US Core Implementation Guide
9.0.0-ballot - STU 9 Ballot United States of America flag

US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 9.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions

Resource Profile: US Core Device Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-device Version: 9.0.0-ballot
Standards status: Trial-use Maturity Level: 3 Computable Name: USCoreDeviceProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.20

Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License

The US Core Device Profile inherits from the FHIR Device resource; refer to it for scope and usage definitions. It sets minimum expectations for the Device resource to record, search, and fetch medical and non-medical devices (for example, software or crutches). This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) Medical Device Data Class, including FDA Unique Device Identification (UDI) information associated with a patient's medical device(s). It specifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains how the elements are used and provides the floor for standards development for specific use cases promotes interoperability and adoption.

Example Usage Scenarios:

The following are example usage scenarios for this profile:

Mandatory and Must Support Data Elements

The following data elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The Formal Views below provides the formal summary, definitions, and terminology requirements.

Each Device Must Have:

  1. a code identifying the type of device

In addition, the following data elements must be supported if the data is present in the sending system (Must Support definition):

Each Device Must Support:

  1. a patient*

Additional USCDI Requirements:

These Additional USCDI Requirements elements are not Mandatory or Must Support but are required for ASTP Health IT certification testing and are included in the formal definition of the profile and the Condition examples.

  1. UDI Unique Device Identifier (UDI) Barcode string.*
    • Unique Device Identifier (UDI) numeric or alphanumeric code as the Human Readable Form (HRF) string representation of the barcode
    • The Device Identifier (UDI-DI)
  2. the manufacture date
  3. the expiration date
  4. the lot number
  5. the serial number
  6. the distinct identification number (e.g., Donation Identification Number(DIN))

*see guidance below

Profile Specific Implementation Guidance

This section provides detailed implementation guidance for the US Core Profile to support implementation and certification.

  • Because this profile aligns with the USCDI Medical Devices Data Class, it supports the exchange of UDI information when available (for example, implantable devices or non-implantable devices, such as ventilators). However, systems are not expected to record UDI data for every use case or device.
  • *Device.patient's minimum cardinality of zero supports use cases where devices may be tracked independently of a patient.

UDI Specific Implementation Guidance

  • This profile supports the requirement to retrieve a 170.315(a)(14) Medical device list. It follows the HL7 Cross Paradigm Implementation Guide: UDI Pattern guidelines for exchanging information about the use and implantation of medical devices in patients.

    • A unique device identifier (UDI) is a unique numeric or alphanumeric code. There is a machine-readable version (AIDC - the Automatic Identification and Data Capture) and a human-readable version of the UDI (HRF - Human Readable Form string). This profile specifies that only the HRF must be supported. Considering the complexity of parsing AIDCs, there is no expectation at this time that one converts an AIDC to HRF upon receipt from a FHIR source that is not conformant to this profile or is using another interchange standard (e.g., C-CDA, HL7 v2, etc.). The UDI generally consists of a mandatory Device Identifier (DI) and a conditional Production identifier (PI) that identifies one or more of the five UDI-PI elements. The UDI and its components are mapped to the *US Core Device Profile elements in the table below:

      UDI component *US Core Device Profile element
      UDI HRF string Device.udiCarrier.carrierHRF
      DI Device.udiCarrier.deviceIdentifier
      manufacture date (UDI-PI element) Device.manufactureDate
      expiration date (UDI-PI elemente Device.expirationDate
      lot number (UDI-PI element) Device.lotNumber
      serial number (UDI-PI element) Device.serialNumber
      distinct identifier (UDI-PI element) Device.distinctIdentifier

    • Implementers are encouraged to use the FDA Global UDI Database (GUDID) and associated APIs to parse and validate the UDI:

      • The AccessGUDID API provides access to device records in GUDID, including safety information and UDI. It includes APIs to query and download a complete list of medical devices registered in GUDID.
      • The Parse UDI API allows users to pass a UDI and return each part of the UDI in a structured format (specifically the serialNumber, lotNumber, expirationDate, distinctIdentifier (returned as donation_id) or manufactureDate).

  • Medical devices with UDI information SHALL represent the UDI code in Device.udiCarrier.carrierHRF. All five UDI-PI elements defined in the UDI code may not always be present in every UDI instance. However, those UDI-PI elements present SHALL be represented in the corresponding *US Core Device Profile elements.

    UDI may not be present in all scenarios, such as historical medical devices, patient-reported implant information, payer-reported devices, or improperly documented implants. If UDI is not present and the manufacturer or model number information is available, they SHOULD be included to support historical reports of medical medical devices as follows:

    data element *US Core Device Profile element
    manufacturer Device.manufacturer
    model Device.model

  • The Quick Start section below describes searching for all devices. Records of implanted devices MAY be queried against UDI data, including:

    • UDI HRF string (udi-carrier)
    • UDI Device Identifier (udi-di)
    • Manufacturer (manufacturer)
    • Model number (model)

    Implementers MAY also adopt custom SearchParameters for searching by:

    • lot numbers
    • serial number
    • expiration date
    • manufacture date
    • distinct identifier

Usages:

You can also check for usages in the FHIR IG Statistics

Changes since version 8.0.0:

  • New Content

    • Formal Views of Profile Content

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

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Device 0..* Device Item used in healthcare
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ... udiCarrier Σ 0..1 BackboneElement 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
    .... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
    .... deviceIdentifier SΣ 1..1 string Mandatory fixed portion of UDI
    .... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
    ... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
    Binding: FHIRDeviceStatus (required): The availability status of the device.
    ... distinctIdentifier 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
    ... manufactureDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
    ... expirationDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
    ... lotNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
    ... serialNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
    ... type S 1..1 CodeableConcept The kind or type of device
    Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
    ... patient S 0..1 Reference(US Core Patient Profile) Patient to whom Device is affixed

    doco Documentation for this format

    Terminology Bindings

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

    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()

    This structure is derived from Device

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Device 0..* Device Item used in healthcare
    ... udiCarrier 0..1 BackboneElement 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
    .... deviceIdentifier S 1..1 string Mandatory fixed portion of UDI
    .... carrierHRF S 0..1 string UDI Human Readable Barcode String
    ... distinctIdentifier 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
    ... manufactureDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
    ... expirationDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
    ... lotNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
    ... serialNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
    ... type S 1..1 CodeableConcept The kind or type of device
    Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
    ... patient S 0..1 Reference(US Core Patient Profile) Patient to whom Device is affixed

    doco Documentation for this format

    Terminology Bindings (Differential)

    PathConformanceValueSetURI
    Device.typeextensibleFHIRDeviceTypes
    http://hl7.org/fhir/ValueSet/device-kind
    From the FHIR Standard
    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Device 0..* Device Item used in healthcare
    ... id Σ 0..1 id Logical id of this artifact
    ... meta Σ 0..1 Meta Metadata about the resource
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ... language 0..1 code Language of the resource content
    Binding: CommonLanguages (preferred): A human language.
    Additional BindingsPurpose
    AllLanguages Max Binding
    ... text 0..1 Narrative Text summary of the resource, for human interpretation
    This profile does not constrain the narrative in regard to content, language, or traceability to data elements
    ... 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 Σ 0..1 BackboneElement 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: 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 Σ 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 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
    ... manufacturer 0..1 string Name of device manufacturer
    ... manufactureDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
    ... expirationDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
    ... lotNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
    ... serialNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
    ... deviceName 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 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 S 0..1 Reference(US Core 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) The parent device

    doco Documentation for this format

    Terminology Bindings

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

    Constraints

    IdGradePath(s)DetailsRequirements
    dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
    : contained.contained.empty()
    dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
    : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
    dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
    : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
    dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
    : contained.meta.security.empty()
    dom-6best practiceDeviceA resource should have narrative for robust management
    : text.`div`.exists()
    ele-1error**ALL** elementsAll FHIR elements must have a @value or children
    : hasValue() or (children().count() > id.count())
    ext-1error**ALL** extensionsMust have either extensions or value[x], not both
    : extension.exists() != value.exists()

    This structure is derived from Device

    Summary

    Mandatory: 1 element(1 nested mandatory element)
    Must-Support: 4 elements

    Structures

    This structure refers to these other structures:

    Maturity: 3

    Key Elements View

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Device 0..* Device Item used in healthcare
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ... udiCarrier Σ 0..1 BackboneElement 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
    .... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
    .... deviceIdentifier SΣ 1..1 string Mandatory fixed portion of UDI
    .... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
    ... status ?!Σ 0..1 code active | inactive | entered-in-error | unknown
    Binding: FHIRDeviceStatus (required): The availability status of the device.
    ... distinctIdentifier 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
    ... manufactureDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
    ... expirationDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
    ... lotNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
    ... serialNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
    ... type S 1..1 CodeableConcept The kind or type of device
    Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
    ... patient S 0..1 Reference(US Core Patient Profile) Patient to whom Device is affixed

    doco Documentation for this format

    Terminology Bindings

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

    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()

    Differential View

    This structure is derived from Device

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Device 0..* Device Item used in healthcare
    ... udiCarrier 0..1 BackboneElement 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
    .... deviceIdentifier S 1..1 string Mandatory fixed portion of UDI
    .... carrierHRF S 0..1 string UDI Human Readable Barcode String
    ... distinctIdentifier 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
    ... manufactureDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
    ... expirationDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
    ... lotNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
    ... serialNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
    ... type S 1..1 CodeableConcept The kind or type of device
    Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
    ... patient S 0..1 Reference(US Core Patient Profile) Patient to whom Device is affixed

    doco Documentation for this format

    Terminology Bindings (Differential)

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

    Snapshot View

    NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
    .. Device 0..* Device Item used in healthcare
    ... id Σ 0..1 id Logical id of this artifact
    ... meta Σ 0..1 Meta Metadata about the resource
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ... language 0..1 code Language of the resource content
    Binding: CommonLanguages (preferred): A human language.
    Additional BindingsPurpose
    AllLanguages Max Binding
    ... text 0..1 Narrative Text summary of the resource, for human interpretation
    This profile does not constrain the narrative in regard to content, language, or traceability to data elements
    ... 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 Σ 0..1 BackboneElement 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: 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 Σ 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 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
    ... manufacturer 0..1 string Name of device manufacturer
    ... manufactureDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
    ... expirationDate 0..1 dateTime 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
    ... lotNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
    ... serialNumber 0..1 string 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
    ... deviceName 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 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 S 0..1 Reference(US Core 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) The parent device

    doco Documentation for this format

    Terminology Bindings

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

    Constraints

    IdGradePath(s)DetailsRequirements
    dom-2errorDeviceIf the resource is contained in another resource, it SHALL NOT contain nested Resources
    : contained.contained.empty()
    dom-3errorDeviceIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
    : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
    dom-4errorDeviceIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
    : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
    dom-5errorDeviceIf a resource is contained in another resource, it SHALL NOT have a security label
    : contained.meta.security.empty()
    dom-6best practiceDeviceA resource should have narrative for robust management
    : text.`div`.exists()
    ele-1error**ALL** elementsAll FHIR elements must have a @value or children
    : hasValue() or (children().count() > id.count())
    ext-1error**ALL** extensionsMust have either extensions or value[x], not both
    : extension.exists() != value.exists()

    This structure is derived from Device

    Summary

    Mandatory: 1 element(1 nested mandatory element)
    Must-Support: 4 elements

    Structures

    This structure refers to these other structures:

    Maturity: 3

     

    Other representations of profile: CSV, Excel, Schematron

    Notes:

    Quick Start

    Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the US Core interactions to access this profile's information (Profile Support + Interaction Support). Note that systems that support only US Core Profiles (Profile Only Support) are not required to support these interactions. See the US Core Server CapabilityStatement for a complete list of supported RESTful interactions for this IG.

    • See the Scopes Format section for a description of the SMART scopes syntax.
    • See the Search Syntax section for a description of the US Core search syntax.
    • See the General Requirements section for additional rules and expectations when a Server requires status parameters.
    • See the General Guidance section for additional guidance on searching for multiple patients.

    US Core Scopes

    Servers providing access to medical device data SHALL support these US Core SMART Scopes:

    Mandatory Search Parameters:

    1. SHALL support searching for all devices for a patient using the patient search parameter:

      GET [base]/Device?patient={Type/}[id]

      Example:

      1. GET [base]/Device?patient=1137192

      Implementation Notes: Fetches a bundle of all Device resources for the specified patient (how to search by reference)

    Optional Search Parameters:

    The following search parameter combinations SHOULD be supported:

    1. SHOULD support searching using the combination of the patient and type search parameters:

      GET [base]/Device?patient={Type/}[id]&type={system|}[code]

      Example:

      1. GET [base]/Device?patient=1316024&type=http://snomed.info/sct|468063009

      Implementation Notes: Fetches a bundle of all Device resources for the specified patient and type. (how to search by reference and how to search by token)

    2. SHOULD support searching using the combination of the patient and status search parameters:

      • including support for OR search on status (e.g.status={system|}[code],{system|}[code],...)

      GET [base]/Device?patient={Type/}[id]&status={system|}[code]{,{system|}[code],...}

      Example:

      1. GET [base]/Device?patient=1316024&status=active

      Implementation Notes: Fetches a bundle of all Device resources for the specified patient and status (how to search by reference and how to search by token)