Integrating Human Factors/Usability Engineering and Usability Testing into Medical Device Total Product Life Cycle

摘要

In 1999, Building a Safer Health System estimated that 44,000 to 98,000 deaths per year were attributed to preventable medical errors. This number was actually low due to underreporting and has since been revised upwards. If we can be responsible and effective in building HFE/UE into our design controls process following quality systems, we can prevent serious incidents and promote quality-driven, userenhancedproduct and service design.