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European Parliament
approves important changes to European health and safety legislation
enabling continued access to Magnetic Resonance Imaging (MRI)
technology for patients in Europe.
Background
The Alliance for MRI is a coalition of European Parliamentarians,
patient groups, leading European scientists and the medical
community, who together are seeking to avert the serious threat
posed by EU health and safety legislation to the clinical use of,
and research into, magnetic resonance imaging (MRI).
The Alliance for MRI was officially launched in March 2007 in
response to the pending implementation of the EU Physical Agents
2004/40/EC (on electromagnetic fields) in April 2008. The Alliance
was founded by the European Society of Radiology, the European
Federation of Neurological Associations and Dr. Hannes Swoboda MEP,
Chair of the Socialist Group in the European Parliament.
In October 2007, the European Commission proposed extending the
implementation deadline from April 2008 to April 2012, to allow more
time for the evaluation of new data on electromagnetic fields and
their short-term effects on the human body. As a result, the
European Commission published a new proposal in June 2011 revising
Directive 2004/40/EC in order to exempt MRI from the exposure limit
values. The MRI safety is already ensured through the MR safety
standard IEC/EN 60601-2-33 (harmonised through the European Medical
Devices Directives) which defines criteria for minimising
physiological effects due to exposure to time-varying
electromagnetic fields for patients and workers.
MRI is a diagnostic technique that uses radio and magnetic waves to
produce images of unrivalled quality, particularly of soft tissues
that are not well depicted using X-rays. It is essential for the
diagnosis and treatment of life-threatening diseases such as cancer,
heart disease and brain disorders. MRI is used for mapping brain
functions prior to surgery for diseases such as epilepsy and to
advance our understanding of how the brain works. New cutting-edge
diagnostic and treatment techniques such as MRI-guided surgery are
constantly being developed, leading to improved patient outcomes.
The Alliance for MRI welcomes the European Parliament's approval of
a derogation for Magnetic Resonance Imaging (MRI) in its draft
report on the revised 2004/40/EC Directive on Protecting Workers
from Exposure to Electromagnetic Fields (EMF Directive).
This derogation is necessary to ensure the unimpeded use of MRI so
that patients have access to the highest standard of care across
Europe. The safe use of this technology is highly regulated.
Criteria have been set to eliminate any danger to workers and
patients.
MRI has been used for almost 30 years, imaging to well over 600
million patients without evidence of harm to workers due to exposure
to electromagnetic fields. The Alliance supports the adoption of
guidelines to ensure that working practices are in line with the
latest technological developments.
On 14 June 2011 the European Commission adopted a proposal to revise
the directive on protecting workers from electromagnetic fields. The
European Commission's proposal includes a derogation for the medical
and research use of MRI from the exposure limit values, which will
ensure that this vital technology will continue to be available for
all patients. Two years later, on 11 June 2013 the European
Parliament adopted the report on the revised Directive on Protecting
Workers from Exposure to Electromagnetic Fields including the
derogation for Magnetic Resonance Imaging (MRI) with 594 votes in
favour out of 672 and 38 abstentions.
The adoption is in line with the First Reading Political Agreement
concluded by Council and Parliament in April 2013, following intense
informal discussions after the European Parliament's Employment and
Social Affairs (EMPL) Committee vote in December 2012.
After almost 10 years of uncertainty, the Members of the European
Parliament today took the step to ensure continued patient access to
MRI by endorsing the MRI derogation in its adoption of the report on
the revised Directive 2004/40/EC on electromagnetic fields. This is
a result of the concerns raised by the Alliance for MRI that the
2004/40/EC Directive severely curtailed the use of MRI to the
detriment of patients in Europe.
It was really good news for both patients and for who us work with
MRI.
http://www.alliance-for-mri.org/cms/website.php?id=/en/eu_affairs_research/alliance_for_mri.htm
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