Originally Published EMDM November 2005
A NOTE FROM THE EDITOR
The EMF Directive May Do More Harm Than Good
In this issue’s Market Watch on safety syringes, we report that approximately 1 million needlesticks occur in Europe each year. That’s truly a scary statistic, given the potential for infection. Yet there is almost no legislation at the European or national levels mandating, where feasible, the use of safety syringes. Perhaps lawmakers have been distracted by more-pressing matters, such as the perils of exposure to electromagnetic fields (EMF).
The European Parliament and Council passed a directive last year that limits operators’ exposure to EMF. Set to come into effect in 2008 throughout the European Union, the directive would curtail the use of magnetic resonance imaging (MRI) in diagnostic, therapeutic, and research applications, according to a number of MRI experts. Alarmed by the law’s ramifications, a group of noted scientists and clinicians, led by Ian Young, a professor of electrical and electronic engineering at Imperial College (London), drafted a letter to the attention of the UK secretary of state for health. Made public in September, the letter urges the government to propose an amendment that would exempt MRI from the scope of the directive and to postpone its transposition into national law until proper research has been conducted.
Article 11.3 of the Physical Agents (Electromagnetic Fields) Directive limits the exposure of operating staff to electromagnetic fields beyond 300 GHz. This would prohibit the use of high-tesla machines that make up a significant portion of MRI scans. It would also hamper research. The EU law notably prevents researchers from being in proximity to the scanner while it is gathering data. But, as one healthcare professional noted, you often want to make adjustments to the machine without interrupting the imaging.
“The limits proposed are huge extrapolations from largely hypothetical conditions and are an overcautious interpretation of very limited experimental data,” write the letter’s authors. “It will end interventional MRI . . . parents and nurses will be unable to comfort children during scans.” Ironically, this will result in a greater reliance on x-rays for paediatric patients, for whom the injection of contrast agents is more traumatic than an MRI scan. It would also increase patient risk, since there is a known mortality rate associated with x-ray agents, add the letter’s signatories. “As researchers, clinicians, and employers, we are particularly concerned that these consequences will arise from legislation that has no apparent benefit to staff or patients.” They add that, contrary to the inference of the directive, MRI scanners cannot be adapted to conform to the EU regulations as written. “The installed base of clinical MRI scanners in [the United Kingdom] would be restricted in their utility and, in some instances, would have to be shut down.”
Signatories include Nottingham University’s Peter Mansfield, a joint winner of the Nobel Prize for medicine in 2003, and the presidents of the Royal College of Radiologists, the Institute of Physics and Engineering in Medicine, and the British Institute of Radiology. The letter can be viewed in its entirety at www.senseaboutscience.org.uk/pdf/IanYoungLetter.pdf.
Numerous organizations have opposed the directive’s scope from the beginning, but their critiques fell on deaf ears at the European level. Perhaps the epistolary gang of 12 will be more successful. A spokesman for the Health and Safety Executive (HSE), which is responsible for putting the directive into action in the United Kingdom, said that a process of consulting on implementing the EU rules had begun. “The HSE is entering into a dialogue with a number of other government departments about the directive,” he told the Scientist (www.the-scientist.com). “We intend to set up a roundtable discussion with representatives of all stakeholders to work on a way to implement the directive.”
Some sunny optimists even hold out hope for a change of heart in Brussels. European Commission president José Manuel Barroso issued a well-publicized pledge to slash red tape and scrap unnecessary EU regulations. The Physical Agents Directive would be a good place to start.
Copyright ©2005 European Medical Device Manufacturer
