New legislation intended to regulate radiation exposure introduced by the European Union will drastically decrease the use of MRI scans to diagnose and treat patients in EU countries, experts claim.
The new rules, set to become law in 2008, are part of the European Union Physical Agents Directive, according to The Guardian. This organization was created in order to protect workers in the telecommunications and electricity industries from health complications associated with overexposure to electromagnetic radiation.
The new guidelines are based on the advice of the International Commission on Non-ionizing Radiation Protection and the National Radiological Protection Board. The rules set a limit on the amount of radiation a person can be exposed to during a given time period.
To the horror of the European medical community, the new limits also will keep doctors and other medical personnel away from MRI machines, which are a source of electromagnetic radiation. According to The Guardian, MRI technology, which has been used on roughly 100 million patients worldwide since its inception over 25 years ago, has revolutionized a doctors' ability to visualize the inside of the body and diagnose diseases such as cancer in the early stages.
The consequences of the legislation are many.According to The Guardian, experts predict a dramatic reduction in the number of MRI scans performed overall, with scans on children seeing the sharpest decrease. Furthermore, the new rules will prevent nervous patients from being accompanied by medical staff during scans, and they may even complicate or hinder cleaning of MRI equipment. A "brain drain" of scientists to the United States also is expected, as many European researchers involved with MRI-related technology attempt to escape the new restrictions on their work.
Although MRI scans generate strong electromagnetic fields, most doctors believe that the scans are not dangerous. It is known that these fields can induce a current within human tissues, causing the tissue to heat up and become damaged. Some controversial studies also claim that electromagnetic radiation has the potential to damage or mutate DNA. Even so, doctors say MRI scans are not dangerous because the heating effects are miniscule and the dose of radiation is too low to cause any permanent tissue damage.
Not everyone believes MRI scans are risk-free.
"We can't rule out any long-term effects," said Michael Clark, a scientist at the Health Protection Agency in the United Kingdom, as quoted in Nature. While he acknowledged there is a lack of clear evidence of harmful effects, he said he still believes the directive is designed solely to protect workers, including those working with MRI scanners.
"We are dealing with a new technology, and perhaps a bit of caution is necessary," he said.
In light of the new legislation, numerous experts, both scientists and doctors alike, have come to the defense of MRI scans as a diagnostic tool. Sir Peter Mansfield, a retired Nobel Prize winner and one of the original pioneers of MRI, told Guardian that the new regulations were overly harsh and "should be sent back to the drawing board." After watching MRI technology grow from its theoretical beginnings in his physics laboratory into a heavily utilized diagnostic tool, Mansfield said he felt the regulations were a step in the wrong direction. He said they would serve only to "hamper clinical practice unnecessarily, stop future MRI developments in their tracks and damage UK industry." He also pointed out that even after 25 years of use, MRI scans have yielded no known harmful effects.
Ian Young, a retired engineer who helped build the first MRI apparatus and performed the first MRI head scan in 1978, echoed Mansfield's sentiments, adding that evidence of adverse effects from standing in close proximity to an MRI scanner is almost nonexistent. In his opinion, as quoted in The Guardian, the new standards set by the EU had taken the precautionary principle to "absurd levels." By comparison, current U.S. regulations for sick patients allow radiation levels that are 1,000 times higher than those the EU will soon allow for fit members of the medical community.
Dr. Stephen Keevil of King's College London, as quoted in The Guardian, believes the "limits will prohibit clinical staff from standing close to an MRI scanner during imaging. In some circumstances, it will be impossible for nurses or doctors to provide the same care for sick or anxious patients while they have their scans. As a result, more patients may have to have a general anesthetic in order to have an MRI scan, and some may have to undergo X-ray imaging instead."
As reported in Nature, experts say those affected by the stricter rules will be anxious or nervous children who are frightened by the intimidating MRI apparatus. These patients most likely will have to undergo X-rays, which are actually more harmful than MRI scans, or be anesthetized, which adds an unwanted element of risk. Patients requiring special cardiac investigations normally done by MRI also will be drastically affected. Certain heart procedures, such as cardiac catherization, in which a doctor uses a live MRI image to guide a catheter from a patient's leg up into his/her heart, would not be possible if medical personnel were banned from the room during MRI scans.
To combat the new regulations, several leading MRI experts in the UK, including Mansfield and Young, have written to Secretary of State for Health Patricia Hewitt requesting time to do research that would justify relaxing the standards imposed by the directive, as reported in The Guardian. The Health Department acknowledged the proposal and said a reply would be issued "in due course."
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