医用内窥镜评价体系的构建与医疗器械全生命周期临床评价

Construction of evaluation system of medical endoscopes and the clinical evaluation of the whole process of medical devices

目的:建立一套适用于医用内窥镜的评价体系,全面、准确地对医疗器械上市前后的产品全生命周期进行科学的评价。方法:经科学遴选和严谨实践,构建一套医用内窥镜评价体系,从临床效果、临床功能及适用性、可靠性、技术性能以及服务体系5个维度展开评价。建立标准化临床评价场景,从纵向和横向、基层医院及三甲医院的使用情况,对10个不同内窥镜型号的5个维度展开评价,实施医疗器械上市前后的产品全生命周期科学评价。结果:全国医疗机构参评单位共51家,实现了国内全方位覆盖。对10个型号内窥镜评价报告显示,硬性医用内窥镜中进口型号STORZ(22202020)综合指标评价最佳,在临床效果、技术性能方面表现最为突出。国产主机中迈瑞(HD3)综合指标评价较高,服务体系优势较明显,但临床应用评价稍落后。软性医用内窥镜中Olympus(CV-290)综合指标评价最佳,在临床效果、临床功能及适用性、技术性能及服务体系等方面均表现突出。国产内窥镜型号均与Olympus存在较大差距。建立的浙江省医疗器械临床评价技术研究重点实验室为内窥镜产品以临床为核心的评价提供了可持续性平台。结论:医用内窥镜评价体系的建立,明确了国产优秀医用内窥镜的优势指标、地位,以及与国际优秀同类产品的差距,为企业、医院做出相应改进提供参考,为国家相关决策提供强力支持。

Objective:To construct a set of comprehensive and accurate evaluation system suiting the medical endoscopes,so as to conduct scientific evaluation for the whole life cycle of products before and after the launch of medical apparatuses.Methods:A set of evaluation system about medical endoscopes was constructed through scientific selection and rigorous practice,which conducted evaluation from 5 dimensions included clinical effect,clinical function and applicability,reliability,technical performance and service system.A standardly clinical evaluation scene was established,and the 5 dimensions of 10 types of endoscopes were evaluated from the usage conditions of vertical and horizontal directions,the grassroots hospital and the class A tertiary hospital.And then,the scientific evaluations of the whole life cycle of products before and after the launch of medical apparatuses were performed.Results:A total of 51 medical institutions participated in the evaluation,which realized the nationally comprehensive coverage.The evaluation report of 10 types of endoscopes showed that the comprehensive evaluation of the imported STORZ(22202020)of hardly medical endoscopes was best,which appearances were outstanding in clinical effect,technical performance.The comprehensive evaluation of Mindray(HD3)of domestic main machines was higher,which advantages of service system was more obvious,while the evaluation of clinical application of that was slightly inferior.Among the flexible medical endoscopes,the comprehensive evaluation of Olympus(CV-290)was the best,which had the outstanding performances in clinical effect,clinical function and applicability,technical performance and service system.There was a big gap in the comprehensive evaluation between domestic endoscope and Olympus.The established Zhejiang Provincial Key Laboratory of Clinical Evaluation Technology for Medical Devices provided a sustainable platform for the evaluation of endoscopic products depended on the clinical practice as center.Conclusion:The construction of the evaluation system of medical endoscope has clarified the advantage indicator and status of domestically excellent medical endoscope,and the distance between domestically medical endoscope and internationally excellent similar products,which can provide strong support for enterprises,hospitals and nation to take corresponding improvement and decision.