The Committee for Employment and Social Affairs exempted workers who deal with MRI from exposure limits contained in the "Directive on Protecting Workers from Exposure to Electromagnetic fields." The committee-approved draft will be used as the basis of informal negotiations with Council. If agreement is reached, it will be voted on next year by the full Parliament.
"Today's vote is an important step that reverses an earlier detrimental decision. Without this change patients could not have benefited from MRI in the diagnosis and treatment of life-threatening diseases," said Gabriel Krestin, president of the European Society for Radiology.
The safe use of MRI is regulated through the Medical Devices Directive. During almost 30 years MRI has been used to create images of more than 600 million patients, without any evidence that workers have been harmed by exposure to electromagnetic fields.
The parliamentary committee's action corrects problems with the original Directive and endorses an updated proposal by the European Commission on Protecting Workers. By subjecting MRI to overly restrictive limits the original version would have curtailed MRI-guided brain surgery and made MRI difficult to use in situations where close patient contact is required, including imaging of vulnerable patients and children. The exemption is also necessary for research and development and for routine cleaning and maintenance of MRI equipment.
Patient Group Representative Mary Baker (European Brain Council) said: "The derogation for Magnetic Resonance Imaging that was endorsed today will ensure that serious medical conditions such as cancer will be diagnosed and treated to the benefit of patients in Europe. I am calling on all Members of the European Parliament to follow the example of their colleagues and to support the MRI derogation in the plenary vote in early 2013".
The 'Alliance for MRI' is a coalition of European Parliamentarians, patient groups, leading European scientists and the medical community, who together are seeking to avert the serious threat posed by EU health and safety legislation to the clinical and research use of Magnetic Resonance Imaging (MRI).
The Alliance for MRI was officially launched in March 2007 in response to pending implementation of the EU Physical Agents 2004/40/EC (on electromagnetic fields) in April 2008. The Alliance was founded by the European Society of Radiology, the European Federation of Neurological Associations and Dr. Swoboda MEP, Chair of the Socialist Group in the European Parliament.
In October 2007 the European Commission proposed the postponement of the implementation deadline from April 2008 to April 2012 to allow more time for the evaluation of new data on EMF and its short-term effects on the human body. As a result in June 2011 the European Commission published a new proposal revising Directive 2004/40/EC in order to exempt MRI from the exposure limit values.
The safety of MRI is already ensured through the established MR safety standard IEC/EN 60601-2-33 (harmonised through the European Medical Devices Directives) which defines criteria for minimizing physiological effects due to exposure to time-varying electromagnetic fields for patients and workers.