Objective There are the inevitable risks of the medical devices due to quality problems in the view of clinical engineering. In this paper, the effective methods of the medical device risk control was studied by using the scientific analysis and risk assessment for the medical equipment, as an example with the medical linear accelerator. Methods The Root Cause Analysis (RCA) system was designed and implemented based on the root cause analysis for the quality control of medical devices and the medical linear accelerators were tested by the RCA system. Results The RCA system can reduce the clinical use risk of medical linear accelerators in a large range, and standardize radiation treatment workflow. Conclusion Medical equipment quality control is an important part for protecting quality and safety of health care, and also a new topic of the medical engineering department In the clinical application of the medical devices, the root causes of the risks to the medical devices need to be accurately identified, and then the appropriate and corrective measures need to be developed to effectively reduce the risk of clinical use of medical devices.%目的 从临床工程学角度考虑医疗设备因质量原因或者正常运行中不可避免的风险问题,以医用直线加速器为例,对医疗设备使用风险进行科学分析和评估,研究将医疗设备使用风险控制在可接受的范围内的有效方法.方法 在基于根本原因分析方法促进医疗设备质量控制研究的基础上,设计并实现根本原因分析系统,使用该系统对医用直线加速器进行测试.结果 该系统可以在很大范围内减少医用直线加速器的临床使用风险,规范放射治疗工作流程.结论 医疗设备质量控制是保障医疗质量和安全的重要环节,也是医疗机构中医学工程部门的新课题,在实施中融人根本原因分析技术,高效准确地找出导致医疗设备风险发生的根本原因,制定相应的纠正措施,有效地降低医疗设备临床应用风险.
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