This page is part of the Point-of-care Device FHIR IG (v0.2.0: STU 1 Ballot 2) based on FHIR v3.5.0. . For a full list of available versions, see the Directory of published versions

This is a pre-release version (Ballot 2) of Point of Care Devices (PoCD) R1/STU. There is no current official version.
For a full list of available versions, see the Directory of published versions .

D.4.1 StructureDefinition: MdsDevice

D.4.1.1 Formal Views of Profile Content

The official URL for this profile is: 

http://hl7.org/fhir/uv/pocd/StructureDefinition/MdsDevice

StructureDefinition for Device resources that represent a Medical Device System (MDS). This is the top-level resource in the hierarchical model of a Point-of-Care device.

This profile builds on Device.

This profile was published on Wed Aug 15 00:00:00 AEST 2018 as a draft by Health Level Seven International (Health Care Devices Work Group).

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

This structure is derived from Device

Summary

The profile defines the following rules:

  • Device.identifier may include an EUI-64 with either base-16 or hex encoding (octets separated by hyphens). See IEEE Guidelines for Use of EUI, OUI, and CID for details.
  • Device.type shall be present and have a coding from the ISO/IEEE 11073 MDC Device nomenclature if there is an appropriate code available.
  • Device.parent is optional and may refer to another MDS Device resource as a composite MDS.

Mandatory: 1 element (2 nested mandatory elements)
Fixed Value: 1 element

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element Device.identifier is sliced based on the value of value:system

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*
... identifier IdentifierSlice: Unordered, Open by value:system
... identifier 0..1IdentifierIEEE 64-bit Extended Unique Identifier (EUI-64)
.... system 1..1uriFixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
.... value 1..1string
... type 1..1CodeableConceptBinding: 11073 MDC Object infrastructure and Device nomenclature (extensible)
... parent 0..1Reference(MDS Device Profile)

doco Documentation for this format

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*Item 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: Common Languages (preferred)
... 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 IdentifierInstance identifier
Slice: Unordered, Open by value:system
... identifier 0..1IdentifierIEEE 64-bit Extended Unique Identifier (EUI-64)
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible)
.... system Σ1..1uriThe namespace for the identifier value
Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
.... value Σ1..1stringThe value that is unique
Example General': 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier ΣI0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored 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)
... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible)
... distinctIdentificationCode 0..1stringThe distinct identification code for a biological product regulated as a device
... 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 I0..*BackboneElementThe name of the device as given by the manufacturer
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored 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)
... modelNumber 0..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type 1..1CodeableConceptThe kind or type of device
Binding: 11073 MDC Object infrastructure and Device nomenclature (extensible)
... specialization I0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored 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 I0..*BackboneElementThe actual design of the device or software version running on the device
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored 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 I0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuanity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1Reference(Patient)Patient to whom Device is affixed
... 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(MDS Device Profile)The parent device

doco Documentation for this format

This structure is derived from Device

Summary

The profile defines the following rules:

  • Device.identifier may include an EUI-64 with either base-16 or hex encoding (octets separated by hyphens). See IEEE Guidelines for Use of EUI, OUI, and CID for details.
  • Device.type shall be present and have a coding from the ISO/IEEE 11073 MDC Device nomenclature if there is an appropriate code available.
  • Device.parent is optional and may refer to another MDS Device resource as a composite MDS.

Mandatory: 1 element (2 nested mandatory elements)
Fixed Value: 1 element

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element Device.identifier is sliced based on the value of value:system

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*
... identifier IdentifierSlice: Unordered, Open by value:system
... identifier 0..1IdentifierIEEE 64-bit Extended Unique Identifier (EUI-64)
.... system 1..1uriFixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
.... value 1..1string
... type 1..1CodeableConceptBinding: 11073 MDC Object infrastructure and Device nomenclature (extensible)
... parent 0..1Reference(MDS Device Profile)

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*Item 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: Common Languages (preferred)
... 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 IdentifierInstance identifier
Slice: Unordered, Open by value:system
... identifier 0..1IdentifierIEEE 64-bit Extended Unique Identifier (EUI-64)
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... use ?!Σ0..1codeusual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required)
.... type Σ0..1CodeableConceptDescription of identifier
Binding: Identifier Type Codes (extensible)
.... system Σ1..1uriThe namespace for the identifier value
Fixed Value: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680
.... value Σ1..1stringThe value that is unique
Example General': 123456
.... period Σ0..1PeriodTime period when id is/was valid for use
.... assigner Σ0..1Reference(Organization)Organization that issued id (may be just text)
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier ΣI0..*BackboneElementUnique Device Identifier (UDI) Barcode string
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored 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)
... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible)
... distinctIdentificationCode 0..1stringThe distinct identification code for a biological product regulated as a device
... 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 I0..*BackboneElementThe name of the device as given by the manufacturer
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored 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)
... modelNumber 0..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type 1..1CodeableConceptThe kind or type of device
Binding: 11073 MDC Object infrastructure and Device nomenclature (extensible)
... specialization I0..*BackboneElementThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored 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 I0..*BackboneElementThe actual design of the device or software version running on the device
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored 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 I0..*BackboneElementThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... id 0..1stringxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored if unrecognized
.... type 1..1CodeableConceptCode that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuanity 0..*QuantityProperty value as a quantity
.... valueCode 0..*CodeableConceptProperty value as a code, e.g., NTP4 (synced to NTP)
... patient 0..1Reference(Patient)Patient to whom Device is affixed
... 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(MDS Device Profile)The parent device

doco Documentation for this format

 

D.4.1.2 Terminology Bindings

Terminology Bindings

PathNameConformanceValueSet
Device.languageLanguagepreferredCommon Languages
Device.identifier.useIdentifierUserequiredIdentifierUse
Device.identifier.typeIdentifierTypeextensibleIdentifier Type Codes
Device.udiCarrier.entryTypeUDIEntryTyperequiredUDIEntryType
Device.statusFHIRDeviceStatusrequiredFHIRDeviceStatus
Device.statusReasonFHIRDeviceStatusReasonextensibleFHIRDeviceStatusReason
Device.deviceName.typeDeviceNameTyperequiredDeviceNameType
Device.type11073 MDC Object infrastructure and Device nomenclatureextensibleMdcObject

D.4.1.3 Constraints

Constraints

IdPathDetailsRequirements
dom-2DeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-4DeviceIf 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-3DeviceIf 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-6DeviceA resource should have narrative for robust management
: text.div.exists()
dom-5DeviceIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
ele-1Device.udiCarrierAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.deviceNameAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.specializationAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.versionAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ele-1Device.propertyAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
.