Risk Analysis And Control For A Medical Robot For Celiac Minimally Invasive Surgery

Comparing with most of the acedemic research that the scientific research teamconsisting of students or teachers in college always focus on the technical indexwhich is the key goal to achieve to satisfy the fuctional requests,a project aiming atmaking a series of applicable products must pay more attention on the additionalsafety issues,especially in the medical field. Not only the technical fuctions need tobe achieved,but also the fuctional safety should be considered.As the medical industry have been developing fast these years,the medicaldevice regulatory agencies like CFDA in China have made strict discipline of accessto market, especially the type ? medical device with high level risk. How to applythe risk management to medical device in acedemic research to optimize design is atopic worth studying.The Celiac Minimally Invasive Surgery RobotSystem(CMISRS) the medical robot in developing is such a type ? medical deviceneed to apply the risk management.This paper is mainly about the procedure of riskmanagement for the CMISRS.This paper has made a full life-cycle activity plan for risk management ofCMISRS.Considering of the present state of the project,the design&developmentphase is the most important part in risk analysis and explained in detail.In thispaper,the method of Expert Consultation is uesd to make risk estimation in conditionof lack of statistical data or experience.It seems to be the most efficient way to applythe risk management standard.First of all,the technical index and fuctional index are obtained.According tothe index,the preliminary general system design scheme is determined.In order toget a better understanding of the following contents,the paper has briefly introductedthe CMISRS,including the robotic arms,the surgical instruments,the mastermanipulater,the vision system and the master-slave control system.Secondly,the paper got the standard list for the CMISRS after anlysis in aspectsof mechanism design,electrical structure,control software development, biologicalhistocompatibility and so on.The application flow was designed according todifferent standards.Thirdly,the risk management procedure was formulated according to thestandard YY0316for the CMISRS including the risk mangement plan,risk analysismethods, risk estimation rules, risk evaluation methods and risk control measures,especially in the design&development phase.After all the above work has done,the risks of the system can be obtainedaccording to the standards and risk anlysis result.Risk estimation and evaluation result can be obtained according to the expert consultation.Risk control measurescan be made in communication with the designers.At last,the safey issues areconsiderd systematiclly for the CMISRS.