Da Vinci Payer Data Exchange
2.1.0-ballot - STU2 Ballot United States of America flag

This page is part of the Da Vinci Payer Data Exchange (v2.1.0-ballot: STU2.1 Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. The current version which supersedes this version is 2.0.0. For a full list of available versions, see the Directory of published versions

Resource Profile: PDex Device

Official URL: http://hl7.org/fhir/us/davinci-pdex/StructureDefinition/pdex-device Version: 2.1.0-ballot
Standards status: Trial-use Computable Name: PdexDevice

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

The PDex Device profile is provided to enable payers to record information about devices used by a member that may not have a UDI number. FHIR-29796 PDex Device uses base resource not US Core Implantable Device Profile. Pdex-Device enables payers to record non-implantable device data. CGP Voted on variance approval: Drew Torres/Eric Haas: 9-0-0

US Core supports the US Core Implantable Device resource. However, payers may need to record information about other non-implantable devices that are used by their members. The PDex-Device profile is used to record this type of information.

NOTE: FHIR-29796: PDex Device uses base resource not US Core Implantable Device Profile. Pdex-Device enables payers to record non-implantable device data. CGP Voted on variance approval: Drew Torres/Eric Haas: 9-0-0

In future versions of this IG there is a desire to ensure that all Device identification information is exchanged using the PDex Device or US Core Implantable Device resource.

he essential fields (Must Support or Cardinality greater than 0..*) to be provided in the PDex Device resource are:

R4 Element Name Cardinality Type
Device.type type 1..1 CodeableConcept
Device.patient patient 1..1 Reference(US Core Patient Profile)

Table Definition

Usage:

Formal Views of Profile Content

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

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
... udiCarrier S 0..1 BackboneElement Unique Device Identifier (UDI) Barcode string
.... deviceIdentifier S 1..1 string Mandatory fixed portion of UDI
.... carrierAIDC S 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF S 0..1 string UDI Human Readable Barcode String
... status S 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... distinctIdentifier S 0..1 string The distinct identification string
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible)
... patient S 1..1 Reference(US Core Patient Profile(6.1.0)) Patient to whom Device is affixed
... url S 0..1 uri Network address to contact device

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status
from the FHIR Standard
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 SΣ 0..1 BackboneElement 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
.... carrierAIDC SΣ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
... distinctIdentifier S 0..1 string The distinct identification string
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible)
... patient S 1..1 Reference(US Core Patient Profile(6.1.0)) Patient to whom Device is affixed
... url S 0..1 uri Network address to contact device

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Device.statusrequiredFHIRDeviceStatus
http://hl7.org/fhir/ValueSet/device-status
from the FHIR Standard
Device.typeextensibleFHIRDeviceTypes
http://hl7.org/fhir/ValueSet/device-kind
from the FHIR Standard
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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 SΣ 0..1 BackboneElement 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 SΣ 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 ?!SΣ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... 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 S 0..1 string The distinct identification string
... manufacturer 0..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string 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)
... 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 1..1 Reference(US Core Patient Profile(6.1.0)) 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 S 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
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
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
from the FHIR Standard
Device.statusReasonextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
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

This structure is derived from Device

Summary

Mandatory: 2 elements(1 nested mandatory element)
Must-Support: 12 elements

Structures

This structure refers to these other structures:

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..* Device Item used in healthcare
... udiCarrier S 0..1 BackboneElement Unique Device Identifier (UDI) Barcode string
.... deviceIdentifier S 1..1 string Mandatory fixed portion of UDI
.... carrierAIDC S 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF S 0..1 string UDI Human Readable Barcode String
... status S 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... distinctIdentifier S 0..1 string The distinct identification string
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible)
... patient S 1..1 Reference(US Core Patient Profile(6.1.0)) Patient to whom Device is affixed
... url S 0..1 uri Network address to contact device

doco Documentation for this format

Terminology Bindings (Differential)

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

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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 SΣ 0..1 BackboneElement 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
.... carrierAIDC SΣ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF SΣ 0..1 string UDI Human Readable Barcode String
... distinctIdentifier S 0..1 string The distinct identification string
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string Serial number assigned by the manufacturer
... type S 1..1 CodeableConcept The kind or type of device
Binding: FHIRDeviceTypes (extensible)
... patient S 1..1 Reference(US Core Patient Profile(6.1.0)) Patient to whom Device is affixed
... url S 0..1 uri Network address to contact device

doco Documentation for this format

Terminology Bindings

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

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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
... 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 SΣ 0..1 BackboneElement 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 SΣ 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 ?!SΣ 0..1 code active | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... 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 S 0..1 string The distinct identification string
... manufacturer 0..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate S 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber S 0..1 string Lot number of manufacture
... serialNumber S 0..1 string 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)
... 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 1..1 Reference(US Core Patient Profile(6.1.0)) 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 S 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
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
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
from the FHIR Standard
Device.statusReasonextensibleFHIRDeviceStatusReason
http://hl7.org/fhir/ValueSet/device-status-reason
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

This structure is derived from Device

Summary

Mandatory: 2 elements(1 nested mandatory element)
Must-Support: 12 elements

Structures

This structure refers to these other structures:

 

Other representations of profile: CSV, Excel, Schematron

Notes: