Smirking aside, it's the responsibility of the Commission - an executive body of 23,000 civil servants representing the 27 member states of the European Union (EU) - to listen to its citizens and eliminate such heavy-handedness when it comes to potentially far-reaching legislation. A case in point is Directive 2004/40/EC. This physical agents directive (PAD), which must be incorporated within the legislation of EU member states by 2008, is intended to protect the health and safety of workers who come into contact with electromagnetic fields - among them clinical and research staff required to carry out MRI procedures.

Herein lies the rub. The MRI community maintains that there are a number of situations in which MRI workers exceed the proposed exposure-limit values for low-frequency, time-varying magnetic fields set out in the PAD. One example is interventional MRI, where the interventionalist is very likely to be positioned within the gradient-coil field so as to be able to reach the patient. "Put simply, the PAD will kill off interventional MRI in Europe, at an early stage of its development and before its value has been properly established," explained Penny Gowland in a Talking Point article on medicalphysicsweb last year (see Prudence, practicality and the future of MRI).

There are other problems, stemming from the fact that the gradient fields actually spill beyond the end of the magnet bore for most scanner designs. In practical terms, this means that it will no longer be possible for an anaesthetist to stand by a patient who is unconscious, or for a nurse to stand by a nervous child. The ultralow frequency limit will also prevent engineers climbing into scanners to maintain them, without costly magnet ramp-downs. It may even prevent staff walking around most magnets, or standing by magnets and turning their heads rapidly.

Action and reaction

For their part, MRI experts reckon that there is already sufficient evidence in the published literature to substantiate such claims. Earlier this month, for example, the European Society of Radiology announced the formation of the Alliance for MRI, a lobbying group comprised of European parliamentarians, patient groups and medical specialists. The Alliance wants the Commission, as a matter of urgency, to inform member states of the unintended consequences of the PAD and to delay the legislation pending further evaluation. Significantly, it is also proposing an EU-wide derogation for MRI.

Elsewhere, the UK's Health and Safety Executive (HSE) has commissioned independent research on the matter from Stuart Crozier, professor and director of biomedical engineering at the University of Queensland, Australia. The full results of the Crozier study are not yet available, but sources close to the process say that interim data shared with the HSE working party on MRI and the PAD suggest that, "depending on scanner design and specification and the imaging techniques used, the limits may be exceeded for staff within about a metre of the scanner".

Brussels, meanwhile, has always maintained that MRI workers do not, or at least need not, exceed the exposure limits. It's somewhat strange then to hear that the Commission is in the process of calling for tenders to carry out very similar work to that already commissioned by the HSE. At a cost of around €0.5 million, this sounds like one study too far. Rather than waiting for the results of its own project, it would be quicker and cheaper for the Commission to use the results of the HSE work to begin the process of amending the PAD.

Behind the scenes, there are whispers of an acceptance of a problem with the PAD, at least in some parts of the Commission. There is also talk of an acceptance on the part of the International Commission on Non-Ionizing Radiation Protection, which originated the exposure limits, that the scientific evidence behind the low-frequency limits is relatively weak. "I have heard rumours from political sources that there is a willingness to consider change on the basis of the HSE results, but there is nothing official as yet," one source close to the matter told medicalphysicsweb.

When all's said and done, a face-saving retreat beats bad legislation every time. Next month provides an obvious opportunity for the former with the completion of the Crozier study for the UK HSE. If the political will is there, it's clear that there is still time to amend the PAD before implementation in April 2008.