Release 5

This page is part of the FHIR Specification (v5.0.0: R5 - STU). This is the current published version. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2

Orders and Observations icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Business Compartments: No defined compartments

Detailed Descriptions for the elements in the Device resource.

Device
Element IdDevice
Definition

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.

Short DisplayItem used in healthcare
Cardinality0..*
TypeDomainResource
Requirements

Allows institutions to track their devices.

Summaryfalse
Invariants
Defined on this element
dev-1Rule only one Device.name.display SHALL be true when there is more than one Device.namename.where(display=true).count() <= 1
Device.identifier
Element IdDevice.identifier
Definition

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

Short DisplayInstance identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summaryfalse
Comments

Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

Device.displayName
Element IdDevice.displayName
Definition

The name used to display by default when the device is referenced. Based on intent of use by the resource creator, this may reflect one of the names in Device.name, or may be another simple name.

Short DisplayThe name used to display by default when the device is referenced
Cardinality0..1
Typestring
Summaryfalse
Device.definition
Element IdDevice.definition
Definition

The reference to the definition for the device.

Short DisplayThe reference to the definition for the device
Cardinality0..1
TypeCodeableReference(DeviceDefinition)
Summaryfalse
Device.udiCarrier
Element IdDevice.udiCarrier
Definition

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.

Short DisplayUnique Device Identifier (UDI) Barcode string
Cardinality0..*
Summarytrue
Comments

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

Device.udiCarrier.deviceIdentifier
Element IdDevice.udiCarrier.deviceIdentifier
Definition

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.

Short DisplayMandatory fixed portion of UDI
Cardinality1..1
Typestring
Alternate NamesDI
Summarytrue
Device.udiCarrier.issuer
Element IdDevice.udiCarrier.issuer
Definition

Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include:

  1. GS1: http://hl7.org/fhir/NamingSystem/gs1-di,
  2. HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI,
  3. ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
  4. ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.
Short DisplayUDI Issuing Organization
Cardinality1..1
Typeuri
Alternate NamesBarcode System
Summarytrue
Device.udiCarrier.jurisdiction
Element IdDevice.udiCarrier.jurisdiction
Definition

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/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi.

Short DisplayRegional UDI authority
Cardinality0..1
Typeuri
Requirements

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

Summaryfalse
Device.udiCarrier.carrierAIDC
Element IdDevice.udiCarrier.carrierAIDC
Definition

The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

Short DisplayUDI Machine Readable Barcode String
Cardinality0..1
Typebase64Binary
Alternate NamesAutomatic Identification and Data Capture
Summarytrue
Comments

The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. 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.udiCarrier.carrierHRF
Element IdDevice.udiCarrier.carrierHRF
Definition

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

Short DisplayUDI Human Readable Barcode String
Cardinality0..1
Typestring
Alternate NamesHuman Readable Form
Summarytrue
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.udiCarrier.entryType
Element IdDevice.udiCarrier.entryType
Definition

A coded entry to indicate how the data was entered.

Short Displaybarcode | rfid | manual | card | self-reported | electronic-transmission | unknown
Cardinality0..1
Terminology BindingUDI Entry Type (Required)
Typecode
Requirements

Supports a way to distinguish hand entered from machine read data.

Summaryfalse
Device.status
Element IdDevice.status
Definition

The Device record status. This is not the status of the device like availability.

Short Displayactive | inactive | entered-in-error
Cardinality0..1
Terminology BindingFHIR Device Status (Required)
Typecode
Is Modifiertrue (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid)
Summarytrue
Device.availabilityStatus
Element IdDevice.availabilityStatus
Definition

The availability of the device.

Short Displaylost | damaged | destroyed | available
Cardinality0..1
Terminology BindingFHIR Device Availability Status (Extensible)
TypeCodeableConcept
Summaryfalse
Device.biologicalSourceEvent
Element IdDevice.biologicalSourceEvent
Definition

An identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled.

Short DisplayAn identifier that supports traceability to the event during which material in this product from one or more biological entities was obtained or pooled
Cardinality0..1
TypeIdentifier
Alternate NamesDistinct Identification Code (DIC)
Summaryfalse
Comments

Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier.

Device.manufacturer
Element IdDevice.manufacturer
Definition

A name of the manufacturer or entity legally responsible for the device.

Short DisplayName of device manufacturer
Cardinality0..1
Typestring
Summaryfalse
Device.manufactureDate
Element IdDevice.manufactureDate
Definition

The date and time when the device was manufactured.

Short DisplayDate when the device was made
Cardinality0..1
TypedateTime
Summaryfalse
Device.expirationDate
Element IdDevice.expirationDate
Definition

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

Short DisplayDate and time of expiry of this device (if applicable)
Cardinality0..1
TypedateTime
Summaryfalse
Device.lotNumber
Element IdDevice.lotNumber
Definition

Lot number assigned by the manufacturer.

Short DisplayLot number of manufacture
Cardinality0..1
Typestring
Summaryfalse
Device.serialNumber
Element IdDevice.serialNumber
Definition

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

Short DisplaySerial number assigned by the manufacturer
Cardinality0..1
Typestring
Summaryfalse
Comments

Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_.

Device.name
Element IdDevice.name
Definition

This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.

Short DisplayThe name or names of the device as known to the manufacturer and/or patient
Cardinality0..*
Summaryfalse
Invariants
Affect this element
dev-1Rule only one Device.name.display SHALL be true when there is more than one Device.namename.where(display=true).count() <= 1
Device.name.value
Element IdDevice.name.value
Definition

The actual name that identifies the device.

Short DisplayThe term that names the device
Cardinality1..1
Typestring
Alternate NamesΣ
Summarytrue
Device.name.type
Element IdDevice.name.type
Definition

Indicates the kind of name. RegisteredName | UserFriendlyName | PatientReportedName.

Short Displayregistered-name | user-friendly-name | patient-reported-name
Cardinality1..1
Terminology BindingDevice Name Type (Required)
Typecode
Summarytrue
Device.name.display
Element IdDevice.name.display
Definition

Indicates the default or preferred name to be displayed.

Short DisplayThe preferred device name
Cardinality0..1
Typeboolean
Is Modifiertrue (Reason: This element is labelled as a modifier because it is a status element that can indicate that that a name is preferred.)
Summarytrue
Invariants
Affect this element
dev-1Rule only one Device.name.display SHALL be true when there is more than one Device.namename.where(display=true).count() <= 1
Device.modelNumber
Element IdDevice.modelNumber
Definition

The manufacturer's model number for the device.

Short DisplayThe manufacturer's model number for the device
Cardinality0..1
Typestring
Summaryfalse
Device.partNumber
Element IdDevice.partNumber
Definition

The part number or catalog number of the device.

Short DisplayThe part number or catalog number of the device
Cardinality0..1
Typestring
Summaryfalse
Comments

Alphanumeric Maximum 20.

Device.category
Element IdDevice.category
Definition

Devices may be associated with one or more categories.

Short DisplayIndicates a high-level grouping of the device
Cardinality0..*
Terminology BindingFHIR Device Category (Example)
TypeCodeableConcept
Summaryfalse
Device.type
Element IdDevice.type
Definition

The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device.

Short DisplayThe kind or type of device
Cardinality0..*
Terminology BindingDevice Type (Example)
TypeCodeableConcept
Summaryfalse
Comments

Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor.

Device.version
Element IdDevice.version
Definition

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

Short DisplayThe actual design of the device or software version running on the device
NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..*
Summaryfalse
Device.version.type
Element IdDevice.version.type
Definition

The type of the device version, e.g. manufacturer, approved, internal.

Short DisplayThe type of the device version, e.g. manufacturer, approved, internal
Cardinality0..1
Terminology BindingDevice Version Type (Example)
TypeCodeableConcept
Alternate NamesΣ
Summaryfalse
Device.version.component
Element IdDevice.version.component
Definition

The hardware or software module of the device to which the version applies.

Short DisplayThe hardware or software module of the device to which the version applies
Cardinality0..1
TypeIdentifier
Summaryfalse
Comments

Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.

Device.version.installDate
Element IdDevice.version.installDate
Definition

The date the version was installed on the device.

Short DisplayThe date the version was installed on the device
Cardinality0..1
TypedateTime
Summaryfalse
Device.version.value
Element IdDevice.version.value
Definition

The version text.

Short DisplayThe version text
Cardinality1..1
Typestring
Summaryfalse
Device.conformsTo
Element IdDevice.conformsTo
Definition

Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.

Short DisplayIdentifies the standards, specifications, or formal guidances for the capabilities supported by the device
Cardinality0..*
Summaryfalse
Device.conformsTo.category
Element IdDevice.conformsTo.category
Definition

Describes the type of the standard, specification, or formal guidance.

Short DisplayDescribes the common type of the standard, specification, or formal guidance. communication | performance | measurement
Cardinality0..1
Terminology BindingDevice Specification Category (Example)
TypeCodeableConcept
Summaryfalse
Device.conformsTo.specification
Element IdDevice.conformsTo.specification
Definition

Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.

Short DisplayIdentifies the standard, specification, or formal guidance that the device adheres to
Cardinality1..1
Terminology BindingDevice Specification Type (Example)
TypeCodeableConcept
Summaryfalse
Device.conformsTo.version
Element IdDevice.conformsTo.version
Definition

Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.

Short DisplaySpecific form or variant of the standard
NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..1
Typestring
Summaryfalse
Device.property
Element IdDevice.property
Definition

Static or essentially fixed characteristics or features of the device (e.g., time or timing attributes, resolution, accuracy, intended use or instructions for use, and physical attributes) that are not otherwise captured in more specific attributes.

Short DisplayInherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
Cardinality0..*
Summaryfalse
Comments

Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific [DeviceMetric] and recorded using [Observation]. Static characteristics of a device could also be documented in an associated [DeviceDefinition] instance. The Device instance's properties, and their values, could be, but need not be, the same as those described in an associated DeviceDefinition.

Device.property.type
Element IdDevice.property.type
Definition

Code that specifies the property, such as resolution, color, size, being represented.

Short DisplayCode that specifies the property being represented
Cardinality1..1
Terminology BindingDevice Property Type (Example)
TypeCodeableConcept
Summaryfalse
Device.property.value[x]
Element IdDevice.property.value[x]
Definition

The value of the property specified by the associated property.type code.

Short DisplayValue of the property
Cardinality1..1
TypeQuantity|CodeableConcept|string|boolean|integer|Range|Attachment
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summaryfalse
Comments

The text element in CodeableConcept.text is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g. a custom implant size, or a security classification which depends on configuration). Otherwise the string choice type is used for descriptive properties, or instructions.

Device.mode
Element IdDevice.mode
Definition

The designated condition for performing a task with the device.

Short DisplayThe designated condition for performing a task
Cardinality0..1
Terminology BindingFHIR Device Operation Mode (Example)
TypeCodeableConcept
Summaryfalse
Device.cycle
Element IdDevice.cycle
Definition

The series of occurrences that repeats during the operation of the device.

Short DisplayThe series of occurrences that repeats during the operation of the device
Cardinality0..1
TypeCount
Summaryfalse
Device.duration
Element IdDevice.duration
Definition

A measurement of time during the device's operation (e.g., days, hours, mins, etc.).

Short DisplayA measurement of time during the device's operation (e.g., days, hours, mins, etc.)
Cardinality0..1
TypeDuration
Summaryfalse
Device.owner
Element IdDevice.owner
Definition

An organization that is responsible for the provision and ongoing maintenance of the device.

Short DisplayOrganization responsible for device
Cardinality0..1
TypeReference(Organization)
Summaryfalse
Device.contact
Element IdDevice.contact
Definition

Contact details for an organization or a particular human that is responsible for the device.

Short DisplayDetails for human/organization for support
Cardinality0..*
TypeContactPoint
Summaryfalse
Comments

used for troubleshooting etc.

Device.location
Element IdDevice.location
Definition

The place where the device can be found.

Short DisplayWhere the device is found
Cardinality0..1
TypeReference(Location)
Requirements

Device.location can be used to track device location.

Summaryfalse
Device.url
Element IdDevice.url
Definition

A network address on which the device may be contacted directly.

Short DisplayNetwork address to contact device
Cardinality0..1
Typeuri
Summaryfalse
Comments

If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

Device.endpoint
Element IdDevice.endpoint
Definition

Technical endpoints providing access to services provided by the device defined at this resource.

Short DisplayTechnical endpoints providing access to electronic services provided by the device
Cardinality0..*
TypeReference(Endpoint)
Summaryfalse
Device.gateway
Element IdDevice.gateway
Definition

The linked device acting as a communication controller, data collector, translator, or concentrator for the current device (e.g., mobile phone application that relays a blood pressure device's data).

Short DisplayLinked device acting as a communication/data collector, translator or controller
Cardinality0..*
TypeCodeableReference(Device)
Summaryfalse
Comments

The Device.gateway may be used when the Device being referenced has a gateway and/or to capture one or more gateways associated with the device. If the Gateway is included in the Observation resource, the Observation.gatewayDevice should be used instead.

Device.note
Element IdDevice.note
Definition

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

Short DisplayDevice notes and comments
Cardinality0..*
TypeAnnotation
Summaryfalse
Device.safety
Element IdDevice.safety
Definition

Provides additional safety characteristics about a medical device. For example devices containing latex.

Short DisplaySafety Characteristics of Device
Cardinality0..*
Terminology BindingDevice Safety (Example)
TypeCodeableConcept
Summarytrue
Device.parent
Element IdDevice.parent
Definition

The higher level or encompassing device that this device is a logical part of.

Short DisplayThe higher level or encompassing device that this device is a logical part of
Cardinality0..1
TypeReference(Device)
HierarchyThis reference is part of a strict Hierarchy
Summaryfalse
Comments

For example a vital signs monitor (parent) where three separate modules can be plugged into such as interchangeable blood pressure, oximeter, temperature modules. These modules are represented as devices with the .parent valued to the vital signs monitor when plugged in.