在用医疗器械质量评价和风险评估的研究  

Research on Quality Evaluation and Risk Assessment of Medical Devices in Use

作　　者：刘永鹏 周飞 魏周华 周莉 施瑛 徐静娴 LIU Yong-peng;ZHOU Fei;WEI Zhou-hua;ZHOU Li;SHI Ying;XU Jing-xian(Gansu Medical Device Inspection and Testing Institute,Gansu Lanzhou 730000)

机构地区：[1]甘肃省医疗器械检验检测所,甘肃兰州730000

出　　处：《中国医疗器械信息》2025年第5期20-22,共3页China Medical Device Information

摘　　要：随着科学技术的发展和医疗需求的增长,越来越多的新技术被应用在医疗器械领域。然而,部分新技术可能对患者造成直接的身体伤害。现代医学对医疗器械的依赖程度越来越高,医疗工作的诸多环节(包括检查、诊断、治疗、生命维持、病危和重伤抢救、康复)都离不开医疗器械的使用。医务人员以医疗器械所提供的数据作为重要的诊疗依据,因此,确保医疗器械各项数据的准确性和性能的稳定性显得尤为重要。文章以部分与临床救治关系密切、风险高、涉及面广且量大、不良事件发生率高、检验检测可操作性强且技术设备较为成熟的在用医疗器械作为研究对象,开展设备在用期间的质量抽检和风险评估。研究发现,在用医疗器械质量保证方面存在诸多问题。为此,提出加强在用医疗器械质量控制管理的意见和建议,旨在推动医疗机构改进质量管理,降低在用医疗器械的使用质量风险,保障在用医疗器械满足安全和性能指标,确保人民群众用械安全。同时,通过对相关理论和方法的研究,结合实际案例分析,阐述质量评价和风险评估的重要性、流程及关键要素,为保障医疗器械使用安全和提高医疗质量提供理论依据和实践指导。With the development of science and technology and the growth of medical demand,more and more new technologies that may cause direct physical harm are being applied in the field of medical devices.The dependence of modern medicine on medical devices is increasing,and every aspect of medical work,including examination,diagnosis,treatment,life support,critical and serious injury rescue,rehabilitation,is closely dependent on medical devices.Medical personnel rely on the data provided by medical devices,and the accuracy and stability of various data and performance of medical devices are particularly important.This paper focuses on in use medical devices that are closely related to clinical treatment,have high risks,involve a wide range of areas,have a high incidence of adverse events,and have mature technical equipment for inspection and testing.Quality sampling and risk assessment of the devices during use were conducted,and problems were found in the quality assurance of in use medical devices.Suggestions were put forward to strengthen the quality control management of in use medical devices,promote the improvement of quality management in medical institutions,reduce the quality risks of in use medical devices,ensure that in use medical devices meet safety and performance indicators,and ensure the safety of the people’s use of medical devices.Through the study of relevant theories and methods,combined with practical case analysis,this article elaborates on the importance,process,and key elements of quality evaluation and risk assessment,providing theoretical basis and practical guidance for ensuring the safety of medical device use and improving medical quality.

关 键 词：在用 医疗器械 质量 风险 评估 

分 类 号：R194[医药卫生—卫生事业管理]