EU postpones MRI directive
The European Commission will postpone and amend legislation which could potentially alter MRI use for scientific research in the European Union.
The EU Physical Agents directive 2004/40/EC will be delayed by four years until April 30, 2012 to allow time for a substantive amendment to be adopted. The Commission said that “the future amendment will aim to ensure that limits will not have an adverse effect on the practice of MRI” and it recommended member states of the EU to put the transposition of the current directive on hold.
If implemented, the directive would limit healthcare staff from assisting or caring for patients during an MRI. It would mean that some patients who need assistance during imaging – the young, elderly, frail or confused – would either be denied imaging, such as x-rays, or have to undergo alternative procedures according to the Commission.
The “application [of an MRI] often relies crucially on the presence of a healthcare worker or researcher. If the European Commission legislation were implemented, it would almost certainly impact on patient welfare and be a major setback for scientific research, denying patients innovative treatments in the future," said Gabriel Krestin, professor of radiology at Erasmus MC, University Medical Center Rotterdam, Netherlands, and leading member of the Alliance for MRI, a European coalition which seeks to prevent legislation against MRI use.
The safety of MRI technicians is already regulated by the EU Medical Devices directive and the established MR safety standard IEC/EN 60601-2-33, which establishes time limits for patients’ and technicians’ exposure to electromagnetic fields.
The EU Physical Agents directive 2004/40/EC will be delayed by four years until April 30, 2012 to allow time for a substantive amendment to be adopted. The Commission said that “the future amendment will aim to ensure that limits will not have an adverse effect on the practice of MRI” and it recommended member states of the EU to put the transposition of the current directive on hold.
If implemented, the directive would limit healthcare staff from assisting or caring for patients during an MRI. It would mean that some patients who need assistance during imaging – the young, elderly, frail or confused – would either be denied imaging, such as x-rays, or have to undergo alternative procedures according to the Commission.
The “application [of an MRI] often relies crucially on the presence of a healthcare worker or researcher. If the European Commission legislation were implemented, it would almost certainly impact on patient welfare and be a major setback for scientific research, denying patients innovative treatments in the future," said Gabriel Krestin, professor of radiology at Erasmus MC, University Medical Center Rotterdam, Netherlands, and leading member of the Alliance for MRI, a European coalition which seeks to prevent legislation against MRI use.
The safety of MRI technicians is already regulated by the EU Medical Devices directive and the established MR safety standard IEC/EN 60601-2-33, which establishes time limits for patients’ and technicians’ exposure to electromagnetic fields.