Human Factors Emphasis Aims to Reduce Risk, Improve Safety

摘要

Anew AAMI course offers guidance to manufacturers on how to meet human factors regulations from the U.S. Food and Drug Administration (FDA), and how to apply the basics of human factors engineering.rnWith the FDA's increased emphasis on the use of human factors engineering in medical device design and development, manufacturers are now required to conduct a thorough userrnperformance validation study, according to Bob North, PhD, chief scientist for Human Centered Strategies Consulting in Colorado Springs.rnThe validation study should focus on "discovering or identifying residual risk" from users interacting with the device, North says.