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.