摘要
目的:通过对303例全自动生化分析仪可疑不良事件报告进行分析,发现全自动生化分析仪潜在使用风险,为风险分析及风险控制建议提供了科学证据。方法:对2016年~2018年福建省收集的303例全自动生化分析仪可疑不良事件报告进行统计分析。结果:全自动生化分析仪主要具有与“可靠性”“可用性(易用性)”和“应用条件不确定性风险”相关的三类风险。结论:全自动生化分析仪生产企业应该主动开展不良事件报告工作,针对监测到的使用风险改进产品,强化对医疗机构使用者的教育培训,保障全自动生化分析仪使用安全。
Objective:Through the analysis of 303 suspicious adverse event reports of full-automatic biochemical analysis,we found the potential use risks of full-automatic biochemical analysis,and provided scientific evidence for risk analysis and risk control suggestions.Methods:We statistically analyzed 303 suspicious adverse event reports of full-automatic biochemical analysis collected in Fujian Province from 2016 to 2018.Results:Full-automatic biochemical analysis mainly has three types of risks related to"reliability","availability(ease of use)"and"wind of uncertainty of application conditions".Conclusion:Full-automatic biochemical analyzer manufacturers should take the initiative to carry out adverse event reporting work,and improve the products according to the monitored use risks,strengthening education and training for users in medical institutions,and ensure the safety of automatic biochemical analyzer.
作者
苏智阳
袁文杰
SU Zhi-yang;YUAN Wen-jie(Xiamen Food and Drug Evaluation Certification and Adverse Reaction Monitoring Center,Fujian Xiamen 351000)
出处
《中国医疗器械信息》
2022年第13期16-19,49,共5页
China Medical Device Information
关键词
全自动生化分析仪
不良事件报告
风险控制
automatic biochemical analyzer
similar adverse event
reporting risk control
