New aspects from legislation, guidelines and safety standards for MRI

Abstract

Many aspects of magnetic resonance (MR) operation are not directly regulated by law but in standards, guidelines and the operating instructions of the MR scanner. The mandatory contents of the operating instructions are regulated in a central standard of the International Electrotechnical Commission (IEC) 60601-2-33. In this standard, the application of static magnetic fields in MRI up to 8 Tesla (T) in the clinical routine (first level controlled mode) has recently been approved. Furthermore, the equally necessary CE certification of ultra-high field scanners (7-8 T) in Europe is expected for future devices. The existing installations will not be automatically certified but will retain their experimental status. The current extension of IEC 60601-2-33 introduces a new add-on option, the so-called fixed parameter option (FPO). This option might also be switched on in addition to the established operating modes and defines a fixed device constellation and certain parameters of the energy output of MR scanners designed to simplify the testing of patients with implants in the future.The employment of pregnant workers in an MRI environment is still not generally regulated in Europe. In parts of Germany and Austria pregnant and lactating employees were prohibited from working in the MR control zone (0.5 mT) in 2014. This is based on the mostly unresolved question of the applicability of limits for employees (exposure of extremities to static magnetic fields up to 8 T allowed) or the thresholds for the general population (maximum 400 mT). According to the European Society of Urogenital Radiology (ESUR), the discarding of breast milk after i.v. administration of gadolinium-based contrast agents in the case of a breastfeeding woman is only recommended when using contrast agents in the nephrogenic systemic fibrosis (NSF) high-risk category.