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5.12 Resource Device - Content

Orders and Observations

Work Group

Maturity Level: 1

Compartments: Device

This resource identifies an instance or a type 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.

5.12.1 Scope and Usage

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. It is used to record and transmit Unique Device Identifer (UDI) information about a device such as a patient's implant.

5.12.2 Boundaries and Relationships

These are the device related resources

Device (this resource)
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. Similarly, 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 differ from medications because they are not "used up" - they remain active in a patient in an ongoing fashion. However, the specific boundary between medications and devices is defined at the implementation level and this standard does not enforce a boundary with the exception of devices that are implanted in a patient. The Medication resource should not be used to represent implanted devices.

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

Structure

Name	Flags	Card.	Type	Description & Constraints
Device			DomainResource	Item used in healthcare
identifier		0..*	Identifier	Instance identifier
udiCarrier		0..1	Identifier	Unique Device Identifier (UDI) Barcode string
status	?! Σ	0..1	code	available \| not-available \| entered-in-error DeviceStatus (Required)
type		1..1	CodeableConcept	What kind of device this is Device Types (Example)
lotNumber		0..1	string	Lot number of manufacture
manufacturer		0..1	string	Name of device manufacturer
manufactureDate		0..1	dateTime	Date when the device was made
expirationDate		0..1	dateTime	Date and time of expiry of this device (if applicable)
model		0..1	string	Model id assigned by the manufacturer
version		0..1	string	Version number (i.e. software)
patient		0..1	Reference(Patient)	Patient to whom Device is affixed
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the resource is found
url		0..1	uri	Network address to contact device
note		0..*	Annotation	Device notes and comments
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 identifier --></identifier>
 <udiCarrier><!-- 0..1 Identifier Unique Device Identifier (UDI) Barcode string --></udiCarrier>
 <status value="[code]"/><!-- 0..1 available | not-available | entered-in-error -->
 <type><!-- 1..1 CodeableConcept What kind of device this is --></type>
 <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture -->
 <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer -->
 <manufactureDate value="[dateTime]"/><!-- 0..1 Date when the device was made -->
 <expirationDate value="[dateTime]"/><!-- 0..1 Date and time of expiry of this device (if applicable) -->
 <model value="[string]"/><!-- 0..1 Model id assigned by the manufacturer -->
 <version value="[string]"/><!-- 0..1 Version number (i.e. software) -->
 <patient><!-- 0..1 Reference(Patient) Patient to whom Device is affixed --></patient>
 <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <location><!-- 0..1 Reference(Location) Where the resource is found --></location>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
 <note><!-- 0..* Annotation Device notes and comments --></note>
</Device>

JSON Template

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

Structure

Name	Flags	Card.	Type	Description & Constraints
Device			DomainResource	Item used in healthcare
identifier		0..*	Identifier	Instance identifier
udiCarrier		0..1	Identifier	Unique Device Identifier (UDI) Barcode string
status	?! Σ	0..1	code	available \| not-available \| entered-in-error DeviceStatus (Required)
type		1..1	CodeableConcept	What kind of device this is Device Types (Example)
lotNumber		0..1	string	Lot number of manufacture
manufacturer		0..1	string	Name of device manufacturer
manufactureDate		0..1	dateTime	Date when the device was made
expirationDate		0..1	dateTime	Date and time of expiry of this device (if applicable)
model		0..1	string	Model id assigned by the manufacturer
version		0..1	string	Version number (i.e. software)
patient		0..1	Reference(Patient)	Patient to whom Device is affixed
owner		0..1	Reference(Organization)	Organization responsible for device
contact		0..*	ContactPoint	Details for human/organization for support
location		0..1	Reference(Location)	Where the resource is found
url		0..1	uri	Network address to contact device
note		0..*	Annotation	Device notes and comments
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 identifier --></identifier>
 <udiCarrier><!-- 0..1 Identifier Unique Device Identifier (UDI) Barcode string --></udiCarrier>
 <status value="[code]"/><!-- 0..1 available | not-available | entered-in-error -->
 <type><!-- 1..1 CodeableConcept What kind of device this is --></type>
 <lotNumber value="[string]"/><!-- 0..1 Lot number of manufacture -->
 <manufacturer value="[string]"/><!-- 0..1 Name of device manufacturer -->
 <manufactureDate value="[dateTime]"/><!-- 0..1 Date when the device was made -->
 <expirationDate value="[dateTime]"/><!-- 0..1 Date and time of expiry of this device (if applicable) -->
 <model value="[string]"/><!-- 0..1 Model id assigned by the manufacturer -->
 <version value="[string]"/><!-- 0..1 Version number (i.e. software) -->
 <patient><!-- 0..1 Reference(Patient) Patient to whom Device is affixed --></patient>
 <owner><!-- 0..1 Reference(Organization) Organization responsible for device --></owner>
 <contact><!-- 0..* ContactPoint Details for human/organization for support --></contact>
 <location><!-- 0..1 Reference(Location) Where the resource is found --></location>
 <url value="[uri]"/><!-- 0..1 Network address to contact device -->
 <note><!-- 0..* Annotation Device notes and comments --></note>
</Device>

JSON Template

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

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

5.12.3.1 Terminology Bindings

Path	Definition	Type	Reference
Device.status	The availability status of the device.	Required	DeviceStatus
Device.type	Codes to identify medical devices	Example	Device Types

Path

Definition

Type

Reference

Device.status

The availability status of the device.

Required

DeviceStatus

Device.type

Codes to identify medical devices

Example

Device Types

5.12.3.2 Notes

5.12.3.2.1 Device Types

The example binding used for the device element is from SNOMED CT. However, there are many other sources of possible codes for device type including:

Global Medical Device Nomenclature (GMDN®)
Rosetta Terminology Mapping (RTM)
A uniform device identifier (UDI) repository (in the US this is the GUDID database)
The DI (GTIN) portion of the device’s UDI

Note that there may be translations of type code using one or more of these and other vocabularies

5.12.3.2.2 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.

5.12.3.2.3 Unique Device Identifier (UDI)

The International Medical Device Regulators Forum IMDRF UDI Working Group published UDI System for Medical Devices (Version 2.0) , the base specification for Unique Device Identifiers (UDI). The United States Food and Drug Administration has produced an implementation guide for Unique Device Identifiers (UDI) which implements the IMDRF specification and other jurisdictions may produce similar IMDRF implementation guides as well. The full UDI string that represents the barcode as printed on the packaging of the device or Automatic Identification and Data Capture (AIDC) representation is called the "UDI carrier". The UDI has 2 components*:

Device identifier (DI)**, which is the actual identification component
Production identifier(s)(PI) which provide the means to track a device through its manufacture, distribution and use.

*non-UDI elements may also appear within the UDI carrier. **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.

The DI of the UDI may be stored in a jurisdictional repository and used as the primary key to access other device information. For example, in the United States, the DI of the UDI is submitted in a device record to the Global Unique Device Identification Database (GUDID) . the The UDI may identify an instance of a device uniquely (when the PI includes a serial number), or it may just identify the type of the device. The UDI is parsed 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, expiriation date, etc.) SHALL be consistent with the information encoded in the UDI string or registered in the local repository.

Best practice guidelines for transmitting UDI data using the Device resource dictate transmitting both the UDI Carrier and all components found within the UDI as described in Device UDI Mapping. Several examples are provided for futher guidance.

5.12.4 Search Parameters

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

Name	Type	Description	Paths
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
udicarrier	token	Barcode string (udi)	Device.udiCarrier
url	uri	Network address to contact device	Device.url