16. June 2010 00:01
MRI research at risk from EC directive
European Medical Research Councils of the European Science Foundation issues Position Statement on the Implications of the EMF Directive 2004/40/EC for European Biomedical Magnetic Resonance Research
Europe must act to prevent new legislation impeding the use of magnetic resonance imaging (MRI) in medical research, diagnosis and treatment, states the European Science Foundation (ESF) in a new report. The report is endorsed by the European Medical Research Councils, representing the medical research communities in 30 countries.
The EC Electromagnetic fields (EMF) directive limits the exposure of workers to EMF with frequencies in the range of zero to 300 GHz. These limits are based on sparse evidence and are so low they could prevent MRI research, and severely hinder further development of the technology for patients with life-threatening diseases. The report recommends an exemption from any limit values for MRI in clinical and research settings, allowing researchers to manage health and safety requirements through other measures.
The EMF directive will come into effect in April 2012. The exposure limits would impair the ability of healthcare staff to care for patients, such as children, the elderly or those who are anaesthetized, who need help or comfort during scans. They would prevent the use of MRI for interventional and surgical procedures, emerging techniques that provide better clinical information and avoid the use of ionising radiation for imaging. Finally, by curtailing cutting edge research in the field of MRI, they would deny patients innovative treatments in the future.
“The Directive is a blunt instrument. It sets exposure limits that either relate to harmless effects, or are well below the threshold at which any effects occur. 2012 is still some time away, but to effect change in the policy we need to act now,” said Dr Stephen Keevil from King’s College London, who co-chaired the report. “Safety is taken very seriously by the MRI community. The directive’s aim of protecting workers is one that MRI researchers fully support, but its unintended effects are potentially disastrous. We are now working very closely with the European Commission to find a mutually acceptable solution.”
MRI uses electromagnetic fields to provide high-resolution images of soft tissues in the body and has been safely used for over 25 years. Scanners are constructed according to an international standard which ensures compliance with the essential requirements of the Medical Devices Directive, including avoidance of known hazards and adverse effects. Around 500 million patients have been exposed up to 100 times the exposure limit set by the Directive without evidence of harm to workers or patients. The limits proposed, particularly in the lower frequency range of up to 100 kHz, are based on over cautious extrapolation from very limited experimental data.
The report is chaired by Professor Gabriel Krestin and co-chaired by Dr Stephen Keevil and Professor Juergen Hennig. It is available online: www.esf.org/publications
Notes to Editors
To request interviews or more information please contact:
Chloe Kembery, ESF press office
media[at]esf.org Tel +33 (0) 388-762-158 Cell +33 (0) 643-172-382
The European Science Foundation (ESF) is an independent, non-governmental organisation that promotes cross-border collaboration in scientific research, research funding and science policy across Europe. The European Medical Research Councils is the membership organisation under the ESF of 37 medical research councils in 30 European countries. Its mission is to promote innovative medical research and its clinical application towards improved human health. www.esf.org
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- Ms. Chloe KemberyE-Mail
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