Application of Human Reliability Analysis in Risk Assessment of Medical Devices
LI Ping1, WANG Zhu2a, KOU Jing-bo3, LI Yan-hua2b
1.Quality Control Office, Shanghai Pudong New Area Zhoupu Hospital, Shanghai 201138, China; 2.a.School of Mechanical Engineering; b.School of Medicine, Tongji University, Shanghai 200092, China; 3. Department of Plastic Surgery, The East Hospital Affiliated to Tongji University, Shanghai 200120, China
Abstract:This paper analyzes the concept, characteristics and use flow of cognitive reliability and error analysis method (CREAM), and detailedly introduces its application process in the reliability analysis of infusion pump. This paper points out that the risk assessment of medical equipment can be improved with the application of CREAM which can evaluate the miss probability of operators during the usage process of medical equipment.
李萍,王竹,寇静波,李艳华. 人因可靠性分析在医疗器械风险评估中的应用[J]. 中国医疗设备, 2014, 29(2): 113-115.
LI Ping, WANG Zhu, KOU Jing-bo, LI Yan-hua. Application of Human Reliability Analysis in Risk Assessment of Medical Devices. China Medical Devices, 2014, 29(2): 113-115.