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8.9 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.

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

8.9.3 Resource Content

 

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

8.9.3.1 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

8.9.3.2 Notes

8.9.3.2.1 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

8.9.3.2.2 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.

8.9.3.2.3 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.

8.9.4 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