Abstract：This paper made analysis of the status quo and deficiencies of MDEA (Medical Device Adverse Events) in the hospital based on the definition of MDEA and corresponding management requirements. Then, the 3-level security management mode was put forward so as to realize the security monitoring of MDEA in the hospital and avoid occurrence of the adverse events, which included the committee system as the hospital-level management, the standing organization as the department-level management and the monitors reporting system as clinic-level management.
蔡梅华. 浅谈医院医疗器械不良事件的三级制安全管理[J]. 中国医疗设备, 2013, 28(10): 91-93.
CAI Mei-hua. Discussion on the 3-level Security Management of Medical Device Adverse Events in the Hospital. China Medical Devices, 2013, 28(10): 91-93.
