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A National Survey on Safety Management at MR Imaging Facilities in Japan
Minako Azuma1, Kanako K Kumamaru2, Toshinori Hirai1
1Department of Radiology, Faculty of Medicine, University of Miyazaki.
Purpose:
To investigate safety management at Japanese facilities performing human MRI studies.
Methods:
All Japanese facilities performing human MRI studies were invited to participate in a comprehensive survey that evaluated their MRI safety management. The survey used a questionnaire prepared with the cooperation of the Safety Committee of the Japanese Society for Magnetic Resonance in Medicine. The survey addressed items pertaining to the overall MRI safety management, questions on the occurrence of incidents, and questions specific to facility and MRI scanner or examination. The survey covered the period from October 2017 to September 2018. Automated machine learning was used to identify factors associated with major incidents.
Results:
Of 5914 facilities, 2015 (34%) responded to the questionnaire. There was a wide variation in the rate of compliance with MRI safety management items among the participating facilities. Among the facilities responding to this questionnaire, 5% reported major incidents and 27% reported minor incidents related to MRI studies. Most major incidents involved the administration of contrast agents. The most influential factor in major incidents was the total number of MRI studies performed at the facility; this number was significantly correlated with the risk of major incidents (P < 0.0001).
Conclusion:
There were large variations in the safety standards applied at Japanese facilities performing clinical MRI studies. The total number of MRI studies performed at a facility affected the number of major incidents.
Insights
Japanese MRI safety management varies significantly. Higher MRI study volumes correlate with increased major incident risks, highlighting a need for improved safety protocols in clinical magnetic resonance imaging.
Area of Science:
- Medical Imaging and Radiology
- Healthcare Safety Management
- Clinical Research Compliance
Background:
- Human magnetic resonance imaging (MRI) studies are crucial for diagnostics and research.
- Effective safety management is paramount to mitigate risks associated with MRI procedures.
- Variations in safety practices can lead to adverse events in clinical settings.
Purpose of the Study:
- To assess the current state of safety management in Japanese facilities conducting human MRI studies.
- To identify factors contributing to safety incidents during MRI examinations.
- To evaluate compliance with established MRI safety protocols.
Main Methods:
- A nationwide survey of Japanese facilities performing human MRI studies was conducted.
- Questionnaires, developed with the Japanese Society for Magnetic Resonance in Medicine, assessed safety management, incident occurrence, and facility specifics.
- Automated machine learning analyzed data from October 2017 to September 2018 to identify key risk factors for major incidents.
Main Results:
- A 34% response rate (2015 out of 5914 facilities) was achieved.
- Significant variability in MRI safety management compliance was observed across facilities.
- 5% of responding facilities reported major incidents, often involving contrast agents, and 27% reported minor incidents.
Conclusions:
- Japanese facilities exhibit considerable disparities in MRI safety standards for clinical studies.
- The total volume of MRI studies performed at a facility is a significant predictor of major incident occurrence.
- Enhanced safety protocols and standardized practices are needed to reduce MRI-related adverse events.
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