植入器械长期失效模式与临床评价  

Research on Sustainable Modes of Troubleshooting and Clinical Evaluation of Implantable Medical Apparatus and Instruments

作　　者：魏洁 李湘媛 施小立 WEI Jie;LI Xiang-yuan;SHI Xiao-li(Peijia Medical(Suzhou)Co.,Ltd.,Jiangsu Suzhou 215000)

机构地区：[1]沛嘉医疗科技(苏州)有限公司,江苏苏州215000

出　　处：《中国医疗器械信息》2022年第1期11-16,共6页China Medical Device Information

摘　　要：植入医疗器械的生产工艺相对复杂,是一个国家制造业和高科技尖端水平的标志之一,在我国属于国家重点鼓励发展的产业。植入式医疗器械的长期使用寿命是贯穿整个产品生命周期,通过上市后的临床评价与研究的方式可以提升产品可靠性,以缓解植入医疗器械因失效而带来的不良影响。随着大量植入产品应用于临床,医疗器械的失效病例也逐年增加,器械的失效会加剧患者的痛苦,降低疾病治疗效果和患者带病生存质量,甚至会导致死亡。植入式医疗器械在使用期限内的安全有效至关重要。研究符合相关法规要求,适合植入式医疗器械发展现状的使用期限评价具有重要的现实意义。加强对国家对植入式医疗器械上市后临床使用及临床评价等相关政策法规的认知,提高生产企业的自律性,同时借鉴FDA的相关程序,加强失效模式及不良反应数据库的建立,以求避免产品失效或在产品失效时可以对产品质量,医生手术操作及患者自身情况等相关因素进行综合性的评价。The production process of the implantable medical devices is relatively complex,symbolizing China’s high-level manufacturing industry and technology.It belongs to the national key industry that the country encouraging its development.The long-term service life of implantable medical devices holistically encompasses the considerations for whole product life cycle.Post-marketing clinical evaluation and research methods can improve product reliability so as to alleviate the adverse effects of failure in implantable medical apparatus and instruments.With increasing numbers of implantable devices being used in clinical practise,more cases failed due to device failure.It should also be noted that these failures aggravate the pain of patients,delaying the treatment of the disease,and may even lead to death.The safety and effectiveness of implantable medical devices during their service lives are hence extremely crucial.It is of great practical significance to study the service life evaluation that meets the requirements of relevant laws and regulations and is suitable for the development status of implantable medical devices.Strengthening the national cognition of relevant policies and regulations on the post-market clinical use and clinical evaluation of implantable medical devices,improving the self-discipline of production enterprises,learn from the experience of the relevant procedures of Food and Drug Administration(FDA)at the same time,and strengthening the establishment of failure mode and adverse reaction database are very important for product failure prevention and comprehensive evaluation of the product quality,the doctor’s surgical operation,the patient’s own condition and other relevant factors in the case of failure.

关 键 词：植入医疗器械 失效模式 上市后临床研究 

分 类 号：R197.39[医药卫生—卫生事业管理]