摘要
目的可靠性是心室辅助装置进入临床使用的先决条件,是影响患者使用安全、决定患者预期临床效果的关键因素。本文针对心室辅助装置可靠性试验的两个关键因素:试验平台设计和接受准则进行论述。前者定义了心室辅助装置可靠性测试的体外环境及平台,后者则规定了心室辅助装置可靠性评价标准。方法通过对心室辅助装置的可靠性测试中体外环境的分析,确定了睡眠、苏醒及运动3种条件下的人体生理条件,明确了试验平台参数。讨论了可靠性试验接受准则,其包含试验中准则和试验后准则。结果实际搭建了耐久性测试平台,验证了耐久系统的可用性。并根据风险将故障划分为四类,明确了接受标准。试验后准则主要建立评价系统性能变化的关键指标。结论该平台可以解决我国高风险心室辅助装置无统一评价平台和规范的困难,提高该类产品可靠性的科学评价能力。
Objective Reliability is a prerequisite for clinical use of left ventricular assist devices. It is a key factor that affects patient safety and determines the expected clinical outcome for patients. In this paper, two key factors （experimental platform parameters and acceptance criteria） determining the success of LVAD reliability test were discussed. The former defned the external environment and platform for the left ventricular assist device in reliability testing, and the latter provided the criteria for evaluating the left ventricular assist reliability. Methods The paper frst analyzed the human load stress in the reliability test of the left ventricular assist device, and determined the threshold and distribution of the key stress under the low, middle and high load conditions of the reliability test. Secondly, the acceptance criteria of reliability test were discussed. The acceptance criteria not only included the evaluation analysis strategy after the reliability test, but also included the possible failures in the reliability test. Results The reliability test platform was successfully built to verify the system. According to the risk, the faults were divided into four categories, and the acceptance criteria were clearly defned. After the test, the key indicators of the performance evaluation were set up. Conclusion This platform can solve the problem that there is no unifed evaluation platform and standard for high-risk ventricular assist devices in China, and improve the scientifc evaluation ability of reliability of this kind of products.
作者
李澍
王浩
任海萍
LI Shu;WANG Hao;REN Haiping(Institute for Medical Devices Control,National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国医疗设备》
2018年第9期1-5,18,共6页
China Medical Devices
基金
国家重点研发计划(2016YFC0103201)
关键词
心室辅助装置
可靠性
试验平台设计
人体负载
接受准则
ventricular assist devices
reliability evaluation
experimental platform parameters
body load stress
acceptance criteria
