Magnetic Resonance Imaging (MRI) over the last twenty years collected a great success due to the gradual improvement of related technology and development of new methods in clinical applications.
MRI is a diagnostic imaging technique characterized by the use of a strong magnetic field and high power radiofrequency waves.
One of the major advantages of this method, regarding patient safety, compared to other conventional radiological techniques (eg. RX and TAC), is that MRI does not use ionizing radiation and produces images of excellent quality in terms of contrast and anatomical details.
These factors have been a concrete reason for which a growing number of physicians are now considering MRI as the preferred investigation way, to better evaluate patients in their specific clinical diagnostic-pathway, and prescribe an MR exam (which can also be performed with contrast medium).
The Presidential Decree n. 542 of 1994 regulates the use of this diagnostic technique.
Currently throughout the national territory in public and private health institutions there are “total body” and sectoral RM (ie dedicated to the study of the limbs) RM scanners, labeled CE as medical devices under Directive 93/42 / EEC.
Some types of MRI scanners, particularly those with high static magnetic field (between 2 and 4 Tesla), are authorized for installation and use by the Ministry of Health, whereas for RM “total body” with magnetic field below 2 tesla are regulated only by a regional authorization.
Currently, in Italy the installation of MRI scanners with magnetic field intensity over 2 tesla is allowed for medical research institutions (University, scientific institute and other research centers); the authorization of these RM scanners requires submission of clinical scientific research projects and must be clearly reported the reasons for the use of magnetic fields greater than 2 Tesla (Article 4, paragraph 2 of the same Presidential Decree 542/94).
Requests of Authorization (accompanied by other information on the structure, on the logistics and organization of the applicant hospital) must be submitted also to the General Directorate of Medical Devices and Pharmaceutical Services, no. III – former DGFDM – Viale G. Ribotta n. 5, 00144 ROME, to the Istituto Superiore di Sanita (ISS) and to the National Institute for insurance against occupational Accidents (INAIL), in order to enable their evaluation on safety levels for patients and operators, and thereby acquire the preliminary approval by the two mentioned institutes.
The complete document files, once acquired the technical judgment of ISS and INAIL, is sent to the National Health Council (CSS) which expresses a reasoned opinion on the request. According to established practice in recent years, the opinion of the CSS regards in particular the research projects, which must be approved by the local ethics committee.
The authorizations have a duration of five years and may be renewed.
At the end of the authorized period of use, the hospital may submit a renewal request of the authorization but must also provide a report on the research results and on the new research projects they intend to under take in the next five years.
Currently in Italy are authorized and operating more than 50 high-field MRI equipment.
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