医疗设备质控管理工作的探索与思考

Exploration and reflection for quality control management of medical equipment

目的质量控制管理是提高医疗设备使用质量安全的有效手段,更是临床工程部门职能转变的重要方向,探讨如何做好医疗设备质控工作是所有临床工程部门面临的重大挑战.方法针对构建质控体系,在技术保障质量管理,尤其在医疗设备定期巡查及周期性检测方面进行了大量延伸及探索.结果经过长期不断地实践与反思,形成了可以实施的工作机制及作业流程,可为广大医学工程同行提供借鉴与参考.同时也发现该工作当前也面临譬如数据分析水平低下、大型影像类设备检测受厂家制约等诸多的问题与挑战.结论医疗设备质控管理工作还需不断思考改进思路、创新管理手段,在保证设备安全、可靠有效以外还能在决策支撑方面提供参考与依据.

Objective Quality control management is the effective means to promote quality and safety of medical devices,and it is also the important direction for transformation of clinical engineering department.The realization of quality control for medical devices is a major challenge for all of clinical engineering departments.Methods In the paper extensive extension and exploration have been attempted for technical support quality management,especially in regular inspection and periodic detection.Results After practice and reflection over a long period of time,the corresponding mechanisms and procedures have been formed which are excellent references for colleagues.Meanwhile,several problems existing in quality control management,such as low level of data analysis and restriction from manufacturers for large-scale equipment quality test,have also been discovered.Conclusion The quality control management of medical equipment also needs continuous improvement and innovation to guarantee the safety,reliability and effectiveness and provide reference and basis for decision support.