Burlington D B
Biomed Instrum Technol. 1996 Mar-Apr;30(2):107-9.
The Food and Drug Administration's new human factors design requirements for medical devices were previewed by the director of the FDA's Center for Devices and Radiological Health (CDRH) at AAMI/FDA's Human Factors in Medical Devices Conference held in September 1995. Director Bruce Burlington, MD, said the FDA plans to take a closer look at how new medical devices are designed to ensure proper attention has been paid to human error prevention. As a medical practitioner who has witnessed use-related deaths and injuries, Burlington stressed the importance of the medical community's reporting use errors as they occur and manufacturers' creating easy-to-use labeling and packaging. He also called for simplicity and quality of design in medical products, and asked for a consolidated effort of all professionals involved in human factors issues to help implement and further the FDA's new human factors program. An edited version of his presentation appears here.
1995年9月，美国食品药品监督管理局（FDA）设备与放射健康中心（CDRH）主任在AAMI/FDA医疗器械人因会议上预告了FDA对医疗器械新的人因设计要求。医学博士布鲁斯·伯灵顿主任表示，FDA计划更深入地研究新医疗器械的设计方式，以确保在预防人为错误方面得到了应有的重视。作为一名目睹过与使用相关的死亡和伤害事件的医生，伯灵顿强调了医疗界在使用错误发生时进行报告以及制造商制作易于使用的标签和包装的重要性。他还呼吁医疗产品设计要简洁且质量高，并要求所有涉及人因问题的专业人员共同努力，以帮助实施并推进FDA的新人因计划。此处呈现的是他演讲的编辑版本。
