DSTU2

This page is part of the FHIR Specification (v1.0.2: DSTU 2). 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

5.10.6 Resource Device - Detailed Descriptions

Detailed Descriptions for the elements in the Device resource.

Device
Definition

This resource identifies an instance 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.

Device.identifier
Definition

Unique instance identifiers assigned to a device by organizations like manufacturers or owners. If the identifier identifies the type of device, Device.type should be used.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Comments

Often fixed to the device as a barcode and may include names given to the device in local usage. Note that some of the barcodes affixed to the device identify its type, not its instance. For the FDA mandated Unique Device Identifier (UDI) use the Device.udi element.

Device.type
Definition

Code or identifier to identify a kind of device.

Control1..1
BindingDeviceKind : Preferred: Global Medical Device Nomenclature (GMDN®). (Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it.)
TypeCodeableConcept
Comments

For the FDA mandated Unique Device Identifier (UDI) use the Device.udi element.

Device.note
Definition

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

Control0..*
TypeAnnotation
Device.status
Definition

Status of the Device availability.

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

A name of the manufacturer.

Control0..1
Typestring
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 identifier (see discussion)
Control0..1
Typestring
Device.manufactureDate
Definition

The date and time when the device was manufactured.

Control0..1
TypedateTime
Device.expiry
Definition

The date and time beyond which this device is no longer valid or should not be used (if applicable).

Control0..1
TypedateTime
Device.udi
Definition

United States Food and Drug Administration mandated Unique Device Identifier (UDI). Use the human readable information (the content that the user sees, which is sometimes different to the exact syntax represented in the barcode) - see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm.

Control0..1
Typestring
Comments

The unique identifier may identify an instance of a device uniquely, or it may only identify the type of the device. A portion of the UDI - the DI part - can be extracted from the UDI when required, and used to look up information about the device through the GUDID.

Device.lotNumber
Definition

Lot number assigned by the manufacturer.

Control0..1
Typestring
Comments

Alphanumeric Maximum 20.

Device.owner
Definition

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

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

The place where the device can be found.

Control0..1
TypeReference(Location)
Device.patient
Definition

Patient information, if the resource is affixed to a person.

Control0..1
TypeReference(Patient)
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.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.