Do It by Design: An Introduction to Human Factors in Medical Devices. Guidance211 Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant 211 Components

摘要

The purpose of this primer is to encourage manufacturers to improve the safety of211u001emedical devices and equipment by reducing the likelihood of user error. This can 211u001ebe accomplished by the systematic and careful design of the user interface, i.e., 211u001ethe hardware and software features that define the interaction between users and 211u001eequipment. This document contains background information about human factors as a 211u001ediscipline, descriptions and illustrations of device problems, and a discussion 211u001eof human factors principles and methods. In addition, the final section of this 211u001edocument contains recommendations for manufacturers and healthcare facilities.