Safety aspects and quality assessment in MRI and MRS: A challenge for health care systems in Europe

Despite advances in international cooperation, the application of the safet y regulations of different countries remains an important challenge for man ufacturers and health care workers In the European Union. Rapid technologic al development during the last 20 years, and the still controversial nature of certain potential effects of magnetic or electromagnetic fields, make t he task particularly difficult for MRI and MRS. As the relevant literature is rather extensive, the present work will limit its goals to four question s: 1) How is MRI and MRS safety regulation managed within the European Unio n? 2) Concerning direct potential physiological effects, what is presently well known and controlled, and, conversely, what are the remaining open (an d often controversial) questions? 3) As metallic implants are probably the main risk in routine AM, what regulatory strategy is in progress in Europe? 4) As indirect risks related to artifacts must not be underestimated, what European programs have been developed for quality assessment in AM and MRS ? In all of these fields, evidence is provided demonstrating the need for a mutual recognition of common standards for the European Union and the Unit ed States. (C) 2001 Wiley-Liss, Inc.