QI-Core Implementation Guide, Clinical Quality Improvement WG - CI build for vesion 4.0.0). This version is based on the current content of https://github.com/cqframework/qi-core/ and changes regularly. See the Directory of published versions
QDM defines Device as an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including a component part or accessory, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and not dependent on being metabolized to achieve any of its primary intended purposes.
FHIR defines the Device Resource as 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. 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.
Documented evidence of a device may exist in a clinical record in various ways:
Thus, specific actions may reference the Device Resource, for example a Procedure, an Observation, a Condition, a DeviceUseStatement, a DeviceRequest, an AdverseEvent and others.
Given the variation in determining evidence of device usage, a measure developer may need to include multiple queries (or retrieves) to assure capture of all devices present in the measure population.
Note that the current use of the QDM datatype “Device, Applied” usually references the procedure to “apply” the device (i.e., to use for the patient, to use on the patient’s body, or to implant in the patient’s body). Each of these current uses should address the concept using the QDM datatypes, Intervention, Performed, or Procedure, Performed.
|QDM Context||QI-Core R4||Comments|
|DeviceUseStatement.status||Probably constrain to "active"|
|Anatomical Location Site||DeviceUseStatement.bodySite|
|Negation Rationale||Pending final modeling in QI Core||DeviceUseStatementStatus does not include a reference to not-done and there is no reference to notDoneReason|
|Pending final modeling in QI Core for timing of negation rationale|
|Relevant dateTime||DeviceUseStatement.timing[x] dateTime|
|Relevant Period||DeviceUseStatement.timing[x] Period|
|Performer||DeviceUseStatement.source||DeviceUseStatement.source references who reported the device was being used by the patient. Thus the individual working with the device may be different as may the individual recording information about the device usage.|
|QDM Context||FHIR R4||Comments|
|DeviceRequest.status||Constrain to active, on-hold, completed|
|Device, Recommended||DeviceRequest.intent||Constrain to "plan"|
|Device, Order||DeviceRequest.intent||Constrain to "order" (include children)|
|Author dateTime||DeviceRequest.authoredOn||FHIR allows dateTime or Period for desired time or schedule for use.|
|Negation Rationale||DeviceRequest.doNotPerform||ServiceRequest includes a doNotPerform; DeviceRequest does not|
|DeviceRequest.doNotPerform.reason||ServiceRequest includes a reason code, but not a doNotPerformReason|