Healthcare in Italy

Medical devices

 

During the past decade, there has been rapid growth in the availability of diagnostic technologies such as computed tomography (CT) scanners and magnetic resonance imaging (MRI) units in Italy.

 

In 2010 there are

  • 22.4 MRIs per million population (well above the OECD average of 12.5).
  • 31.6 CT scanners per million population (above the OECD average of 22.6).
  • 118 PET and CT/PET integrated systems (2 units per million population).
  • 189.2 mammography systems per million women in the age group 45-69.



 

The New Health Information System (NSIS) of the Ministry of Health in 2009 started to assess medical equipment available in all hospitals of the National Health Service with the aim to acquire a more complete and updated knowledge of their use, promote scientific research, monitor accidents or malfunctions and give, in general, more attention to the quality of the medical equipment and devices sold to hospitals.



To this end, the NSIS introduced a new Classification of Medical Devices (CND) and a new Database and Repertory of Medical Device (RDM) to assess their quality, cost and clinical benefits and implement a system to monitor the expenditure on medical devices by public hospitals.

 

The registration in the Database and Repertory of Medical Devices (RDM) is mandatory in order to supply medical devices and equipment to hospitals in Italy. In fact, according to the Ministry of Health Decree (DM) issued on December 21, 2009, without this mandatory registration medical and surgical devices cannot be supplied to Italian hospitals.