The future of MRI in Europe - Safetey yes, exposure limits no
The Alliance for MRI aims to ensure that the threat posed by the EU Physical Agents 2004/40/EC (EMF) to the future of MR is averted and that patients in Europe will not be precluded from state-of-the-art healthcare services.
In early 2010 the European Parliament and Council will be sent a proposal from the European Commission to amend Directive 2004/40/EC on electromagnetic fields. This revision is a result of the concerns raised by the Alliance for MRI and a recognition by the EU institutions that the Directive severely curtails the use of MRI to the detriment of patients in Europe.
MRI (magnetic resonance imaging) is essential in fighting against life-threatening diseases such as brain tumours, cancers and heart conditions. Europe currently holds a leading position in the research and development of this technology and patients are provided with the highest standard of care.
The exposure limits in the Directive have now been proven to be detrimental to patient care, most notably restricting and limiting the use of MRI in interventional applications and in imaging vulnerable patients and children where closer patient contact is required. Furthermore, new research and developments in MRI will be severely restricted as will routine cleaning and maintenance of MRI equipment.
MRI has been used for over 25 years, imaging up to 500 million patients without evidence of harm to workers due to EMF exposure. It is also well known that MRI is free from most health risks associated with ionising radiation such as x-rays, which would form the alternative to MRI in many situations.
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 therefore requests an EU-wide exemption for medical use of MRI and related research from any exposure limit values set in the Physical Agents 2004/40/EC (EMF) Directive and the implementation of user guidelines
• The safe use of the technology is already regulated for. The established MR safety standard IEC/EN 60601-2-33 (as amended and harmonised under the Medical Devices Directive) establishes limit values for time-varying electromagnetic fields which have been set so that any danger to patients and workers is excluded.
• The Alliance for MRI supports the adoption of guidelines to support the safety standard as these allow for the incorporation of changes to ensure working practices are in line with technological developments. The Alliance for MRI welcomes the commitment by the European Commission and the support of the European Parliament to address the threat posed to MRI. In the revision of Directive 2004/40/EC the following considerations should be taken into account
• It is important that that an acceptable proposal is agreed upon in First Reading to ensure that this legislation is adopted as soon as possible. The current Directive remains on the statute book and some member states have proceeded to transpose it into national law.
• The Alliance for MRI will not support an amendment which provides an exemption for any fixed period. This approach would hamper the development of the technology and thereby undermine the highest standards of patient care.
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