摘要
医疗领域的技术创新为患者提供了更好的医疗服务,然而也带来了潜在的风险。医疗设备的临床应用中存在着患者安全风险、设备故障风险和信息安全风险等问题。为确保医疗设备的安全性和有效性,风险评估变得至关重要。风险评估流程包括风险识别、分析、评估和控制等阶段,国际标准如ISO 14971为风险管理提供了指导。HAZOP分析、失效模式与影响分析和人因工程学是常用的评估方法,有助于识别设备操作和技术上的风险。风险管理策略应贯穿设备设计、制造、培训和沟通等阶段,确保医务人员和患者的安全意识,并促进风险信息的共享与反馈。
Technological innovation in the medical field provides better medical services for patients,but it also brings potential risks.There are issues such as patient safety risks,device failure risks,and information security risks in the clinical application of medical equipment.To ensure the safety and effectiveness of medical equipment,risk assessment has become crucial.The risk assessment process includes stages such as risk identification,analysis,evaluation,and control,and international standards such as ISO 14971 provide guidance for risk management.HAZOP analysis,FMEA analysis,and human factors engineering are commonly used evaluation methods that help identify equipment operation and technical risks.The risk management strategy should run through the stages of equipment design,manufacturing,training,and communication,ensuring the safety awareness of medical personnel and patients,and promoting the sharing and feedback of risk information.
作者
王静
董旭辉
WANG Jing;DONG Xu-hui(Medical Insurance Department,Xianyang Central Hospital,Shaanxi Xianyang 712000;Equipment Department,Xianyang Central Hospital,Shaanxi Xianyang 712000)
出处
《中国医疗器械信息》
2023年第23期167-169,共3页
China Medical Device Information
关键词
医疗设备
临床应用风险
评估规范研究
medical equipment
risks in clinical applications
norm study of evaluating
