Example Usage Scenarios:

The following are example usage scenarios for this profile:

• Query for a Patient's Devices
• Record or update a Patient Device

Mandatory and Must Support Data Elements

The following data elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The Formal Views below provides the formal summary, definitions, and terminology requirements.

Each Device Must Have:

1. a code identifying the type of device

In addition, the following data elements must be supported if the data is present in the sending system (Must Support definition):

Each Device Must Support:

1. a patient¹

Additional USCDI Requirements:

These Additional USCDI Requirements elements are not Mandatory or Must Support but are required for ONC Health IT certification testing and are included in the formal definition of the profile and the Condition examples.

1. UDI Unique Device Identifier (UDI) Barcode string.²
   • Unique Device Identifier (UDI) numeric or alphanumeric code as the Human Readable Form (HRF) string representation of the barcode
   • The Device Identifier (UDI-DI)
2. the manufacture date
3. the expiration date
4. the lot number
5. the serial number
6. the distinct identification number (e.g., Donation Identification Number(DIN))

^1,2 see guidance below

Profile Specific Implementation Guidance

This section provides detailed implementation guidance for the US Core Profile to support implementation and certification.

• Because this profile aligns with the USCDI Medical Devices Data Class, it supports the exchange of UDI information when available (for example, implantable devices or non-implantable medical devices, such as ventilators). However, systems are not expected to record any UDI data for every use case or device.
• *Device.patient's minimum cardinality of zero supports use cases where devices may be tracked independently of a patient.

UDI Specific Implementation Guidance

• This profile follows the HL7 Cross Paradigm Implementation Guide: UDI Pattern guidelines for exchanging information about the use and implantation of medical devices in patients.

  • ²A unique device identifier (UDI) is a unique numeric or alphanumeric code. There is a machine-readable version (AIDC - the Automatic Identification and Data Capture) and a human-readable version of the UDI (HRF - Human Readable Form string). This profile specifies that only the HRF must be supported. Considering the complexity of parsing AIDCs, there is no expectation at this time that one converts an AIDC to HRF upon receipt from a FHIR source that is not conformant to this profile or is using another interchange standard (e.g., C-CDA, HL7 v2, etc.). The UDI generally consists of a mandatory Device Identifier (DI) and a conditional Production identifier (PI) that identifies one or more of the five UDI-PI elements. The UDI and its components are mapped to the US Core Device Profile elements in the table below:

    UDI component	US Core Device Profile element
    UDI HRF string	Device.udiCarrier.carrierHRF
    DI	Device.udiCarrier.deviceIdentifier
    manufacture date (UDI-PI element)	Device.manufactureDate
    expiration date (UDI-PI element)	Device.expirationDate
    lot number (UDI-PI element)	Device.lotNumber
    serial number (UDI-PI element)	Device.serialNumber
    distinct identifier (UDI-PI element)	Device.distinctIdentifier

  • Implementers SHOULD use the FDA Global UDI Database (GUDID) and associated APIs to parse and validate the UDI:^§

    • The AccessGUDID API provides access to device records in GUDID, including safety information and UDI. It includes APIs to query and download a complete list of medical devices registered in GUDID.
    • 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 manufactureDate).

• Medical devices with UDI information SHALL represent the UDI code in Device.udiCarrier.carrierHRF.^§ All five UDI-PI elements defined in the UDI code may not always be present in every UDI instance. However, those UDI-PI elements present SHALL be represented in the corresponding US Core Device Profile elements.^§

  UDI may not be present in all scenarios, such as historical medical devices, patient-reported implant information, payer-reported devices, or improperly documented implants. If UDI is not present and the manufacturer or model number information is available, they SHOULD be included to support historical reports of medical devices as follows:^§,§

  data element	US Core Device Profile element
  manufacturer	Device.manufacturer
  model	Device.model

• The Quick Start section below describes searching for all devices. Records of implanted devices MAY be queried against UDI data, including:^§,§,§,§

  • UDI HRF string (udi-carrier)
  • UDI Device Identifier (udi-di)
  • Manufacturer (manufacturer)
  • Model number (model)

  Implementers MAY also adopt custom SearchParameters for searching by:^{§,§,§,§,§}

  • lot numbers
  • serial number
  • expiration date
  • manufacture date
  • distinct identifier

Changes since version 9.0.0:

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Item used in healthcare
Device.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Device.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Device.udiCarrier	Σ This element is included in summaries.	0..1	BackboneElement	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
Device.udiCarrier.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.udiCarrier.deviceIdentifier	S This element must be supported. Σ This element is included in summaries.	1..1	string	Mandatory fixed portion of UDI
Device.udiCarrier.carrierHRF	S This element must be supported. Σ This element is included in summaries.	0..1	string	UDI Human Readable Barcode String
Device.status	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
Device.distinctIdentifier		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
Device.manufactureDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
Device.expirationDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
Device.lotNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
Device.serialNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
Device.type	S This element must be supported.	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
Device.patient	S This element must be supported.	0..1	Reference(US Core Patient Profile)	Patient to whom Device is assigned
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Device.status	Base	required	FHIRDeviceStatus	📍4.0.1	FHIR Std.
Device.type	Base	extensible	FHIR Device Types	📦4.0.1	FHIR Std.

Constraints

Id

Grade

Path(s)

Description

Expression

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Item used in healthcare
Device.udiCarrier		0..1	BackboneElement	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
Device.udiCarrier.deviceIdentifier	S This element must be supported.	1..1	string	Mandatory fixed portion of UDI
Device.udiCarrier.carrierHRF	S This element must be supported.	0..1	string	UDI Human Readable Barcode String
Device.distinctIdentifier		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
Device.manufactureDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
Device.expirationDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
Device.lotNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
Device.serialNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
Device.type	S This element must be supported.	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
Device.patient	S This element must be supported.	0..1	Reference(US Core Patient Profile)	Patient to whom Device is assigned
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Device.type	Base	extensible	FHIR Device Types	📦4.0.1	FHIR Std.

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Item used in healthcare
Device.id	Σ This element is included in summaries.	0..1	id	Logical id of this artifact
Device.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
Device.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Device.language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
Device.text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
Device.contained		0..*	Resource	Contained, inline Resources
Device.extension		0..*	Extension	Additional content defined by implementations
Device.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Device.identifier		0..*	Identifier	Instance identifier
Device.definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
Device.udiCarrier	Σ This element is included in summaries.	0..1	BackboneElement	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
Device.udiCarrier.id		0..1	string	Unique id for inter-element referencing
Device.udiCarrier.extension		0..*	Extension	Additional content defined by implementations
Device.udiCarrier.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.udiCarrier.deviceIdentifier	S This element must be supported. Σ This element is included in summaries.	1..1	string	Mandatory fixed portion of UDI
Device.udiCarrier.issuer		0..1	uri	UDI Issuing Organization
Device.udiCarrier.jurisdiction		0..1	uri	Regional UDI authority
Device.udiCarrier.carrierAIDC	Σ This element is included in summaries.	0..1	base64Binary	UDI Machine Readable Barcode String
Device.udiCarrier.carrierHRF	S This element must be supported. Σ This element is included in summaries.	0..1	string	UDI Human Readable Barcode String
Device.udiCarrier.entryType		0..1	code	barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
Device.status	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
Device.statusReason		0..*	CodeableConcept	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
Device.distinctIdentifier		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
Device.manufacturer		0..1	string	Name of device manufacturer
Device.manufactureDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
Device.expirationDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
Device.lotNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
Device.serialNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
Device.deviceName		0..*	BackboneElement	The name of the device as given by the manufacturer
Device.deviceName.id		0..1	string	Unique id for inter-element referencing
Device.deviceName.extension		0..*	Extension	Additional content defined by implementations
Device.deviceName.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.deviceName.name		1..1	string	The name of the device
Device.deviceName.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.
Device.modelNumber		0..1	string	The model number for the device
Device.partNumber		0..1	string	The part number of the device
Device.type	S This element must be supported.	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
Device.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
Device.specialization.id		0..1	string	Unique id for inter-element referencing
Device.specialization.extension		0..*	Extension	Additional content defined by implementations
Device.specialization.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.specialization.systemType		1..1	CodeableConcept	The standard that is used to operate and communicate
Device.specialization.version		0..1	string	The version of the standard that is used to operate and communicate
Device.version		0..*	BackboneElement	The actual design of the device or software version running on the device
Device.version.id		0..1	string	Unique id for inter-element referencing
Device.version.extension		0..*	Extension	Additional content defined by implementations
Device.version.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.version.type		0..1	CodeableConcept	The type of the device version
Device.version.component		0..1	Identifier	A single component of the device version
Device.version.value		1..1	string	The version text
Device.property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
Device.property.id		0..1	string	Unique id for inter-element referencing
Device.property.extension		0..*	Extension	Additional content defined by implementations
Device.property.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.property.type		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
Device.property.valueQuantity		0..*	Quantity	Property value as a quantity
Device.property.valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
Device.patient	S This element must be supported.	0..1	Reference(US Core Patient Profile)	Patient to whom Device is assigned
Device.owner		0..1	Reference(Organization)	Organization responsible for device
Device.contact		0..*	ContactPoint	Details for human/organization for support
Device.location		0..1	Reference(Location)	Where the device is found
Device.url		0..1	uri	Network address to contact device
Device.note		0..*	Annotation	Device notes and comments
Device.safety	Σ This element is included in summaries.	0..*	CodeableConcept	Safety Characteristics of Device
Device.parent		0..1	Reference(Device)	The parent device
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Device.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Device.udiCarrier.entryType	Base	required	UDIEntryType	📍4.0.1	FHIR Std.
Device.status	Base	required	FHIRDeviceStatus	📍4.0.1	FHIR Std.
Device.statusReason	Base	extensible	FHIRDeviceStatusReason	📍4.0.1	FHIR Std.
Device.deviceName.type	Base	required	DeviceNameType	📍4.0.1	FHIR Std.
Device.type	Base	extensible	FHIR Device Types	📦4.0.1	FHIR Std.

Constraints

Id

Grade

Path(s)

Description

Expression

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Item used in healthcare
Device.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Device.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Device.udiCarrier	Σ This element is included in summaries.	0..1	BackboneElement	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
Device.udiCarrier.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.udiCarrier.deviceIdentifier	S This element must be supported. Σ This element is included in summaries.	1..1	string	Mandatory fixed portion of UDI
Device.udiCarrier.carrierHRF	S This element must be supported. Σ This element is included in summaries.	0..1	string	UDI Human Readable Barcode String
Device.status	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
Device.distinctIdentifier		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
Device.manufactureDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
Device.expirationDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
Device.lotNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
Device.serialNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
Device.type	S This element must be supported.	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
Device.patient	S This element must be supported.	0..1	Reference(US Core Patient Profile)	Patient to whom Device is assigned
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Device.status	Base	required	FHIRDeviceStatus	📍4.0.1	FHIR Std.
Device.type	Base	extensible	FHIR Device Types	📦4.0.1	FHIR Std.

Constraints

Id

Grade

Path(s)

Description

Expression

Differential View

This structure is derived from Device

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Item used in healthcare
Device.udiCarrier		0..1	BackboneElement	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
Device.udiCarrier.deviceIdentifier	S This element must be supported.	1..1	string	Mandatory fixed portion of UDI
Device.udiCarrier.carrierHRF	S This element must be supported.	0..1	string	UDI Human Readable Barcode String
Device.distinctIdentifier		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
Device.manufactureDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
Device.expirationDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
Device.lotNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
Device.serialNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
Device.type	S This element must be supported.	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
Device.patient	S This element must be supported.	0..1	Reference(US Core Patient Profile)	Patient to whom Device is assigned
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Device.type	Base	extensible	FHIR Device Types	📦4.0.1	FHIR Std.

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Device		0..*	Device	Item used in healthcare
Device.id	Σ This element is included in summaries.	0..1	id	Logical id of this artifact
Device.meta	Σ This element is included in summaries.	0..1	Meta	Metadata about the resource
Device.implicitRules	?! This element is a modifier element. Σ This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Device.language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
Device.text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
Device.contained		0..*	Resource	Contained, inline Resources
Device.extension		0..*	Extension	Additional content defined by implementations
Device.modifierExtension	?! This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Device.identifier		0..*	Identifier	Instance identifier
Device.definition		0..1	Reference(DeviceDefinition)	The reference to the definition for the device
Device.udiCarrier	Σ This element is included in summaries.	0..1	BackboneElement	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Unique Device Identifier (UDI) Barcode string
Device.udiCarrier.id		0..1	string	Unique id for inter-element referencing
Device.udiCarrier.extension		0..*	Extension	Additional content defined by implementations
Device.udiCarrier.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.udiCarrier.deviceIdentifier	S This element must be supported. Σ This element is included in summaries.	1..1	string	Mandatory fixed portion of UDI
Device.udiCarrier.issuer		0..1	uri	UDI Issuing Organization
Device.udiCarrier.jurisdiction		0..1	uri	Regional UDI authority
Device.udiCarrier.carrierAIDC	Σ This element is included in summaries.	0..1	base64Binary	UDI Machine Readable Barcode String
Device.udiCarrier.carrierHRF	S This element must be supported. Σ This element is included in summaries.	0..1	string	UDI Human Readable Barcode String
Device.udiCarrier.entryType		0..1	code	barcode | rfid | manual + Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
Device.status	?! This element is a modifier element. Σ This element is included in summaries.	0..1	code	active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
Device.statusReason		0..*	CodeableConcept	online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
Device.distinctIdentifier		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: The distinct identification string
Device.manufacturer		0..1	string	Name of device manufacturer
Device.manufactureDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date when the device was made
Device.expirationDate		0..1	dateTime	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Date and time of expiry of this device (if applicable)
Device.lotNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Lot number of manufacture
Device.serialNumber		0..1	string	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: Serial number assigned by the manufacturer
Device.deviceName		0..*	BackboneElement	The name of the device as given by the manufacturer
Device.deviceName.id		0..1	string	Unique id for inter-element referencing
Device.deviceName.extension		0..*	Extension	Additional content defined by implementations
Device.deviceName.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.deviceName.name		1..1	string	The name of the device
Device.deviceName.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.
Device.modelNumber		0..1	string	The model number for the device
Device.partNumber		0..1	string	The part number of the device
Device.type	S This element must be supported.	1..1	CodeableConcept	The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
Device.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
Device.specialization.id		0..1	string	Unique id for inter-element referencing
Device.specialization.extension		0..*	Extension	Additional content defined by implementations
Device.specialization.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.specialization.systemType		1..1	CodeableConcept	The standard that is used to operate and communicate
Device.specialization.version		0..1	string	The version of the standard that is used to operate and communicate
Device.version		0..*	BackboneElement	The actual design of the device or software version running on the device
Device.version.id		0..1	string	Unique id for inter-element referencing
Device.version.extension		0..*	Extension	Additional content defined by implementations
Device.version.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.version.type		0..1	CodeableConcept	The type of the device version
Device.version.component		0..1	Identifier	A single component of the device version
Device.version.value		1..1	string	The version text
Device.property		0..*	BackboneElement	The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
Device.property.id		0..1	string	Unique id for inter-element referencing
Device.property.extension		0..*	Extension	Additional content defined by implementations
Device.property.modifierExtension	?! This element is a modifier element. Σ This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Device.property.type		1..1	CodeableConcept	Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
Device.property.valueQuantity		0..*	Quantity	Property value as a quantity
Device.property.valueCode		0..*	CodeableConcept	Property value as a code, e.g., NTP4 (synced to NTP)
Device.patient	S This element must be supported.	0..1	Reference(US Core Patient Profile)	Patient to whom Device is assigned
Device.owner		0..1	Reference(Organization)	Organization responsible for device
Device.contact		0..*	ContactPoint	Details for human/organization for support
Device.location		0..1	Reference(Location)	Where the device is found
Device.url		0..1	uri	Network address to contact device
Device.note		0..*	Annotation	Device notes and comments
Device.safety	Σ This element is included in summaries.	0..*	CodeableConcept	Safety Characteristics of Device
Device.parent		0..1	Reference(Device)	The parent device
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Device.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Device.udiCarrier.entryType	Base	required	UDIEntryType	📍4.0.1	FHIR Std.
Device.status	Base	required	FHIRDeviceStatus	📍4.0.1	FHIR Std.
Device.statusReason	Base	extensible	FHIRDeviceStatusReason	📍4.0.1	FHIR Std.
Device.deviceName.type	Base	required	DeviceNameType	📍4.0.1	FHIR Std.
Device.type	Base	extensible	FHIR Device Types	📦4.0.1	FHIR Std.

Constraints

Id

Grade

Path(s)

Description

Expression

This structure is derived from Device

Summary

Mandatory: 1 element(1 nested mandatory element)
Must-Support: 4 elements

Structures

This structure refers to these other structures:

• US Core Patient Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient)

Maturity: 4

Quick Start

Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the US Core interactions to access this profile's information (Profile Support + Interaction Support). Note that systems that support only US Core Profiles (Profile Only Support) are not required to support these interactions. See the US Core Server CapabilityStatement for a complete list of supported RESTful interactions for this IG.

• See the Scopes Format section for a description of the SMART scopes syntax.
• See the Search Syntax section for a description of the US Core search syntax.
• See the General Requirements section for additional rules and expectations when a Server requires status parameters.
• See the General Guidance section for additional guidance on searching for multiple patients.

US Core Scopes

Servers providing access to medical device data SHALL support these US Core SMART Scopes:

• resource level scopes: <patient|user|system>/Device.rs ^§

Mandatory Search Parameters:

The following search parameters and search parameter combinations SHALL be supported:

1. SHALL support searching for all devices for a patient using the patient search parameter

   GET [base]/Device?patient={Patient/}[id]

   Example:

   1. GET [base]/Device?patient=Patient/1137192

   Implementation Notes: Fetches a bundle of all US Core Device Profile resources for the specified patient ( see how to search by reference).

Optional Search Parameters:

The following search parameters and search parameter combinations SHOULD be supported

1. SHOULD support searching for a specific device type for a patient (for example, implantable devices) using the combination of the patient and type search parameters

   GET [base]/Device?patient={Patient/}[id]&type={system|}[search_code]

   Example:

   1. GET [base]/Device?patient=Patient/1137192&type=http://snomed.info/sct|468063009

   Implementation Notes: Fetches a bundle of all US Core Device Profile resources for the specified patient and type. ( see how to search by reference and how to search by token).

2. SHOULD support searching for all devices with a given status for a patient (for example all active devices) using the combination of the patient and status search parameters

   • Including support OR search on status (e.g.status={system|}[code],{system|}[code],...)

   GET [base]/Device?patient={Patient/}[id]&status={system|}[search_code]{,{system|}[code],...}

   Example:

   1. GET [base]/Device?patient=Patient/1137192&status=active

   Implementation Notes: Fetches a bundle of all US Core Device Profile resources for the specified patient and status ( see how to search by reference and how to search by token).