With the Ministerial Decree of August 10, 2018, safety standards for the installation and use of magnetic resonance (MR) for clinical use, with a static magnetic induction field not exceeding 4 teslas, were set. This Decree, published in the Official Gazette, no. 236 of October 10, 2018, repeals the previous Ministerial Decrees of November 29, 1985, of August 2, 1991, and of August 3, 1993.
The definition of the standards at the national level, provided for by Article 2, Paragraph 1 of the Presidential Decree no. 542 of 1994, will be an instrument of guidance and support for the Regions and users, to guarantee the uniformity of health protection throughout the nation.
The legal representative of the healthcare facility in which the MR equipment is installed must ensure compliance with the standards for the physical protection and medical surveillance of operators, patients and the occasionally exposed population.
This Ministerial Decree also contains an example of an information note for patients, an anamnestic questionnaire and an informed consent prior to the MRI scanning, based on the available knowledge to be adopted with possible modifications and integrations deemed appropriate by the radiologist, who is responsible for the clinical safety and efficacy diagnostics of the MR equipment. Furthermore, the Decree contains an example of an access card, reserved for visitors, carers and all those who access the controlled area.
See the full report in Italian here.
See the Ministerial Decree that brought this decision here.
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