ANALYZING PRODUCT FAILURES AND IMPROVING DESIGN: A CASE STUDY IN MEDICAL ROBOTICS

摘要

Robotic assistance is utilized in complex surgeries due to claims citing better procedure planning, enhanced user training, and overall improved operation when compared with conventional surgery.Robot-assisted surgery seems to be an increasingly viable and acceptable option to the patient community with continual advances in technology.However, questions arise about the safety aspects of the robotic assistance in surgical procedures as there is a probability that the complexity of the constituent modules in the robotic system could lead to certain malfunctions and failures.The objective of the paper is to review the failures and safety considerations linked with robot-assisted surgery and to make recommendations to enhance certain safety features and protocols.The present project was undertaken as a research project by a sophomore student in Biomedical Engineering.Malfunctions and failures that occur during robot-assisted surgery may be broadly classified under operator errors and mechanical, electrical, and software failures.Reported electronic failures in robot assisted surgeries mention incidents of burns in patients and the ability to burn flesh due to leakage currents.Software failures in robot assisted surgeries are associated with a lawsuit detailing a situation where a surgical robot froze and the surgery had to be completed by other means.The cited paper claims that damages resulted directly from a software failure and mentions that the manufacturer had not completely eliminated the errors.Operator errors can lead to serious undesirable consequences in surgical procedures and subsequent outcomes.It was reported that a malpractice case was filed involving a mishandled robot-assisted hysterectomy.In this operation, a surgical error occurred in the hands of a not-so-skilled and not-fully-trained surgeon when both of the patient's ureters were severed.A review of literature illustrates the increasing number of lawsuits against surgical robotic assistant systems due to the lack of standardized comprehensive training.While performing rigorous analysis and applying current technologies may lead to many solutions of the cited problems, achieving a high degree of safety coupled with no failures is required in clinical settings.A systematic approach of thorough root cause analysis of failures and corresponding corrective actions would render the constituent modules and the robotic system safe, resulting in a safer and more effective robotic procedure.A large percentage of malfunctions with robotic systems can be avoided by diligently reviewing, analyzing, and testing the modules and the entire system during the design and subsequent phases while making necessary changes and corrections.Improved safety will result in a greater acceptance of robotic assistants while potentially assuring a higher quality procedure and care delivery necessary for patients.In conclusion, detailed analysis of failures in medically engineered systems such as robotic assistants in surgery and a proposal of methods to circumvent the problem will enhance their safety, and improve product performance resulting in a higher quality robotic surgery.The techniques learned by students in this project are valuable to biomedical engineering students, especially at the undergraduate level.