By Stuart G. Hall

Up to €500,000 (approximately US$650,000) could be wasted on a MRI safety research contract by the European Commission to support their own flawed Directive when new research already provides enough evidence to scrap the legislation, and start again.

In 2004, the European Union adopted legislation to reduce health effects on workers linked to short-term exposure to electro-magnetic fields. Governments are now working to ensure its implementation by the April 2008 deadline. The Directive (see ‘Related Reading’ below) will introduce new restrictions on the use of MRI, effectively banning the use of MRI for interventional and surgical procedures. In response Members of Parliament, patient groups, leading European scientists and the medical community joined forces in Vienna on 9 March to launch a coalition called 'Alliance for MRI'. The Alliance's aim is to prevent the European Union from limiting clinical and research use of Magnetic Resonance Imaging (MRI).

Dr. Stephen Keevil, Consultant Physicist, Head of Magnetic Resonance Physics Guy's and St Thomas' NHS Foundation Trust, and Honorary Senior Lecturer in Imaging Sciences at King's College London, argues in an interview with Medicexchange that sufficient evidence exists with what’s already been published, plus new research led by Professor Stuart Crozier commissioned by the UK’s Health and Safety Executive from the University of Queensland in Australia, to force a change in policy. That work has been completed and it’s in the process right now of being published in preliminary form in the preceedings of the International Society for Magnetic Resonance in Medicine conference next week. Keevil’s expertise includes last year’s parliamentary enquiry in the UK into this when he wrote the MR submission and went to gave evidence to the select committee, which is also how he became involved with the European Society of Radiology.

Keevil says that what in essence has been found in that research is that the extent of exposure varies according to the scanner being used and where people are standing and moving a whole host of different variables but the headline is that within about a metre of the magnet there is a problem with the exposure limit. The impact would be of anything that needs to take place within a metre of the scanner, which covers any situation where a nurse or radiographer needs to be close enough to the scanner to care for a patient while they’re inside. Keevil adds that an emerging area that’s going to be very important in the future is interventional MRI, with clinicians carrying out surgical or other invasive procedures on patients inside the scanner. “You simply can’t get close enough to do that because of these new exposure limits – that’s the Crozier results. The HSE have now got the full set of results of that work last week – none of us have seen those yet.”

Enoughs enough

“In my view there’s enough already there with what’s been already published and certainly with Crozier on top of that to demonstrate there’s a problem. I don’t think we need that extra piece of work that the Commission are going to pay for in order to demonstrate that’s there’s a problem. It will refine the detail we will understand a bit more exactly when it occurs but to some extent we don’t need to know when it occurs the fact is it does occur and it means that MRI as it’s currently practiced is incompatible with the limits that are within the Directive. I think there’s enough there already to demonstrate there’s a problem and they should already be drafting an amendment to the Directive.”

Keevil also points out that the Commission has said is where there is a problem if countries don’t incorporate the Directive into their law by the April deadline, the Commission is effectively not going to do anything about it: “However, the Commission is obliged to pursue countries that don’t implement Directives in time through the European Court, countries are obliged to do that under the Treaty of Rome. Which is quite a significant concession but not necessarily tremendously helpful because that leaves the individual countries to decide whether they want to put themselves in breach of their treaty obligations.” He adds that this meant Europeans could get to the situation where some countries introduce legislation and others don’t and others don’t know quite what they’re going to do, which is probably the case in the UK, and it’s not very satisfactory.

“There really isn’t much evidence for adverse effects at all for this very conservative approach which has been taken, the low limits from point of view of MRI are extremely restrictive. It prevents people from working close to the MR scanner. Which will have a number of implications for patients and staff working with patients in MRI situations. Essentially any situation where people need to be close to the scanner while the patient’s inside and while the scanner is acquiring images will be a problem. It’s possible that even walking around in the scanner room close to the magnets will fall foul of the regulations as well which would even prevent people from cleaning the magnet.”

In a letter from the Commission to the newly formed body, the Alliance for MRI, the value of the new research from the HSE, Commission Director Generals Nikolaus G. van der Pas and Robert Madelin for Employment, Social Affairs and Equal Opportunities and Health and Consumer Protection, admit that: “If at any of the above stages, substantial evidence becomes available that the exposure limits laid down in the Directive would unduly affect medical procedures, we will be prepared to address the problem, not excluding a proposal to amend the Directive.”

The Commission's commission

As well as writing to national authorities alerting them to the issue the Commission has set up a group "to assist the Commission in finding a resolution to issues regarding unintended effects of the Directive on the use of Magnetic Resonance Imaging. This will include analysing research emerging from various member states and the Commission, formulating potential solutions, and providing a draft opinion for adoption by the Advisory Committee." But as well as looking at the HSE study, the Commission decided to spend up to half a million euros on the second study which they themselves admit will have to operate at speed. An official in charge of the tender process at the Commission, Georges Herbillon, says: “One of the main challenges is to make good measurements but in a very short time, that’s why we need a good team that can run the thing quickly and in various places at the same time – to act speedily and with the appropriate quality.” As outlined in the tender specification the installations have been selected at the following locations:

1. Leuven (Belgium, 3 Tesla installation, diagnostic on patients).
2. Nottingham (United Kingdom, 7 Tesla, research installation).
3. Cologne (Germany, 1 Tesla, open system for surgical interventions).
4. Strasbourg (France, 1.5 Tesla, for paediatric medical procedures).

The tight timescale has the tender selection finishing a week or ten days from now, then advancing through the Commission’s stringent financial procedures, with the aim to formally select a contractor in the last part of June, and to start measurements immediately after that. No doubt it’s no coincidence that the ‘Joint International Workshop on Medical Management of EMF Health Risk according to the EU Directive 2004/40/EC’ is taking place in Italy at the beginning of October. It’s organized by the International Commission on Non-Ionizing Radiation Protection, the body whose own guidelines formed the basis of the 2004 Directive.

Principal Scientific Officer Dr. Zenon Sienkiewicz at the UK’s Health Protection Agency, who’s remit includes radiation protection duties, says he believes that the time needs to be given for detailed assessment work to be carried out to assess the risks. While he understood there was a lot of concern about the impact of the Directive on MRI work the aim of the legislation was not to stop it: “It’s unfortunate when the initial Directive consultation was undertaken that the MRI community did not make their concerns more apparent at that stage.”

Related Reading
European MRI Diective 2004/40/EC
Dr Keevil's presentation to the EU on the MRI directive

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