The European Parliament has recently approved the request by the European Commission to postpone the Directive on the use of MRI for a period of four years in order to have sufficient time to review the EU Physical Agents Directive 2004/40/EC (EMF).
The European Parliament approved the postponement with a clear majority. The Directive will be delayed by four years until April 30, 2012, to allow time for a substantive amendment to be adopted. Prior to this, the European Commission will be undertaking a comprehensive impact assessment of the Directive and a broad stakeholder consultation.
The Alliance for MRI, an initiative launched with the aim of addressing the impact of the directive on the use of MRI in healthcare in Europe, while welcoming this recent development, remains concerned that a number of member states have proceeded with transposition of the Directive. It has called on the European Commission to address this situation.
The current published Directive prevents healthcare staff from assisting or caring for patients during MR imaging. As a result, some patients who cannot be imaged without this care – if they are young, elderly, frail or confused – would either be denied imaging or have to undergo alternative procedures such as x-rays.
Derogation Necessary to Ensure Future of MRI
The Alliance for MRI has stated that a derogation for MRI from the scope of the EU Physical Agents Directive 2004/40/EC (EMF) is necessary to ensure the future unimpeded use of MRI, particularly for research and MR-guided interventions. The safety of MRI workers is already regulated by the EU Medical Devices Directive (amend. Direct 93/42/EEC) and the established MR safety standard IEC/ EN 60601-2-33 (as amended to include users and workers). The IEC standard establishes limit values for time-varying electromagnetic fields which have been set so that any danger to patients and workers is excluded.