INNOVATION ARTICLES THE IDEA SUBMISSION PORTAL FROM MEDTRONIC

Robotics in the real world are advancing rapidly and as Asmiov’s robots become closer to fact than science fiction, issues are coming to light. Robotic surgery is now an established concept and more commonplace in hospitals now allowing surgeons to have superhuman capabilities like never before: the ability to perform procedures with inordinate precision, with minimal invasiveness and even remotely.

But as the trend becomes more established and more procedures are being performed on patients using this cutting-edge technology, the probability of things going wrong increases as well. And when mistakes do happen who is to blame? The manufacturer? The surgeon? The hospital? Robotics is currently in a legal grey area and the debate is ongoing.

Andrea Bertolini, Adjunct Professor of Private Law, University of Pisa, hopes that this debate will not deter innovators and investors in these important technologies. He was involved in a project called RoboLaw, which aimed to confront the legal status of emerging robotics and to consider the important precarious legal, ethical and regulatory questions that have come hand in hand with the concept. RoboLaw’s consortium researched and recommended guidelines for regulations that were presented to the European Commission and Parliament last year, which are now being considered based off this research.

Dr Bertolini and his colleagues assessed driverless vehicles, robot companions, robotic prostheses and exoskeletons, brain-computer interfaces and surgical robotics. As the technology gets more advanced, it raises the question of where responsibility lies. Typically legal actions in cases where the outcome of an operation or treatment are not satisfactory are brought against the doctor, explained Dr Bertolini. “But as devices become more sophisticated, claims may be made that state the procedure was not successful because there was a malfunction in the robotic system, and thus blame be shifted from the doctor to the manufacturer.”

Dr Bertolini is concerned about what this move will mean for emerging technologies in this field. He is keen to ensure that producers and researchers are not excessively burdened. “Regulations need to be put in place that will somewhat try to minimise the risk of a radical shift in litigation from medical liability to product liability claims against the producer.”

Other issues the project highlighted were safety and training. Existing technological safety standards were not necessarily conceived for robot technologies and currently these may not be adequate. “One problem that we identified, by also speaking with surgeons themselves, is that there is not much, specific training for surgeons.”

Professor Paolo Fiorini, University of Verona, agrees and is concerned that the safety of robotics is not being taken seriously with no current regulations in place in Europe for service robots, such as surgical robotics. Initially starting out at NASA, Professor Fiorini, worked at the Jet Propulsion Laboratory in Pasadena, California. The focus of his work was on space robots to perform repair on orbiting satellites, experiments on the space station and planetary exploration. After moving to Italy in 2001, Fiorini moved his attention to medical and surgical robotics, which he said had similar constraints and challenges.

Fiorini is glad that work is ongoing on defining new safety standards in service robotics but he is worried that progress is not moving fast enough and by the time any standards are published, perhaps by then laws and robotics would have taken a different course. “A clear fact is the lack of trained personnel using robots.”

Training is already being considered and a training program for surgeons is currently being developed for users of the Da Vinci robotic surgical system, which is widely used in the United States and becoming more commonplace in Europe.

RoboLaw also addressed data protection. “Another thing that is very relevant is how the data regarding the procedure is stored, used and eventually accessed. This is important information for all parties involved.” Some systems are capable of recording the operation according to existing privacy regulations but sometimes it is not the case that this information is made accessible to the doctor or the patient. “Why is this important? Because that information can also allow the patient, for instance, should the patient be willing to sue the producer or the doctor, and that information could be vital, to establish who is at fault. The varied consequences of the operation could be traced back to the surgeon and to one of his errors, or perhaps a malfunction of the device. So this was an important recommendation that we made to the European Commission.”

Dr Bertolini is keen to point out that new regulations in Europe for trends like surgical robotics should be considered a limiting factor and should not be feared and he hopes that research will continue and investors will continue to invest. “Robotics is already out there, and it is progressing. We need to have a very practical way of reasoning and seeing all the benefits we can get from it. We can only get benefits if you manage to transform what is being done in research laboratories into products that get to the market. Therefore our regulations need to be enabling, smart and specific to robotic products to make sure they are safe, but also the make sure they get out there soon enough.”

Professor Fiorini’s laboratory current work is focusing on the development of algorithms to automate surgical processes explained Professor Fiorini. “Not to replace surgeons or to do automatic surgery but to provide ’cognitive’ help to surgeons in terms of information and specific control, user interfaces and simulations.”

Professor Fiorini has also set up a group called EUROSURGE, which is a coordination and support action group, funded by the European Commission, to stimulate and strengthen the collaboration between robotics and cognitive science communities--that is making surgical robotics more ’intelligent’. “In this way we have started the field of ’cognitive surgical robotics’ that could be an important tool for surgeons but it is still not clear how this could be implemented in real systems, besides laboratory proof-of-concepts.”

All in all headway in surgical robotics is being made and in order to ensure continued development, regulations need to be considered in Europe. “Progress is unstoppable and new machines and new devices will come to the market in one way or another,” said Professor Fiorini. “We need to educate a new generation of engineers, technicians and users that understand the risks and advantages of the technology, pretty much like computer and smart phones. In robotics, we are as we were in 1980’s with computers, no killer application, high cost, and lack of confidence. Thirty years later who could live now without computers? Will see in 30 years from now, where robotics will be.”