(HFE/UE analysis testing)
(according to (Draft) Guidance for Industry and Food and Drug Administration Staff – Applying Human Factors and Usability Engineering to Optimize Medical Device Design)
Via user testing we “Demonstrate safe and effective device use through human factors validation”
To demonstrate that the intended users of a medical device can safely and effectively perform critical tasks for the intended uses in the expected use environments a small patient observation study is conducted.
Considerations to be discussed in order to identify specific aspects of device use that are associated with potential use-related hazards that should be investigated through HFE/UE analysis and testing.
Timing of the user test
The idealized timing would be after the risk mitigation and verification. I.E. when no new use-related hazards are introduced through HFE/UE analysis and testing.
User test protocol
The testing protocol should reflect a focus on the highest-priority tasks or use scenarios and describe methods to collect sufficient and appropriate data to demonstrate that all critical aspects of use can be performed well and that users do not report patterns of difficulty arising from features of the user interface or elements that are not provided but necessary.
In the validation section of the report you can find i.e.
- Rationale for test type selected (i.e., simulated use or clinical evaluation)
- Number and type of test participants and rationale for how they represent the intended user populations
- Test goals, critical tasks and use scenarios studied
- Technique for capturing unanticipated use errors
- Definition of performance failures
For all EU dossiers we use the EMA readability guideline