STU 3 Ballot

This page is part of the FHIR Specification (v1.6.0: STU 3 Ballot 4). 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

8.9.6 Resource Device - Detailed Descriptions

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 includes 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.

To DoDetermine whether HCT/TP stuff gos here or in new resource and determine boundaries.
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.udiCarrier
Definition

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

Control0..1
TypeIdentifier
Alternate NamesUDI; Barcode String
Comments

The udiCarrier string may identify an unique instance of a device, or it may only identify the type of the device. The Human Readable format (HRF) is required in FHIR. AIDC identifiers cannot be conveyed in FHIR, Because of limitations on character sets in XML and the need to round-trip JSON data through XML. See UDI mappings for a complete mapping of UDI parts to Device.

Device.status
Definition

Status of the Device availability.

Control0..1
BindingDeviceStatus: The availability status of the device. (Required)
Typecode
Is Modifiertrue
Summarytrue
Device.type
Definition

Code or identifier to identify a kind of device.

Control1..1
BindingDevice Types: Codes to identify medical devices (Example)
TypeCodeableConcept
Comments

There can be different code values thath may correspond to different granularities of the same concept. These can be represented as translations using the codeableConcept datatype. For UDI, this element corresponds to the UDI device identifier (DI) part. See UDI mappings for a complete mapping of UDI parts to Device.

Device.lotNumber
Definition

Lot number assigned by the manufacturer.

Control0..1
Typestring
Comments

Alphanumeric. For UDI, this element corresponds to the variable portion of a UDI that identifies the lot or batch number within which a physical instance of a device was manufactured. See UDI mappings for a complete mapping of UDI parts to Device.

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
Comments

For UDI, this element corresponds to the variable portion of a UDI that identifies the date a physical instance of a device was manufactured. See UDI mappings for a complete mapping of UDI parts to Device.

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
Comments

For UDI, this element corresponds to the variable portion of a UDI that identifies the expiration date of a physical instance of a device. See UDI mappings for a complete mapping of UDI parts to Device.

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 root 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