医疗器械临床试验风险管理的问题及对策

Risk management of medical equipment clinical trial

目的:探索一套医疗器械临床试验风险最小化及持续改进的管理方法以确保医疗器械临床试验质量。方法:总结医疗器械临床试验在试验前准备工作、知情同意书设计与签署、投保情况、监查与质控、对不良事件认识程度等方面存在的问题,结合实际工作归纳降低风险的具体措施。结果:形成了医疗器械临床试验风险管理体系,实现了医疗器械临床试验全过程的有效管理。结论:临床试验风险管理应该对各环节风险点进行规划、识别,评估与评价,确立应对措施,最终实现风险最小化,并通过持续改进形成良性循环。

Objective To propose a set of management methods for minimized risk and continuous improvement of medical equipment clinical trial.Methods The problems were summarized on pre-trial preparation,design and signing of informed consent,insurance-related issues,supervision and quality control,perception of adverse events,and then some countermeas-ures were put forward accordingly.Results A risk management system was established for medical equipment clinical trial whole-course management.Conclusion Planning,recognition and evaluation have to be implemented over all the links of medical equipment clinical trial risk management,and corresponding countermeasures should be carried out for minimized risk and continuous improvement