Title: Safety on robotic telesurgery with reference to EU (European Union) normative.
Author: prof. Alberto Rovetta N. AP-1

Proceedings of the IXth IFToMM World Congress, Vol.3, Milan, 28 August - 1 September, 1995

The use of surgical telerobotics for a human patient on 1st September 1995, during the Sessions of the IXth World Congress of IFToMM on Theory of Machines and Mechanisms, during a session on robotics, in front of 600 scientists from 51 Countries, authorized by Ethical Committees and by Italian Ministry of Health, opened the problem of acceptance of surgical robotics and surgical telerobotics on human patients.

The robotic system of the project is constituted by an operating theatre equipped with a robot, its controller, the control computer, the surgical process processing computer and the overall control computer, plus a remote station in which the surgeon performing the operation uses a keyboard, mouse or virtual glove to impart commands to the computer which transmits the operative data to the operating theatre, actuating the robot.
The first experiment in telerobotic surgery carried out between the Jet Propulsion Laboratory in Pasadena, California and the Telerobotics Laboratory of the Politecnico di Milano on 7 July 1993. An Italian robot in the Telerobotics Laboratory was remotely controlled by an Italian surgeon in the USA. The robot's task was to perform a surgical operation on a model containing a pig's organs, involving execution of a biopsy, aspiration of organic material and two incisions in preparation of laparoscopy. Transmission was effected by means of a double satellite link with three transceiver stations one in Italy, one close to New York and one in Pasadena - and two geostationary satellites, the first over the Atlantic and the second over the United States. The route length of the signals was 150,000 km in each direction and the two centers are 10,000 km apart.
After this, the telerobotic system was successfully used to telecontrol a robotized system during the execution of a prostate biopsy on a human patient on 1st September 1995 with optical fibers. The realization of the first prostate biopsy involving the use of a robotic and telerobotic system, designed in Politecnico di Milano, on a human patient, took place on 7th April 1995 in the Hospital Policlinico in Milan, Italy for the robotic operation, and on 1st September 1995 for the telerobotic operation, on human patients. The reliability and safety have been assessed by a series of experimental tests, aimed at guaranteeing working efficiency.
The problems that emerged and was subsequently solved, concerned: - mechanical behavior of the human body, which varies between one person and another; - the presence of a certain nervous tension due to the novelty of the experiment; - the stability of the patient's position, who on account of being under an anesthetic, did not move during the operation; - the presence of magnetic and electric fields, caused by other machinery for surgery, which did not, however, influence the robot's behavior, or that of his controller or the computer.

The EEC Directive indicates which conditions must be respected in order to obtain the required safety. The directive of EU requires that it is compulsory to observe the "necessary qualification" of safety. Technical standards are not included in the Directive, because the quick change of technologies could make them obsolete, and are changed, according to new technologies. EU also provides a "Good Manufacturing Practice" (GMP) which referees to the suggestions that must be observed in design and production, even if no detailed standards are included in GMP.
The biomedical equipment must be certified and they must be accompanied by a declaration of conformity. This declaration is identical in all the Countries of the European Union. The name of the Directive is 93/42/EEC; it was published in 1993.
Every UE member will define the structure for overseeing and checking the certification. CENELEC is the Comitè Europèen de Normalization Electrotechnique and CEN is the Comitè Europèen de Normalisation which define the safety required qualifications.A basic specific technical standard for telerobotic surgery is EN 60 601-1, adopted by CENELC on 11 June 1990, which deals with safety for electromedical devices.
The 10 paragraphs are: -generality; environmental conditions; - protection against electrical dangers; - protection against dangers due to radiation; - protection against dangers due to lighting of inflammable anaesthetic; - protection against a too high temperature; -precision of working data and protection against distribution mistakes, - abnormal working and failure conditions; - building prescription: The general prescription is to carry out a series of tests.

Future possible developments
The list of requirements to be respected before that the robot may be introduced in surgical room for a biopsy is of 42 elements; after the certification about 42 elements, the robot is ready for tests in the pre-surgery room, before it is accepted in the surgery room.

Telesurgery with robots is a new methodology for medical use. Its use must be adopted in the world and it requires the accomplishment of many conditions, rules for practical and ethical reasons. The European Normative is very clear and requires many efforts tin order to follow them with the most complete prevention in front of mistakes and damages.