Implementation Guide (Release 0.2.0 )

This page is part of the Womens Health Technology Coordinated Registry Network FHIR IG (v0.2.0: STU 1 Ballot 2) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

StructureDefinition-device-crn

Device profile for CRN project

Scope and Usage

The profile is to be used for the WHT CRN project to capture the specific device information used to treat women with various health conditions.

Mandatory Data Elements and Terminology

The following data-elements are mandatory (i.e data MUST be present).

must have:

  1. identifier
  2. patient

Additional Profile specific implementation guidance:

The udiCarrier can only contain either carrierAIDC or carrierHRF along with its appropriate entryType. In case an organization wants to represent both carrierAIDC or carrierHRF, then multiple udiCarrier entries must be used. Also refer to the invariants present on the various data elements in the profile.

In order to parse the UDI – the AccessGUDID Parse UDI API should be used: GET /parse_udi (https://accessgudid.nlm.nih.gov/resources/developers/parse_udi_api).

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 manufacturineDate).

Formal Views of Profile Content

Description of Profiles, Differentials, and Snapshots.

The official URL for this profile is: http://hl7.org/fhir/us/womens-health-registries/StructureDefinition/device-crn

Published on Sun Mar 24 00:00:00 AEDT 2019 as a active by BRR.

This profile builds on US Core Implanted Device Profile

Summary

Mandatory: 2 elements (1 nested mandatory element)
Must-Support: 14 elements

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*crn-device-data: If UDI is included at least one of (distinctIdentifier, manufactureDate, expirationDate, lotNumber, serialNumber) must be included.
... identifier S1..1Identifier
... definition S0..1Reference(DeviceDefinition)
... udiCarrier S0..*BackboneElement
.... carrierAIDC S0..1base64Binary
.... carrierHRF S0..1string
.... entryType S1..1code
... status SI0..1codecrn-device-status: Status must be present if udiCarrier is present.
... distinctIdentifier SI0..1string
... manufactureDate S0..1dateTime
... expirationDate S0..1dateTime
... lotNumber S0..1string
... serialNumber S0..1string
... patient S1..1Reference(Patient)
... parent S0..1Reference(Device)

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*US Core Implanted Device Profile
crn-device-data: If UDI is included at least one of (distinctIdentifier, manufactureDate, expirationDate, lotNumber, serialNumber) must be included.
... 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)
Max Binding: AllLanguages
... 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 S1..1IdentifierInstance identifier
... definition S0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier SΣI0..*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 SΣ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF SΣ0..1stringUDI Human Readable Barcode String
.... entryType S1..1codebarcode | rfid | manual +
Binding: UDIEntryType (required)
... status ?!SΣI0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
crn-device-status: Status must be present if udiCarrier is present.
... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible)
... distinctIdentifier S0..1stringThe distinct identification string
... manufacturer 0..1stringName of device manufacturer
... manufactureDate S0..1dateTimeDate when the device was made
... expirationDate S0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber S0..1stringLot number of manufacture
... serialNumber S0..1stringSerial number assigned by the manufacturer
... deviceName I0..*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)
... modelNumber 0..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type S1..1CodeableConceptThe kind or type of device
Binding: FHIRDeviceTypes (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..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 I0..*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 I0..*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)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 S0..1Reference(Device)The parent device

doco Documentation for this format

Summary

Mandatory: 2 elements (1 nested mandatory element)
Must-Support: 14 elements

Differential View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*crn-device-data: If UDI is included at least one of (distinctIdentifier, manufactureDate, expirationDate, lotNumber, serialNumber) must be included.
... identifier S1..1Identifier
... definition S0..1Reference(DeviceDefinition)
... udiCarrier S0..*BackboneElement
.... carrierAIDC S0..1base64Binary
.... carrierHRF S0..1string
.... entryType S1..1code
... status SI0..1codecrn-device-status: Status must be present if udiCarrier is present.
... distinctIdentifier SI0..1string
... manufactureDate S0..1dateTime
... expirationDate S0..1dateTime
... lotNumber S0..1string
... serialNumber S0..1string
... patient S1..1Reference(Patient)
... parent S0..1Reference(Device)

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device I0..*US Core Implanted Device Profile
crn-device-data: If UDI is included at least one of (distinctIdentifier, manufactureDate, expirationDate, lotNumber, serialNumber) must be included.
... 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)
Max Binding: AllLanguages
... 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 S1..1IdentifierInstance identifier
... definition S0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier SΣI0..*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 SΣ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF SΣ0..1stringUDI Human Readable Barcode String
.... entryType S1..1codebarcode | rfid | manual +
Binding: UDIEntryType (required)
... status ?!SΣI0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
crn-device-status: Status must be present if udiCarrier is present.
... statusReason 0..*CodeableConceptonline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible)
... distinctIdentifier S0..1stringThe distinct identification string
... manufacturer 0..1stringName of device manufacturer
... manufactureDate S0..1dateTimeDate when the device was made
... expirationDate S0..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber S0..1stringLot number of manufacture
... serialNumber S0..1stringSerial number assigned by the manufacturer
... deviceName I0..*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)
... modelNumber 0..1stringThe model number for the device
... partNumber 0..1stringThe part number of the device
... type S1..1CodeableConceptThe kind or type of device
Binding: FHIRDeviceTypes (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..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 I0..*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 I0..*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)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 S0..1Reference(Device)The parent device

doco Documentation for this format

Downloads: StructureDefinition: (XML, JSON), Schema: XML Schematron


Quick Start

Below is an overview of the required set of RESTful FHIR interactions - for example, search and read operations - for this profile. See the Conformance requirements for a complete list of supported RESTful interactions for this IG.

Search Requirements

There are no specific search requirements by the WHT CRN IG beyond what is required by the base resource.