2nd DSTU Draft For Comment

This page is part of the FHIR Specification (v0.4.0: DSTU 2 Draft). 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

5.8.5 Resource Device - Detailed Descriptions

Detailed Descriptions for the elements in the Device resource.

Device
Definition

This resource identifies an instance of a manufactured thing that is used in the provision of healthcare without being substantially changed through that activity. The device may be a machine, an insert, a computer, an application, etc. This includes durable (reusable) medical equipment as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health.

Control1..1
Requirements

Allows institutions to track their devices.

Device.identifier
Definition

Unique instance identifiers assigned to a device by organizations like manufacturers, owners or regulatory agencies. If the identifier identifies the type of device, Device.type should be used. An example is the FDA Mandated Unique Device Identifier (UDI) which identifies an instance of a device uniquely if the serial number is present, . - see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm.

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.

Device.type
Definition

Code or identifier to identify a kind of device An example is the FDA Mandated Unique Device Identifier (UDI) which identifies a type of a device when the serial number is absent, otherwise it uniquely identifies the device instance and Device.identifier should be used instead of Device.type. - see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm.

Control1..1
BindingDeviceKind: Example: RTM Management Service (Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it)
TypeCodeableConcept
Device.manufacturer
Definition

A name of the manufacturer.

Control0..1
Typestring
Device.model
Definition

The "model" - 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.

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.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 resource may be found in a literal location (i.e. GPS coordinates), a logical place (i.e. "in/with the patient"), or a coded location.

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.