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5.10 Resource Device - Content

Orders and Observations Work Group

Maturity Level: 1

Compartments: Device

This resource identifies an instance of a manufactured item 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 include items such as a machine, cellphone, computer, application, etc.

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
• UML
• XML
• JSON
• All

Structure

Name	Flags	Card.	Type	Description & Constraints
Device			DomainResource	An instance of a manufactured te that is used in the provision of healthcare
identifier		0..*	Identifier	Instance id from manufacturer, owner, and others
type		1..1	CodeableConcept	What kind of device this is DeviceKind (Preferred)
note		0..*	Annotation	Device notes and comments
status	?! Σ	0..1	code	available | not-available | entered-in-error DeviceStatus (Required)
manufacturer		0..1	string	Name of device manufacturer
model		0..1	string	Model id assigned by the manufacturer
version		0..1	string	Version number (i.e. software)
manufactureDate		0..1	dateTime	Manufacture date
expiry		0..1	dateTime	Date and time of expiry of this device (if applicable)
udi		0..1	string	FDA mandated Unique Device Identifier
lotNumber		0..1	string	Lot number of manufacture
owner		0..1	Reference(Organization)	Organization responsible for device
location		0..1	Reference(Location)	Where the resource is found
patient		0..1	Reference(Patient)	If the resource is affixed to a person
contact		0..*	ContactPoint	Details for human/organization for support
url		0..1	uri	Network address to contact device
Documentation for this format

UML Diagram

XML Template

<Device xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Instance id from manufacturer, owner, and others --></identifier>
 <type><!-- 1..1 CodeableConcept What kind of device this is  --></type>
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <status value="[code]"/><!-- 0..1 available | not-available | entered-in-error -->
 <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) -->
 <manufactureDate value="[dateTime]"/><!-- 0..1 Manufacture date -->
 <expiry value="[dateTime]"/><!-- 0..1 Date and time 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 Reference(Organization) Organization responsible for device --></owner>
 <location><!-- 0..1 Reference(Location) Where the resource is found --></location>
 <patient><!-- 0..1 Reference(Patient) If the resource is affixed to a person --></patient>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
</Device>

JSON Template

{
  "resourceType" : "Device",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Instance id from manufacturer, owner, and others
  "type" : { CodeableConcept }, // R!  What kind of device this is 
  "note" : [{ Annotation }], // Device notes and comments
  "status" : "<code>", // available | not-available | entered-in-error
  "manufacturer" : "<string>", // Name of device manufacturer
  "model" : "<string>", // Model id assigned by the manufacturer
  "version" : "<string>", // Version number (i.e. software)
  "manufactureDate" : "<dateTime>", // Manufacture date
  "expiry" : "<dateTime>", // Date and time of expiry of this device (if applicable)
  "udi" : "<string>", // FDA mandated Unique Device Identifier
  "lotNumber" : "<string>", // Lot number of manufacture
  "owner" : { Reference(Organization) }, // Organization responsible for device
  "location" : { Reference(Location) }, // Where the resource is found
  "patient" : { Reference(Patient) }, // If the resource is affixed to a person
  "contact" : [{ ContactPoint }], // Details for human/organization for support
  "url" : "<uri>" // Network address to contact device
}

Structure

Name	Flags	Card.	Type	Description & Constraints
Device			DomainResource	An instance of a manufactured te that is used in the provision of healthcare
identifier		0..*	Identifier	Instance id from manufacturer, owner, and others
type		1..1	CodeableConcept	What kind of device this is DeviceKind (Preferred)
note		0..*	Annotation	Device notes and comments
status	?! Σ	0..1	code	available | not-available | entered-in-error DeviceStatus (Required)
manufacturer		0..1	string	Name of device manufacturer
model		0..1	string	Model id assigned by the manufacturer
version		0..1	string	Version number (i.e. software)
manufactureDate		0..1	dateTime	Manufacture date
expiry		0..1	dateTime	Date and time of expiry of this device (if applicable)
udi		0..1	string	FDA mandated Unique Device Identifier
lotNumber		0..1	string	Lot number of manufacture
owner		0..1	Reference(Organization)	Organization responsible for device
location		0..1	Reference(Location)	Where the resource is found
patient		0..1	Reference(Patient)	If the resource is affixed to a person
contact		0..*	ContactPoint	Details for human/organization for support
url		0..1	uri	Network address to contact device
Documentation for this format

UML Diagram

XML Template

<Device xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Instance id from manufacturer, owner, and others --></identifier>
 <type><!-- 1..1 CodeableConcept What kind of device this is  --></type>
 <note><!-- 0..* Annotation Device notes and comments --></note>
 <status value="[code]"/><!-- 0..1 available | not-available | entered-in-error -->
 <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) -->
 <manufactureDate value="[dateTime]"/><!-- 0..1 Manufacture date -->
 <expiry value="[dateTime]"/><!-- 0..1 Date and time 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 Reference(Organization) Organization responsible for device --></owner>
 <location><!-- 0..1 Reference(Location) Where the resource is found --></location>
 <patient><!-- 0..1 Reference(Patient) If the resource is affixed to a person --></patient>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
</Device>

JSON Template

{
  "resourceType" : "Device",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Instance id from manufacturer, owner, and others
  "type" : { CodeableConcept }, // R!  What kind of device this is 
  "note" : [{ Annotation }], // Device notes and comments
  "status" : "<code>", // available | not-available | entered-in-error
  "manufacturer" : "<string>", // Name of device manufacturer
  "model" : "<string>", // Model id assigned by the manufacturer
  "version" : "<string>", // Version number (i.e. software)
  "manufactureDate" : "<dateTime>", // Manufacture date
  "expiry" : "<dateTime>", // Date and time of expiry of this device (if applicable)
  "udi" : "<string>", // FDA mandated Unique Device Identifier
  "lotNumber" : "<string>", // Lot number of manufacture
  "owner" : { Reference(Organization) }, // Organization responsible for device
  "location" : { Reference(Location) }, // Where the resource is found
  "patient" : { Reference(Patient) }, // If the resource is affixed to a person
  "contact" : [{ ContactPoint }], // Details for human/organization for support
  "url" : "<uri>" // Network address to contact device
}

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

5.10.3.1 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.	Preferred	Global Medical Device Nomenclature (GMDN®).
Device.status	The availability status of the device.	Required	DeviceStatus

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 repository 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.

  <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.