Commissioners tell scientists they need more evidence before reviewing legislation that could make medical MRI scans 'impractical'
The European Commission (EC) has told scientists it is not yet ready to change proposed European physical agents legislation, criticised by scientists for posing a ’serious threat’ to legislation on medical imaging. The statement was made by the employment and social affairs commissioner, Vladimir Spidla, during a meeting in Brussels earlier today, in response to new findings highlighting problems that the directive will cause for patients.
The legislation was adopted by the European Union in 2004 and is set to be fully implemented by April 2008. According to some medical experts, the limits it sets could keep patients from undergoing valuable magnetic resonance imaging (MRI) scans. At today’s meeting, scientists presented the results from a number of studies that have confirmed their concerns.
Under the new law, workers must not exceed fixed limits on the level of exposure to electro-magnetic fields, to avoid any potential physiological damage. Workers include doctors, nurses and other hospital staff who operate or work closely with MRI scanners.
Scientists representing the European Society of Radiology’s Alliance for MRI met with Spidla and members of the European Parliament to present research illustrating the dangers posed by the directive. Stephen Keevil from Kings College London, UK, presented the latest findings from research commissioned by the UK Health and Safety Executive and carried out by Stuart Crozier and colleagues at the University of Brisbane, Australia. It showed that anyone standing within one metre of an MRI machine while it is operating will exceed proposed EU limits.
’Spilda said that the commission would be willing to consider legislative change but I am very disappointed that they didn’t take the decision to change the law in the face of this new evidence,’ Keevil told Chemistry World.
In a statement responding to Crozier’s findings, the Alliance for MRI said: ’This will prevent healthcare staff from assisting or caring for patients during imaging, and will mean that some patients who cannot be imaged without this care - perhaps because they are young, elderly, frail or confused - will either be denied imaging or have to undergo an alternative procedure using x rays.’
The alliance was launched earlier this year to avert the ’serious threat’ posed by the legislation. It is a coalition of scientists; European parliamentarians, patient groups and the medical community.
’We have now supplied specific, tangible evidence that this directive will damage MRI,’ said Keevil. ’They are looking for a solution that will balance worker protection with patient care, but the limits they have set are extremely over-cautious.’
Keevil noted that worker protection is a consideration for all medical imaging. ’There are sufficient measures taken to protect workers from ionising radiation,’ he explained. ’We have approached the commission as a group of medical workers who have to undergo this exposure, so we’re not forcing it upon other employees. We need to address the issue of patient care too.’
During the meeting, commissioners reiterated plans to further study the limits imposed by the directive, which it hopes will be concluded by October this year. ’This study hasn’t been commissioned yet and they’re running out of time,’ said Keevil. ’Why not just delay the implementation now?’
Meanwhile, this prospective setback for MRI has not prevented the launch of two major biomedical imaging centres in Europe this month. The Centre for Biomedical Imaging (CIBM) in Lausanne, Switzerland includes a 14-Tesla MRI machine, claimed to be the most powerful in the world. GlaxoSmithKline (GSK) has also opened a ?50 million Clinical Imaging Centre at Imperial College London, UK. Both centres include new MRI facilities for research purposes and clinical treatment.
S Crozier et al, Proc. Intl. Soc. Mag. Reson. Med., 2007, 15, 1089
S Crozier et al, Proc. Intl. Soc. Mag. Reson. Med., 2007, 15, 1098