US Core Implementation Guide
8.0.1 - STU 8

US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 8.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions

## Resource Profile: US Core Implantable Device Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-implantable-device | Version: 8.0.1
Standards status: Trial-use | Maturity Level: 3 | Computable Name: USCoreImplantableDeviceProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.32
Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License

The US Core Device Profile inherits from the FHIR Device resource; refer to it for scope and usage definitions. This profile meets the requirements of the U.S. Core Data for Interoperability (USCDI) Unique Device Identifier - Implantable Data Element. It sets minimum expectations for the Device resource to record, search, and fetch UDI information associated with a patient's implantable device(s). It specifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

Example Usage Scenarios:

The following are example usage scenarios for this profile:

- Query for a Patient's Implantable Devices
- Record or update a Patient Implantable 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 Implantable Device Must Have:

1. a code identifying the type of device
2. a patient

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

Each Implantable Device Must Support:

1. A Unique Device Identifier (UDI) numeric or alphanumeric code as the Human Readable Form (HRF) string representation of the barcode
2. The Device Identifier (UDI-DI)
3. the manufacture date
4. the expiration date
5. the lot number
6. the serial number
7. the distinct identifier (i.e., the distinct identification code)

Profile Specific Implementation Guidance:

- For non-implantable devices (for example, software or crutches), use the base FHIR Device resource or other use case-specific Device profiles.
- This profile supports the requirement to retrieve a 170.315(a)(14) Implantable device list. It follows the HL7 Cross Paradigm Implementation Guide: UDI Pattern guidelines for exchanging information about the use and implantation of medical devices in patients.

  - A 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 Implantable Device Profile elements in the table below:

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

  - Implementers are encouraged to 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 implantable 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).

- Implantable 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 Implantable Device Profile elements.

  UDI may not be present in all scenarios, such as historical implantable 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 implantable medical devices as follows:

  data element | US Core Implantable Device Profile element
  --- | ---
  manufacturer | `Device.manufacturer`
  model | `Device.model`

- Servers SHOULD support query by `Device.type` to allow Clients to request the patient's devices by a specific type. Note: `Device.type` is too granular to differentiate implantable vs. non-implantable devices.

- 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

Usages:

- Examples for this Profile: Device/udi-1, Device/udi-2 and Device/udi-3
- CapabilityStatements using this Profile: US Core Client CapabilityStatement and US Core Server CapabilityStatement

You can also check for usages in the FHIR IG Statistics

Changes since version 7.0.0:

- No changes

### Formal Views of Profile Content

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

- 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
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored
udiCarrier | S Σ | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S Σ | 1..1 | string | Mandatory fixed portion of UDI
carrierHRF | S Σ | 0..1 | string | UDI Human Readable Barcode String
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
distinctIdentifier | S | 0..1 | string | The distinct identification string
manufactureDate | S | 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
type | S | 1..1 | CodeableConcept | The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
patient | S | 1..1 | Reference(US Core Patient Profile) | Patient to whom Device is affixed
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
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Device | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Device | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Device | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

This structure is derived from Device

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
carrierHRF | S | 0..1 | string | UDI Human Readable Barcode String
distinctIdentifier | S | 0..1 | string | The distinct identification string
manufactureDate | S | 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
type | S | 1..1 | CodeableConcept | The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
patient | S | 1..1 | Reference(US Core Patient Profile) | Patient to whom Device is affixed
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
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 Bindings | Purpose
AllLanguages | Max Binding
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
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 | S Σ | 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 | S Σ | 1..1 | string | Mandatory fixed portion of UDI
issuer |  | 0..1 | uri | UDI Issuing Organization
jurisdiction |  | 0..1 | uri | Regional UDI authority
carrierAIDC | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String
carrierHRF | S Σ | 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 | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the 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.
distinctIdentifier | S | 0..1 | string | The distinct identification string
manufacturer |  | 0..1 | string | Name of device manufacturer
manufactureDate | S | 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): Codes to identify medical devices
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) | 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 |  | 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
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
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Device | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Device | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Device | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

This structure is derived from Device

Summary

Mandatory: 2 elements(1 nested mandatory element)
Must-Support: 10 elements

Structures

This structure refers to these other structures:

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

Maturity: 3

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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 | S Σ | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
deviceIdentifier | S Σ | 1..1 | string | Mandatory fixed portion of UDI
carrierHRF | S Σ | 0..1 | string | UDI Human Readable Barcode String
status | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the device.
distinctIdentifier | S | 0..1 | string | The distinct identification string
manufactureDate | S | 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
type | S | 1..1 | CodeableConcept | The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
patient | S | 1..1 | Reference(US Core Patient Profile) | Patient to whom Device is affixed
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
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Device | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Device | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Device | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

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
udiCarrier | S | 0..1 | BackboneElement | Unique Device Identifier (UDI) Barcode string
deviceIdentifier | S | 1..1 | string | Mandatory fixed portion of UDI
carrierHRF | S | 0..1 | string | UDI Human Readable Barcode String
distinctIdentifier | S | 0..1 | string | The distinct identification string
manufactureDate | S | 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
type | S | 1..1 | CodeableConcept | The kind or type of device Binding: FHIRDeviceTypes (extensible): Codes to identify medical devices
patient | S | 1..1 | Reference(US Core Patient Profile) | Patient to whom Device is affixed
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
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 Bindings | Purpose
AllLanguages | Max Binding
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
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 | S Σ | 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 | S Σ | 1..1 | string | Mandatory fixed portion of UDI
issuer |  | 0..1 | uri | UDI Issuing Organization
jurisdiction |  | 0..1 | uri | Regional UDI authority
carrierAIDC | Σ | 0..1 | base64Binary | UDI Machine Readable Barcode String
carrierHRF | S Σ | 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 | ?!Σ | 0..1 | code | active | inactive | entered-in-error | unknown Binding: FHIRDeviceStatus (required): The availability status of the 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.
distinctIdentifier | S | 0..1 | string | The distinct identification string
manufacturer |  | 0..1 | string | Name of device manufacturer
manufactureDate | S | 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): Codes to identify medical devices
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) | 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 |  | 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
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
dom-2 | error | Device | If the resource is contained in another resource, it SHALL NOT contain nested Resources | `contained.contained.empty()`
dom-3 | error | Device | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource | `contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4 | error | Device | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated | `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5 | error | Device | If a resource is contained in another resource, it SHALL NOT have a security label | `contained.meta.security.empty()`
dom-6 | best practice | Device | A resource should have narrative for robust management | `text.`div`.exists()`
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children | `hasValue() or (children().count() > id.count())`
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both | `extension.exists() != value.exists()`

This structure is derived from Device

Summary

Mandatory: 2 elements(1 nested mandatory element)
Must-Support: 10 elements

Structures

This structure refers to these other structures:

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

Maturity: 3

Other representations of profile: CSV, Excel, Schematron

### Notes:

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 implantable device data SHALL support these US Core SMART Scopes:

- resource level scopes: `<patient|user|system>/Device.rs`

#### Mandatory Search Parameters:

1. SHALL support searching for all devices for a patient, including implantable devices using the `patient` search parameter:

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

   Example:

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

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

#### Optional Search Parameters:

The following search parameter combinations SHOULD be supported:

1. SHOULD support searching using the combination of the `patient` and `type` search parameters:

   `GET [base]/Device?patient={Type/}[id]&type={system|}[code]`

   Example:

   1. GET [base]/Device?patient=1316024&type=http://snomed.info/sct|468063009

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

2. SHOULD support searching using the combination of the `patient` and `status` search parameters:

   - including support for OR search on `status` (e.g.`status={system|}[code],{system|}[code],...`)

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

   Example:

   1. GET [base]/Device?patient=1316024&status=active

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