MRI‐related FDA adverse event reports: A 10‐yr review

Delfino, Jana G.; Krainak, Daniel M.; Flesher, Stephanie A.; Miller, Donald L.

doi:10.1002/mp.13768

Cited by 72 publications

(61 citation statements)

References 20 publications

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“…Anxiety before the examination was reported by 412 of the subjects (43%) (Fig. ) with a mean anxiety level of 1.8 on a 6‐grade Likert scale for patients and a mean anxiety level of 1.6 for healthy volunteers. The difference in anxiety level reported by patients and healthy volunteers was significant, with a higher anxiety level for patients prior to the 7T MRI examination (Mann–Whitney U ‐test, P = 0.03), where the term “patients” covers those who underwent clinical scans and those who were included in a clinical, disease‐specific research study.…”

Section: Resultsmentioning

confidence: 99%

“…Experienced effects and MRI safety risks at all field strengths involve mainly three types of electromagnetic field exposure. The static magnetic field (causing, for example, projectile risk) or translational forces and dizziness/vertigo originating from Lorenz forces due to ionic currents within the vestibular system, the radiofrequency field (causing, for example, energy deposition, possible burns, or increase of temperature), and the gradient field (causing, for example, peripheral nerve stimulation [PNS] and acoustic noise) …”

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confidence: 99%

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Subjectively Reported Effects Experienced in an Actively Shielded 7T MRI: A Large‐Scale Study

Hansson

Bloch

Owman

et al. 2020

Magnetic Resonance Imaging

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Background Ultrahigh‐field (UHF) MRI advances towards clinical use. Patient compliance is generally high, but few large‐scale studies have investigated the effects experienced in 7T MRI systems, especially considering peripheral nerve stimulation (PNS) and caregiving. Purpose To evaluate the quantity, the intensity, and subjective experiences from short‐term effects, focusing on the levels of comfort and compliance of subjects. Study Type Prospective. Population In all, 954 consecutive MRIs in 801 subjects for 3 years. Field Strength 7T. Assessment After the 7T examination, a questionnaire was used to collect data. Statistical Tests Descriptive statistics, Spearman's rank correlation, Mann–Whitney U‐test, and t‐test. Results The majority (63%) of subjects agreed that the MRI experience was comfortable and 93% would be willing to undergo future 7T MRI as a patient (5% undecided) and 82% for research purposes (12% undecided). The most common short‐term effects experienced were dizziness (81%), inconsistent movement (68%), PNS (63%), headache (40%), nausea (32%), metallic taste (12%), and light flashes (8%). Of the subjects who reported having PNS (n = 603), 44% experienced PNS as “not uncomfortable at all,” 45% as “little or very little uncomfortable,” and 11% as “moderate to very much uncomfortable.” Scanner room temperature was experienced more comfortable before (78%) than during (58%) examinations, and the noise level was acceptable by 90% of subjects. Anxiety before the examination was reported by 43%. Patients differed from healthy volunteers regarding an experience of headache, metallic taste, dizziness, or anxiety. Room for improvement was pointed out after 117 examinations concerning given information (n = 73), communication and sound system (n = 35), or nursing care (n = 15). Data Conclusion Subjectively reported effects occur in actively shielded 7T MRI and include physiological responses and individual psychological issues. Although leaving room for improvement, few subjects experienced these effects being so uncomfortable that they would lead to aversion to future UHF examinations. Level of Evidence 1 Technical Efficacy Stage 5 J. Magn. Reson. Imaging 2020;52:1265–1276.

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Section: Resultsmentioning

confidence: 99%

mentioning

confidence: 99%

Subjectively Reported Effects Experienced in an Actively Shielded 7T MRI: A Large‐Scale Study

Hansson

Bloch

Owman

et al. 2020

Magnetic Resonance Imaging

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“…The incidents were also categorised into (1) thermal, (2) mechanical, (3) projectile, (4) peripheral nerve stimulation and (5) miscellaneous. This categorisation was adopted from a study by Delfino et al [15]. The 'actual reporting rate' (R) was calculated in the following manner:…”

Section: Methodsmentioning

confidence: 99%

Magnetic resonance imaging incidents are severely underreported: a finding in a multicentre interview survey

et al. 2021

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Objectives The purpose of this study was to develop a procedure to investigate the occurrence, character and causes of magnetic resonance (MR) imaging incidents. Methods A semi-structured questionnaire was developed containing details such as safety zones, examination complexity, staff MR knowledge, staff categories, and implementation of EU directive 2013/35. We focused on formally reported incidents that had occurred during 2014–2019, and unreported incidents during one year. Thirteen clinical MR units were visited, and the managing radiographer was interviewed. Open questions were analysed using conventionally adopted content analysis. Results Thirty-seven written reports for 5 years and an additional 12 oral reports for 1 year were analysed. Only 38% of the incidents were reported formally. Some of these incidents were catastrophic. Negative correlations were observed between the number of annual incidents (per scanner) and staff MR knowledge (Spearman’s rho − 0.41, p < 0.05) as well as the number of MR physicists per scanner (− 0.48, p < 0.05). It was notable that only half of the sites had implemented the EU directive. Quotes like ‘Burns are to be expected in MR’ and not even knowing the name of the incident reporting system suggested an inadequate safety culture. Finally, there was a desire among staff for MR safety education. Conclusions MR-related incidents were greatly underreported, and some incidents could have had catastrophic outcomes. There is a great desire among radiographers to enhance the safety culture, but to achieve this, much more accessible education is required, as well as focused involvement of the management of the operations. Key Points • Only one in three magnetic resonance–related incidents were reported. • Several magnetic resonance incidents could have led to catastrophic consequences. • Much increased knowledge about magnetic resonance safety is needed by radiologists and radiographers.

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“…Das zusammengenommen kann die diagnostische Wertigkeit der MRT verbessern, birgt aber möglicherweise neue, andere oder größere Gefahren für die Patienten. Eine Zusammenfassung von bei der FDA gemeldeten Zwischenfällen in der MRT umfasste 1548 Berichte über einen Zeitraum von 10 Jahren (2008-2017) [3].…”

Section: Risiken Der Mrt Und Kontraindikationenunclassified

Statement of the German Roentgen Society, German Society of Neuroradiology, and Society of German-speaking Pediatric Radiologists on Requirements for the Performance and Reporting of MR Imaging Examinations Outside of Radiology

Hunold¹,

Bucher

Sandstede³

et al. 2021

Rofo

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Background Magnetic Resonance Imaging (MRI) is a very innovative, but at the same time complex and technically demanding diagnostic method in radiology. It plays an increasing role in high-quality and efficient patient management. Quality assurance in MRI is of utmost importance to avoid patient risks due to errors before and during the examination and when reporting the results. Therefore, MRI requires higher physician qualification and expertise than any other diagnostic imaging technique in medicine. This holds true for indication, performance of the examination itself, and in particular for image evaluation and writing of the report. In Germany, the radiologist is the only specialist who is systematically educated in all aspects of MRI during medical specialty training and who must document a specified, high number of examinations during this training. However, also non-radiologist physicians are increasingly endeavoring to conduct and bill MRI examinations on their own. Method In this position statement, the following aspects of quality assurance for MRI examinations and billing by radiologists and non-radiologist physician specialists are examined scientifically: Requirements for specialist physician training, MRI risks and contraindications, radiation protection in the case of non-ionizing radiation, application of MR contrast agents, requirements regarding image quality, significance of image artifacts and incidental findings, image evaluation and reporting, interdisciplinary communication and multiple-eyes principle, and impact on healthcare system costs. Conclusion The German Roentgen Society, German Society of Neuroradiology, and Society of German-speaking Pediatric Radiologists are critical with regard to MRI performance by non-radiologists in the interest of quality standards, patient welfare, and healthcare payers. The 24-month additional qualification in MRI as defined by the physician specialization regulations (Weiterbildungsordnung) through the German state medical associations (Landesärztekammern) is the only competence-based and quality-assured training program for board-certified specialist physicians outside radiology. This has to be required as the minimum standard for performance and reporting of MRI exams. Exclusively unstructured MRI training outside the physician specialization regulations has to be strictly rejected for reasons of patient safety. The performance and reporting of MRI examinations must be reserved for adequately trained and continuously educated specialist physicians. Key Points: Citation Format

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MRI‐related FDA adverse event reports: A 10‐yr review

Cited by 72 publications

References 20 publications

Subjectively Reported Effects Experienced in an Actively Shielded 7T MRI: A Large‐Scale Study

Subjectively Reported Effects Experienced in an Actively Shielded 7T MRI: A Large‐Scale Study

Magnetic resonance imaging incidents are severely underreported: a finding in a multicentre interview survey

Statement of the German Roentgen Society, German Society of Neuroradiology, and Society of German-speaking Pediatric Radiologists on Requirements for the Performance and Reporting of MR Imaging Examinations Outside of Radiology

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