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

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.

Swedish national survey on MR safety compared with CT: a false sense of security?

OBJECTIVES: The objectives were to survey MR safety incidents in Sweden during a 12-month period, to assess severity scores, and to evaluate the confidence of MR personnel in incident-reporting mechanisms. METHOD: Data were collected within a web-based questionnaire on safety in clinical MR environments with CT for comparison. Data reported MR and CT safety incidents (human injury, material damage, and close calls), incident severity, and confidence of participants in incident-reporting systems. RESULTS: The study population consisted of 529 eligible participants. Participants reported 200 MR and 156 CT safety incidents. Among MR incidents, 16% were given the highest potential severity score. More MR workers (73%) than CT workers (50%) were confident in being aware of any incident occurring at their workplace. However, 69% MR workers (83% for CT) were not aware of reported incidents at their hospitals. CONCLUSION: Safety incidents resulting in human injury, material damage, and close calls in clinical MR environments do occur. According to national risk assessment recommendations, risk level is high. Results indicated that MR personnel tend to a false sense of security, as a high proportion of staff members were sure that they would have been aware of any incident occurring in their own department, while in reality, incidents did occur without their knowledge. We conclude that false sense of security exists for MR. KEY POINTS: • Safety incidents in clinical MR environments still result in human injury and material damage. • Severity level of MR incidents-assessed using Swedish national risk assessment recommendations-is high. • Confidence of MR personnel in incident-reporting mechanisms is high, but reflects a false sense of security, as a high proportion of staff is unaware of reported incidents in the same workplace.

Guidelines for documentation and consent for nonclinical, nonresearch MRI in human subjects.

Magnetic resonance imaging (MRI) of human subjects is widely performed for clinical and research purposes. Clinical MRI requires a physician order, while research MRI typically requires an approved protocol from a local Institutional Review Board, as well as informed consent. However, there are several circumstances in which it is appropriate to perform MRI in human subjects, that constitute neither clinical nor research activities. Examples include clinical protocol development, training and teaching, and quality assurance testing. We refer to such activities as nonclinical, nonresearch MRI. The purpose of this document is to provide principles and guidelines for appropriate and safe use of MRI in human subjects for nonclinical, nonresearch purposes. LEVEL OF EVIDENCE: 1 J. Magn. Reson. Imaging 2017;45:36-41.

MR system operator: recommended minimum requirements for performing MRI in human subjects in a research setting.

This article is intended to provide guidelines for the minimum level of safety and operational knowledge that an MR system operator should exhibit in order to safely perform an MR procedure in a human subject in a research setting. This article represents the position of the International Society for Magnetic Resonance in Medicine (ISMRM) regarding this important topic and was developed by members of this society's MR Safety Committee.