European Commission asks to exempt MRI from EMF exposure limits

June 16, 2011
by Brendon Nafziger, DOTmed News Associate Editor
To the relief of European radiologists, regulators in Europe have proposed exempting magnetic resonance imaging from rules meant to curb exposure to electromagnetic fields.

The European Commission proposed Wednesday to amend a controversial 2004 directive aimed at limiting occupational exposure from EMF to workers in fields dealing with radar, high-tension power lines or other EMF sources.

Medical professionals feared the original rules would have severely limited MRI use in hospitals and clinics. A 2007 study suggested technologists standing three feet from an MRI would be in violation of the directive, posing especially difficult problems for those running scans of children, the elderly or for MRI-guided surgery.

"This proposal is good news for patients around Europe, and we look forward to its quick adoption, which will clarify the law on MRI," Hannes Swoboda, a member of the European Parliament from Austria, said in a statement.

Swoboda is also a founder of Alliance for MRI, a group of European medical societies and charities that was formed in 2007 in reaction to the directive. Member groups include the European Society of Radiology and the British charity The Wellcome Trust.

The proposal calls for replacing the revised Directive 2004/40/EC with a modified version that includes the exemption for MRI as well as other clarifications and updates.

The relevant paragraph comes in Article 3 of the revised draft:

By way of derogation, paragraphs 1 and 2 [limiting magnetic and electrical field exposures] shall not apply to medical applications using the magnetic resonance effect and the following related activities: integral system testing before release for shipment, installation, cleaning, maintenance, research and development activities. In these particular cases, specific protection measures shall be put in place.


The directive originally was meant to take effect in 2008, but doctors and other groups petitioned the EC to incorporate revisions and to delay the implementation until April 2012.

COCIR, a lobby of European imaging device manufacturers, also welcomed the news.

“Because the safety of patients and workers -- a priority for COCIR members -- is already addressed by specific international standards, the proposed exemption is the only solution that safeguards further development of MRI, ensuring continued innovation in patient care,” COCIR's Secretary General Nicole Denjoy said in a statement.

The European Parliament and Council will meet later this year to act on the proposal, the Alliance said.

Few short-term adverse effects

The directive is not aimed at long-term adverse effects from EMF exposure, as the EC said there was no conclusive scientific evidence linking EMF to, say, cancer.

Instead, the directive seeks to protect workers from known short-term adverse effects in the body.

In a February document, the Alliance explained that the only such effect reported with MRI is peripheral nerve stimulation, when sensory nerves are stimulated by electrical currents induced by time-varying magnetic fields. This can result in tingling or even extreme pain. However, the Alliance said that workers are already protected by existing regulation of equipment. Also, PNS is extremely rare. In the United Kingdom, for instance, there have only been two reported cases over the past decade, for an incidence of one out of three million scans, the Alliance said.

"MRI has been used for over 25 years, imaging up to 500 million patients without evidence of harm to workers due to exposure to electromagnetic fields," the group said in a position paper.