新疆地区医疗器械质量控制现状分析与措施探讨

Analysis and Discussion on Current Situation of Medical Device Quality Control in Xinjiang Province

目的全面加强新疆地区医疗机构医疗质量控制管理,保障医疗质量。方法新疆地区质控中心根据地域各医疗机构实际情况,结合全疆三级公立医院探讨意见,制订新疆地区医疗器械质量控制状况评价标准;并开展自查,从医院类别、所属地区两方面进行统计分析,找出新疆地区医疗设备质量控制管理工作在制度制定、体系建设、实施管理、持续改进及临床培训等方面存在的共性问题,针对部分医疗机构进行现场抽查,发现问题,提出整改要求。结果新疆地区医疗设备质量控制工作开展存在的共性问题主要集中在制度欠完备、质控团队建设不完善、人员配置不足、质控场地不符合要求、人员资质不全、培训频次低及效益评价缺失等方面。需从引导关注度、完善体系建设、加强人员资质、实施质控、持续改进、提高培训频次6个方面制定改进措施,不断提高医疗机构对医疗器械质量控制管理重要性的认识,由急到缓循序渐进推动质量控制管理的建设与实施,完善优化医疗器械质量控制管理体系。结论医疗器械质量控制体系的建设是医学工程新时代的要求与任务,可以有效保障医疗设备临床安全使用,符合新时代新发展的要求。

Objective To comprehensively strengthen the medical quality control and management of medical institutions in Xinjiang and ensure the medical quality.Methods According to the actual situation of medical institutions in Xinjiang and the discussion opinions of tertiary public hospitals in Xinjiang,the evaluation standard of medical device quality control in Xinjiang was formulated.And the self-examination was carried out,and statistical analysis was carried out from the two aspects of hospital category and region,so as to find out the common problems of medical device quality control management in Xinjiang in system formulation,system construction,implementation management,continuous improvement and clinical training.Spot checks were conducted for some medical institutions,and rectification requirements were put forward after problems were found.Results The common problems existed in the quality control of medical equipment in Xinjiang mainly focused on the following aspects:incomplete system,imperfect quality control team construction,insufficient personnel allocation,unqualified quality control site,incomplete personnel qualification,low training frequency and lack of benefit evaluation.The improvement measures should be formulated from the following six aspects:guiding attention,improving system construction,strengthening personnel qualification,implementing quality control,continuous improvement and improving the training frequency,so as to constantly improve medical institutions’understanding of the importance of medical device quality control management,promote the construction and implementation of quality control management step by step from urgent to slow,and improve and optimized the medical device quality control management system.Conclusion The construction of medical device quality control system is the requirement and task of the new era of medical engineering,which can effectively ensure the clinical safe use of medical devices and meet the requirements of the new era and new development.