This page is part of the FHIR Specification (v0.0.82: DSTU 1). 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 Content Examples Formal Definitions Mappings Profiles 5.5 Resource Device - Content 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. 5.5.1 Scope and Usage This resource is primarily used for recording which device performed an action and can also be used to track device location. It is also used for prescribing and dispensing devices for patient use. If the device is implanted in a patient, then the patient element will be present, and there would be no location. Devices that are implanted in a patient differ from medications because they are not "used up" - they remain active in a patient in an ongoing fashion. The Medication resource SHOULD not be used to represent implanted devices. 5.5.2 Boundaries and Relationships There are two device related resources Device (this resource) - an administrative resource that tracks individual devices and their location. Primarily used for attribution of actions to devices Device Observation Report - A report of observations from a device The device capabilities and log resources are used when communicating with a device, either directly or indirectly. When a channel is opened with the device, or its proxy, it first sends the Capabilities resource, and then a series of log resources. The FHIR JSON format is used in this case. The application that receives the log resources may choose to merge the log with the capabilities statement to create a device observation, which is suitable for wider use within a EHR/Clinical record context. 5.5.3 Resource Content Device ( Resource ) Identifiers assigned to this device by various organizations. The most likely organizations to assign identifiers are the manufacturer and the owner, though regulatory agencies may also assign an identifier. The identifiers identify the particular device, not the kind of device identifier : Identifier 0..* A kind of this device type : CodeableConcept 1..1 << Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it DeviceKind >> A name of the manufacturer manufacturer : string 0..1 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 model : string 0..1 The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware version : string 0..1 Date of expiry of this device (if applicable) expiry : date 0..1 FDA Mandated Unique Device Identifier. 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 udi : string 0..1 Lot number assigned by the manufacturer lotNumber : string 0..1 An organization that is responsible for the provision and ongoing maintenance of the device owner : Resource ( Organization ) 0..1 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 location : Resource ( Location ) 0..1 Patient information, if the resource is affixed to a person patient : Resource ( Patient ) 0..1 Contact details for an organization or a particular human that is responsible for the device contact : Contact 0..* A network address on which the device may be contacted directly url : uri 0..1 This resource is referenced by Alert , Composition , DeviceObservationReport , DiagnosticOrder , DiagnosticReport , DocumentManifest , DocumentReference , Group , List , Media , MedicationAdministration , MedicationStatement , MessageHeader , Observation , Order , OrderResponse , SecurityEvent , Specimen and Supply < <!-- from --> <</identifier> <</type> < < < < < < <</owner> <</location> <</patient> <</contact> < </Device> Alternate definitions: Schema / Schematron , Resource Profile 5.5.3.1 Terminology Bindings Path Definition Type Reference Device.type Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it Example RTM Management Service 5.5.3.2 Notes There are many sources of possible codes for device type. The example suggests to use device codes from RTM, which has many codes suitable to devices that make Device Observation Reports . Another source which will be appropriate for many devices is the FDA GUDID (see below) or equivalent. Alternatively, many jurisdictions have their own supply chain arrangements which define many useful codes. 5.5.3.3 Device Identifiers Nearly all devices are assigned one or more identifiers, which are usually printed or affixed to the device using either barcodes or RFIDs. The identifiers can come from the manufacturer (often called the "serial number", various institution and registries. Any of these identifiers assigned to the device can and should be recorded in the device resource. The different identifiers are differentiated by their use, label, and system values. The most important of the identifiers is the Unique Device Identifier (UDI), which most medical devices are required to carry and which can be used to access the Global Unique Device Identification Database (GUDID). The UDI has its own element ( udi ). The UDI may identify an instance of a device uniquely, or it may just 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. Where the device has an assigned UDI, the other details carried in the resource (e.g. lot, expiry date etc) SHALL be consistent with the information encoded in the UDI or registered in the GUDID. Note that a GTIN (sometimes also called an EAN number) is a code for the kind of device, not an identifier for the device. The GTIN may be part of the UDI, but it may also be known separately, in which case GTINs should be carried in the type element: GTIN example <type> <coding> <system value="urn:oid:1.3.160‎"/> <value value="00614141999996"/> </coding> <!-- other codes for type --> </type> 5.5.4 Search Parameters Search parameters for this resource. The standard parameters also apply. See Searching for more information about searching in REST, messaging, and services. Name Type Description Paths _id token The logical resource id associated with the resource (must be supported by all servers) _language token The language of the resource identifier token Instance id from manufacturer, owner and others Device.identifier location reference A location, where the resource is found Device.location ( Location ) manufacturer string The manufacturer of the device Device.manufacturer model string The model of the device Device.model organization reference The organization responsible for the device Device.owner ( Organization ) patient reference Patient information, if the resource is affixed to a person Device.patient ( Patient ) type token The type of the device Device.type udi string FDA Mandated Unique Device Identifier Device.udi © HL7.org 2011+. FHIR DSTU (v0.0.82.2943) generated on Tue, Sep 30, 2014 18:09+1000. 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