The role of the ISS in the Italian Health Service, and the need for medical device market surveillance.

After the First World War, attempts were made to improve both health administration and research policies, worldwide. Thanks to the financial support of the Rockefeller Foundation and the role of the League of Nations, national health institutes were created in many countries, Italy included. The Istituto Superiore di Sanita (ISS) was thus created (in 1934) for the safeguard of public health. The decree establishing the Institute envisaged the creation of a number of scientific laboratories, operating in the different sectors of public health (1,2). In 1935, Domenico Marotta was appointed as Director of the ISS. He acted as a catalyst and organizer of research in different fields, and shaped the ISS into one of the most up-to-date scientific centers. During Dr. Marotta’s direction, two Nobel Prize winners worked at ISS. Daniel Bovet (Nobel Prize for Medicine in 1957) was the Director of the Laboratory of Therapeutical Chemistry from 1948 to 1964, and Ernst Chain (who investigated with Howard Florey and Alexander Fleming the activity of natural antibacterial agents, including penicillin) directed the International Centre for Microbiological Chemistry of the Institute in 1948. He produced semi-synthetic derivatives of great therapeutic as well as commercial value, and thus Italy entered the ‘club of antibiotics’. From the very beginning, the management of ISS was aware of the need to equip laboratories with the most modern research instruments. Hence, an electron microscope for the Physics Laboratory was ordered from Siemens in 1939 and operating in spring 1943. On October 8, 1943 one month after the armistice of Italy the microscope was withdrawn by order of the German military command “...to be put in safe keeping with the promise to give it back after the undeniable victory”. In the same way, ISS realized a linear accelerator Cockcroft Walton in 1938, following a project promoted by Enrico Fermi, just before his leaving for the USA, in order to guarantee the highest levels of nuclear research performed in Italy by “I Ragazzi di Via Panisperna” (Fermi’s boys). In the thoughts of Domenico Marotta was a program for the production of artificial radioactive substances for therapeutic use in oncology. Finally, the governmental production of penicillin led to the realization for new patents, both in Italy and abroad. The same tasks of research, control and training as activities for the safeguard of health will continue to characterize all the efforts of ISS researchers and technical personnel in the spirit of a service to patients. Under the direction of Francesco Pocchiari (1971-89), the research orientation of the ISS was focused on major themes of biomedical research by developing links with the leading organizations of the sector, notably the World Health Organization. The Engineering Laboratory was instituted in 1941, and several new laboratories were subsequently added to the ISS structure. The structure of the Laboratory of Biomedical Engineering was defined by a Decree of the Minister of Health, 29 April 1982, with four operative units: Biomaterials, Diagnostics and functional monitoring, Technology of the biomedical imaging, and Technologies for Therapy and Rehabilitation. Initially, the laboratory activities were devoted to the use of electronics in the design and development of new instrumentation for internal needs or for patient monitoring, after which tasks for the control of devices on the market, ruled by national decrees as in the case of pacemaker, were developed. Since 1988, one operative unit at the ISS has been devoted to the in-vitro testing of implantable cardiovascular devices, including artificial heart valves, grafts and stents (3-13). In this respect, several techniques have been set up to investigate the biomechanical and fluid dynamic performance of these devices, such as steady and pulsatile flow in-vitro testing tools, Presented at The ideal human heart valve substitute: 50 years between perceptions and realities meeting, September 2003, Naples, Italy