基于PDCA循环模式优化医疗器械技术审评质量的设想

目的：分析医疗器械技术审评工作中的不足，为提高医疗器械技术审评工作质量提供参考。方法：采用质量管理理论中的PDCA循环模式，将整个审评工作划分为策划（Plan）、实施（Do）、检查（Check）、处理（Action）4个阶段，对各阶段的内涵及相互联系进行探索并分析问题。结果与结论：江西省医疗器械技术审评工作主要存在4个不足：审评人员数量不足、专业结构匹配不合理；审评公开化程度不高；审评记录简单，审评信息积累和利用率不高；审评失误不能杜绝。应用PDCA循环方法，加强技术审评工作质量管理，优化技术审评程序，增强审评人员的质量意识，提高了技术审评工作水平。为了取得技术审评工作质量管理的突破性进展，应系统地、持之以恒地在审评工作中实践PDCA管理方法，形成技术审评质量自我提高的长效机制，使技术审评工作高效、规范地开展。

The Assumption of Optimizing the Quality of Technical Evaluation of Medical Devices Based on PDCA Cycle Mode

Objective:To analyze the deficiency of the current technical evaluation of medical devices and to provide references for improving its quality. Methods:The whole evaluation was divided into 4 stages, that is, plan, do, check and action according to the PDCA cycle mode of the quality management theory. The connotation and mutual relation of each stage were expounded. Results and Conclusion:The four main deficiencies found in the technical evaluation of medical devices in Jiangxi Province were as follows:insufficient reviewers, unreasonable professional structure, low degree of evaluation transparency, simple review record, low accumulation and utilization rate of evaluation information and evaluation errors. The quality management of the technical review was strengthened, the technical evaluation process was optimized, the quality awareness of the reviewers was enhanced, and the level of technical evaluation was improved after the PDCA cycle theory was applied. In order to make a breakthrough in the quality management of technical evaluation, the PDCA theory should be practiced systematically and consistently in the work of evaluation so as to form a long-term mechanism to improve the quality of technical evaluation so that the technical evaluation work can be carried out more efficiently and effectively.