This page is part of the FHIR Specification (v1.0.2: DSTU 2). The current version which supercedes this version is

This page is part of the FHIR Specification (v1.6.0: STU 3 Ballot 4). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions . For a full list of available versions, see the Directory of published versions . Page versions: . Page versions: R5 R4B R4 R3 R2

• Content
• Examples
• Detailed Descriptions Detailed Descriptions
• Mappings
• Profiles Profiles & Extensions

5.10 8.9 Resource Device - Content Resource Device - Content

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.

Orders and Observations Orders and Observations Work Group Work Group

Maturity Level : 1 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.

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

5.10.3 Resource Content 8.9.3 Resource Content

 

Alternate definitions: Master Definition ( XML , JSON ), XML Schema / Schematron , Resource Profile ( XML , (for ) + JSON Schema , ShEx (for Turtle ), Questionnaire )

5.10.3.1 Terminology Bindings 8.9.3.1 Terminology Bindings

Device.type Device.status

Path	Definition	Type	Reference
Device.status	Defines the nature of the device and the kind of functionality/services/behavior that may be expected from it. The availability status of the device.	Preferred Required	Global Medical Device Nomenclature (GMDN®). DeviceStatus
Device.type	The availability status of the device. Codes to identify medical devices	Required Example	DeviceStatus Device Types

5.10.3.2 8.9.3.2 Notes Notes

5.10.3.2.1 8.9.3.2.1 Device Types 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.

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®) 5.10.3.2.2 Device Identifiers
• Rosetta Terminology Mapping (RTM) 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
• 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

(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 8.9.3.2.2 Device Identifiers (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>

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.

5.10.4 Search Parameters 8.9.3.2.3 Unique Device Identifier (UDI) Search parameters for this resource. The common parameters

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.

8.9.4 Search Parameters also apply. See

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

© HL7.org 2011+. FHIR DSTU2 (v1.0.2-7202) generated on Sat, Oct 24, 2015 07:43+1100. Links: Search | Version History | Table of Contents | Compare to DSTU1

Name	Type	Description	Paths
identifier	token	Instance id from manufacturer, owner, and others Instance id from manufacturer, owner, and others	Device.identifier
location	reference	A location, where the resource is found A location, where the resource is found	Device.location ( Location )
manufacturer	string	The manufacturer of the device The manufacturer of the device	Device.manufacturer
model	string	The model of the device The model of the device	Device.model
organization	reference	The organization responsible for the device The organization responsible for the device	Device.owner ( Organization )
patient	reference	Patient information, if the resource is affixed to a person Patient information, if the resource is affixed to a person	Device.patient ( Patient )
type	token	The type of the device The type of the device	Device.type
udi udicarrier	string token	FDA mandated Unique Device Identifier Barcode string (udi)	Device.udi Device.udiCarrier
url	uri	Network address to contact device Network address to contact device	Device.url