手术机器人风险分析及质量评价探讨

Discussion on Risk Analysis and Quality Evaluation of Surgical Robot

目的分析手术机器人的临床使用风险,研究对应的质量评价方法,为加强手术机器人质量评价及风险控制提供参考。方法分析手术机器人产品国内外临床应用的不良事件反馈,结合实际检验工作中发现的产品问题,从仪器质量评价层面分析主要风险点的预防措施和整改方法。结果手术机器人作为一种特殊的高风险医用电气设备或医用电气系统,从产品设计阶段就要全方面考虑系统的安全性、合规性,要特别关注电源、线缆等关键部件选型,过程中要根据产品整体使用环境综合考虑。结论通过对手术机器人实际检测过程中的风险问题分析,探索对应质量风险点的质控方法,为今后此类产品的检测和监管提出思路。

Objective To analyze the risk of surgical robots in clinical use,and study the corresponding quality evaluation methods,so as to provide references for strengthening the quality evaluation and risk control of surgical robots.Methods Combined with the product problems found in the actual inspection work,the adverse event feedback of the clinical application of surgical robot products at home and abroad was analyzed,and the preventive measures and rectification methods of the main risk points were analyzed from the level of instrument quality evaluation.Results As a special type of high-risk medical electrical equipment or medical electrical system,the safety and compliance of the system should be considered in all aspects in the product design stage,especially in the selection of key components such as power supply units and cables.The design process should fully consider the comprehensive application environment.Conclusion Through the risk analysis in the verification testing of the surgical robot,the quality control methods corresponding to the quality risk points are explored,and the insights for the future quality evaluation and supervision of such products are put forward.