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-devicedefinition-crn

Defines constraints on DeviceDefinition for WHT CRN project.

Scope and Usage

The profile is to be used for the WHT CRN project to capture the specific device information that is the present in the GUDID database for devices 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. manufacturer

Additional Profile specific implementation guidance:

When available, the DeviceDefinition data elements manufacturer, deviceName, modelNumber and type should be populated when found in the GUDID database using the deviceIdentifier.

In order to retrieve the AccessGUDID data the following APIs should be used:

  • The Device Lookup API [GET /devices/lookup (https://accessgudid.nlm.nih.gov/resources/developers/device_lookup_api)] allows users to retrieve the Manufacturer.Organization.name (returned as companyName), deviceName (retuned as brandName), and modelNumber (returned as versionModelNumber) by sending the device identifier.
  • The Device SNOMED API [GET /devices/snomed (https://accessgudid.nlm.nih.gov/resources/developers/device_snomed_api)] allows users to retrieve the device type – i.e., the SNOMED code and term by sending the device identifier.

Note: Implementer must generate a UMLS single-use ticket to retrieve the coded value.

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/devicedefinition-crn

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

This profile builds on DeviceDefinition

Summary

Mandatory: 1 element (5 nested mandatory elements)
Must-Support: 10 elements

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition I0..*An instance of a medical-related component of a medical device
... 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 0..*IdentifierInstance identifier
... udiDeviceIdentifier SI0..1BackboneElementUnique 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 S1..1stringThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
.... issuer S1..1uriThe organization that assigns the identifier algorithm
.... jurisdiction S1..1uriThe jurisdiction to which the deviceIdentifier applies
... manufacturerString S1..1stringName of device manufacturer
... deviceName SI0..1BackboneElementA name given to the device to identify it
.... 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 S1..1stringThe name of the device
.... type S1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required)
... modelNumber S0..1stringThe model number for the device
... type S0..1CodeableConceptWhat kind of device or device system this is
Binding: FHIRDeviceTypes (example)
... 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..1stringThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*stringAvailable versions
... safety Σ0..*CodeableConceptSafety characteristics of the device
Binding: DeviceSafety (example)
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicDimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability I0..*BackboneElementDevice capabilities
.... 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..1CodeableConceptType of capability
.... description 0..*CodeableConceptDescription of capability
... 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)
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... url 0..1uriNetwork address to contact device
... onlineInformation 0..1uriAccess to on-line information
... note 0..*AnnotationDevice notes and comments
... quantity 0..1QuantityThe quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
... parentDevice Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material I0..*BackboneElementA substance used to create the material(s) of which the device is made
.... 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
.... substance 1..1CodeableConceptThe substance
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen

doco Documentation for this format

Summary

Mandatory: 1 element (5 nested mandatory elements)
Must-Support: 10 elements

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. DeviceDefinition I0..*An instance of a medical-related component of a medical device
... 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 0..*IdentifierInstance identifier
... udiDeviceIdentifier SI0..1BackboneElementUnique 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 S1..1stringThe identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdication porvided in the DeviceDefinition.udiDeviceIdentifier
.... issuer S1..1uriThe organization that assigns the identifier algorithm
.... jurisdiction S1..1uriThe jurisdiction to which the deviceIdentifier applies
... manufacturerString S1..1stringName of device manufacturer
... deviceName SI0..1BackboneElementA name given to the device to identify it
.... 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 S1..1stringThe name of the device
.... type S1..1codeudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required)
... modelNumber S0..1stringThe model number for the device
... type S0..1CodeableConceptWhat kind of device or device system this is
Binding: FHIRDeviceTypes (example)
... 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..1stringThe standard that is used to operate and communicate
.... version 0..1stringThe version of the standard that is used to operate and communicate
... version 0..*stringAvailable versions
... safety Σ0..*CodeableConceptSafety characteristics of the device
Binding: DeviceSafety (example)
... shelfLifeStorage 0..*ProductShelfLifeShelf Life and storage information
... physicalCharacteristics 0..1ProdCharacteristicDimensions, color etc.
... languageCode 0..*CodeableConceptLanguage code for the human-readable text strings produced by the device (all supported)
... capability I0..*BackboneElementDevice capabilities
.... 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..1CodeableConceptType of capability
.... description 0..*CodeableConceptDescription of capability
... 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)
... owner 0..1Reference(Organization)Organization responsible for device
... contact 0..*ContactPointDetails for human/organization for support
... url 0..1uriNetwork address to contact device
... onlineInformation 0..1uriAccess to on-line information
... note 0..*AnnotationDevice notes and comments
... quantity 0..1QuantityThe quantity of the device present in the packaging (e.g. the number of devices present in a pack, or the number of devices in the same package of the medicinal product)
... parentDevice Σ0..1Reference(DeviceDefinition)The parent device it can be part of
... material I0..*BackboneElementA substance used to create the material(s) of which the device is made
.... 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
.... substance 1..1CodeableConceptThe substance
.... alternate 0..1booleanIndicates an alternative material of the device
.... allergenicIndicator 0..1booleanWhether the substance is a known or suspected allergen

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.