of devices relevant for purpose of this IPS, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set.
Binding: Medical Devices - SNOMED CT + Absent/Unknown - IPS (preferred): The type of device or a code for absent/unknown device

Additional BindingsPurpose
Medical Devices - SNOMED CT IPS Free SetCandidate Validation Binding
Absent or Unknown Devices - IPSCandidate Validation Binding
... patient S1..1Reference(Patient (IPS))Patient to whom Device is affixed
.... reference S1..1stringLiteral reference, Relative, internal or absolute URL

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Device.typepreferredMedicalDevicesSnomedAbsentUnknownUvIps
Additional Bindings Purpose Documentation
Medical Devices - SNOMED CT IPS Free Set Candidate Validation Binding

Codes for medical devices in SNOMED IPS Free Set
Absent or Unknown Devices - IPS Candidate Validation Binding

Codes for absent or unknown medical devices
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceItem used in healthcare
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... patient S1..1Reference(Patient (IPS))Patient to whom Device is affixed
.... reference SΣC1..1stringLiteral reference, Relative, internal or absolute URL

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Device.statusrequiredFHIRDeviceStatus
Device.typepreferredMedicalDevicesSnomedAbsentUnknownUvIps
Additional Bindings Purpose Documentation
Medical Devices - SNOMED CT IPS Free Set Candidate Validation Binding

Codes for medical devices in SNOMED IPS Free Set
Absent or Unknown Devices - IPS Candidate Validation Binding

Codes for absent or unknown medical devices

Constraints

IdGradePath(s)DetailsRequirements
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 0..*DeviceItem used in healthcare
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierInstance identifier
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier Σ0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... entryType 0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

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


... distinctIdentifier 0..1stringThe distinct identification string
... manufacturer 0..1stringName of device manufacturer
... manufactureDate 0..1dateTimeDate when the device was made
... expirationDate 0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber 0..1stringLot number of manufacture
... serialNumber 0..1stringSerial number assigned by the manufacturer
... deviceName 0..*BackboneElementThe name of the device as given by the manufacturer
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringThe name of the device
.... type 1..1codeudi-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..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type S0..1CodeableConceptIPSType of device. Preferably valued by using SNOMED CT. The absence of information, or of devices relevant for purpose of this IPS, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set.
Binding: Medical Devices - SNOMED CT + Absent/Unknown - IPS (preferred): The type of device or a code for absent/unknown device

Additional BindingsPurpose
Medical Devices - SNOMED CT IPS Free SetCandidate Validation Binding
Absent or Unknown Devices - IPSCandidate Validation Binding
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... systemType 1..1CodeableConceptThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*BackboneElementThe actual design of the device or software version running on the device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 0..1CodeableConceptThe type of the device version
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... patient S1..1Reference(Patient (IPS))Patient to whom Device is affixed
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference SΣC1..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
.... display Σ0..1stringText alternative for the resource
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... location 0..1Reference(Location)Where the device is found
... url 0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
... safety Σ0..*CodeableConceptSafety Characteristics of Device
... parent 0..1Reference(Device)The parent device

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Device.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Device.udiCarrier.entryTyperequiredUDIEntryType
Device.statusrequiredFHIRDeviceStatus
Device.statusReasonextensibleFHIRDeviceStatusReason
Device.deviceName.typerequiredDeviceNameType
Device.typepreferredMedicalDevicesSnomedAbsentUnknownUvIps
Additional Bindings Purpose Documentation
Medical Devices - SNOMED CT IPS Free Set Candidate Validation Binding

Codes for medical devices in SNOMED IPS Free Set
Absent or Unknown Devices - IPS Candidate Validation Binding

Codes for absent or unknown medical devices
Device.patient.typeextensibleResourceType

Constraints

IdGradePath(s)DetailsRequirements
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 0..*DeviceItem used in healthcare
... type S0..1CodeableConceptIPSType of device. Preferably valued by using SNOMED CT. The absence of information, or of devices relevant for purpose of this IPS, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set.
Binding: Medical Devices - SNOMED CT + Absent/Unknown - IPS (preferred): The type of device or a code for absent/unknown device

Additional BindingsPurpose
Medical Devices - SNOMED CT IPS Free SetCandidate Validation Binding
Absent or Unknown Devices - IPSCandidate Validation Binding
... patient S1..1Reference(Patient (IPS))Patient to whom Device is affixed
.... reference S1..1stringLiteral reference, Relative, internal or absolute URL

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Device.typepreferredMedicalDevicesSnomedAbsentUnknownUvIps
Additional Bindings Purpose Documentation
Medical Devices - SNOMED CT IPS Free Set Candidate Validation Binding

Codes for medical devices in SNOMED IPS Free Set
Absent or Unknown Devices - IPS Candidate Validation Binding

Codes for absent or unknown medical devices

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceItem used in healthcare
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... patient S1..1Reference(Patient (IPS))Patient to whom Device is affixed
.... reference SΣC1..1stringLiteral reference, Relative, internal or absolute URL

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Device.statusrequiredFHIRDeviceStatus
Device.typepreferredMedicalDevicesSnomedAbsentUnknownUvIps
Additional Bindings Purpose Documentation
Medical Devices - SNOMED CT IPS Free Set Candidate Validation Binding

Codes for medical devices in SNOMED IPS Free Set
Absent or Unknown Devices - IPS Candidate Validation Binding

Codes for absent or unknown medical devices

Constraints

IdGradePath(s)DetailsRequirements
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 0..*DeviceItem used in healthcare
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier 0..*IdentifierInstance identifier
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier Σ0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifier Σ0..1stringMandatory fixed portion of UDI
.... issuer 0..1uriUDI Issuing Organization
.... jurisdiction 0..1uriRegional UDI authority
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
.... entryType 0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

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


... distinctIdentifier 0..1stringThe distinct identification string
... manufacturer 0..1stringName of device manufacturer
... manufactureDate 0..1dateTimeDate when the device was made
... expirationDate 0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber 0..1stringLot number of manufacture
... serialNumber 0..1stringSerial number assigned by the manufacturer
... deviceName 0..*BackboneElementThe name of the device as given by the manufacturer
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... name 1..1stringThe name of the device
.... type 1..1codeudi-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..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type S0..1CodeableConceptIPSType of device. Preferably valued by using SNOMED CT. The absence of information, or of devices relevant for purpose of this IPS, shall be explicitly stated by using the codes included in the absent-or-unknown-devices-uv-ips value set.
Binding: Medical Devices - SNOMED CT + Absent/Unknown - IPS (preferred): The type of device or a code for absent/unknown device

Additional BindingsPurpose
Medical Devices - SNOMED CT IPS Free SetCandidate Validation Binding
Absent or Unknown Devices - IPSCandidate Validation Binding
... specialization 0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... systemType 1..1CodeableConceptThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*BackboneElementThe actual design of the device or software version running on the device
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 0..1CodeableConceptThe type of the device version
.... component 0..1IdentifierA single component of the device version
.... value 1..1stringThe version text
... property 0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... patient S1..1Reference(Patient (IPS))Patient to whom Device is affixed
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... reference SΣC1..1stringLiteral reference, Relative, internal or absolute URL
.... type Σ0..1uriType the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

.... identifier Σ0..1IdentifierLogical reference, when literal reference is not known
.... display Σ0..1stringText alternative for the resource
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... location 0..1Reference(Location)Where the device is found
... url 0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
... safety Σ0..*CodeableConceptSafety Characteristics of Device
... parent 0..1Reference(Device)The parent device

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Device.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Device.udiCarrier.entryTyperequiredUDIEntryType
Device.statusrequiredFHIRDeviceStatus
Device.statusReasonextensibleFHIRDeviceStatusReason
Device.deviceName.typerequiredDeviceNameType
Device.typepreferredMedicalDevicesSnomedAbsentUnknownUvIps
Additional Bindings Purpose Documentation
Medical Devices - SNOMED CT IPS Free Set Candidate Validation Binding

Codes for medical devices in SNOMED IPS Free Set
Absent or Unknown Devices - IPS Candidate Validation Binding

Codes for absent or unknown medical devices
Device.patient.typeextensibleResourceType

Constraints

IdGradePath(s)DetailsRequirements
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

Summary

Mandatory: 2 elements
Must-Support: 3 elements

Structures

This structure refers to these other structures:

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron