Heuristic analysis: A tool to improve medical device safety and usability

Abstract

Although there are efforts from regulatory agencies, academic studies and end-users demonstrating the need to consider human factors during the manufacturing process and acquisition of new medical devices, our study showed that there are still widely-used products with usability problems in the market. Deficiencies in the design of a device, coupled with complex activities (e.g., task is rarely performed by a single operator) and high stress environments, may contribute to usability errors and lead to adverse events. This article shows how the application of the Heuristic analysis to health technology can help to reduce problems of use pre and post-market