医疗器械临床试验开展前的风险评估

Risk Assessment before Conducting Clinical Trials of Medical Devices

由于新型医疗器械的迅速发展和国家对医疗器械审评审批的政策调整,临床试验机构及伦理委员会对医疗器械临床试验风险评估的难度有较大提升。通过对医疗器械相关的法律规范、标准和安全性评价资料进行梳理,从生物样本的采集利用、场地环境安全、信息安全、产品的生产和检验、器械使用、临床试验设计和技术能力共7个方面对医疗器械临床试验存在的风险进行系统性归纳和建议,为申办者、临床试验机构及伦理委员会科学地建立医疗器械临床试验前的风险评估体系提供参考依据,从而降低临床试验过程中潜在的合规性和安全性风险。

Due to the rapid development of new medical devices and the national policy adjustment of medical device review and approval,the difficulty of clinical trial institution and ethics committee in the risk assessment of medical device clinical trials has greatly increased.By sorting out the legal norms,standards and safety evaluation materials of medical devices,this paper systematically summarized and suggested the existing risks in clinical trials of medical devices from seven aspects,including the collection and utilization of biological sample,site environment safety,information security,product production and inspection,use of device,clinical trial design,and technical capabilities,with a view to providing a reference basis for the sponsors,clinical trial institutions,and ethics committees to scientifically establish a risk assessment system for medical devices before clinical trials,thereby reducing potential risks of compliance and safety during the clinical trial process.