Device

Device represents 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.

Documented evidence of a device may exist in a clinical record in various ways:

• A provider may document placement of a device as an intervention or procedure (e.g., the QDM datatypes Intervention, Performed, or Procedure, Performed). Example: Procedure, Performed: Pacemaker insertion.
• The provider may document presence of the device as a finding, perhaps including the finding on the problem list. Example: Diagnosis: Pacemaker present, or Assessment, Performed: Pacemaker present.
• A provider may also document the device in a specific device use statement or assessment.
  • Example: Device, Applied: Transtelephonic monitoring of pacemaker assessment. 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.

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. The QDM datatype, Device, Applied, provides the best method to determine specific details about the device in use if a device usage assessment exists to provide such information. It also allows a measure developer to explicitly express which devices should be included in the query.