Release 5 Draft Ballot

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions

Orders and Observations Work GroupMaturity Level: 2 Trial UseSecurity Category: Business Compartments: Patient

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.

Cardinality0..*
TypeDomainResource
Requirements

Allows institutions to track their devices.

Summaryfalse
Device.identifier
Element IdDevice.identifier
Definition

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

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.deviceName, or may be another simple name.

Cardinality0..1
Typestring
Summaryfalse
Device.definition
Element IdDevice.definition
Definition

The 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.

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.

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.
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.

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.

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.

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.

Cardinality0..1
Terminology BindingUDIEntryType (Required)
Typecode
Requirements

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

Summaryfalse
Device.status
Element IdDevice.status
Definition

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

Cardinality0..1
Terminology BindingFHIRDeviceStatus (Required)
Typecode
Is Modifiertrue (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)
Summarytrue
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.statusReason
Element IdDevice.statusReason
Definition

Reason for the status of the Device record. For example, why is the record not active.

Cardinality0..*
Terminology BindingFHIRDeviceStatusReason :
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.

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.

Cardinality0..1
Typestring
Summaryfalse
Device.manufactureDate
Element IdDevice.manufactureDate
Definition

The date and time when the device was manufactured.

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).

Cardinality0..1
TypedateTime
Summaryfalse
Device.lotNumber
Element IdDevice.lotNumber
Definition

Lot number assigned by the manufacturer.

Cardinality0..1
Typestring
Summaryfalse
Device.serialNumber
Element IdDevice.serialNumber
Definition

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

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.deviceName
Element IdDevice.deviceName
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.

Cardinality0..*
Summaryfalse
Device.deviceName.name
Element IdDevice.deviceName.name
Definition

The name that identifies the device.

Cardinality1..1
Typestring
Alternate NamesΣ
Summaryfalse
Device.deviceName.type
Element IdDevice.deviceName.type
Definition

The type of deviceName. Note that ManufactureDeviceName means that the name is the name as given by the manufacturer, not the name of the manufacturer. RegisteredName | UserFriendlyName | PatientReportedName.

Cardinality1..1
Terminology BindingDeviceNameType (Required)
Typecode
Summaryfalse
Device.modelNumber
Element IdDevice.modelNumber
Definition

The 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.

Cardinality0..1
Typestring
Summaryfalse
Comments

Alphanumeric Maximum 20.

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.

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.

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.

Cardinality0..1
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.

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.

Cardinality0..1
TypedateTime
Summaryfalse
Device.version.value
Element IdDevice.version.value
Definition

The version text.

Cardinality1..1
Typestring
Summaryfalse
Device.specialization
Element IdDevice.specialization
Definition

The standards to which the device adheres and may be certified to in support of its capabilities, e.g., communication, performance, process, or measurement standards.

Cardinality0..*
Summaryfalse
Device.specialization.systemType
Element IdDevice.specialization.systemType
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.

Cardinality1..1
TypeCodeableConcept
Summaryfalse
Device.specialization.version
Element IdDevice.specialization.version
Definition

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

NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..1
Typestring
Summaryfalse
Device.specialization.category
Element IdDevice.specialization.category
Definition

Kind of standards that the device adheres to, e.g., communication, performance or communication.

Cardinality0..1
Terminology BindingFHIRDeviceSpecializationCategory (Extensible)
TypeCoding
Summaryfalse
Device.property
Element IdDevice.property
Definition

Characteristics or features of the device that are otherwise not captured in available attributes, e.g., actual configuration settings, time or timing attributes, resolution, accuracy, and physical attributes. The focus is on properties of the device actually in use while DeviceDefinition focuses on properties that are available to be used.

Cardinality0..*
Summaryfalse
Device.property.type
Element IdDevice.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.

Cardinality1..1
TypeCodeableConcept
Summaryfalse
Device.property.value[x]
Element IdDevice.property.value[x]
Definition

Property value - can be a code, quantity, boolean, string or attachment.

Cardinality1..1
TypeQuantity|CodeableConcept|string|boolean|integer|Range|Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
Comments

The string is used for properties that are intrinsically text, such as warning text, or assemlby instructions. CodeableConcept.text also supports unencoded text but should be used where the characteristic is a concept that might be coded but there is no assigned code for the present value. For example, a security class can be a code like 'Class 1' but in some cases may contain a string like 'Depending on the settings' - in this case the property is normally coded but this is an exception

Device.subject
Element IdDevice.subject
Definition

Patient information, if the device is affixed to, or associated to a patient for their specific use, irrespective of the procedure, use, observation, or other activity that the device is involved in. The use of Patient is also appropriate for the use of devices outside a healthcare setting, such as a fitness tracker.

Cardinality0..1
TypeReference(Patient | Practitioner)
PatternsReference(Patient,Practitioner): Common patterns = Participant, ParticipantContactable, ParticipantLiving
Requirements

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

Summaryfalse
Device.operationalState
Element IdDevice.operationalState
Definition

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

Cardinality0..*
Summaryfalse
Device.operationalState.status
Element IdDevice.operationalState.status
Definition

The state or condition of the device's operation.

Cardinality1..1
Terminology BindingFHIRDeviceOperationalStatus (Example)
TypeCodeableConcept
Summaryfalse
Device.operationalState.statusReason
Element IdDevice.operationalState.statusReason
Definition

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

Cardinality0..*
Terminology BindingFHIRDeviceOperatonStatusReason (Example)
TypeCodeableConcept
Summaryfalse
Device.operationalState.operator
Element IdDevice.operationalState.operator
Definition

The individual performing the action enabled by the device.

Cardinality0..*
TypeReference(Patient | Practitioner | RelatedPerson)
PatternsReference(Patient,Practitioner,RelatedPerson): Common patterns = Participant, ParticipantContactable, ParticipantLiving
Summaryfalse
Device.operationalState.mode
Element IdDevice.operationalState.mode
Definition

The designated condition for performing a task with the device.

Cardinality0..1
Terminology BindingFHIRDeviceOperationalStateMode (Example)
TypeCodeableConcept
Summaryfalse
Device.operationalState.cycle
Element IdDevice.operationalState.cycle
Definition

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

Cardinality0..1
TypeCount
Summaryfalse
Device.operationalState.duration
Element IdDevice.operationalState.duration
Definition

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

Cardinality0..1
Terminology BindingFHIRDeviceOperationalStateMode (Example)
TypeCodeableConcept
Summaryfalse
Device.associationState
Element IdDevice.associationState
Definition

The details about the device when it is affixed or inside of a patient.

Cardinality0..*
Summaryfalse
Device.associationState.status
Element IdDevice.associationState.status
Definition

The state of the usage or application of the device.

Cardinality1..1
Terminology BindingDeviceAssociationState :
TypeCodeableConcept
Summaryfalse
Device.associationState.statusReason
Element IdDevice.associationState.statusReason
Definition

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

Cardinality0..*
TypeCodeableConcept
Summaryfalse
Device.associationState.humanSubject
Element IdDevice.associationState.humanSubject
Definition

The individual to whom the device is affixed or inserted in their body.

Cardinality0..1
TypeReference(Patient)
Summaryfalse
Device.owner
Element IdDevice.owner
Definition

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

Cardinality0..*
TypeContactPoint
Summaryfalse
Comments

used for troubleshooting etc.

Device.location
Element IdDevice.location
Definition

The place where the device can be 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.

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.

Cardinality0..*
TypeReference(Endpoint)
Summaryfalse
Device.link
Element IdDevice.link
Definition

An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.

Cardinality0..*
Summaryfalse
Device.link.relation
Element IdDevice.link.relation
Definition

The type indicates the relationship of the related device to the device instance.

Cardinality1..1
Terminology BindingDeviceRelationType (Extensible)
TypeCoding
Summaryfalse
Device.link.relatedDevice
Element IdDevice.link.relatedDevice
Definition

A reference to the linked device.

Cardinality1..1
TypeCodeableReference(Device)
Summaryfalse
Device.note
Element IdDevice.note
Definition

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

Cardinality0..*
TypeAnnotation
Summaryfalse
Device.safety
Element IdDevice.safety
Definition

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

Cardinality0..*
TypeCodeableConcept
Summarytrue
Device.parent
Element IdDevice.parent
Definition

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

Cardinality0..1
TypeReference(Device)
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.