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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.

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
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.

Device.definition
Element IdDevice.definition
Definition

The reference to the definition for the device.

Cardinality0..1
TypeReference(DeviceDefinition)
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.

Cardinality0..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-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.
Cardinality0..1
Typeuri
Alternate NamesBarcode System
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/fda-udi.

Cardinality0..1
Typeuri
Requirements

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

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.

Device.status
Element IdDevice.status
Definition

Status of the Device 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 dtatus of the Device availability.

Cardinality0..*
Terminology BindingFHIRDeviceStatusReason (Extensible)
TypeCodeableConcept
Device.distinctIdentifier
Element IdDevice.distinctIdentifier
Definition

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

Cardinality0..1
Typestring
Alternate NamesDistinct 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 IdDevice.manufacturer
Definition

A name of the manufacturer.

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

The date and time when the device was manufactured.

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

Lot number assigned by the manufacturer.

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

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

Cardinality0..1
Typestring
Comments

Alphanumeric Maximum 20.

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

The name that identifies the device.

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

The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

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

The manufacturer's model number for the device.

Cardinality0..1
Typestring
Device.partNumber
Element IdDevice.partNumber
Definition

The part number or catalog number of the device.

Cardinality0..1
Typestring
Comments

Alphanumeric Maximum 20.

Device.type
Element IdDevice.type
Definition

The kind or type of device.

Cardinality0..1
Terminology BindingDevice Type (Example)
TypeCodeableConcept
Device.specialization
Element IdDevice.specialization
Definition

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

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

The standard that is used to operate and communicate.

Cardinality1..1
TypeCodeableConcept
Alternate NamesΣ
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
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..*
Device.version.type
Element IdDevice.version.type
Definition

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

Cardinality0..1
TypeCodeableConcept
Alternate NamesΣ
Device.version.component
Element IdDevice.version.component
Definition

A single component of the device version.

Cardinality0..1
TypeIdentifier
Device.version.value
Element IdDevice.version.value
Definition

The version text.

Cardinality1..1
Typestring
Device.property
Element IdDevice.property
Definition

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

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

Code that specifies the property DeviceDefinitionPropetyCode (Extensible).

Cardinality1..1
TypeCodeableConcept
Device.property.valueQuantity
Element IdDevice.property.valueQuantity
Definition

Property value as a quantity.

Cardinality0..*
TypeQuantity
Device.property.valueCode
Element IdDevice.property.valueCode
Definition

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

Cardinality0..*
TypeCodeableConcept
Device.patient
Element IdDevice.patient
Definition

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

Cardinality0..1
TypeReference(Patient)
Requirements

If the device is implanted in a patient, then need to associate the device to the patient.

Device.owner
Element IdDevice.owner
Definition

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

Cardinality0..1
TypeReference(Organization)
Device.contact
Element IdDevice.contact
Definition

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

Cardinality0..*
TypeContactPoint
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.

Device.url
Element IdDevice.url
Definition

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

Cardinality0..1
Typeuri
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 IdDevice.note
Definition

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

Cardinality0..*
TypeAnnotation
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 device that this device is attached to or is part of.

Cardinality0..1
TypeReference(Device)