Device

A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.

Overview

Device is used to record and transmit Unique Device Identifier (UDI) information about a device such as a patient's implant.It is referenced by other resources for recording which device performed an action such as a procedure or an observation, referenced when prescribing and dispensing devices for patient use or for ordering supplies.

This profile is used to define the content that will be returned by the API Server in response to requests to access Device resources. All elements described in the Definition and Detailed Definitions below are supported, which means that the API Server is capable of supplying these fields from the product database when they have been populated via the product or its APIs.

This resource is referenced by: Procedure.

List of profiles we support:

Definition

The official URL for this profile is:

https://fhir.athena.io/StructureDefinition/ah-device

The base definition for this profile is:

Device

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device0..*DeviceItem used in healthcare
... idΣ0..1stringLogical id of this artifact
... metaΣ0..1MetaMetadata about the resource
... implicitRules?!Σ0..1uriA set of rules under which this content was created
... text0..1NarrativeText summary of the resource, for human interpretation
... contained0..*ResourceContained, inline Resources
... Slices for extension1..*ExtensionExtension
Slice: Unordered, Open by value:url
... ahChartSharingGroup0..1Reference(Organization)athenahealth Chart Sharing Group
URL: https://fhir.athena.io/StructureDefinition/ah-chart-sharing-group
... ahPractice1..1Reference(Organization)athenahealth Practice
URL: https://fhir.athena.io/StructureDefinition/ah-practice
... ahDeviceImplantDetails0..1(Complex)athenahealth Device Implant Details
URL: https://fhir.athena.io/StructureDefinition/ah-device-implant-details
... modifierExtension?!0..*ExtensionExtensions that cannot be ignored
... udiCarrierΣ0..1BackboneElementUnique Device Identifier (UDI) Barcode string
.... id0..1stringUnique id for inter-element referencing
.... extension0..*ExtensionAdditional content defined by implementations
.... modifierExtension?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... deviceIdentifierΣ0..1stringMandatory fixed portion of UDI
.... jurisdiction0..1uriRegional UDI authority
.... carrierHRFΣ0..1stringUDI Human Readable Barcode String
... status?!Σ0..1codeactive | inactive | entered-in-error | unknown
Binding: FHIRDeviceStatus (required): The availability status of the device.

... distinctIdentifier0..1stringThe distinct identification string
... manufactureDate0..1dateTime (YYYY-MM-DDThh:mm:ss+zz:zz)Date when the device was made
... expirationDate0..1dateTime (YYYY-MM-DDThh:mm:ss+zz:zz)Date and time of expiry of this device (if applicable)
... lotNumber0..1stringLot number of manufacture
... serialNumber0..1stringSerial number assigned by the manufacturer
... type0..1CodeableConceptThe kind or type of device
Binding: DeviceType (example): Codes to identify medical devices.

... version0..*BackboneElementThe actual design of the device or software version running on the device
.... id0..1stringUnique id for inter-element referencing
.... extension0..*ExtensionAdditional content defined by implementations
.... modifierExtension?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... type0..1CodeableConceptThe type of the device version
.... component0..1IdentifierA single component of the device version
.... value1..1stringThe version text
... patient0..1Reference(Patient)Patient to whom Device is affixed
... note0..*AnnotationDevice notes and comments

doco Documentation for this format

Detailed Definitions


Device

A type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.

Cardinality 0..*
Type Root

Device.id

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Cardinality 0..1
Type string
Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Device.meta

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

Cardinality 0..1
Type Meta

Device.implicitRules

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

Cardinality 0..1
Type uri
Comments Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Device.language

The base language in which the resource is written.

Cardinality 0..1
Type code Binding: CommonLanguages (preferred)
Comments Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Device.text

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Cardinality 0..1
Type Narrative
Comments Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Device.contained

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Cardinality 0..*
Type Resource
Comments This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Device.extension

An Extension

Cardinality 1..*
Type Extension

Device.extension:ahChartSharingGroup

An Extension used to reference a specific athenahealth chart sharing group Organization.

Cardinality 0..1
Type Extension(AthenaChartSharingGroup)

Device.extension:ahPractice

An Extension used to reference a specific athenahealth practice Organization.

Cardinality 1..1
Type Extension(AthenaPractice)

Device.extension:ahDeviceImplantDetails

An Extension containing details about a Device and the implant details for the referenced patient.

Cardinality 0..1
Type Extension(AthenaDeviceImplantDetails)

Device.modifierExtension

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality 0..*
Type Extension
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Requirements Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Device.udiCarrier

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

Cardinality 0..1
Type BackboneElement
Comments UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](device-mappings.html#udi) for a complete mapping of UDI parts to Device.

Device.udiCarrier.id

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Cardinality 0..1
Type string

Device.udiCarrier.extension

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Cardinality 0..*
Type Extension
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Device.udiCarrier.modifierExtension

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality 0..*
Type Extension
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Requirements Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Device.udiCarrier.deviceIdentifier

The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

Cardinality 0..1
Type string

Device.udiCarrier.jurisdiction

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

Cardinality 0..1
Type uri
Requirements Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

Device.udiCarrier.carrierHRF

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

Cardinality 0..1
Type string
Comments If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Device.status

Status of the Device availability.

Cardinality 0..1
Type code Binding: FHIRDeviceStatus (required)
Comments This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

Device.distinctIdentifier

The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.

Cardinality 0..1
Type string
Comments For example, this applies to devices in the United States regulated under *Code of Federal Regulation 21CFR§1271.290(c)*.

Device.manufactureDate

The date and time when the device was manufactured.

Cardinality 0..1
Type dateTime (YYYY-MM-DDThh:mm:ss+zz:zz)

Device.expirationDate

The date and time beyond which this device is no longer valid or should not be used (if applicable).

Cardinality 0..1
Type dateTime (YYYY-MM-DDThh:mm:ss+zz:zz)

Device.lotNumber

Lot number assigned by the manufacturer.

Cardinality 0..1
Type string

Device.serialNumber

The serial number assigned by the organization when the device was manufactured.

Cardinality 0..1
Type string
Comments Alphanumeric Maximum 20.

Device.type

The kind or type of device.

Cardinality 0..1
Type CodeableConcept Binding: DeviceType (example)

Device.version

The actual design of the device or software version running on the device.

Cardinality 0..*
Type BackboneElement

Device.version.id

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Cardinality 0..1
Type string

Device.version.extension

May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Cardinality 0..*
Type Extension
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Device.version.modifierExtension

May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Cardinality 0..*
Type Extension
Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Requirements Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Device.version.type

The type of the device version.

Cardinality 0..1
Type CodeableConcept

Device.version.component

A single component of the device version.

Cardinality 0..1
Type Identifier

Device.version.value

The version text.

Cardinality 1..1
Type string

Device.patient

Patient information, If the device is affixed to a person.

Cardinality 0..1
Type Reference(Patient)
Requirements If the device is implanted in a patient, then need to associate the device to the patient.

Device.note

Descriptive information, usage information or implantation information that is not captured in an existing element.

Cardinality 0..*
Type Annotation

Interactions

READ

Read interactions are executed as specified in the HL7 FHIR RESTful API read specification. To read Device resources, an application will perform an HTTP GET specifying the logical ID of the Device being retrieved.

The [patient|user|system]/Device.read authorization scope is required.

GET
/fhir/r4/Device/{logicalId}
Try in Postman

Parameters

required

conditional required

Name Type Description
logicalId string (REQUIRED) The logical ID of the resource (alias: Resource.id). It is specified in the URL path and not as a query parameter.

Response Codes

Response code Description
200 OK The requested Device resource was found and is contained within the body of the HTTP response.
400 Bad Request The server could not understand the request due to invalid syntax. The body of the HTTP response will contain an OperationOutcome resource that indicates the invalid request could not be processed.
404 Not Found The requested resource does not exist. The body of the HTTP response will contain an OperationOutcome resource that indicates the resource could not be found.
410 Gone The requested resource has been permanently deleted from server with no forwarding address. The body of the HTTP response will contain an OperationOutcome resource that indicates the resource could not be found.
500 Internal Server Error The server has encountered a situation it doesn't know how to handle. The body of the HTTP response will contain an OperationOutcome resource that indicates the nature of the error.
5xx Server Error The server may return other error codes to indicate other error conditions. The body of the HTTP response will contain an OperationOutcome resource that indicates the nature of the error.

GET SEARCH

Search interactions are executed as specified in the HL7 FHIR RESTful API search specification. To search for Device resources using the HTTP GET method, an application will perform the HTTP GET specifying the query parameters associated with the Device in the URL.

The [patient|user|system]/Device.read authorization scope is required.

The following additional authorization scopes might be required depending on _include and/or _revinclude search parameters used:

  • [patient|user|system]/Organization.read
  • [patient|user|system]/Patient.read
  • [patient|user|system]/Provenance.read

GET
/fhir/r4/Device
Try in Postman

Parameters

Device search requests conditionally require one of the following search parameters or search parameter combinations in order to match and return a result set:
  • patient
  • _id

required

conditional required

Name Type Description
ah-practice reference Identify the athenahealth Practice Organization (e.g., 'ah-practice=Organization/a-1.Practice-[practiceId]')
patient reference (CONDITIONAL REQUIRED) Device.patient resource reference to FHIR Patient resource
_count number The number of Device resources to return per page for paged search results.
cursor token Search by cursor token for first resource to return in a paged search result
_id token (CONDITIONAL REQUIRED) Device._id resource reference to FHIR device resource
ah-chart-sharing-group reference Search by athenahealth Chart Sharing Group (e.g., 'ah-chart-sharing-group=Organization/a-[practiceId].CSG-[csgId]') for resources containing the 'Athena Chart Sharing Group' Extension
_include string Requests the server to include the referenced resource(s) in the search results according to the specified search parameter. Additional authorization scope(s) will be required. The supported _include parameter values are:
  • Device:ah-chart-sharing-group - Included resource(s) Organization and required scope(s) [patient|user|system]/Organization.read
  • Device:ah-practice - Included resource(s) Organization and required scope(s) [patient|user|system]/Organization.read
  • Device:patient - Included resource(s) Patient and required scope(s) [patient|user|system]/Patient.read
_revinclude string Requests the server to include the associated resource(s) in the search results according to the specified search parameter. Additional authorization scope(s) will be required. The supported _revinclude parameter values are:
  • Provenance:target - Associated resource(s) Provenance and required scope(s) [patient|user|system]/Provenance.read

Response Codes

Response code Description
200 OK The search request succeeded. The body of the HTTP response will contain a Bundle resource containing the results of the search.
403 Forbidden The server refused to perform the search due to a missing required search parameter. The body of the HTTP response will contain an OperationOutcome resource that includes the required search parameters.
500 Internal Server Error The server has encountered a situation it doesn't know how to handle. The body of the HTTP response will contain an OperationOutcome resource that indicates the nature of the error.
5xx Server Error The server may return other error codes to indicate other error conditions. The body of the HTTP response will contain an OperationOutcome resource that indicates the nature of the error.

POST SEARCH

Search interactions are executed as specified in the HL7 FHIR RESTful API search specification. To search for Device resources using the HTTP POST method, an application will perform the HTTP POST specifying the query parameters associated with the Device in the request body.

The [patient|user|system]/Device.read authorization scope is required.

The following additional authorization scopes might be required depending on _include and/or _revinclude search parameters used:

  • [patient|user|system]/Organization.read
  • [patient|user|system]/Patient.read
  • [patient|user|system]/Provenance.read

POST
/fhir/r4/Device/_search
Try in Postman

Request Header

Content-Type: application/x-www-form-urlencoded

Request Body

param1=value1&param2=value2...

Parameters

Device search requests conditionally require one of the following search parameters or search parameter combinations in order to match and return a result set:
  • patient
  • _id

required

conditional required

Name Type Description
ah-practice reference Identify the athenahealth Practice Organization (e.g., 'ah-practice=Organization/a-1.Practice-[practiceId]')
patient reference (CONDITIONAL REQUIRED) Device.patient resource reference to FHIR Patient resource
_count number The number of Device resources to return per page for paged search results.
cursor token Search by cursor token for first resource to return in a paged search result
_id token (CONDITIONAL REQUIRED) Device._id resource reference to FHIR device resource
ah-chart-sharing-group reference Search by athenahealth Chart Sharing Group (e.g., 'ah-chart-sharing-group=Organization/a-[practiceId].CSG-[csgId]') for resources containing the 'Athena Chart Sharing Group' Extension
_include string Requests the server to include the referenced resource(s) in the search results according to the specified search parameter. Additional authorization scope(s) will be required. The supported _include parameter values are:
  • Device:ah-chart-sharing-group - Included resource(s) Organization and required scope(s) [patient|user|system]/Organization.read
  • Device:ah-practice - Included resource(s) Organization and required scope(s) [patient|user|system]/Organization.read
  • Device:patient - Included resource(s) Patient and required scope(s) [patient|user|system]/Patient.read
_revinclude string Requests the server to include the associated resource(s) in the search results according to the specified search parameter. Additional authorization scope(s) will be required. The supported _revinclude parameter values are:
  • Provenance:target - Associated resource(s) Provenance and required scope(s) [patient|user|system]/Provenance.read

Response Codes

Response code Description
200 OK The search request succeeded. The body of the HTTP response will contain a Bundle resource containing the results of the search.
403 Forbidden The server refused to perform the search due to a missing required search parameter. The body of the HTTP response will contain an OperationOutcome resource that includes the required search parameters.
500 Internal Server Error The server has encountered a situation it doesn't know how to handle. The body of the HTTP response will contain an OperationOutcome resource that indicates the nature of the error.
5xx Server Error The server may return other error codes to indicate other error conditions. The body of the HTTP response will contain an OperationOutcome resource that indicates the nature of the error.
Was this information helpful? Yes | No Thank you for your feedback! What went wrong? Incomplete or incorrect information | Irrelevant Content | Others
Submit

On this Page