FHIR Release 3 (STU)

This page is part of the FHIR Specification (v3.0.2: STU 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3 R2

Orders and Observations Work GroupMaturity Level: 2 Trial UseCompartments: Device

Detailed Descriptions for the elements in the Device resource.

Device
Definition

This resource identifies an instance or 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.

Control1..1
Requirements

Allows institutions to track their devices.

Device.identifier
Definition

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

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Alternate NamesSerial Number
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 to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

Device.udi
Definition

Unique device identifier (UDI) assigned to device label or package.

Control0..1
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.udi.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.

Control0..1
Typestring
Alternate NamesDI
Summarytrue
Device.udi.name
Definition

Name of device as used in labeling or catalog.

Control0..1
Typestring
Alternate NamesBrand Name
Summarytrue
Comments

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
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.

Control0..1
Typeuri
Requirements

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

Device.udi.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.

Control0..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.udi.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.

Control0..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.udi.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.

Control0..1
Typeuri
Alternate NamesBarcode System
Device.udi.entryType
Definition

A coded entry to indicate how the data was entered.

Control0..1
Terminology BindingUDIEntryType (Required)
Typecode
Requirements

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

Device.status
Definition

Status of the Device availability.

Control0..1
Terminology BindingFHIRDeviceStatus (Required)
Typecode
Is Modifiertrue
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.type
Definition

Code or identifier to identify a kind of device.

Control0..1
Terminology BindingFHIR Device Types (Example)
TypeCodeableConcept
Device.lotNumber
Definition

Lot number assigned by the manufacturer.

Control0..1
Typestring
Device.manufacturer
Definition

A name of the manufacturer.

Control0..1
Typestring
Device.manufactureDate
Definition

The date and time when the device was manufactured.

Control0..1
TypedateTime
Device.expirationDate
Definition

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

Control0..1
TypedateTime
Device.model
Definition

The "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type.

Control0..1
Typestring
Device.version
Definition

The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
Typestring
Device.patient
Definition

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

Control0..1
TypeReference(Patient)
Requirements

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

Device.owner
Definition

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

Control0..1
TypeReference(Organization)
Device.contact
Definition

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

Control0..*
TypeContactPoint
Comments

used for troubleshooting etc.

Device.location
Definition

The place where the device can be found.

Control0..1
TypeReference(Location)
Requirements

Device.location can be used to track device location.

Device.url
Definition

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

Control0..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
Definition

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

Control0..*
TypeAnnotation
Device.safety
Definition

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

Control0..*
Terminology BindingDeviceSafety (Example)
TypeCodeableConcept
Summarytrue