Global Standardization of Human Factors for Medical Devices and Systems

Abstract

This panel addresses current domestic and international standards for medical devices and systems in Latin America, Europe, Asia, Canada and the United States. Following a presentation of current standards development efforts, there will be an open discussion of HF standard overlaps and conflicts, opportunities for harmonization, and additional areas of need. Time permitting, the value of technical standards versus performance standards as a means to reduce the probability of use error involving medical devices and systems will be discussed.