MRI research at risk from EC directive

Europe must act to prevent new legislation impeding the use of MRI in medical research, diagnosis and treatment, ESF says in a new report, which is endorsed by the European Medical Research Councils, representing medical research communities in 30 countries.

The EC Electromagnetic fields (EMF) directive 2004/40/EC limits the exposure of workers to EMF with frequencies in the range of zero to 300 GHz. ESF says these limits are based on sparse evidence and are so low they could prevent MRI research, and severely hinder further development of the technology.

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 is due to 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 anaesthetised, 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, claims the ESF.

“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 Stephen Keevil from King’s College London, who co-chaired the report.

He added: “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’ve started working with the European Commission to find a mutually acceptable solution.”

MRI, using electromagnetic fields to provide high-resolution images of soft tissues in the body, 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, says the ESF.