腹腔镜手术机器人应用质量与安全评价标准体系研究

Research on the Application Quality and Safety Evaluation Standard System of Robot-Assisted Laparoscopic Surgery

腹腔镜手术机器人能提高操作精度,缩短手术用时,患者出血少,恢复速度快。近年来,国产创新手术机器人的研发取得了显著成果,但目前国内外缺乏相关评价标准,增加了临床应用的风险。为科学评价腹腔镜手术机器人的应用质量与安全,急需研究建立质量检测与评价标准。该研究从控制系统、图像质量、机械精度、电气安全4个维度优选评价指标。在控制系统方面选取软件功能检测规范指标;在图像质量方面选取图像质量检测规范指标;在机械精度方面选取机械臂检测规范指标;在电气安全方面选取设备外观检测规范和产品故障预防与维护控制规范两个指标。通过验证试验研究合理可行的检测与评价方法,为腹腔镜手术机器人的应用质量与安全评价提供依据,填补国内外腹腔镜手术机器人相关标准方面的空白。

Laparoscopic surgical robots can improve operation precision,shorten operation time,less patient bleeding and faster recovery.In recent years,the research and development of domestic innovative surgical robots have achieved remarkable results.However,there is a lack of relevant evaluation standards at home and abroad,which increases the risk of clinical application.In order to scientifically evaluate the application quality and safety of laparoscopic surgical robots,there is an urgent need to study and establish quality testing and evaluation standards.In this study,evaluation indexes are preferred based on four dimensions:mechanical precision,electrical safety,control system,and image quality.In terms of control system,the software function detection standardized indexes are selected,and in terms of image quality,the image quality detection standardized indexes are selected;in terms of mechanical precision,the mechanical arm detection standardized indexes are selected,and in terms of electrical safety,the two indexes of the equipment appearance detection standardized and the product failure prevention and maintenance control standardized are selected.Through the validation test research reasonable and feasible detection and evaluation methods for the application of laparoscopic surgical robots to provide a basis for quality and safety evaluation,filling the gaps in domestic and foreign laparoscopic surgical robots related standards.