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type: resourceresource: Device

Device

Introduction

Note to Balloters: To ensure the Device resource is ready for Normative status, we are seeking ballot comments on the substantive content. The key changes made since R5 include:

For an overview of this resource and others in the Device domain, also see the Device Module page.

The Device scope and usage has been revised. A majority of content has been moved DeviceDefinition to describe the types of devices in scope.

The following element was added:

  • Device.additive as a backbone.

The following elements have been revised:

  • Updated Device.definition datatype to canonical(DeviceDefinition).
  • Updated Device.version to Device.deviceVersion.

The following elements have been removed from Device:

  • Device.displayName as it was duplicated in Device.name backbone.
  • Device.owner has been removed and was moved to DeviceAssociation.relationship of the subject. Please comment on the revision if there are issues with removing the identification of individuals in the Device resource.
  • Device.mode, Device.cycle, Device.duration, Device.gateway, Device.endpoint have been removed and the following extensions were added: device-mode, device-cycle, device-duration, device-gateway, and device-endpoint.

The following extensions were added:

  • device-alertDetection to describe the alert detection activation states for the overall device.
  • device-conformsTo-source – represents the source of the device specification.

Scope and Usage

This is a base resource that tracks individual instances of a device and their location. It is referenced by other resources for recording which device performed an action such as a procedure or an observation, which device was implanted in or explanted from a patient, dispensing a device to a patient for their use, managing inventory, or when requesting a specific device for a patient's use. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Medical devices may also include some types of software.

Non-medical devices may include items such as a machine, cellphone, computer, software application or algorithm, etc. In short, a Device can range from a tongue depressor to an MRI. The fields in the Device resource must be flexible enough to cover this range.

The resource may be used to document the Unique Device Identifier (UDI) and information about a device where appropriate or necessary according to local jurisdictions over time. Additional information about UDI is provided in the Unique Device Identifier (UDI) section.

Devices may be categorized and may be associated with one or more categories. Device category examples include, but are not limited to: active, communicating, durable medical equipment, home use, implantable, InVitro diagnostics, personal health, point-of-care, single use, re-usable, and software. See DeviceDefinition for detailed descriptions of device categories.

Device and DeviceDefinition

When referring to a specific instance, even without specific instance details, Device is to be used, not a DeviceDefinition. The context of a data exchange indicates whether the data is representing a physical instance or a "kind", not the presence of instance data such as lot and serial numbers.

Some examples:

  1. In a Procedure, reporting the use of a pump for which we have no instance data - the pump is a physical instance. Whether the lot number (for example) is known or not, depends on the circumstance - in another Procedure or in an update of the Procedure, the lot number could be added. Hence the use of Device.
  2. When a device gets replaced by another device of the same type. In this case, a procedure indicates that one instance of the device is removed/explanted/discarded, and another instance is used. These are physical instances for which instance data might exist and be known, or not.

Boundaries and Relationships

[%stu-note dstu%] The module pages under development by Orders and Observations will further describe the variations of device use cases across the device resources, e.g., Device, DeviceDefinition, DeviceAssociation, DeviceDispense, DeviceMetric, DeviceRequest, and Device Usage.

[%end-note-np%]

There are several resources that can be used to represent device related events, requests or definitions. The following Resources should be used in the following manner:

In FHIR, the Device represents either the device in total, or a component of an encapsulating device when there is a need for individual tracking of a component. A Device as a component then points to the parent device it is part of. The top-level Device captures the actual data about the instance of the device and the instances of all its children that either provides identifying characteristics of the Device (including applicable UDI – unique device identification) and data that can vary dynamically by device, e.g., specific settings at a particular point in time.

Devices differ from medications because they are not "used up" - they remain active in or for a patient for a longer duration. They also may be re-used, particularly non-implanted devices and those used for diagnostics and procedures. Frequently, when a device is packaged with a medication, the ordering, dispense, and administration processes typically focus on the medication aspects and reference the device.

In the case of an infusion pump, while some actions are focused on the device (e.g., ordering to a room or maintaining the pump), the focus is as well on the medication while the device is used for administration. However, that separation is not always as clear and may be impacted by specific implementations. Regardless, the Medication resource should not be used to represent (implanted) devices, rather reference the relationship where an actual device needs to be tracked in addition to the medication. In some sense the Medication is analogous to the Observation generated by a Blood Pressure personal health device. The Observation resource contains the blood pressure values, units and the time stamp while the Device resource contains the manufacturer name, model number, serial number, firmware and hardware versions, exchange protocol information, any clock capabilities, etc.

Notes

Notes

Device Identifier and Device Type

Nearly all devices are assigned a string of characters to represent one or more identifiers or codes, which are usually printed or affixed to the device using either barcodes or RFIDs. The identifier or code can come from the manufacturer (for example, a 'serial number', 'reference number', or 'catalog number'), various institution and registries. Any of these identifiers or codes assigned to the device can and should be recorded in the device resource. However, there can there can be confusion where to represent them in the resource because codes and identifiers are represented in FHIR as semantically distinct elements and because organizations may conflate the term 'code' for an identifier or 'identifier' for a code in their names.

The identifier element is only intended for use when it's an actual identifier for a specific instance of a device. That would mean that each device would have a separate serial number and would be represented using this element - devices without serial numbers (for example, a box of syringes) would not. Concepts such as a reference number or catalog number or GTIN describe a code which represents a kind of device and are conveyed using the type element. Some sources of standard codes for devices and translations within type are listed below:

For systems that do have a system URI for device types (indicating the model number or part number), they can and should appear as codings in Device.type.

Device.type relates DeviceDefinition.classification.type using the same binding enabling referencing. Please see the Search Parameters for details on how to search for devices by type.

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(1):

  1. non-UDI elements may also appear within the UDI carrier.
  2. 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 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, expiration 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 further guidance.

Status Elements

Device.status is about the record, while .availabilityStatus is about the device itself.

StructureDefinition

Elements (Simplified)

Mappings

Implementation Guide

implementationguide-Device-core.xml

<?xml version="1.0" encoding="UTF-8"?>

<ImplementationGuide xmlns="http://hl7.org/fhir">
  <id value="Device-core"/>
  <version value="0.1"/>
  <name value="DeviceHL7Extensions"/>
  <title value="Device  H L7  Extensions"/>
  <status value="draft"/>
  <date value="2015-02-21T00:00:00.000"/>
  <publisher value="Health Level Seven, Inc. - FHIR WG"/>
  <description value="Defines common extensions used with or related to the Device resource"/>
</ImplementationGuide>

Resource Packs

list-Device-packs.xml

<?xml version="1.0" encoding="UTF-8"?>

<List xmlns="http://hl7.org/fhir">
  <id value="Device-packs"/>
  <status value="current"/>
  <mode value="working"/>
  <entry>
    <item>
      <reference value="ImplementationGuide/Device-core"/>
    </item>
  </entry>
</List>

Search Parameters

Full Search Parameters

Examples

Full Examples

Mapping Exceptions

device-fivews-mapping-exceptions.xml

Divergent Elements

Unmapped Elements

device-participant-mapping-exceptions.xml

Divergent Elements