In comparison to conventional medical equipment,surgical robots exhibit greater autonomy and complexity.The designers responsible for developing their software and systems play a pivotal role in the entire process including design,production and use,with a distinct position that sets them apart from producers,transporters,warehousing operators,and medical institutions.However,the distinctiveness and significance of surgical robot designers have not received adequate recognition.This study reviews current legal and regulatory frameworks and identifies numerous challenges faced by designers concerning tort liability,including disputes regarding their status,difficulties in design defect identification,and the application of liability types.In response,this pa-per proposes elevating the status of surgical robot designers to be on par with producers,designating them as key subjects for bearing tort liability.To address these challenges,it recommends establishing a"risk-benefit"standard for identifying design defects,clearly defining the types of applicable product liability,and enhancing provisions for tort liability,resulting in a more equitable distribution of responsibility.
NETL
NSTL
维普
万方数据
