by
Brendon Nafziger, DOTmed News Associate Editor | June 16, 2011
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.
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"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.
