手术机器人产品责任之适用困境与对策

Dilemmas and Responses to the Application of Product Liability for Surgical Robots

手术机器人是集多学科于一身的新型医疗体,手术机器人临床应用中,因缺陷导致的侵权问题引起多方主体间的争议,日益受到学界关注。现阶段,虽有机器人之名,但其使用仍然离不开专业医师的操作,应将其界定为法律上之“物”,具有产品属性,并依据医疗产品责任的规定进行处理。现有机器人辅助手术致人损害案件的涉诉维权思路较为单一,较少使用产品责任之诉。针对固定初步证据难、因果关系难以说明、产品责任涉及主体多、现有缺陷标准不明确这类问题进行描摹,对症下药地建议设立初步的证据保存环节;增设手术机器人专业鉴定人意见;扩大责任主体范围,如将产品设计者纳入其中;差异化调整缺陷认定标准。正确地适用产品责任,发挥好预防风险和填补损失的作用,为医患双方提供合理保障,促进行业技术更好发展。

Surgical robot is a new type of medical body integrating multiple disciplines.In the clinical application of da Vinci Surgical Robot and so on,the infringement problem caused by defects has aroused controversy among multiple parties,and has been increasingly concerned by the academic community.Currently,in spite of the name of the robot,but its use is still dependent on the operation of a professional physician,so it should be defined as a legal“thing”with product attributes,and should be treated in accordance with the provisions of the medical product liability.Existing prosecutions cases of human injury caused by robotic-assisted surgery follow a more homogeneous way,with less use of product liability claims.Based on the clarity of the problems such as the difficulties in fixing preliminary evidence,unclear causation relationship,multiple subjects involved in product liability,lack of clarity of existing defect standards,correspondingly,it should set up a preliminary evidence preservation process,provide additional professional expert opinions on surgical robots,expand the scope of the subject of responsibility such as the product designer,and differentiate the adjustment of the defect identification standards.