For several years now, a directive from Brussels has posed a serious threat to clinical MRI use in Europe. Our two-part update explains why you still need to be concerned about the situation and why you must watch it closely.
German opposition to a deal with the European Commission (EC) exempting MRI systems from limits on electromagnetic fields (EMF) in the workplace is spreading ahead of a vote on the new law.
The draft of the Physical Agents EMF Directive now being sent to the European Parliament contains a hard-fought exemption for MRI systems, but it is not expected to pass on its first reading, according to European Society of Radiology (ESR) vice president Dr. Gabriel Krestin, PhD.
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| What's coming next from Brussels? Dr. Gabriel Krestin, PhD, contemplates the future. |
The German Ministry of Employment and Social Affairs says exposure limits and guidelines are not needed, though it may consider an exemption for MRI research applications.
Poland and Sweden are expected to side with Germany in imposing limits on MRI system use, said Krestin, who is ESR's point man for the Alliance for MRI.
The U.K. and France support the Alliance deal with the EC that proposes work safety guidelines for MRI systems rather than imposing fixed limits on the gradient field of scanners.
"We can expect to see changes and modification to the text, and in a worst case the parliament will adopt the changes proposed by Germany," said Krestin, who is head of the radiology department at Rotterdam University Hospital in the Netherlands.
The Alliance for MRI has been successful in a Brussels-based lobbying effort with the EC, he said, but the effort to win over members of parliament, as well as the European Council, requires a pan-European campaign.
"ESR has neither the money nor the manpower to carry the campaign through at the national level," he said.
"It takes work and we need the help of individuals from the national societies," he said. "The Parliament is a big body with more than 700 members."
For example, the positions of Spain and Italy are an unknown to the Alliance, yet could prove crucial as larger members of the European Union can influence the voting by other Member States.
The Alliance seeks the help of ESR members in those countries to approach lawmakers and the officials sitting on the European Council of Ministers.
Originally scheduled to come into effect in 2008, the EMF Directive was postponed when ESR and the Alliance convinced the commission that new rules meant to control the exposure of workers in diverse industries would have an unintended consequence on medical uses of MRI.
"Most radiologists thought we had the problem solved with the postponement of this directive, and by negotiating an exemption," said Krestin.
"We did win a battle, but we did not win the war; we only succeeded in postponing the problem," he said.
The German position
The Alliance for MRI won agreement from the European Commission for exempting MRI from the fixed limits set by the EMF Directive. The Alliance instead supports practice guidelines and training for the safety of employees and patients exposed to MRI. However the German Federal Ministry for Employment and Social Affairs (BMAS) objected in a position paper that is winning support among member states.
There are three key points of disagreement.
BMAS insists the limits it proposes for the low frequency range are intended to avoid peripheral nervous system syndrome.
The Alliance counters that the IEC standard followed by the European Union in the Medical Device Directive offers an assurance of safety.
The safety factor proposed by BMAS would result in a reduction in the switched gradient system by a factor of up to three, according to the Alliance, with a corresponding negative impact on imaging speed and performance -- particularly important for cardiac imaging and functional MRI of the brain.
BMAS believes the proposed exposure limits will be helpful in avoiding accidents with MRI.
The Alliance supports worker training and guidelines rather than exposure limits to prevent accidents in the workplace, pointing out that the most dangerous accidents from flying objects are due to the forces of the static magnetic field, which would not be addressed by the limits recommended in the BMAS proposal.
Finally, while arguing against an exemption for MRI in clinical settings, BMAS says it is open to the idea of an exemption from the exposure limit values for MRI research.
The Alliance asserts an exemption for both clinical and research uses is required.
The second part of this article will appear tomorrow on AuntMinnieEurope.com. It will provide useful background information about the EMF Directive and how it could affect you.
