DSTU2 QA Preview

This page is part of the FHIR Specification (v1.0.0: DSTU 2 Ballot 3). 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 Resource Device - Content

Orders and Observations Work GroupMaturity Level: 0Compartments: Device

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 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 includes things such as a machine, a cellphone, a computer, an application, etc.

5.10.1 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.

5.10.2 Boundaries and Relationships

These are the device related resources

  • Device (this resource) - An administrative resource that tracks individual device types or instances of a device and their location. It Is referenced by other resource for recording which device performed an action such as a procedure or an observation. It is also referenced when prescribing and dispensing devices for patient use or for ordering supplies.
  • DeviceMetric - Describes a measurement, calculation or setting capability of a medical device.
  • DeviceComponent that the DeviceMetric is part of. This can be a DeviceComponent of any kind like a VirtualMedicalDevice (VMD), a MedicalDeviceSystem (MDS) , or a Channel

In FHIR, the "Device" is the "administrative" resource for the device (it does not change much and has manufacturer information etc.), where as the DeviceComponent and DeviceMetric (which is really a kind of DeviceComponent) model the physical part, including operation status and is much more volatile. The physical composition of a Device is done by the DeviceComponents pointing to their "parent" component using DeviceComponent.parent, e.g. channel to VMD and VMD to the MDS. All components point to the "logical" Device they belong to, using DeviceComponent.source. Similarily. if for example you want to express which logical device your observation came from, you can just use Device, but if you need to be more specific observation can point to DeviceMetric which in turn points to the "logical" Device it belongs to, using DeviceMetric.source.

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.

This resource is referenced by Account, Appointment, AppointmentResponse, AuditEvent, Communication, CommunicationRequest, Composition, Contract, DetectedIssue, DeviceComponent, DeviceMetric, DeviceUseRequest, DeviceUseStatement, DiagnosticOrder, DiagnosticReport, DocumentManifest, DocumentReference, Flag, Group, ImagingObjectSelection, List, Media, MedicationAdministration, MessageHeader, Observation, Order, OrderResponse, Procedure, ProcedureRequest, Provenance, QuestionnaireResponse, RiskAssessment, Schedule, Specimen, SupplyDelivery and SupplyRequest

5.10.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device DomainResourceAn instance of a manufactured thing that is used in the provision of healthcare
... identifier 0..*IdentifierInstance id from manufacturer, owner, and others
... type 1..1CodeableConceptWhat kind of device this is
DeviceKind (Preferred)
... note 0..*AnnotationDevice notes and comments
... status ?! Σ0..1codeavailable | not-available | entered-in-error
DeviceStatus (Required)
... manufacturer 0..1stringName of device manufacturer
... model 0..1stringModel id assigned by the manufacturer
... version 0..1stringVersion number (i.e. software)
... manufactureDate 0..1dateTimeManufacture date
... expiry 0..1dateTimeDate and time of expiry of this device (if applicable)
... udi 0..1stringFDA Mandated Unique Device Identifier
... lotNumber 0..1stringLot number of manufacture
... owner 0..1Reference(Organization)Organization responsible for device
... location 0..1Reference(Location)Where the resource is found
... patient 0..1Reference(Patient)If the resource is affixed to a person
... contact 0..*ContactPointDetails for human/organization for support
... url 0..1uriNetwork address to contact device

doco Documentation for this format

UML Diagram

Device (DomainResource)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 usedidentifier : Identifier [0..*]Code or identifier to identify a kind of devicetype : CodeableConcept [1..1] « Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it (Strength=Preferred)DeviceKind? »Descriptive information, usage information or implantation information that is not captured in an existing elementnote : Annotation [0..*]Status of the Device availability (this element modifies the meaning of other elements)status : code [0..1] « The availability status of the device (Strength=Required)DeviceStatus! »A name of the manufacturermanufacturer : 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 typemodel : 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 firmwareversion : string [0..1]The Date and time when the device was manufacturedmanufactureDate : dateTime [0..1]The date and time beyond which this device is no longer valid or should not be used (if applicable)expiry : dateTime [0..1]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.htmudi : string [0..1]Lot number assigned by the manufacturerlotNumber : string [0..1]An organization that is responsible for the provision and ongoing maintenance of the deviceowner : Reference [0..1] « Organization »The place where the device can be foundlocation : Reference [0..1] « Location »Patient information, if the resource is affixed to a personpatient : Reference [0..1] « Patient »Contact details for an organization or a particular human that is responsible for the devicecontact : ContactPoint [0..*]A network address on which the device may be contacted directlyurl : uri [0..1]

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. Device DomainResourceAn instance of a manufactured thing that is used in the provision of healthcare
... identifier 0..*IdentifierInstance id from manufacturer, owner, and others
... type 1..1CodeableConceptWhat kind of device this is
DeviceKind (Preferred)
... note 0..*AnnotationDevice notes and comments
... status ?! Σ0..1codeavailable | not-available | entered-in-error
DeviceStatus (Required)
... manufacturer 0..1stringName of device manufacturer
... model 0..1stringModel id assigned by the manufacturer
... version 0..1stringVersion number (i.e. software)
... manufactureDate 0..1dateTimeManufacture date
... expiry 0..1dateTimeDate and time of expiry of this device (if applicable)
... udi 0..1stringFDA Mandated Unique Device Identifier
... lotNumber 0..1stringLot number of manufacture
... owner 0..1Reference(Organization)Organization responsible for device
... location 0..1Reference(Location)Where the resource is found
... patient 0..1Reference(Patient)If the resource is affixed to a person
... contact 0..*ContactPointDetails for human/organization for support
... url 0..1uriNetwork address to contact device

doco Documentation for this format

UML Diagram

Device (DomainResource)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 usedidentifier : Identifier [0..*]Code or identifier to identify a kind of devicetype : CodeableConcept [1..1] « Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it (Strength=Preferred)DeviceKind? »Descriptive information, usage information or implantation information that is not captured in an existing elementnote : Annotation [0..*]Status of the Device availability (this element modifies the meaning of other elements)status : code [0..1] « The availability status of the device (Strength=Required)DeviceStatus! »A name of the manufacturermanufacturer : 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 typemodel : 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 firmwareversion : string [0..1]The Date and time when the device was manufacturedmanufactureDate : dateTime [0..1]The date and time beyond which this device is no longer valid or should not be used (if applicable)expiry : dateTime [0..1]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.htmudi : string [0..1]Lot number assigned by the manufacturerlotNumber : string [0..1]An organization that is responsible for the provision and ongoing maintenance of the deviceowner : Reference [0..1] « Organization »The place where the device can be foundlocation : Reference [0..1] « Location »Patient information, if the resource is affixed to a personpatient : Reference [0..1] « Patient »Contact details for an organization or a particular human that is responsible for the devicecontact : ContactPoint [0..*]A network address on which the device may be contacted directlyurl : uri [0..1]

 

Alternate definitions: Schema/Schematron, Resource Profile (XML, JSON), Questionnaire

5.10.3.1 Terminology Bindings

PathDefinitionTypeReference
Device.type Defines the nature of the device and the kind of functionality/services/behavior that may be expected from itPreferredGlobal Medical Device Nomenclature (GMDN®)
Device.status The availability status of the deviceRequiredDeviceStatus

5.10.3.2 Notes

5.10.3.2.1 Device Types

There are many sources of possible codes for device type. The example uses device codes from Global Medical Device Nomenclature (GMDN®). Another source which may be appropriate is RTM (Rosetta Terminology Mapping). The local UDI repository (in the US this is the GUDID database) is another source as well, however, the full UDI string is placed in the Device.udi element. Alternatively, many jurisdictions have their own supply chain arrangements which define many useful codes.

5.10.3.2.2 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," "reference number," or "catalog 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 US Realm FDA Mandated Unique Device Identifier (UDI) required by the FDA for every medical device to bear on its label (unless excepted). The UDI has 2 components - the device identifier (DI), which is assigned at the version/model level of the device and the production identifier(s)(PI) which provide the means to track a device through its manufacture, distribution and use. The UDI string may also contain additional elements which are not formally part of the local defined UDI elements but which are non-the-less contained within the same string and are of value locally. The DI of the UDI may be stored in a jurisdictional respository and used as the primary key to access other device information. The UDI may identify an instance of a device uniquely (when the PI(s) include a serial number), or it may just identify the type of the device. The UDI can be broken into its constituent parts (DI, PI and other elements) by parsing rules developed by each Issuing Agency standard. 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 string or registered in the local repository. In the US, a UDI will be required by the FDA for every medical device to bear on its label (unless excepted). The DI of the UDI is submitted in a device record to the Global Unique Device Identification Database (GUDID) and is used as the primary key to access other device information.

Note that a GTIN (sometimes also called an EAN number) is a code developed by GS1 for the kind of device not an identifier for the device. A GTIN may appear on its own or it may appear in a UDI string as the DI component.

GTIN example

  <type>
    <coding>
      <system value="urn:oid:1.3.160‎"/>
      <value value="00614141999996"/>
    </coding>
    <!-- other codes for type -->
  </type>

5.10.4 Search Parameters

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionPaths
identifiertokenInstance id from manufacturer, owner, and othersDevice.identifier
locationreferenceA location, where the resource is foundDevice.location
(Location)
manufacturerstringThe manufacturer of the deviceDevice.manufacturer
modelstringThe model of the deviceDevice.model
organizationreferenceThe organization responsible for the deviceDevice.owner
(Organization)
patientreferencePatient information, if the resource is affixed to a personDevice.patient
(Patient)
typetokenThe type of the deviceDevice.type
udistringFDA Mandated Unique Device IdentifierDevice.udi
urluriNetwork address to contact deviceDevice.url