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MR Safety Update 2015: Where Do the Risks Come From?

  • MRI Safety (M Bock, Section Editor)
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Abstract

Given the high technological complexity of magnetic resonance imaging (MRI) systems, there is particular concern for potential harm. Safety issues arise from the three main components of the MRI system: its main static magnetic field, which is always on in superconducting magnets, and the switched radiofrequency electromagnetic fields and gradient magnetic fields that are activated during imaging. This article reviews published literature mainly from 2015 with regard to these general safety considerations and their interaction with implanted medical devices. Furthermore, an update on regulatory issues will be provided along with an overview of miscellaneous other safety aspects that are related to an MRI exam but do not arise from the technology per se.

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References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. IMV. MR Market Outlook Report. 2015. http://www.imvinfo.com/index.aspx?sec=mri&sub=dis&itemid=200085. Accessed 02 Jan 2016.

  2. Siemens Healthcare GmbH. 2016. http://www.healthcare.siemens.com/magnetic-resonance-imaging/7t-mri-scanner/magnetom-terra/features. Accessed 02 Jan 2016.

  3. Alizai H, Chang G, Regatte RR. MRI of the musculoskeletal system: advanced applications using high and ultrahigh field MRI. Semin Musculoskelet Radiol. 2015;19(4):363–74.

    Article  PubMed  Google Scholar 

  4. •• Kraff O, Fischer A, Nagel AM, Monninghoff C, Ladd ME. MRI at 7 tesla and above: demonstrated and potential capabilities. J Magn Reson Imaging. 2015;41(1):13–33. Comprehensive overview of current status of ultra-high-field imaging. Technical aspects are reviewed as well as clinical applications.

  5. Sinnecker T, Kuchling J, Dusek P, Dorr J, Niendorf T, Paul F, Wuerfel J. Ultrahigh field MRI in clinical neuroimmunology: a potential contribution to improved diagnostics and personalised disease management. Epma J. 2015;6:1.

    Article  Google Scholar 

  6. The European Parliament and the European Council. Directive 2007/47/EC amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. J Eur Union. 2007;L247:21–55.

    Google Scholar 

  7. •• International Electrotechnical Commission. Medical electrical equipment—Part 2-33: Particular requirements for the safety of magnetic resonance diagnostic devices. In IEC 60601-2-33. 2015. Latest version of the most important safety standard in MRI with impact for future clinical utilization of 7 T systems.

  8. United States Food and Drug Administration. Guidance for industry and FDA staff: criteria for significant risk investigations of magnetic resonance diagnostic devices. 2003.

  9. International Commission on Non-Ionizing Radiation Protection. Amendment to the ICNIRP statement on medical magnetic resonance (MR) procedures: protection of patients. 2009. Health Physics.

  10. Siemens Healthcare GmbH. New 7 T MRI research system ready for future clinical use. 2016. Available from: http://www.siemens.com/press/en/pressrelease/?press=/en/pressrelease/2015/healthcare/pr2015060231hcen.htm&content[]=HC. Accessed 02 Jan 2016.

  11. International Standards Organization (ISO). Technical Specification (TS) 10974: Requirements for the safety of magnetic resonance imaging for patients with an active implantable medical device. 2012.

  12. American Society for Testing and Materials (ASTM) International, Standard test method for measurement of radio frequency induced heating on or near passive implants during magnetic resonance imaging. In: ASTM F2182-11a, 2011.

  13. Guttler FV, Heinrich A, Teichgraber UK. Whole-body ferromagnetic detector systems in clinical MRI. Radiologe. 2015;55(8):649–53.

    Article  CAS  PubMed  Google Scholar 

  14. Gilk T, Kanal E. Planning an MR suite: what can be done to enhance safety? J Magn Reson Imaging. 2015;42(3):566–71.

    Article  PubMed  Google Scholar 

  15. United States Food and Drug Administration. MAUDE - Manufacturer and User Facility Device Experience. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Accessed 02 Jan 2016.

  16. Weidman EK, Dean KE, Rivera W, Loftus ML, Stokes TW, Min RJ. MRI safety: a report of current practice and advancements in patient preparation and screening. Clin Imaging. 2015;39(6):935–7.

    Article  PubMed  Google Scholar 

  17. Expert Panel on MR Safety, Kanal E, Barkovich AJ, Bell C, Borgstede JP, Bradley WG Jr., Froelich JW, Gimbel JR, Gosbee JW, Kuhni-Kaminski E, Larson PA, Lester JW Jr., Nyenhuis J, Schaefer DJ, Sebek EA, Weinreb J, Wilkoff BL, Woods TO, Lucey L, Hernandez D., ACR guidance document on MR safe practices: 2013. J Magn Reson Imaging 2013;37(3):501–30

  18. • Kanal E, Froelich J, Barkovich AJ, Borgstede J, Bradley W Jr., Gimbel JR, Gosbee J, Greenberg T, Jackson E, Larson P, Lester J Jr., Sebek E, Shellock FG, Weinreb J, Wilkoff BL, Hernandez D, American College of Radiology Subcommittee on MR Safety. Standardized MR terminology and reporting of implants and devices as recommended by the American College of Radiology Subcommittee on MR Safety. Radiology 2015;274(3):866–70. This paper describes a common confusion within the MR community regarding terminology and the reporting of safety assessments for implants, and provides solutions for better understanding.

  19. Calamante F, Faulkner WH Jr, Ittermann B, Kanal E, Kimbrell V, Owman T, Reeder SB, Sawyer AM, Shellock FG, van den Brink JS, ISMRM Safety Committee. MR system operator: recommended minimum requirements for performing MRI in human subjects in a research setting. J Magn Reson Imaging 2015;41(4):899–902.

    Article  PubMed  Google Scholar 

  20. van Osch JP, Webb AG. Safety of Ultra-High Field MRI: What are the Specific Risks? Curr Radiol Rep. 2014;2:1.

    Google Scholar 

  21. Hoult DI, Phil D. Sensitivity and power deposition in a high-field imaging experiment. J Magn Reson Imaging. 2000;12(1):46–67.

    Article  CAS  PubMed  Google Scholar 

  22. Landman DA, Srinivasan S, Ennis DB. What is the SAR for routine clinical MRI exams at 1.5 T. In: Proceedings 23rd Annual Meeting of the International Society for Magnetic Resonance in Medicine, Toronto, ON; 2015.

  23. Katscher U, Bornert P, Leussler C, van den Brink JS. Transmit SENSE. Magn Reson Med. 2003;49(1):144–50.

    Article  PubMed  Google Scholar 

  24. • Murbach M, Neufeld E, Cabot E, Zastrow E, Corcoles J, Kainz W, Kuster N. Virtual population-based assessment of the impact of 3 T radiofrequency shimming and thermoregulation on safety and B1 + uniformity. Magn Reson Med. 2015. Important and comprehensive study on RF induced heating for state-of-the-art 3 T systems capable of RF shimming.

  25. Sapareto SA, Dewey WC. Thermal dose determination in cancer-therapy. Int J Radiat Oncol Biol Phys. 1984;10(6):787–800.

    Article  CAS  PubMed  Google Scholar 

  26. van Rhoon GC, Samaras T, Yarmolenko PS, Dewhirst MW, Neufeld E, Kuster N. CEM43A degrees C thermal dose thresholds: a potential guide for magnetic resonance radiofrequency exposure levels? Eur Radiol. 2013;23(8):2215–27.

    Article  PubMed  PubMed Central  Google Scholar 

  27. • Neufeld E, Fuetterer M, Murbach M, Kuster N. Rapid method for thermal dose-based safety supervision during MR scans. Bioelectromagnetics 2015;36(5):398–407. Very practical approach with which the novel CEM43 model could be applied for safety supervision in MRI.

  28. Langman DA, Goldberg IB, Finn JP, Ennis DB. Pacemaker lead tip heating in abandoned and pacemaker-attached leads at 1.5 T MRI. J Magn Reson Imaging 2011;33(2):426–31

  29. • Sommer T, Luechinger R, Barkhausen J, Gutberlet M, Quick HH, Fischbach K, Working Group on Cardiovascular Imaging, German Roentgen Society (DRG), German Roentgen Society statement on MR imaging of patients with cardiac pacemakers. Rofo 2015;187(9):777–87. Detailed statement by the German Roentgen Society on imaging patients with implanted pacemakers. The paper describes risks assessments and provides highly useful information to ensure safety of these patients.

  30. • Nordbeck P, Ertl G, Ritter O. Magnetic resonance imaging safety in pacemaker and implantable cardioverter defibrillator patients: how far have we come? Eur Heart J. 2015;36(24):1505–11. This review lists key findings from basic research and clinical trials over the last 20 years and discusses the impact on clinical routine.

  31. • Noureddine Y, Bitz AK, Ladd ME, Thurling M, Ladd SC, Schaefers G, Kraff O. Experience with magnetic resonance imaging of human subjects with passive implants and tattoos at 7 T: a retrospective study. Magn Reson Mater Phy. 2015;28(6): 577–90. First report on experience in imaging a large number of subjects with implants and tattoos at 7 T. Site-specific information on the decision-making process is given.

  32. Heismann B, Ott M, Grodzki D. Sequence-based acoustic noise reduction of clinical MRI scans. Magn Reson Med. 2015;73(3):1104–9.

    Article  PubMed  Google Scholar 

  33. Ott M, Blaimer M, Breuer F, Grodzki D, Heismann B, Jakob P. Acoustic noise reduction in T1- and proton-density-weighted turbo spin-echo imaging. Magn Reson Mater Phy. 2016;29:5.

    Article  CAS  Google Scholar 

  34. Corcuera-Solano I, Doshi A, Pawha PS, Gui D, Gaddipati A, Tanenbaum L. Quiet PROPELLER MRI techniques match the quality of conventional PROPELLER brain imaging techniques. AJNR Am J Neuroradiol. 2015;36(6):1124–7.

    Article  CAS  PubMed  Google Scholar 

  35. Dournes G, Grodzki D, Macey J, Girodet PO, Fayon M, Chateil JF, Montaudon M, Berger P, Laurent F. Quiet submillimeter MR imaging of the lung is feasible with a PETRA sequence at 1.5 T. Radiology. 2015;276(1):258–65.

    Article  PubMed  Google Scholar 

  36. Strizek B, Jani JC, Mucyo E, De Keyzer F, Pauwels I, Ziane S, Mansbach AL, Deltenre P, Cos T, Cannie MM. Safety of MR imaging at 1.5 T in fetuses: A retrospective case-control study of birth weights and the effects of acoustic noise. Radiology. 2015;275(2):530–7.

    Article  PubMed  Google Scholar 

  37. Mansouri M, Aran S, Harvey HB, Shaqdan KW, Abujudeh HH. Rates of safety incident reporting in MRI in a large academic medical center. J Magn Reson Imaging. 2015. doi:10.1002/jmri.25055.

    PubMed  Google Scholar 

  38. Grobner T. Gadolinium—a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transpl. 2006;21(4):1104–8.

    Article  CAS  Google Scholar 

  39. •• Haneder S, Kucharczyk W, Schoenberg SO, Michaely HJ. Safety of magnetic resonance contrast media: a review with special focus on nephrogenic systemic fibrosis. Top Magn Reson Imaging, 2015;24(1):57–65. Excellent review on safety of MRI contrast agents including drug–drug interactions, pediatric applications, and current status of NSF.

  40. McDonald RJ, McDonald JS, Kallmes DF, Jentoft ME, Murray DL, Thielen KR, Williamson EE, Eckel LJ. Intracranial gadolinium deposition after contrast-enhanced MR Imaging. Radiology. 2015;275(3):772–82.

    Article  PubMed  Google Scholar 

  41. Radbruch A, Weberling LD, Kieslich PJ, Eidel O, Burth S, Kickingereder P, Heiland S, Wick W, Schlemmer HP, Bendszus M. Gadolinium retention in the dentate nucleus and globus pallidus is dependent on the class of contrast agent. Radiology. 2015;275(3):783–91.

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. Erwin L. Hahn Institute for Magnetic Resonance Imaging, University Duisburg-Essen, Kokereiallee 7, Building C84, 45141, Essen, Germany

    Oliver Kraff & Mark E. Ladd

  2. Medical Physics in Radiology, German Cancer Research Center (DKFZ), Heidelberg, Germany

    Mark E. Ladd

Authors
  1. Oliver Kraff
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  2. Mark E. Ladd
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Correspondence to Oliver Kraff.

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This article is part of the Topical collection on MRI Safety.

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Kraff, O., Ladd, M.E. MR Safety Update 2015: Where Do the Risks Come From?. Curr Radiol Rep 4, 34 (2016). https://doi.org/10.1007/s40134-016-0163-y

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