National and International analysis of guidelines for diagnostic MR systems and health services' compliance with the Brazilian legislation

Authors

DOI:

https://doi.org/10.29384/rbfm.2023.v17.19849001669

Keywords:

Magnetic Resonance Imaging; Brazilian Health Regulatory Agency; MRI safety.

Abstract

Magnetic Resonance Imaging (MRI) systems are widely used due to its diagnostic power. The risks associated with this technique justify the adequacy of specific norms that aim at the safety of both patients and MRI Technologists. This study provides a literature review and comparative analysis of the current Brazilian legislation and the existing recommendations in the USA (United States of America) and Europe, as well as identifying which guidelines are currently applied in health services and the impact of the new Brazilian standards on these services. A questionnaire was developed and applied to professionals working with clinical MRI diagnostic systems, with specific questions for each area of work. It was found that the main safety requirements are applied in most health services, however, several issues still do not receive the necessary attention. There is still the challenge of covering even more safety issues in national regulations, and an even greater challenge to make sure that the requirements are applied and fulfilled.

 

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References

Mazzola AA. Ressonância magnética: princípios de formação da imagem e aplicações em imagem funcional. Rev Bras Fis Med [Internet]. 2015 Oct [cited 2020 Mar 10];3(1):117-29. Avaliable from: https://www.rbfm.org.br/rbfm/article/view/51

Ehrlich RA, Coakes DM. Patient care in radiography-e-book: with an introduction to medical imaging. 10. Ed. Amsterdam:Elsevier Health Sciences; 2020. 512 p.

Agência Nacional de Vigilância Sanitária. Instrução Normativa N° 97, de 27 de maio de 2021. Dispõe sobre requisitos sanitários para a garantia da qualidade e da segurança em sistemas de ressonância magnética nuclear, e dá outras providências. Diário Oficial da União. 2021 May 31; (101 seção 1):163.

Agência Nacional de Vigilância Sanitária. Resolução RDC 611, de 9 de março de 2022. Estabelece os requisitos sanitários para a organização e o funcionamento de serviços de radiologia diagnóstica ou intervencionista e regulamenta o controle das exposições médicas, ocupacionais e do público decorrentes do uso de tecnologias radiológicas diagnósticas ou intervencionistas. Diário Oficial da União. 2022 Mar 16; (51 seção 1): 107.

American College of Radiology. ACR Manual on MR Safety [Internet]. ACR; 2020 [cited 15 Apr 2021]. Available from: https://www.acr.org/-/media/ACR/Files/Radiology-Safety/MR-Safety/Manual-on-MR-Safety.pdf .

Medicines and Healthcare products Regulatory Agency. Safety guidelines for magnetic resonance imaging equipment in clinical use [Internet]. MHRA; 2021 Feb [cited 20 Sept 2021]. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/958486/MRI_guidance_2021-4-03c.pdf .

Mazzola AA, Stieven KI, Neto GH, Cardoso G de M. Segurança em Imagem por Ressonância Magnética. Rev Bras Fis Med [Internet]. 2019 Sept [cited 2020 Mar 10]];13(1):76-91. Avaliable from: https://www.rbfm.org.br/rbfm/article/view/519

Medical Professionals. MRI ZONES: A guide for Rad Techs [Internet]. 2021. [cited 2020 Nov 21]. Available from: https://www.medical-professionals.com/en/mri-zones-guide// .

American Society for Testing and Materials. ASTM F2503-20. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. West Conshohocken (PA): ASTM International. 2020. 9 p.

Stehling MK, Turner R, Mansfield P. Echo-planar imaging: magnetic resonance imaging in a fraction of a second. Science. [Internet]. 1991 Oct 4 [cited 2020 Jun 26]; 254(5028):43-50. Available from: https://doi.org/10.1126/science.1925560.

Allison J, Yanasak N. What MRI Sequences Produce the Highest Specific Absorption Rate (SAR), and Is There Something We Should Be Doing to Reduce the SAR During Standard Examinations? Am J Roentgenol. [Internet]. 2015 [cited 2020 Apr 2];205(2):W140. Available from: https://doi.org/10.2214/AJR.14.14173

International Electrotechnical Commission. IEC 60601-2-33: Medical electrical equipment - part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. In: International Electrotechnical Commission (IEC); 2010. 302 p.

Weishaupt D, Köchli VD, Marincek B. How does MRI work?: an introduction to the physics and function of magnetic resonance imaging. 4. ed. [place unknown]: Springer, 2003.170 p.

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JD, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform [Internet]. 2009 Apr [cited 2021 Apr 21];42(2):377-81. Available from: https://doi.org/10.1016/j.jbi.2008.08.010 .

Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, McLeod L, et al. The REDCap consortium: Building an international community of software partners. J Biomed Inform [Internet]. 2019 May 9 [cited 2021 Apr 21]. Available from: https://doi.org/10.1016/j.jbi.2019.103208 .

Published

2023-03-29

How to Cite

Moreno Vidotto, M., Taverna Chaim, K. ., & Papoti, D. (2023). National and International analysis of guidelines for diagnostic MR systems and health services’ compliance with the Brazilian legislation. Brazilian Journal of Medical Physics, 17, 669. https://doi.org/10.29384/rbfm.2023.v17.19849001669

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Artigo Original

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