Objective: To modify the traditional heuristic evaluation method of assessing software usability so that it can be applied to medical devices and used to evaluate the patient safety of those devices through the identification and assessment of usability problems.
Design: Heuristic evaluation, a usability inspection method commonly used for software usability evaluation, was modified and extended for medical devices. The modified method was used to evaluate and compare the patient safety of two 1-channel volumetric infusion pumps.
Results: The modified heuristic evaluation method was successfully applied to medical devices. One hundred and ninety-two heuristic violations were categorized for 89 usability problems identified for Pump 1, and 121 heuristic violations were categorized for the 52 usability problems identified for Pump 2. Pump 1 had more usability problems with high severity ratings than Pump 2. In general, Pump 1 was found to have more usability issues that are likely to induce more medical errors.
Conclusions: Heuristic evaluation, when modified for medical devices, is a useful, efficient, and low cost method for evaluating patient safety features of medical devices through the identification of usability problems and their severities.