Nyheter från MR-alliansen
Senaste nytt från MR-alliansen
(2010-08-04)
Dear Members of the Alliance for MRI,
We are now entering a crucial phase in the Alliance for MRI Campaign to safeguard the future of MR technology. We are expecting the European Commission proposal to revise Directive 2004/40/EC on electromagnetic fields in the autumn and are looking forward to working with you to ensure the key decision-makers in the EU and in the member states understand the importance of exempting MRI from the limit values set in the Directive.
1. Save the Date! Alliance for MRI Annual Meeting and Reception, Wednesday September 29, 2010
Annual Meeting 17.00-18.00
The annual meeting will be to update all members on the latest developments. The Alliance Secretariat will also provide toolkits upon request to reflect your specific needs. Alliance for MRI Reception 18.30–20.00 hosted by MEPs Alejandro Cercas, Elizabeth Lynne and Françoise Grossetête Commissioner Andor will be invited to present the outline of the European Commission's proposal to amend Directive 2004/40/EC.
We very much hope that you will be able to attend. An invitation will follow shortly. Please confirm your attendance with the Alliance for MRI Secretariat.
2. Current status: revision of the Directive
The second stage consultation is now concluded (for the Alliance for MRI response see http://www.myesr.org/html/img/pool/20100528_Alliance_Statement_2nd_social_partner_con sultation_final.pdf).
The European Commission is currently undertaking an impact assessment.
It is anticipated that the Commission's proposal will be adopted some time in November under the Belgian presidency. The Council's position is likely to be adopted under the Hungarian presidency, early in 2011 and the First Reading in the European Parliament is also likely to be concluded in 2011.
3. Alliance for MRI Meetings with European Commission - DG Employment, DG Research and DG Health and Consumers
Alliance representatives met with Commissioner for Employment Andor on 2 July. Commissioner Andor fully agrees that a solution needs to be secured that ensures the unrestricted clinical and research use of MRI in the future.
In addition, the Alliance has met with Patricia Reilly, responsible for public health related policy in the cabinet of Máire Geoghegan-Quinn (Commissioner for Research, Innovation and Science) and with Paula Duarte Gaspar from the Cabinet of Commissioner Dalli (Commissioner for Public Health and Consumer Policy) in order to raise awareness of the issue prior to the inter-service consultation which will take place before the proposal is adopted by the European Commission.
The Alliance for MRI petition was presented at these meetings. A total of 7,434 signatories have signed the Petition including representatives of 22 patient groups, a high number of medical professionals from various disciplines, including radiology, neurology, cardiology, nuclear medicine and oncology, as well as by medical physicists. (The Alliance for MRI petition is still open at http://petition.myesr.org)
4. European Science Foundation Position Paper on EMF Directive
The European Science Foundation (http://www.esf.org), with whom the Alliance for MRI closely co-operates, has published its Position Statement on the Implications of the EMF Directive 2004/40/EC for European Biomedical Magnetic Resonance Research http://www.myesr.org/html/img/pool/mri_position_paper.pdf
5. Press
Nature magazine article on Revision of EMF Directive
On June 15 Nature Magazine published an article on the revision of the EMF Directive http://www.nature.com/news/2010/100615/full/465854a.html An article is also due to appear in The Lancet; we will keep you informed as soon as it has been published.
6. European Science Open Forum Conference (ESOF) in Turin, Italy 2-7 July
A panel session on the impact of the EMF Directive on MRI was organised by the Institute of Physics at the ESOF Conference in Turin on 6th July. The Alliance for MRI was represented by Dr Stephen Keevil, who also gave a press conference.
Please feel free to share this information with your colleagues and associate members. We very much look forward to seeing you in September and working together to protect the future of MRI.
We wish you relaxing summer holidays!
Monika Hierath
Alliance for MRI Secretariat
www.alliance-for-mri.org
phone: +43-1-5334064-20
Europarådet godkänner beslutet om förskjutning av införandet av direktiv om vistelse i magnetfält.
(2008-05-05)
Europarådet godkänner nu EU-komissionens tidigare förslag att skjuta beslutet om begränsningar i arbetstagares vistelse i magnetfält (The EU Physical Agents Directive 2004/40/EC). Beslutet har tidigare godkänts av Europaparlamentet. Beslutet innebär att frågan om hur MR-undersökningar skall utföras och vilka begränsningar som skall finnas för personalens vistelse i magnetfält skjuts till 20 april 2012. Under tiden skall frågan utredas och förhoppningsvis skall ett mer realistiskt beslut komma efter detta.
Det finns nu ytterligare en rapport om exponering för magnetfält i MR-utrustning, denna gång publicerad av EU-kommissionen och där man konstaterar att de högsta exponeringsniväerna förkalras av nya arbetssätt, MR-intervention bl.a., och där dessa innebär mindre risker än de etablerade radiologiska metoderna. Denna rapport skall ingå i det arbete som nu påbörjats för att definitivt ta ställning till vilka nivåer för exponering som EU kan acceptera.
Läs mer på: http://www.myesr.org/cms/website.php?id=/en/research/Alliance-for-MRI/background-dokumentation.htm
Europaparlamentet skjuter definitivt beslutet om direktiv angående vistelse i magnetiska fält fyra år framåt
(2008-02-22)
Europaparlamentet godkänner EU-komissionens tidigare förslag att skjuta beslutet om begränsningar i arbetstagares vistelse i magnetfält (The EU Physical Agents Directive 2004/40/EC). Detta innebär att frågan om hur MR-undersökningar skall utföras och vilka begränsningar som skall finnas för personalens vistelse i magnetfält skjuts fyra år framåt. Under tiden skall frågan utredas och förhoppningsvis skall ett mer realistiskt beslut komma efter detta.
Här följer gårdagens pressrelease från Europaparlamentet:
PRESS RELEASE, February 21, 2008
Alliance for MRI welcomes European Parliament approval of postponement of EU Directive on electromagnetic fields to protect MRI
The Alliance for MRI welcomes the European Parliament's approval on February 19 of the request by the European Commission to postpone this Directive for a period of 4 years in order to have sufficient time to review the EU Physical Agents Directive 2004/40/EC (EMF).
This important vote represents another major, laudable step forward in the right direction. The European Parliament approved the postponement with a clear majority. Following the positive vote in the Parliament, the next major step in the legislative procedure will be the vote at the Council of Ministers, which is expected at the end of February.
The Directive will be delayed by four years until 30th April 2012 to allow time for a substantive amendment to be adopted. Prior to a proposal being adopted, the European Commission will be undertaking a comprehensive impact assessment of the Directive and a broad stakeholder consultation. The Alliance for MRI and its members look forward to contributing to this process.
The Alliance for MRI remains concerned, however, that a number of member states have proceeded with transposition of the Directive, and calls on the European Commission to address this situation.
The current published Directive prevents healthcare staff from assisting or caring for patients during MR imaging. As a result, some patients who cannot be imaged without this care – if they are young, elderly, frail or confused – would either be denied imaging or have to undergo alternative procedures such as X-rays.
Note for Alliance members
The Alliance for MRI looks forward to working with its members and to continued co-operation in order to address the ongoing threat posed to MRI by the EU Physical Agents Electromagnetic Fields Directive 2004/40/EC.
Members may also be interested in the article published in the Lancet Oncology, (January 2008, Vol 9). The Alliance for MRI supports the Lancet’s comment that ‘effective measures have to be put in place to ensure scientific evidence from the experts is translated, given appropriate weight, and transmitted and listened to by politicians in a more rational and pragmatic way’.
The Alliance for MRI believes that a derogation for MRI from the scope of the EU Physical Agents Directive 2004/40/EC (EMF) is necessary to ensure the future unimpeded use of MRI, particularly for cutting edge research and MR-guided interventions. It is essential that this major advance in healthcare technology is not threatened by burdensome legislation when concerns can be addressed through responsible guidance to medical and service personnel.
The safety of MRI workers is already regulated by the EU Medical Devices Directive (amend. Direct 93/42/EEC) and the established MR safety standard IEC/EN 60601-2-33 (as amended to include users and workers). The IEC standard establishes limit values for time-varying electromagnetic fields which have been set so that any danger to patients and workers is excluded.
Contact:
Ms. Monika Hierath
Alliance for MRI Secretariat European Society of Radiology
Neutorgasse 9,
AT-1010 Vienna
Phone: +43 1 533 40 64 – 20
Fax: +43 1 535 70 41
monika.hierath@myESR.org
EU-komissionen backar om direktivet angående personal och vistelse i magnetiska fält
(2007-10-30)
I en pressrelease från "Alliance for MRI" meddelas att EU-komissionen har beslutat att skjuta beslutet om begränsningar i arbetstagares vistelse i magnetfält (The EU Physical Agents Directive 2004/40/EC (EMF). Beslutet skjuts fyra år framåt till 2012 och udner tiden skall direktivet utredas och förhoppningsvis ändras i en riktning som gör medicinska MR-undersöknignar möjliga.
 Ladda ner och läs pressreleasen i sin helhet
Bakgrund: EU-regler hotar MR-verksamheten, därför bildas MR-alliansen
EU har 2004 antagit ett direktiv som reglerar säkerhet i arbetsmiljön i och runt elektromagnetiska fält. Generellt kan direktivet beskrivas så att arbetande personal inte får vistas i elektromagnetiska fält vars styrka överstiger ett definierat gränsvärde. Direktivet, som alltså har funnits en tid, behöver inte vara verkställt förrän nästa år, men därefter finns ingen möjlighet att strunta i reglerna.
Tanken med EU-direktivet är vällovligt att skydda arbetare som jobbar i stora magnetfält, fr.a. i och omkring kraftstationer etc, men det ställer tyvärr också till avsevärda bekymmer på andra områden, fr.a. i sjukvården. Våra vanliga MR-undersökningar sker i en elektromagnetisk miljö som ligger långt över EUs gränsvärden och därför måste dessa göras helt utan närvaro av personal eller anhöriga. MR-undersökningar i narkos, undersökningar av barn och undersökningar där någon utöver patienten närvar av olika skäl blir förbjudna. Personalen kan inte heller följa patienten till undersökningsbritsen och psoitionera osv. I praktiken innebär alltså direktivet att all MR-verksamhet i Europa måste upphöra.
För att undvika den utvecklingen har det i Europa bildats en "Allians för MR" där bl.a. European Society of Radiology och andra organisationer och föreningar ingår. Därutöver finns t.ex. EU-parlamentariker, patientorganisationer och industrin representerad. Målet för alliansen är att få EU att förstå orimligheten i direktivet och konsekvenserna av det samt naturlligtvis att dra tillbaka beslutet elelr förändra regelverket till rimliga nivåer.
Läs mer på ESR:s hemsida »
Ladda ner senaste information från "Alliance for MRI" (Juli 2007)
Ladda ner ESR:s syn på konsekvenserna av EU-direktivet
Här följer listan på de organisationer och personer som idag bildar alliansen
EU-parlamentariker
Jan Andersson, (PES) SE, John Bowis (EPP/ED) UK, Philip Bushill Matthews, (EPP/ED)UK, Harald Ettl (PES) AT, Robert Goebbels, (PES) LU, Stephen Hughes, (PES) UK, Ville Itälä (EPP/ED) FI, Anneli Jäätteenmäki, (EPP/ED) FI,Karin Joens (PES) DE, Piia-Noora Kauppi, (EPP/ED) FI, Eija-Riitta Korhola, (EPP/ED) FI, Elizabeth Lynne, (ALDE) UK, Jules Maaten, (ALDE) NL, Linda McAvan (PES)UK, Dr Angelika Niebler (EPP/ED) DE, Ria Oomen-Ruijten, (EPP/ED) NL, Antonio Panzeri Pier, (PES) IT, Jean Spautz, (EPP/ED) LU, Hannes Swoboda (PES) AT (Founding member), Thomas Ulmer (EPP/ED) DE , Anne Van Lancker (PES) BE, Dr Anja Weisgerber (EPP/ED) DE
Europeiska och nationella patientorganisationer
• European Federation of Neurological Associations (Founding member);
• European Parkinson's Disease Association,
• European MS Platform
• European Heart Network
• Europa Donna
• European Patients Platform
• International Diabetes Federation - Europe
• Alzheimer Europe
• WHO Collaborative Centre for Research, training and treatment in Epilepsy
• European Headache Alliance
• Austrian Lung Association
• Austrian Epilepsy Association
• Werkgroep Hersentumoren vzw (Belgian Brain Tumour Group)
• Epilepsy Centres of the Netherlands Foundation:
Vetenskapliga organisationer
• European Society of Radiology (Founding Member)
• European Union of Medical Specialists (Radiology Section)
• European Brain Council
• Luxembourg Medical Council
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