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EU-Directive: Potentially dangerous consequences for MRI

9 March 2007:  In 2004, the European Union adopted the EU Physical Agents (EMF) Directive with the laudable aim of reducing health effects on workers linked to short-term exposure to electro-magnetic fields, such as those emitted by mobile phones and electrical power lines, but also by MRI systems. The Directive puts limits on the exposure of operating staff in an extremely wide range of frequencies. MRI scans produce detailed pictures of the inner workings of patients’ bodies using strong magnetic fields and radio waves.

“The Directive’s proposed exposure limits threaten our ability to diagnose and treat many patients, particularly those who are frail, anxious or anaesthetised. Nurses and other health workers will be unable to comfort children during scans. We will have to rely more, instead of less, on x-ray examinations of paediatric patients, for which their age is regarded as an absolute contraindication”, said Professor Dr. Gabriel P. Krestin (ESR Research Committee Chairman, Department of Radiology, Universal Medical Center Rotterdam (NL)) “It will end interventional MRI, with the loss of well-documented improved outcomes for tumour, cardiac and other patients.”

Any decision to severely curtail the use of MRI must be based on firm scientific evidence. MRI has been safely used for over 25 years, with over 500 million patients exposed to time-varying magnetic fields at amplitudes up to 100 times the occupational exposure limit, without any evidence of harm to workers or patients. “There are no known long-term effects of exposure to magnetic fields”, said Prof. Krestin. “This is not to argue that there should be no limits on exposure, rather that exposure limits should be based on current scientific knowledge. The limits proposed are huge extrapolations from largely hypothetical conditions and are an over-cautious interpretation of very limited experimental data.”

Due to our concerns, officials from ESR and the Directorate General for Employment Social Affairs and Equal Opportunity of the EC have decided to contract an independent expert group to perform an analysis of the implications of the Directive on the clinical use of MRI, said Prof. Krestin: “Meanwhile, interim findings from the UK Health and Safety Executive already indicate that both exposure to switched gradient fields during image acquisition and movement through the static field become problematic within about 1m of the magnet bore. This would mean that almost all of the approximately 8 million MRI examinations per year in the EU would be affected.”

“We are increasingly concerned with timing; if, as expected, the results to be published this autumn justify our concerns, it will be very difficult to amend the legislation prior to implementation in April 2008”, said Prof. Krestin. “We strongly advise that the deadline for implementation of the Directive be deferred by at least one year (to April 2009), to allow the results of the impact assessments, being undertaken by the European Commission and the member states, to be concluded.” This delay would allow the new scientific evidence to be taken into account and make an amendment to the legislation possible, prior to the deadline for implementation.

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