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

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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.

5.5.3 Resource Content

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

<Device xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: extension, modifierExtension, language, text, and contained -->
 <identifier><!-- 0..* Identifier Instance id from manufacturer, owner and others --></identifier>
 <type><!-- 1..1 CodeableConcept What kind of device this is --></type>
 <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer -->
 <model value="[string]"/><!-- 0..1 Model id assigned by the manufacturer -->
 <version value="[string]"/><!-- 0..1 Version number (i.e. software) -->
 <expiry value="[date]"/><!-- 0..1 Date of expiry of this device (if applicable) -->
 <udi value="[string]"/><!-- 0..1 FDA Mandated Unique Device Identifier -->
 <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture -->
 <owner><!-- 0..1 Resource(Organization) Organization responsible for device --></owner>
 <location><!-- 0..1 Resource(Location) Where the resource is found --></location>
 <patient><!-- 0..1 Resource(Patient) If the resource is affixed to a person --></patient>
 <contact><!-- 0..* Contact Details for human/organization for support --></contact>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
</Device>

Alternate definitions: Schema/Schematron, Resource Profile

5.5.3.1 Terminology Bindings

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:

  <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.