Womens Health Technology Coordinated Registry Network Implementation Guide For Comment Ballot

This page is part of the Womens Health Technology Coordinated Registry Network FHIR IG (v0.1.0: STU 1 Draft) based on FHIR v3.5.0. . For a full list of available versions, see the Directory of published versions

StructureDefinition-device-crn

source file: source/pages/_includes/device-crn-intro.md

Scope and Usage

The profile is to be used for the WTH 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). blah blah blah

must have:

  1. identifier
  2. udiCarrier
  3. status
  4. distinctIdentificationCode
  5. manufactureDate
  6. expirationDate
  7. lotNumber
  8. serialNumber
  9. patient

Additional Profile specific implementation guidance:

Examples

  • Examples to be added after finalization of data elements.

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 Wed Feb 15 00:00:00 AEST 2017 as a active by .

This profile builds on Device


Summary

Mandatory: 10 elements
Must-Support: 13 elements

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 S1..1IdentifierInstance identifier
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier SΣI1..*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 SΣ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF SΣ0..1stringUDI Human Readable Barcode String
.... entryType S1..1codebarcode | rfid | manual +
Binding: UDIEntryType (required)
... status ?!SΣ1..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 S1..1stringThe distinct identification code for a biological product regulated as a device
... manufacturer 0..1stringName of device manufacturer
... manufactureDate S1..1dateTimeDate when the device was made
... expirationDate S1..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber S1..1stringLot number of manufacture
... serialNumber S1..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 0..1CodeableConceptThe kind or type of device
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..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 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
       // 
 {
   "resourceType" : "Device",
    "id" : "<id>", // Logical id of this artifact
    "meta" : {Meta}, // Metadata about the resource
    "implicitRules" : "<uri>", // A set of rules under which this content was created
    "language" : "<code>", // Language of the resource content
    "text" : {Narrative}, // Text summary of the resource, for human interpretation
    "contained" : [{Resource}], // Contained, inline Resources
    "extension": [
    ],
    "identifier" : [{Identifier}], // R! Only One!  Instance identifier
    "definition" : {Reference(DeviceDefinition)}, // The reference to the definition for the device
    "udiCarrier" : [{ // C? R! Unique Device Identifier (UDI) Barcode string
      "extension": [
      ],
      "deviceIdentifier" : "<string>", // Mandatory fixed portion of UDI
      "issuer" : "<uri>", // UDI Issuing Organization
      "jurisdiction" : "<uri>", // Regional UDI authority
      "carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
      "carrierHRF" : "<string>", // UDI Human Readable Barcode String
      "entryType" : "<code>", // R! barcode | rfid | manual +
    }],
    "status" : "<code>", // R! active | inactive | entered-in-error | unknown
    "statusReason" : [{CodeableConcept}], // online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
    "distinctIdentificationCode" : "<string>", // R! The distinct identification code for a biological product regulated as a device
    "manufacturer" : "<string>", // Name of device manufacturer
    "manufactureDate" : "<dateTime>", // R! Date when the device was made
    "expirationDate" : "<dateTime>", // R! Date and time of expiry of this device (if applicable)
    "lotNumber" : "<string>", // R! Lot number of manufacture
    "serialNumber" : "<string>", // R! Serial number assigned by the manufacturer
    "deviceName" : [{ // C? The name of the device as given by the manufacturer
      "extension": [
      ],
      "name" : "<string>", // R! The name of the device
      "type" : "<code>", // R! udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
    }],
    "modelNumber" : "<string>", // The model number for the device
    "partNumber" : "<string>", // The part number of the device
    "type" : {CodeableConcept}, // The kind or type of device
    "specialization" : [{ // C? The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
      "extension": [
      ],
      "systemType" : {CodeableConcept}, // R! The standard that is used to operate and communicate
      "version" : "<string>", // The version of the standard that is used to operate and communicate
    }],
    "version" : [{ // C? The actual design of the device or software version running on the device
      "extension": [
      ],
      "type" : {CodeableConcept}, // The type of the device version
      "component" : {Identifier}, // A single component of the device version
      "value" : "<string>", // R! The version text
    }],
    "property" : [{ // C? The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
      "extension": [
      ],
      "type" : {CodeableConcept}, // R! Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
      "valueQuanity" : [{Quantity}], // Property value as a quantity
      "valueCode" : [{CodeableConcept}], // Property value as a code, e.g., NTP4 (synced to NTP)
    }],
    "patient" : {Reference(Patient)}, // R! Patient to whom Device is affixed
    "owner" : {Reference(Organization)}, // Organization responsible for device
    "contact" : [{ContactPoint}], // Details for human/organization for support
    "location" : {Reference(Location)}, // Where the device is found
    "url" : "<uri>", // Network address to contact device
    "note" : [{Annotation}], // Device notes and comments
    "safety" : [{CodeableConcept}], // Safety Characteristics of Device
    "parent" : {Reference(Device)}, // The parent device
  }

     

Summary

Mandatory: 10 elements
Must-Support: 13 elements

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 S1..1IdentifierInstance identifier
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier SΣI1..*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 SΣ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF SΣ0..1stringUDI Human Readable Barcode String
.... entryType S1..1codebarcode | rfid | manual +
Binding: UDIEntryType (required)
... status ?!SΣ1..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 S1..1stringThe distinct identification code for a biological product regulated as a device
... manufacturer 0..1stringName of device manufacturer
... manufactureDate S1..1dateTimeDate when the device was made
... expirationDate S1..1dateTimeDate and time of expiry of this device (if applicable)
... lotNumber S1..1stringLot number of manufacture
... serialNumber S1..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 0..1CodeableConceptThe kind or type of device
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..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 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

JSON Template

          // 
 {
   "resourceType" : "Device",
    "id" : "<id>", // Logical id of this artifact
    "meta" : {Meta}, // Metadata about the resource
    "implicitRules" : "<uri>", // A set of rules under which this content was created
    "language" : "<code>", // Language of the resource content
    "text" : {Narrative}, // Text summary of the resource, for human interpretation
    "contained" : [{Resource}], // Contained, inline Resources
    "extension": [
    ],
    "identifier" : [{Identifier}], // R! Only One!  Instance identifier
    "definition" : {Reference(DeviceDefinition)}, // The reference to the definition for the device
    "udiCarrier" : [{ // C? R! Unique Device Identifier (UDI) Barcode string
      "extension": [
      ],
      "deviceIdentifier" : "<string>", // Mandatory fixed portion of UDI
      "issuer" : "<uri>", // UDI Issuing Organization
      "jurisdiction" : "<uri>", // Regional UDI authority
      "carrierAIDC" : "<base64Binary>", // UDI Machine Readable Barcode String
      "carrierHRF" : "<string>", // UDI Human Readable Barcode String
      "entryType" : "<code>", // R! barcode | rfid | manual +
    }],
    "status" : "<code>", // R! active | inactive | entered-in-error | unknown
    "statusReason" : [{CodeableConcept}], // online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
    "distinctIdentificationCode" : "<string>", // R! The distinct identification code for a biological product regulated as a device
    "manufacturer" : "<string>", // Name of device manufacturer
    "manufactureDate" : "<dateTime>", // R! Date when the device was made
    "expirationDate" : "<dateTime>", // R! Date and time of expiry of this device (if applicable)
    "lotNumber" : "<string>", // R! Lot number of manufacture
    "serialNumber" : "<string>", // R! Serial number assigned by the manufacturer
    "deviceName" : [{ // C? The name of the device as given by the manufacturer
      "extension": [
      ],
      "name" : "<string>", // R! The name of the device
      "type" : "<code>", // R! udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
    }],
    "modelNumber" : "<string>", // The model number for the device
    "partNumber" : "<string>", // The part number of the device
    "type" : {CodeableConcept}, // The kind or type of device
    "specialization" : [{ // C? The capabilities supported on a  device, the standards to which the device conforms for a particular purpose, and used for the communication
      "extension": [
      ],
      "systemType" : {CodeableConcept}, // R! The standard that is used to operate and communicate
      "version" : "<string>", // The version of the standard that is used to operate and communicate
    }],
    "version" : [{ // C? The actual design of the device or software version running on the device
      "extension": [
      ],
      "type" : {CodeableConcept}, // The type of the device version
      "component" : {Identifier}, // A single component of the device version
      "value" : "<string>", // R! The version text
    }],
    "property" : [{ // C? The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
      "extension": [
      ],
      "type" : {CodeableConcept}, // R! Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
      "valueQuanity" : [{Quantity}], // Property value as a quantity
      "valueCode" : [{CodeableConcept}], // Property value as a code, e.g., NTP4 (synced to NTP)
    }],
    "patient" : {Reference(Patient)}, // R! Patient to whom Device is affixed
    "owner" : {Reference(Organization)}, // Organization responsible for device
    "contact" : [{ContactPoint}], // Details for human/organization for support
    "location" : {Reference(Location)}, // Where the device is found
    "url" : "<uri>", // Network address to contact device
    "note" : [{Annotation}], // Device notes and comments
    "safety" : [{CodeableConcept}], // Safety Characteristics of Device
    "parent" : {Reference(Device)}, // The parent device
  }

        

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.