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New Insights into MR Safety for Implantable Medical Devices

Over the last two decades, the status of MR safety has dramatically changed. In particular, ever since the MR-conditional cardiac device was approved by the Food and Drug Administration (FDA) in 2008 and by the Pharmaceuticals and Medical Devices Agency (PMDA) in 2012, the safety of patients with an...

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Autores principales: Kuroda, Kagayaki, Yatsushiro, Satoshi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Japanese Society for Magnetic Resonance in Medicine 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9199981/
https://www.ncbi.nlm.nih.gov/pubmed/35228487
http://dx.doi.org/10.2463/mrms.rev.2021-0160
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author Kuroda, Kagayaki
Yatsushiro, Satoshi
author_facet Kuroda, Kagayaki
Yatsushiro, Satoshi
author_sort Kuroda, Kagayaki
collection PubMed
description Over the last two decades, the status of MR safety has dramatically changed. In particular, ever since the MR-conditional cardiac device was approved by the Food and Drug Administration (FDA) in 2008 and by the Pharmaceuticals and Medical Devices Agency (PMDA) in 2012, the safety of patients with an implantable medical device (IMD) has been one of the most important issues in terms of MR use. In conjunction with the regulatory approvals for various IMDs, standards, technical specifications, and guidelines have also been rapidly created and developed. Many invaluable papers investigating and reviewing the history and status of MR use in the presence of IMDs already exist. As such, this review paper seeks to bridge the gap between clinical practice and the information that is obtained by standard-based tests and provided by an IMD’s package insert or instructions for use. Interpretation of the gradient of the magnetic flux density intensity of the static magnetic field with respect to the magnetic displacement force is discussed, along with the physical background of RF field. The relationship between specific absorption rate (SAR) and B(1+RMS), and their effects on image quality are described. In addition, insofar as providing new directions for future research and practice, the feasibility of safety test methods for RF-induced heating of IMDs using MR thermometry, evaluation of tissue heat damage, and challenges in cardiac IMDs will be discussed.
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spelling pubmed-91999812022-07-06 New Insights into MR Safety for Implantable Medical Devices Kuroda, Kagayaki Yatsushiro, Satoshi Magn Reson Med Sci Review Over the last two decades, the status of MR safety has dramatically changed. In particular, ever since the MR-conditional cardiac device was approved by the Food and Drug Administration (FDA) in 2008 and by the Pharmaceuticals and Medical Devices Agency (PMDA) in 2012, the safety of patients with an implantable medical device (IMD) has been one of the most important issues in terms of MR use. In conjunction with the regulatory approvals for various IMDs, standards, technical specifications, and guidelines have also been rapidly created and developed. Many invaluable papers investigating and reviewing the history and status of MR use in the presence of IMDs already exist. As such, this review paper seeks to bridge the gap between clinical practice and the information that is obtained by standard-based tests and provided by an IMD’s package insert or instructions for use. Interpretation of the gradient of the magnetic flux density intensity of the static magnetic field with respect to the magnetic displacement force is discussed, along with the physical background of RF field. The relationship between specific absorption rate (SAR) and B(1+RMS), and their effects on image quality are described. In addition, insofar as providing new directions for future research and practice, the feasibility of safety test methods for RF-induced heating of IMDs using MR thermometry, evaluation of tissue heat damage, and challenges in cardiac IMDs will be discussed. Japanese Society for Magnetic Resonance in Medicine 2022-02-25 /pmc/articles/PMC9199981/ /pubmed/35228487 http://dx.doi.org/10.2463/mrms.rev.2021-0160 Text en ©2022 Japanese Society for Magnetic Resonance in Medicine https://creativecommons.org/licenses/by-nc-nd/4.0/This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/)
spellingShingle Review
Kuroda, Kagayaki
Yatsushiro, Satoshi
New Insights into MR Safety for Implantable Medical Devices
title New Insights into MR Safety for Implantable Medical Devices
title_full New Insights into MR Safety for Implantable Medical Devices
title_fullStr New Insights into MR Safety for Implantable Medical Devices
title_full_unstemmed New Insights into MR Safety for Implantable Medical Devices
title_short New Insights into MR Safety for Implantable Medical Devices
title_sort new insights into mr safety for implantable medical devices
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9199981/
https://www.ncbi.nlm.nih.gov/pubmed/35228487
http://dx.doi.org/10.2463/mrms.rev.2021-0160
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