Da Vinci Payer Data Exchange
2.0.0-ballot - ballot US

This page is part of the Da Vinci Payer Data Exchange (v2.0.0-ballot: STU2 Ballot 1) based on FHIR R4. The current version which supercedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Resource Profile: PDex Device ( Experimental )

Official URL: http://hl7.org/fhir/us/davinci-pdex/StructureDefinition/pdex-device Version: 2.0.0-ballot
Draft as of 2022-02-18 Computable Name: PdexDevice

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

Formal Views of Profile Content

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

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:

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceItem used in healthcare
... udiCarrier S0..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier S1..1stringMandatory fixed portion of UDI
.... carrierAIDC S0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF S0..1stringUDI Human Readable Barcode String
... status S0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... distinctIdentifier S0..1stringThe distinct identification string
... lotNumber S0..1stringLot number of manufacture
... serialNumber S0..1stringSerial number assigned by the manufacturer
... type S1..1CodeableConceptThe kind or type of device
Binding: FHIRDeviceTypes (extensible)
... patient S1..1Reference(US Core Patient Profile)Patient to whom Device is affixed
... url S0..1uriNetwork address to contact device

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceItem used in healthcare
... id Σ0..1stringLogical 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: A human language.

... 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
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier SΣ0..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 SΣ1..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 0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!SΣ0..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): The availability status reason of the device.


... distinctIdentifier S0..1stringThe distinct identification string
... manufacturer 0..1stringName of device manufacturer
... manufactureDate 0..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 0..*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): The type of name the device is referred by.

... 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 0..*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 0..*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 0..*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(US Core Patient Profile)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 S0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
... safety Σ0..*CodeableConceptSafety Characteristics of Device
... parent 0..1Reference(Device)The parent device

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceItem used in healthcare
... udiCarrier Σ0..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier Σ1..1stringMandatory fixed portion of UDI
.... carrierAIDC Σ0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF Σ0..1stringUDI Human Readable Barcode String
... status ?!Σ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... distinctIdentifier 0..1stringThe distinct identification string
... lotNumber 0..1stringLot number of manufacture
... serialNumber 0..1stringSerial number assigned by the manufacturer
... type 1..1CodeableConceptThe kind or type of device
Binding: FHIRDeviceTypes (extensible)
... patient 1..1Reference(US Core Patient Profile)Patient to whom Device is affixed
... url 0..1uriNetwork address to contact device

doco Documentation for this format

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..*DeviceItem used in healthcare
... udiCarrier S0..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... deviceIdentifier S1..1stringMandatory fixed portion of UDI
.... carrierAIDC S0..1base64BinaryUDI Machine Readable Barcode String
.... carrierHRF S0..1stringUDI Human Readable Barcode String
... status S0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required)
... distinctIdentifier S0..1stringThe distinct identification string
... lotNumber S0..1stringLot number of manufacture
... serialNumber S0..1stringSerial number assigned by the manufacturer
... type S1..1CodeableConceptThe kind or type of device
Binding: FHIRDeviceTypes (extensible)
... patient S1..1Reference(US Core Patient Profile)Patient to whom Device is affixed
... url S0..1uriNetwork address to contact device

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device 0..*DeviceItem used in healthcare
... id Σ0..1stringLogical 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: A human language.

... 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
... definition 0..1Reference(DeviceDefinition)The reference to the definition for the device
... udiCarrier SΣ0..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 SΣ1..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 0..1codebarcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.

... status ?!SΣ0..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): The availability status reason of the device.


... distinctIdentifier S0..1stringThe distinct identification string
... manufacturer 0..1stringName of device manufacturer
... manufactureDate 0..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 0..*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): The type of name the device is referred by.

... 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 0..*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 0..*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 0..*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(US Core Patient Profile)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 S0..1uriNetwork address to contact device
... note 0..*AnnotationDevice notes and comments
... safety Σ0..*CodeableConceptSafety Characteristics of Device
... parent 0..1Reference(Device)The parent device

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSet
Device.languagepreferredCommonLanguages
Max Binding: AllLanguages
Device.udiCarrier.entryTyperequiredUDIEntryType
Device.statusrequiredFHIRDeviceStatus
Device.statusReasonextensibleFHIRDeviceStatusReason
Device.deviceName.typerequiredDeviceNameType
Device.typeextensibleFHIRDeviceTypes

Notes: