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• Investigation Research •
Analysis of MRI-related adverse event reports
ZHENG Chen  YANG Pengfei 

Cite this article as: Zheng C, Yang PF. Analysis of MRI-related adverse event reports. Chin J Magn Reson Imaging, 2020, 11(6): 438-443. DOI:10.12015/issn.1674-8034.2020.06.008.


[Abstract] Objective: To analyze the types and causes of adverse events and recall data through MRI 10-years adverse events in US combined with active recall data in China.Materials and Methods: Based on SUS database, collected 1548 MRI instruments, MRI dedicated coils, MR spectroscopy imaging and PET/MRI adverse events from January 1, 2008 to December 31, 2017; Based on the website of National Medical Products Administration, included 30 MRI, PET/MRI incidents reported to China from January 1, 2011 to December 31, 2019.Results: The type and number of MRI adverse events of fruit 1548 were 906(58.5%) of overheating injury, 170(11.0%) of mechanical damage, 133(8.6%) of ferromagnetic projection damage, 109(7.0%) of confounding events, 89(5.7%) of image quality, 86(5.6%) of noise, 55(43.6%) of unknown cause, 0(0%) of peripheral nerve stimulation; the type and number of MRI overheating injury-adverse events of fruit 906 were 348(38.4%) of unknown cause, 257(28.4%) of contact with a conductive object, 147(16.2%) of skin-to-skin contact, 97(10.7%)of bore contact, 57(6.3%) of not RF related events; the types and number of active MRI recall events in China were helium leakage 7(23.3%), overheating damage 6(20.0%), image quality 6(20.0%), mechanical damage 5(16.7%), magnet loss 3(10.0%), label 3(10.0%).Conclusions: The types and causes of adverse events and recall data are of great value to China manufacturers, clinical institutions and regulators in controlling MRI-related risks.
[Keywords] magnetic resonance imaging；adverse events；recalls

ZHENG Chen* Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China

YANG Pengfei Center for Medical Device Evaluation, National Medical Products Administration, Beijing 100081, China

*Corresponding to: Zheng C, E-mail: zhengchen@cmde.org.cn

Conflicts of interest   None.

Received  2020-02-08
Accepted  2020-03-13
DOI: 10.12015/issn.1674-8034.2020.06.008
Cite this article as: Zheng C, Yang PF. Analysis of MRI-related adverse event reports. Chin J Magn Reson Imaging, 2020, 11(6): 438-443. DOI:10.12015/issn.1674-8034.2020.06.008.

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