体外诊断医用设备使用期限的确方法及其意义

摘要

目的:探讨体外诊断医用设备使用期限确定的常见方法和标注该类设备使用期限的积极意义.方法:根据体外诊断医用设备特点,结合新发布的《医疗器械注册管理办法》要求,通过查阅相关文献,对确定该类设备使用期限的常见方法进行分析研究.结果:该方法可以对设备使用期限进行有效估算,但预估后应当根据风险管理原则,对设备的使用期限进行监测与适时校正.结论:体外诊断医用设备说明书和标签中标注产品使用期限可以提高体外诊断医用设备使用的安全性和有效性,促使生产企业不断推陈出新,规范使用者的各种行为,对行业发展有着积极意义.%Objective To explore the common methods for determining the expiration rate of the in vitro diagnostic medical device and the significance for signing the expiration date.Methods The methods for determining the expiration date were analyzed based on the features of the in vitro diagnostic medical device and Regulations for Medical Devices Registration and Management.Results The methods estimated the expiration date effectively,while the expiration date had to be monitored and calibrated in time according to risk management principle.Conclusion The safety and efficiency of the in vitro diagnostic medical device are enhanced by signing the expiration date in the technical manual and label.