Enter Your Email Address to Receive a
Copy of MedicExhange Member Demograhpics

The European Commission has defended Slovakia’s unilateral decision to go ahead and implement in advance a new law effectively banning the use of MRI, on the grounds that it was based on “the assumption” that the limits which the law sets would have no effect.

This defence has been roundly criticised by imaging expert Dr Stephen Keevil who says: “The assumption that Slovakia is making is incorrect, and the Crozier study demonstrates that continuing with MRI in that country is now illegal.

“In English law at least ignorance is no defence for breaking the law, and now they can't even claim ignorance!”. In a related development a spokesperson for the industry body, the COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry), says: "With regard to the Slovakian situation, lawyers of our corporate company members are studying the consequences for their own technicians as well as hospital personnel."

Dr Keevil is Consultant Physicist, Head of Magnetic Resonance Physics Guy's and St Thomas' NHS Foundation Trust, Honorary Senior Lecturer in Imaging Sciences at King's College London, and a leading member of the Alliance for MRI set up to ensure that the directive is amended before the implementation deadline on 30 April 2008.

He also recently presented to a key meeting with the commission findings of research commissioned by the UK Health and Safety Executive and undertaken by Professor Stuart Crozier. The study demonstrates that anyone standing within about 1m of an MRI scanner while it is acquiring images will exceed the exposure limits set out in the directive: "In my personal view, the existing evidence is sufficient to justify substantive change to the directive, not just a delay in transposition which can only prolong uncertainty."

Gabriel Krestin, professor and chairman of the Department of Radiology at Erasmus University in the Netherlands, and a member of the Alliance for MRI, agrees: “Slovakia has already implemented the directive. At any moment a worker could sue the hospital, or the companies could stop maintaining the machines because it’s illegal for their workers to maintain or service the machines. So practically, it’s illegal to use MR in that country.”

A spokesperson for the Slovak Republic's Ministry of Health says: "The directive was implemented according to the legislation rules, in the period that is legal, and there were not any official objections to it."

A letter to Medicexchange from Jan Jarab, with the office of Commissioner for Employment and Social Affairs Commissioner, sets out the case for the defence of the commission's actions in general and Slovakia's in particular:

“The Electromagnetic Fields Directive 2004/40/EC, which is due to come into force in April 2008, was based on the best then-available scientific evidence, as reflected in the recommendations of the ICNIRP (International Committee for Non-Ionizing Radiation Protection). The directive aims to protect workers in a number of industries and other settings. It was never intended to restrict the practice of MRI; and indeed the scientific consensus of the day appeared to be that the limits established in the directive would not be exceeded in the correct practice of MRI.

“Early in 2006, the European Commission was alerted to concerns expressed by senior members of the radiology profession who argued that the limits set by the directive could actually be exceeded. Vladimír Špidla, the Commissioner for Employment, Social Affairs and Equal Opportunities, immediately reacted to those concerns by meeting a representative delegation of the European Society of Radiology, headed by its president Mr. Gourtsoyannis. The Commissioner fully agreed with the representatives of the profession that MRI was such a hugely beneficial diagnostic instrument that the directive would have to be amended if it was shown that the practice of MRI would be incompatible with the limits it establishes.

“The question remained, however, whether that was really the case. Therefore, the commissioner authorized the creation of a working group including members of the European Society of Radiology, Professors Krestin and Norris. Common terms of reference were agreed and a call for tender was launched. The results of the study are due in October or November 2007.

“In the meantime, however, the commission also learned about the British Government study on the same topic (the so-called Crozier study). The commission decided, therefore, to adopt a highly pro-active approach. In a letter to the relevant ministers of the member states, the commission stated clearly that it would take into account not just its own study, but also the British study, which was scheduled to appear already in April 2007.

“It also indicated that if the results would prove that the directive might restrict the use of MRI, legislative amendments were not excluded. As a result, member states have all but stopped implementation of the directive. Apparently, only Slovakia has implemented it, but there are no indications that it would have done so in order to restrict the access of patients to MRI investigations (which, let me re-iterate, is simply not among the objectives of the directive). Rather, it appears that Slovakia has implemented the directive under the assumption that the limits which it sets would have no effect on the practice of MRI.

“The British (Crozier) study has finally been officially presented on 13 June 2007, just a week ago. Its findings appear to confirm the concerns that the limits set in the directive would indeed restrict the use of MRI. The commission is studying these findings and will take a decision on further steps as soon as possible.

“I would like to emphasize that the commission has not been at all defensive about the directive, that it has acted rapidly and pro-actively, and that the relevant British study has now been available as an official document for less than a week. You will surely agree that the commission could not have proposed amendments to valid legislation - which had been adopted by council and parliament - merely on the basis of concerns of a professional group, before having solid scientific arguments for such a proposal.”

In response to the commission's letter Dr Keevil backs up his argument that sufficient scientific evidence already exists to justify change to the directive:

"The commission letter claims that they were alerted to the MRI issue early in 2006. It is true that this is when we had our first meeting with the commissioner, but in fact the problem was drawn to the attention of the European institutions at a much earlier stage, prior to adoption of the directive in 2004. As early as September 2003, members of the Social Questions Working Party were taken to visit an MRI site in Leuven and told about the issues.

"At about the same time, COCIR submitted a very detailed document setting out all the issues about static field, time varying field and RF. It is not credible for them to claim now that they were only told about the problem in 2006.

"The commission also claims that it has not able to act until now because of the lack of solid scientific evidence that there is a problem for MRI with the directive. While it is true that the Crozier study provides the most complete set of data to date on the extent of the problem, the fact that there is a problem has been clear for some time from existing published, peer-reviewed papers.

"We have repeatedly brought these to the attention of the commission. While I understand the commission's reluctance to initiate change on the basis of the claims of what might be seen as a group with a vested interest, these claims have been backed throughout by scientific evidence and have been presented by leading scientists in the field.

"The commission's own study will further refine our understanding of situations where the exposure limits are exceeded by workers in MRI, but it will not make the problem go away."

The COCIR spokesperson confirms it has "sought to advise policymakers since 2003 of the impact on this legislation on the quality of healthcare in Europe and we keep on doing this".

Related reading
http://www.medicexchange.com/apps/medicexchange/articlefiles/11256-1875_1.pdf
http://www.medicexchange.com/apps/medicexchange/articlefiles/11256-1875_2.pdf