Role of human factors / usability engineering in medical device design

Abstract

There is mounting evidence that medical device use error is a significant factor in thousands of patient deaths and injuries. Doctors, nurses and patients make mistakes while using medical devices that result in patient harm. Poor human factors design is one of the root causes of the problem. The Food and Drug Administration (FDA) and other International Regulatory agencies identified that manufacturers must pay more attention to human factors at the earliest stages of product design and development, when user input can make a difference. To this end, the FDA has developed guidance documents and recognized standards (e.g. AAMI/ANSI HE75:2009, Human Factors Engineering-Design of Medical Devices and IEC 62366, Medical Devices - Application of Usability Engineering to Medical Devices) to help medical device manufacturers understand and use human factors engineering during the development and validation of medical devices.