DeviceDefinition FHIR Resource Proposal

DeviceDefinition

Owning Committee Name

Orders & Observations

Committee Approval Date:

Please enter the date that the committee approved this Resource proposal

June 12, 2018 - http://confluence.hl7.org/display/OO/OO+Conf+Call+Minutes+-+Device+-+20180612

Contributing or Reviewing Work Groups

Healthcare Devices

• Work Group Name
• or link
• or "None"

FHIR Resource Development Project Insight ID

PI 952

Scope of coverage

This is a specialized resource that defines the characteristics and capabilities of a device. Devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment and research for healthcare and public health, as well as devices such as an x-ray machine, lab analyzer, cellphone, computer, software/application, etc. A device may also be a simpler entity such as a syringe or applicator, provided with a medicinal product.

The DeviceDefinition resource is used to describe the common characteristics and capabilities of a device of a certain type or kind, e.g., a certain model or class of a device such as a x-ray model or personal wearable device model, whereas a Device resource documents an actual instance of a device such as the actual x-ray machine that is installed or the personal wearable device being worn

The DeviceDefinition is typically used in catalogs, publications, or other use cases where the reference to a device is generically to a type of device, not a specific instance of a device. For example, a catalog of orderable devices, or the mapping of device specific test codes and result values to industry standards.

RIM scope

There does not appear to be a DeviceDefinition concept in the RIM, rather only the Device instance is referenced The Common Product Model touches on elements, but not all.

Resource appropriateness

The DeviceDefinition resource contains the "catalog" definition of a device - whether that definition is authored by the manufacturer or a regulatory entity and allows defining valid hierarchical device configurations (devices as part of other devices).

Device vs DeviceDefinition: The Device resource is meant to refer to a physical instance of a device - hence having attributes like lot number, patient, location and operational status, which the DeviceDefinition resource does not have.

Separating the DeviceDefinition from Device enables clearer distinction, considering that a number of use cases primarily focus on Device, while others focus on DeviceDefinition. There will be many more Device instances than there will be DeviceDefinition instances. The DeviceDefinition would be used in catalogs and would have a different update lifecycle to the Device resource instances.

Expected implementations

Implementations of catalogs, e.g., LIVD as well as implementations needing to reference device definitions. The LIVD implementation guide addresses Lab device manufacturers to document recommended mapping of test codes and result values used on their devices using proprietary/local code systems to (inter)national vocabularies such as LOINC and SNOMED.

EMA plan to use this for representing the devices that are commonly supplied with medication items, within the same packaging (e.g., syringe, spoon etc). This "SPOR" project is currently implementing, with a first release in early 2020.

Content sources

• HL7 FHIR Device and DeviceMetrics
• HL7 V2 EQU and DEV segments
• EMA XEVPRM implementation of regulatory medications information

Example Scenarios

Ordering supplies using SupplyRequest would typically reference DeviceDefinitions rather than specific devices.

Ordering DME would typically reference DeviceDefinitions rather than specific devices.

Standard vocabulary mappings for devices typically define common mappings based on device models, thus DeviceDefinition rather than for each individual device.

Submission by a pharmaceutical manufacturer of the details of a packaged medicinal product for licencing by regulators (e.g. EMA, FDA, MHRA) would typically include definitions of the devices included (description, dimensions, materials, manufacturer etc).

Resource Relationships

• Device
• Composition
• ObservationDefinition
• PackagedMedicinalProductDefinition (contains devices as defined by DeviceDefinition)

Timelines

September 2018 inclusion in FHIR R4.

gForge Users

Eric Haas, Jose Costa Teixeira

When Resource Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org