EU restrictions may still pose threat to MRI

October 1, 2008

The deadline for implementation of the EU Physical Agents (Electromagnetic Field) Directive was originally set as April 2008. As this deadline approached, information about the legislation's likely impact on the daily use of MRI was distributed widely.

The deadline for implementation of the EU Physical Agents (Electromagnetic Field) Directive was originally set as April 2008. As this deadline approached, information about the legislation's likely impact on the daily use of MRI was distributed widely. Most radiologists in Europe were aware of the problems they were likely to face, in both routine clinical work and MR research. So when the European Commission announced in late October 2007 that the execution of the EMF Directive would be put on hold, the radiological community breathed a huge sigh of relief.

Many radiologists now have the impression that the threat has passed, that the fight against the European Commission has been won. Unfortunately, this is not the case. What we have obtained is merely a postponement until 30 April 2012, to allow time for a substantive amendment to be adopted.

So what is going to happen over the next three and a half years? We already have information showing how MR workers could exceed the proposed occupational exposure limits for EMF by performing certain activities. This is provided in a study by Prof. Stuart Crozier of the University of Queens-land, commissioned by the U.K. Health and Safety Executive,1 and in experimental data gathered from four MRI facilities at the request of the EC.2 No further work is needed in this area.

What we don't have is information on the effects of these magnetic fields on radiologists, anesthetists, nurses, medical physicists, and technicians. After all, the Directive is designed to protect workers. Professionals agree that exposure to EMF can induce some short-term physiological effects, such as peripheral nerve stimulation and a metallic taste in the mouth. It is thought that these effects are not harmful to health, but this is very difficult to prove.

As it stands, the directive does not consider the long-term or cumulative effects of exposure to EMF. The amended version may do so. This is another area that requires more research. The only information we have on long-lasting effects from EMF exposure is from animal studies. More data are needed on this topic.

The modified EMF Directive is expected to be available toward the end of 2009. It will include amended recommendations on exposure limits from the International Commission on Non-Ionizing Radiation Protection (ICNIRP). It will also take into account the results of a socioeconomic impact assessment, which has yet to be commissioned. After a period of public consultation, it is expected that the revised legislation will be adopted by April 2011 and implemented by all EU member states within the next 12 months.

This time frame is extremely tight. There will not be enough time to gather any substantial scientific data about the side effects of EMF exposure. The limits suggested by the ICNIRP in the original directive were cautious. We have no idea what the revised advice will be. This time the commisson may include limits on static fields, which were left out of the earlier version. We have no guarantee that the amended EMF Directive will cause fewer problems for the MRI community.

The Alliance for MRI is still lobbying hard. Ideally, we would like a derogation for MRI from this directive, though achieving this concession is going to be challenging. We believe that such a derogation is necessary to ensure the future unimpeded use of MRI, particularly for interventional procedures and cutting-edge research.

The safety of MRI workers is already regulated by the EU Medical Devices Directive (amend. Direct 93/42/EEC) and the established MR safety standard IEC/EN 60601-2-33 (as amended to include users/workers), so they would not be unprotected.I do not want to play down what we have achieved already. This is the first time in the history of the European Commission that a directive has been withdrawn or postponed at such a late stage. Two EU countries-Slovakia and Italy-had even incorporated it into national law.

It is important, however, for the European radiological community to appreciate that the problem has not been solved. Work is still ongoing, and there may be more battles ahead.

PROF. KRESTIN is head of radiology at the Erasmus Medical Center, University of Rotterdam, the Netherlands, and a member of the Alliance for MRI.

References

1. Assessment of electromagnetic fields around magnetic resonance imaging (MRI) equipment. U.K. Health and Safety Executive, 2007 (

www.hse.gov.uk/research/rrpdf/rr570.pdf

).
2. An investigation into occupational exposure to electromagnetic fields for personnel working with and around medical magnetic resonance imaging equipment. EC Employment, Social ffairs nd Equal Opportunities DG, April 2008 (

www.myesr.org/html/img/pool/VT2007017FinalReportv04.pdf

).