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 safety regulations of different countries remains an important challenge for manufacturers and health care workers in the European Union. Rapid technological development during the last 20 years, and the still controversial nature of certain potential effects of magnetic or electromagnetic fields, make the task particularly difficult for MRI and MRS. As the relevant literature is rather extensive, the present work will limit its goals to four questions: 1) How is MRI and MRS safety regulation managed within the European Union? 2) Concerning direct potential physiological effects, what is presently well known and controlled, and, conversely, what are the remaining open (and often controversial) questions? 3) As metallic implants are probably the main risk in routine MRI, 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 MRI 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 United States.
de Certaines
J D
JD
Eugène Marquis Cancer Institute, Biomedical NMR Laboratory, Rennes, France. jaques.de-certaines@univ-rennes1.fr
Cathelineau
G
G
D004869:Equipment Safety / Q000592:standards*; D005062:European Union; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000009:adverse effects / Q000592:standards*; D009682:Magnetic Resonance Spectroscopy / Q000009:adverse effects / Q000592:standards*; D011785:Quality Assurance, Health Care; D018570:Risk Assessment