全面质量管理下的医疗器械风险防控

A discussion on the risk prevention and control of medical devices under total quality management

目的:基于医疗器械的全面质量管理,探讨医疗器械风险防控。方法:从全面质量管理和风险防控管理两方面分析医疗器械风险管理;从政府监管、企业自控及医疗机构管理三方面分析风险防控现状及存在问题;从成立质量控制中心、设立医疗设备管理员和开展医疗器械不良事件监测三方面,探索与实践医疗器械风险防控方法,降低医疗器械使用风险。结果:医疗器械的全面质量管理形成了医疗器械风险防控基本体系,加强了设备管理部门与临床科室间的沟通与联系,提高了医疗器械专业的同质化水平。结论:医疗器械风险防控的核心在于预防,医疗器械的全面质量管理,可降低医疗器械使用风险,维护患者和医务人员生命安全和身体健康。

Objective: To discuss the risk prevention and control of medical devices based on the total quality management of medical devices. Methods: The risk management of medical devices was analyzed from two aspects included total quality management and risk prevention and control. The present situation and existing problems of risk prevention and control were analyzed from three aspects: government supervision, enterprise self-control and medical organization management. And from three aspects included the establishment of quality control center, the establishment of medical equipment managers and the implementing of monitoring adverse events of medical devices to explore and practice the methods of risk prevention and control of medical devices, and to reduce the risk of using medical device. Results: The total quality management of medical devices has formed the basic system of risk prevention and control of medical devices. The communication and contact between the department of equipment management and clinical departments have been strengthened, and the homogenization level of the specialty of medical device has been enhanced. Conclusion: The core of the risk prevention and control of medical devices is prevention, and the total quality management of medical devices can reduce the risk of using medical devices, and can maintain and protect the life safety and physical health of patients and medical personnel.