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
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.
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.
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
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.