Safety in application of robots to surgery

摘要

We would like to consider the recent developments regarding the safety of the use of robots in surgery and to outline the research project we have been working on in this field. We have pursued the task of making safe and so certifiable a medical device which is able to perform automatically, by the use of a robot, a liver biopsy. Our work began with the study of the actual regulation in force regarding safety and product certification of medical devices, and went on to study the actual procedure in a liver biopsy normally executed in hospital, in order to understand the risks of this operation, the context in which it is performed and the possible ways of improvement. This analysis led us to define three different robotised bioptic processes and among these, following technical and economical criteria, we chose the one which was supposed to be the best. Having clarified specifications and methodologies, we made the risk analysis, which is not only a document to be presented for the certification, but also a guide to find solutions which follow principles of safety, in relation to the state of technology. Finally, we demonstrated that, as requested by the norms, the benefit is greater than the risk to the patient and the operating team.