DeviceUseStatement includes information regarding the use of a device as expected. However, there are times within a clinical workflow when a device is ordered but the clinician using or applying the device has a reason to avoid fulfilling the order/request. That reason for failing to fulfill the request needs to be documented and, therefore, should be part of the DeviceUseStatement.

The CQI Work Group suggested the following workflow instances where negation rationale might apply:
a. Ordering workflow
An order set or event-condition-action Clinical Decision Support (CDS) rule suggests the provider order a device to be used. The provider indicates a reason for failing to comply with the recommendation. The software stores and can access the reason for non-compliance for use in evaluating the effectiveness of the order set or CDS rule, and to avoid repeatedly recommending the same action when reasons for non-compliance are acceptable.
a. Clinical care workflow
A clinician performs the task generated by the order and determines that fulfilling the order is inappropriate based on direct knowledge of the patient. For example, a nurse reviews the task to place anti-thrombotic pneumatic devices on the patient's legs to reduce the likelihood of thromboembolic events. The nurse determines that use of the devices would be detrimental to healing the patient's thermal leg burns. The nurse indicates the reason for failing to comply with the order in the electronic record.
The clinical care workflow should be accommodated as part of the DeviceUseStatement.