FHIR Release 3 (STU) 5 Preview #3
This page is part of the FHIR Specification (v3.0.2: STU 3). The current version which supercedes this version is 4.0.1 . For a full list of available versions, see the Directory of published versions
Orders and Observations Work Group Maturity Level : 2   Trial Use Security Category : Business Compartments : Device Not linked to any defined compartments

Detailed Descriptions for the elements in the Device resource.

Alternate Names Serial Number CodeableConcept
Device
Element Id Device
Definition

This resource identifies an instance or a 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. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.

Control Cardinality 1..1 0..*
Type DomainResource
Requirements

Allows institutions to track their devices.

Device.identifier
Element Id Device.identifier
Definition

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

Note This is a business identifer, identifier, not a resource identifier (see discussion )
Control Cardinality 0..*
Type Identifier
Comments

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. For UDI , this element corresponds

Device.displayName
Element Id Device.displayName
Definition

The name used to display by default when the variable portion device is referenced. Based on intent of use by the UDI that identifies the serial number resource creator, this may reflect one of a specific device. See UDI mappings the names in Device.deviceName, or may be another simple name.

Cardinality for a complete mapping of UDI parts 0..1
Type string
Device.definition
Element Id Device.definition
Definition

The reference to Device. the definition for the device.

Cardinality 0..1
Type Reference ( DeviceDefinition )
Device.udi Device.udiCarrier
Element Id Device.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.

Control Cardinality 0..1 0..*
Summary true
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.udi.deviceIdentifier Device.udiCarrier.deviceIdentifier
Element Id Device.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.

Control Cardinality 0..1
Type string
Alternate Names DI
Summary true
Device.udi.name Device.udiCarrier.issuer
Element Id Device.udiCarrier.issuer
Definition

Name of device as used in labeling or catalog. 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-dI,
  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.
Control Cardinality 0..1
Type string uri
Alternate Names Brand Name Barcode System
Summary true Device.udiCarrier.jurisdiction
Comments Element Id Use the Device.type for a generic type or kind of device name. Note the GUDID lists the name as the 'Brand Name'. Device.udi.jurisdiction Device.udiCarrier.jurisdiction
Definition

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. 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.

Control Cardinality 0..1
Type uri
Requirements

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

Device.udi.carrierHRF Device.udiCarrier.carrierAIDC
Definition The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. Control 0..1 Type string Alternate Names Human Readable Form Summary true Comments Element Id 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.udi.carrierAIDC Device.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 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.

Control Cardinality 0..1
Type base64Binary
Alternate Names Automatic Identification and Data Capture
Summary true
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.udi.issuer Device.udiCarrier.carrierHRF
Element Id Device.udiCarrier.carrierHRF
Definition

Organization that is charged with issuing UDIs for devices. For example, The full UDI carrier as the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 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. human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

Control Cardinality 0..1
Type uri string
Alternate Names Barcode System Human Readable Form
Summary true
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.udi.entryType Device.udiCarrier.entryType
Element Id Device.udiCarrier.entryType
Definition

A coded entry to indicate how the data was entered.

Control Cardinality 0..1
Terminology Binding UDIEntryType ( Required )
Type code
Requirements

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

Device.status
Element Id Device.status
Definition

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

Control Cardinality 0..1
Terminology Binding FHIRDeviceStatus ( Required )
Type code
Is Modifier true (Reason: This element is labelled 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)
Summary true
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.type Device.statusReason
Element Id Device.statusReason
Definition

Code or identifier to identify a kind Reason for the status of device. the Device record. For example, why is the record not active.

Control Cardinality 0..1 0..*
Terminology Binding FHIR Device Types FHIRDeviceStatusReason ( Example Extensible )
Type CodeableConcept
Device.lotNumber Device.distinctIdentifier
Element Id Device.distinctIdentifier
Definition

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

Control Cardinality 0..1
Type string
Alternate Names Distinct Identification Code (DIC)
Comments

For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c) .

Device.manufacturer
Element Id Device.manufacturer
Definition

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

Control Cardinality 0..1
Type string
Device.manufactureDate
Element Id Device.manufactureDate
Definition

The date and time when the device was manufactured.

Control Cardinality 0..1
Type dateTime
Device.expirationDate
Element Id Device.expirationDate
Definition

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

Control Cardinality 0..1
Type dateTime
Device.model Device.lotNumber
Element Id Device.lotNumber
Definition

Lot number assigned by the manufacturer.

Cardinality 0..1
Type string
Device.serialNumber
Element Id Device.serialNumber
Definition

The "model" is an identifier serial number assigned by the manufacturer to identify organization when the product device was manufactured.

Cardinality 0..1
Type string
Comments

Alphanumeric Maximum 20.

Device.deviceName
Element Id Device.deviceName
Definition

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

Cardinality 0..*
Device.deviceName.name
Element Id Device.deviceName.name
Definition

The name that identifies the device.

Cardinality 1..1
Type string
Alternate Names Σ
Device.deviceName.type
Element Id Device.deviceName.type
Definition

The type of deviceName. Note that ManufactureDeviceName means that the name is shared by the all devices sold name as given by the same type. manufacturer, not the name of the manufacturer. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

Control Cardinality 1..1
Terminology Binding DeviceNameType ( Required )
Type code
Device.modelNumber
Element Id Device.modelNumber
Definition

The manufacturer's model number for the device.

Cardinality 0..1
Type string
Device.version Device.partNumber
Element Id Device.partNumber
Definition

The version part number or catalog number of the device, if device.

Cardinality 0..1
Type string
Comments

Alphanumeric Maximum 20.

Device.type
Element Id Device.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.

Cardinality 0..*
Terminology Binding Device Type ( Example )
Type CodeableConcept
Device.specialization
Element Id Device.specialization
Definition

The device has multiple releases under function, including in some cases whether or not the same model, functionality conforms to some standard. For example, a PHD blood pressure specialization indicates that the device conforms to the IEEE 11073-10407 Blood Pressure Specialization. This is NOT an alternate name or an additional descriptive name given by the manufacturer. That would be found in the deviceName element. In the PHD case, there are 11073 10101 nomenclature codes that define the specialization standards and that will be used, for example, in the PHD case for the specialization.systemType element. The specialization.version would be the version of the standard if the device systemType referred to a standard.

Cardinality 0..*
Device.specialization.systemType
Element Id Device.specialization.systemType
Definition

The standard that is software used to operate and communicate.

Cardinality 1..1
Type CodeableConcept
Alternate Names Σ
Device.specialization.version
Element Id Device.specialization.version
Definition

The version of the standard that is used to operate and communicate.

Note This is a business versionId, not a resource version id (see discussion )
Cardinality 0..1
Type string
Device.version
Element Id Device.version
Definition

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

Note This is a business versionId, not a resource version id (see discussion )
Control Cardinality 0..*
Device.version.type
Element Id Device.version.type
Definition

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

Cardinality 0..1
Type CodeableConcept
Alternate Names Σ
Device.version.component
Element Id Device.version.component
Definition

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

Cardinality 0..1
Type Identifier
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.value
Element Id Device.version.value
Definition

The version text.

Cardinality 1..1
Type string
Device.property
Element Id Device.property
Definition

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

Cardinality 0..*
Device.property.type
Element Id Device.property.type
Definition

Code that specifies the property being represented. No codes are specified but the MDC codes are an example: https://build.fhir.org/mdc.html.

Cardinality 1..1
Type CodeableConcept
Device.property.valueQuantity
Element Id Device.property.valueQuantity
Definition

Property value as a quantity.

Cardinality 0..*
Type Quantity
Device.property.valueCode
Element Id Device.property.valueCode
Definition

Property value as a code, e.g., NTP4 (synced to NTP).

Cardinality 0..*
Type CodeableConcept
Device.patient
Element Id Device.patient
Definition

Patient information, If if the device is affixed to, or associated to a person. patient for their specific use, irrespective of the procedure, use, observation, or other activity that the device is involved in.

Control Cardinality 0..1
Type Reference ( Patient )
Requirements

If the device is implanted implanted, or otherwise in a patient, use by the patient (e.g., wheelchair, oxygen tank), without further describing its specific use, then need the device needs to associate be associated to the patient.

Device.operationalStatus
Element Id Device.operationalStatus
Definition

The status of the device itself - whether it is switched on, or activated, etc.

Cardinality 0..1
Device.operationalStatus.value
Element Id Device.operationalStatus.value
Definition

on |off | standby.

Cardinality 0..1
Type CodeableConcept
Device.operationalStatus.reason
Element Id Device.operationalStatus.reason
Definition

The reasons given for the current operational status - i.e. why is the device switched on etc.

Cardinality 0..*
Type CodeableConcept
Device.associationStatus
Element Id Device.associationStatus
Definition

The state of the usage or application of the device - whether the device is implanted, or explanted, or attached to the patient.

Cardinality 0..1
Device.associationStatus.value
Element Id Device.associationStatus.value
Definition

implanted|explanted|attached.

Cardinality 0..1
Type CodeableConcept
Device.associationStatus.reason
Element Id Device.associationStatus.reason
Definition

The reasons given for the current association status - i.e. why is the device explanted, or attached to the patient, etc.

Cardinality 0..*
Type CodeableConcept
Device.owner
Element Id Device.owner
Definition

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

Control Cardinality 0..1
Type Reference ( Organization )
Device.contact
Element Id Device.contact
Definition

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

Control Cardinality 0..*
Type ContactPoint
Comments

used for troubleshooting etc.

Device.location
Element Id Device.location
Definition

The place where the device can be found.

Control Cardinality 0..1
Type Reference ( Location )
Requirements

Device.location can be used to track device location.

Device.url
Element Id Device.url
Definition

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

Control Cardinality 0..1
Type uri
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.note
Element Id Device.note
Definition

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

Control Cardinality 0..*
Type Annotation
Device.safety
Element Id Device.safety
Definition

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

Control Cardinality 0..*
Terminology Binding Type DeviceSafety ( Example CodeableConcept )
Type Summary true
Device.parent
Element Id Device.parent
Definition

The device that this device is attached to or is part of.

Cardinality 0..1
Summary Type true Reference ( Device )