PATIENT ADMINISTRTAION (PA) Workgroup Development Draft

5.11 Resource Device - Content

This resource maintained by the Orders and Observations Work Group

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.

5.11.1 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.

These are the device related resources

  • Device (this resource) - an administrative resource that tracks individual devices and their location. Primarily used for attribution of actions to devices
  • 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, a MedicalDeviceSystem, or a Channel

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.

5.11.2 Boundaries and Relationships

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, Contraindication, DeviceComponent, DeviceMetric, DeviceUseRequest, DeviceUseStatement, DiagnosticOrder, DiagnosticReport, DocumentManifest, DocumentReference, Flag, Group, ImagingObjectSelection, List, Media, MedicationAdministration, MessageHeader, Observation, Order, OrderResponse, Procedure, ProcedureRequest, Provenance, QuestionnaireAnswers, RiskAssessment, Specimen, Supply, SupplyDelivery and SupplyRequest

5.11.3 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)
... 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..1OrganizationOrganization responsible for device
... location 0..1LocationWhere the resource is found
... patient 0..1PatientIf the resource is affixed to a person
... contact 0..*ContactPointDetails for human/organization for support
... url 0..1uriNetwork address to contact device

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 itDeviceKind+ »Status of the Device availability (this element modifies the meaning of other elements)status : code 0..1 « The availability status of the deviceDeviceStatus »A name of the manufacturermanufacturer : string 0..1The "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..1The 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..1The Date and time when the device was manufacturedmanufactureDate : dateTime 0..1The date and time beyond which this device is no longer valid or should not be used (if applicable)expiry : dateTime 0..1United 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..1Lot number assigned by the manufacturerlotNumber : string 0..1An organization that is responsible for the provision and ongoing maintenance of the deviceowner : Reference(Organization) 0..1The resource may be found in a literal location (i.e. GPS coordinates), a logical place (i.e. "in/with the patient"), or a coded locationlocation : Reference(Location) 0..1Patient information, if the resource is affixed to a personpatient : Reference(Patient) 0..1Contact 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)
... 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..1OrganizationOrganization responsible for device
... location 0..1LocationWhere the resource is found
... patient 0..1PatientIf the resource is affixed to a person
... contact 0..*ContactPointDetails for human/organization for support
... url 0..1uriNetwork address to contact device

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 itDeviceKind+ »Status of the Device availability (this element modifies the meaning of other elements)status : code 0..1 « The availability status of the deviceDeviceStatus »A name of the manufacturermanufacturer : string 0..1The "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..1The 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..1The Date and time when the device was manufacturedmanufactureDate : dateTime 0..1The date and time beyond which this device is no longer valid or should not be used (if applicable)expiry : dateTime 0..1United 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..1Lot number assigned by the manufacturerlotNumber : string 0..1An organization that is responsible for the provision and ongoing maintenance of the deviceowner : Reference(Organization) 0..1The resource may be found in a literal location (i.e. GPS coordinates), a logical place (i.e. "in/with the patient"), or a coded locationlocation : Reference(Location) 0..1Patient information, if the resource is affixed to a personpatient : Reference(Patient) 0..1Contact 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)

5.11.3.1 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 deviceRequiredhttp://hl7.org/fhir/devicestatus

5.11.3.2 Notes

5.11.3.2.1 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.

5.11.3.2.2 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>

5.11.4 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