Using usability heuristics to evaluate patient safety of medical devices

• Published in: Journal of biomedical informatics Vol. 36; no. 1; pp. 23 - 30
• Main Authors: Zhang, Jiajie, Johnson, Todd R, Patel, Vimla L, Paige, Danielle L, Kubose, Tate
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2003
• Subjects: Algorithms; Benchmarking - methods; Decision Support Techniques; Equipment Failure; Equipment Failure Analysis - methods; Equipment Failure Analysis - standards; Equipment Safety - methods; Equipment Safety - standards; Heuristic evaluation; Infusion pump; Infusion Pumps; Man-Machine Systems; Medical device; Medical error; Medical Errors - prevention & control; Medical Errors - standards; Patient safety; Quality Assurance, Health Care - methods; Quality Assurance, Health Care - standards; Safety Management - methods; Safety Management - standards; Software Validation; Usability; User-Computer Interface; Patient safety; Medical device; Infusion pump; Usability; Medical error; Heuristic evaluation
• ISSN: 1532-0464; 1532-0480
• DOI: 10.1016/S1532-0464(03)00060-1

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.