Freddy Ståhlberg, Bo Nordell och Johan Olsrud,

Lund University  Karolinska University Hospital and Lund University Hospital

In 2004, the above directive was taken (see http://europa.eu.int/eur-   lex/pri/en/oj/dat/2004/l_184/l_18420040524en00010009.pdf).  This directive governs exposure to time-varying electromagnetic fields regardless of application, and is to a large extent based on a ICNIRP report (Guidelines for Limiting Exposure to Time-Varying Electric, Magnetic, and Electromagnetic Fields (up to 300 GHz); Health Physics 74 (4): 494-522; 1998).

Several organisations, including ISMRM, ESMRMB and COCIR already at an early preparatory stage warned for the consequences of the directive in the field of medical MRI. On the web homepages of each of these organisations, thorough discussions describing possible health aspects on MRI, as well as consequences of the directive for the MRI community can be found.

The debate has been ongoing also after the formalisation of the directive in 2004, simulations have been made regarding expected EMF exposure levels in MRI (Crozier S, Liu F, Progr Bioph Molec Biol 87: 267- 278, 2005), and it is very likely that consequences of the directive (specifically regarding the limits for induced currents in time-varying magnetic fields) could highly influence MRI practice at conventional field strengths, e.g. 1.5 and 3.0 tesla. As a consequence of the continued discussion, an expert group (S Keevil, UK; D Norris, NL and G Krestin, NL) was appointed by the EU to further investigate possible effects of the directive. In parallel, a UK investigation has been conducted and results will be reported very soon. Preliminary data from this investigation indeed point towards severe consequences for clinical MRI (Proc. joint ISMRM-ESMRMB meeting, Berlin May 2007, ISSN 1 545- 4436, presentations 1083,1089,1098). As an example, the results presented indicate that safe distance from the surface cover of a conventional clinical magnet, in order to fulfil the criteria in the directive with respect to induced currents from gradient fields and/or motion in the stray field, could be as high as in the order of meters.

A thorough description of the recent steps taken by the EU Advisory Committee for Safety and Health at Work is given in a letter from Mr. Nikolaus G. van der Pas (enclosure 1) to representatives from all member countries. In reply to this letter, the Swedish Ministry of employment has written a statement (enclosure 2).

Even though a discussion is obviously ongoing, and steps are taken also from the EU side to investigate consequences further, there is now a time problem. The EU directive has a deadline for ratification in the member states by April 30 2008 and there is a risk that any results obtained during 2007 can not be used as base for an amendment of the directive before this date, since the amendment process in itself is a time-consuming procedure.

Hence, it is of large importance that responsible governmental bodies in the member countries are aware of the consequences of the directive, should they implement it in their country by the above date.

Our conclusion is therefore that it is of vital importance that professional national organizations as well other relevant bodies such as national labour unions in Sweden approach the Swedish Ministry of employment in order to highlight the above mentioned concerns