European radiology mobilizes to stave off MRI safety rules

Mar 8, 2007

VIENNA - A number of European academic societies, including the European Society of Radiology (ESR), have formed a coalition to try to prevent the adoption of safety rules set to go into effect in 2008 that could severely limit the types of MRI studies that can be conducted in the European Union.

Called the Alliance for MRI, the coalition was launched here today at the European Congress of Radiology (ECR). The ESR was joined by other medical societies, patient-advocacy groups, and even a member of the European Parliament.

At issue is the looming implementation of a European Union directive that mandates EU member states adopt stringent guidelines on how much exposure workers receive to electromagnetic fields. Originally passed in 2004, the EU Physical Agents 2004/40/EC Directive (also known as the EMF directive), was designed to reduce worker exposure in a wide range of industries to electromagnetic fields that vary over time. But European radiologists have discovered that the directive can also apply to MRI studies, according to Dr. Gabriel Krestin, professor of radiology at Erasmus Medical Center in Rotterdam, Netherlands.

"In MRI we use a very strong static magnetic field, in which the patient is brought into this field, and we apply (radiofrequency) waves and changing electromagnetic fields during the acquisition of images in order to localize signals. These changing magnetic fields are the problem for this directive," Krestin said. "We know that all workers who would be close to the magnet, from a distance of 1 to 1.5 meters from the magnet during acquisition, would exceed the limit values that have been described in the directive."

The directive could potentially affect all of the estimated 8 million MRI studies conducted in EU member states, as radiologic technologists/radiographers are required to enter the MRI suite to position patients and provide other assistance. But the directive would have a particularly profound effect on studies that require workers to remain in the suite during scans.

Krestin estimated that some 400,000 of these types of scans are conducted every year, ranging from pediatric studies to exams conducted under anesthesia. Also affected would be interventional MRI procedures, as well as research studies such as those conducted with functional MRI (fMRI).

EU rules require that the EMF directive be "transposed," or adopted by member countries, through national legislation no later than April 1, 2008. If member countries fail to do so, they could be subject to litigation filed by the EU, Krestin said.

Mobilizing opposition

Individual radiologists have been voicing their opposition to the EMF directive for the past several years, as has Europe's main radiology industry trade group, the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR). But today's press conference marked the beginning of a last-ditch campaign to derail or postpone the directive before it can go into effect, according to Dr. Nicholas Gourtsoyiannis, president of the ESR.

Gourtsoyiannis said the exposure limits imposed by the EMF directive were based on incomplete scientific data, and he touted the lack of any evidence pointing to adverse health effects caused by electromagnetic radiation. "MRI has been safely used for over 25 years … without evidence of harm to workers or patients," he said.

Also speaking out against the directive was Hannes Swoboda, a member of the European Parliament, who pointed out the fact that the directive was originally not meant to target healthcare at all, but rather other industries in which strong electromagnetic fields were used. In addition to offering recommendations for revising the directive, he advised members of the alliance to focus on EU member countries that may be drafting legislation, and advise them to use caution in moving forward.

Latvia and Slovakia have already adopted legislation that transposes the EU directive into national law, Krestin said. Meanwhile, two countries that have studied the directive's impact in more detail, Finland and Austria, have adopted "derogation" laws that basically state that they intend to deviate from the guidelines. These countries could be subject to litigation filed by the EU if they maintain their positions, Krestin said.

In any event, Europe could become a patchwork of fragmented laws if the trend continues, Krestin said.

Making progress

While the situation appears dire, Alliance for MRI members have been making progress. They have succeeded in persuading the EU agency charged with implementing the directive, the Directorate General for Employment, Social Affairs and Equal Opportunities, to conduct an impact study examining whether MRI workers would indeed exceed the directive's limit values for exposure to electromagnetic fields in the course of normal work.

The directorate general will post a tender on March 10 soliciting offers from research groups to conduct the impact study, according to Georges Herbillon, principal administrator of the directorate general. (Herbillon attended the news conference as an observer rather than as a participant of the alliance.) The agency has already lined up four imaging facilities around Europe that will participate in the study, Herbillon said.

The directorate general hopes to have a contract with a research agency signed by June 30, with site visits occurring in July and preliminary results available in September/October. A final report would be published in December.

"We have to be open to any problem with the implementation of the directive, and in this framework we said, 'OK, we are going to make a measurement and see what really is the extent of the problem,'" Herbillon said. "We are hearing, 'We are over the limits.' We say, 'OK, fine but let's see why' and 'Can't you do something about it?' That's because this is all part of a legislative framework with a philosophy behind it. Normally, a hospital is an employer, and they have to make sure that their people are working under good conditions."

Gourtsoyiannis said the Alliance for MRI is asking the European Commission to perform three actions:

Inform member states of the "unintended consequences" of the directive, and its potential impact on MRI facilities.
Inform member states of the commission's impact study under way, and request a delay in implementing the legislation until the study's results are published.
Propose an amendment to the legislation introducing an EU-wide exemption for MRI from the requirements of the law.

The potential impact of the rules on patients was brought home by Ingele Meulenbergs, a brain cancer survivor and member of the European Federation of Neurological Associations. Meulenbergs was diagnosed with a brain tumor the size of a tennis ball three years ago, and fMRI was used as part of her surgical planning process to ensure that no vital structures would be damaged in the removal of the tumor.

"MRI for me made a difference between life and death, between having a tumor removed partially or in totality," Meulenbergs said. "I want other people who are not as yet diagnosed or treated to have the same chances that I had. Let us not compromise our options and handicap our abilities to treat and find a cure for neurological problems in the near future."

By Brian Casey
AuntMinnie.com staff writer
March 9, 2007