Incident Learning, Governance, Quality and Jurisdictions in MR Safety — What the Surveys Show, What Each Framework Requires of Reporting, Roles and Training, and Where the Documents Differ

Incident Learning, Governance, Quality and Jurisdictions in MR Safety — What the Surveys Show, What Each Framework Requires of Reporting, Roles and Training, and Where the Documents Differ

MRIninja Knowledge Base | Child Page — MRI Safety (deep dive S13) Version 1.0 — October 2026

Parent page: MRI Safety — Master Page (governance and personnel in Section 5; occupational exposure in Section 8.3). Builds on: MR Site Zones and Access Control (responsibility for access policy) · Projectile and Torque Hazards in the Static Field (incident evidence on projectiles) · Claustrophobia, Sedation, Monitoring, Equipment and Emergencies (emergencies) · Cryogens, Quench and Oxygen Depletion in MRI (quench)

1. Scope, Status and Boundaries

This page is the last of the deep dives under the MRI Safety master. It gathers what the sources read state on four questions: what is known about the frequency and the under-reporting of MR safety incidents; what is reported, to whom and when under the frameworks that could be read; which roles, training and audit the frameworks describe beyond the ACR and MHRA role comparison already held in MRI Safety — Master Page; and where the frameworks differ. The roles of the ACR and the MHRA (MR Medical Director, MR Safety Officer, MR Safety Expert, MR Responsible Person and others) are not repeated; the comparison of the ACR and MHRA positions is in MRI Safety — Master Page (Section 5), and Directive 2013/35/EU (Article 10 and its conditions for MRI) is in MRI Safety — Master Page (Section 8.3).

Reading status. The page rests on the full text of the 2017 RANZCR guideline (through a summarising tool of a PDF copy), a review tool that restates the Joint Commission Sentinel Event Alert #38 and the 2013 ACR guidance, the web pages of the US FDA (device reporting), the UK HSE (exemption for MRI), the NHS (reporting to the MHRA) and Health Canada (archived Safety Code 26), a poster of a UK professional society, two European surveys (abstracts), one Swedish national survey (abstract and text) and one analysis of US adverse-event reports. The regulations themselves (21 CFR 803, the UK Control of Electromagnetic Fields at Work Regulations 2016, national laws transposing Directive 2013/35/EU), the MHRA guideline chapters on reporting and training, the ACR Manual on MR Safety, the 2021 (third) version of the RANZCR guideline, the legislation or guidance of Japan, Germany, France, Italy and other countries, and the content of the four-tier European training curriculum were not read. No incident database with denominators, no study of the effect of a reporting system on harm, and no audit study of MR safety programmes were found.

What this page does not do. It is not a legal analysis and does not say what the law of any country requires; a unit applies the law and the guidance that bind it. No jurisdiction is treated as the default. Statements that are the page’s own inference are marked Reasoning; where a source needed to complete a statement was not found they are marked (to be sourced).

2. Sources Read and What They State

Table 1. Documents used, what they were used for and how they were read.

3. What the Incident Evidence Shows

A Swedish national web survey covering 12 months collected reports from 529 eligible participants of 200 MR safety incidents and 156 CT safety incidents (human injury, material damage and close calls); 16% of the MR incidents received the highest potential severity score, and the authors concluded that incidents occur in clinical MR environments and that the assessed risk level is high [8]. A European survey distributed through ESR member societies in 2023 received 793 responses from 44 countries: 77% said their institution had a clear MR safety guideline, 52% said nobody there had received specific MR safety training, about 12% reported MR-related accidents causing injury to patients or personnel, MR Conditional cardiac devices were scanned at 75% of respondents’ university hospitals and 42% of outpatient facilities, and MR Unsafe cardiac devices were scanned off-label at 27% of university hospitals [9]. The analysis of US adverse-event reports is a set of spontaneous voluntary reports without a denominator [11]; its narratives on projectiles are on Projectile and Torque Hazards in the Static Field. Figure 1 shows some of the percentages.

Figure 1 — Selected self-reported results of two surveys (not comparable with each other)

Reasoning. None of these sources gives a rate of incidents per examination, a rate by type of incident, or a trend over time. The two surveys differ in country, year, respondents and wording, so their percentages cannot be compared or combined; each respondent counted incidents or accidents by its own definition (the definitions were not retrieved). The sources support the statements that incidents with injury and with high potential severity are reported by respondents in two settings, and that reported training and guidelines were incomplete in the European sample; they do not support an estimate of how frequent incidents are.

4. Under-Reporting and Confidence in Reporting

In the Swedish survey, 73% of MR workers (50% of CT workers) were confident they would be aware of any incident at their workplace, yet 69% of MR workers (83% of CT workers) were not aware of reported incidents at their hospitals; the authors describe a false sense of security [8]. A poster of a UK professional society states that MR incidents are widely under-reported across Europe, citing a multicentre interview survey and a three-year review of a UK independent-sector provider; the poster gives no figures and the two cited studies were not read [5]. The US adverse-event analysis is limited by voluntary reporting and gives no estimate of under-reporting [11].

Reasoning. The Swedish figures are a measure of what staff believe about their reporting system and not of how many incidents go unreported: they show that many respondents did not know of incidents that had been reported at their own hospitals, which suggests that learning from reports was not reaching them. The sources read do not state the proportion of incidents that are reported, and none evaluates a reporting system by its effect on later incidents (to be sourced).

5. What Is Reported, to Whom and When

The documents read name different recipients and different deadlines. They are of different kinds (a regulator’s requirement, a guidance page for adopters, a professional guideline), so the table gives each in the terms of its source and does not equate them.

Table 2. Reporting of MR-related incidents, by source.

Reasoning. The sources do not say, for any of these systems, which MR incidents fall within a legal reporting duty: the FDA page defines the duty for “device-related” deaths and serious injuries without saying how an MR accident such as a projectile or a burn is classified, and the NHS page gives criteria that require suspicion of the device as a contributory cause. A unit should establish with its regulator and its manufacturer how each type of incident is classified (to be sourced). The existence of an internal reporting system is stated by the Australian and New Zealand guideline; the other sources read describe external routes and do not state whether an internal system must exist.

6. Roles, Training and Screening Beyond the ACR and MHRA Comparison

The 2017 RANZCR guideline states that responsibility for the safe operation of the MRI site must be explicitly assigned to a nominated medical practitioner (the Responsible Person, the MRI Medical Director), that an MRI Safety Officer handles day-to-day implementation and need not be a medical practitioner, that an MRI Safety Expert, often from another practice, provides third-party advice and audits, and that a safety committee is optional for larger sites [1]. It describes three levels of training (Level I: controlled-area rules, hearing protection, emergencies, quench procedures and magnet screening; Level II: electrical, static, gradient and RF safety, exposure limits, cryogens and implant conditions; Level III: bio-effects and contrast agent risks), states that junior personnel need Level I and senior personnel Levels I and II, and that all training must be documented with at least an annual refresher [1]. It recommends three safety screenings, of which at least two on site (at booking, on arrival and immediately before the scan), reviewed with the patient by a senior staff member who initials the checklist, with annual screening of MRI staff [1].

The review tool of the Joint Commission alert lists as objectives that all MR personnel receive safety education at least annually, that non-emergent patients are screened twice by trained personnel, that a safety officer is appointed, and that written MR safety policies are kept and their compliance reviewed periodically [2]. The European survey proposes a four-tier curriculum for MR safety training; its content was not read [9]. Health Canada’s archived Safety Code 26 contains no content on safety management [7].

Reasoning. The frameworks agree on a named accountable function, annual training and repeated screening, and differ on the qualification of the accountable person, on the number of screenings and on how training is graded. The sources give no evidence that any of these arrangements reduces incidents; the guidance is consensus without stated evidence grading, and the European survey reports that in its sample 52% had no specific training [9]. The responsibility for access policy is on MR Site Zones and Access Control (Section 12.3).

7. Occupational Exposure Rules

The conditions of Directive 2013/35/EU for MRI are in MRI Safety — Master Page (Section 8.3). The UK Health and Safety Executive page states that the exemption from the exposure limits of the Control of Electromagnetic Fields at Work Regulations covers work with MRI equipment for patients in the health sector, including development, testing, installation, use, maintenance and related research, on condition that exposure is kept as low as reasonably practicable and employees are protected against the related health effects and safety risks; employers must comply with all other requirements except the action plan, and MRI not used for patients in the health sector falls outside the exemption [6]. The archived Canadian Safety Code 26 stated that operators should not be continuously exposed to more than 0.01 T during the working day, with higher levels allowed for about 10 minutes per hour; it described its levels as not strict limits, and Health Canada archived it as no longer reflecting current MRI technologies [7].

Reasoning. The exemption described by the HSE is conditional on a duty to reduce exposure, not an absence of duty, and its condition is stated in general terms; the sources read do not give a numerical limit for staff in either the HSE page or the Directive summary held on MRI Safety — Master Page. The Canadian values are those of an archived guideline and should not be read as a current limit. National laws transposing the Directive, and the rules of countries outside the United Kingdom and Canada, were not read (to be sourced).

8. Quality Assurance and Audit

The RANZCR guideline states that the safe practice manual is reviewed at least annually and after hardware or major software changes, that periodic quality assurance and screening audits are required, that records are reviewed annually and that maintenance records should comply with accreditation standards [1]. The review tool lists periodic review of compliance with written policies [2]. A European survey on MRI quality assurance and quality control (269 responses from 37 countries, 2024) found that only a few countries mandate national QA/QC legislation, that many rely on voluntary guidelines or lack formal protocols, and that respondents agreed on the need for harmonised guidelines; it concerns image and system quality rather than safety incidents [10].

Reasoning. The documents read describe audit as a periodic review of policy, screening records and maintenance; they do not give an audit method, an indicator, or a standard against which an audit is scored, and none reports an audit result (to be sourced). The survey of quality assurance shows heterogeneity, not an association with safety outcomes.

9. The Frameworks Side by Side

No framework is treated as the default. Each cell states what the source read says; “not read” means the source exists but was not available in the text used.

Table 3. Frameworks side by side (as read).

Reasoning. The rows are not equivalent in weight: two are professional guidelines, one is a regulator’s requirement for device events, and one is an archived guideline. Japan, Germany, France, Italy and most other countries are absent because their rules were not read; the European survey states only that respondents from five countries said MR safety was mandated by law, of which two could be confirmed [9].

10. Where the Documents Differ and Open Questions

Table 4. Differences and unresolved questions.

11. Practice: the Arrangements the Sources Support

Reasoning. The following arrangements are the page’s synthesis of statements in the sources and are not a recommendation of any one source, and a unit applies the law and the guidance that bind it. (1) Name the accountable person and the day-to-day safety officer in writing, and record who provides independent advice [1][2]. (2) Keep written policies with a periodic review and an audit of screening and training records [1][2]. (3) Document training and repeat it at least annually for staff who enter the controlled areas [1][2]. (4) Establish an internal reporting system that includes near misses and gives feedback to staff, because the Swedish survey found that most MR workers did not know of incidents reported at their own hospital [8]. (5) Establish with the regulator and the manufacturer which incidents must be notified externally and by when, and keep the notification separate from the internal report [3][4]. (6) Record the legal basis of the unit’s occupational exposure arrangement (see MRI Safety — Master Page, Section 8.3, and the HSE page for the UK) [6]. (7) Review incident reports for root causes at a committee or an equivalent forum where the site is large enough [1].

12. Limits of the Evidence and What Was Not Read

The evidence on frequency is two self-reported surveys and a set of voluntary reports; the evidence on governance is consensus guidance and regulators’ web pages. No source read gives an incident rate with a denominator, quantifies under-reporting, evaluates the effect of a reporting system, a safety officer, a training programme or an audit on incidents, or reports audit results. The regulations, the MHRA chapters on reporting and training, the ACR Manual, the 2021 version of the RANZCR guideline, the content of the European four-tier curriculum and the rules of most countries were not read, so the page cannot say what is currently required in any country. The 2017 RANZCR text may differ from the 2021 version. All statements are those of the documents as returned by summarising tools and were not checked page by page.

13. Topics Not Covered

National legislation and its transposition of Directive 2013/35/EU; the legal text of any reporting duty; the rules of Japan, Germany, France, Italy and other countries; accreditation schemes and their requirements; root-cause analysis methods and the content of an incident form; just culture and legal protection of reporters; contrast-agent reaction treatment and its governance (not covered on the contrast page either, because the ACR Manual on Contrast Media could not be read); research-volunteer governance; MR-guided radiotherapy and interventional suites; and insurance and liability.

14. Evidence-Based References

No systematic review, no incident database with denominators and no evaluation of a reporting or governance system was read; the sections below follow the hierarchy of the sources actually read, and the guidance documents rest on consensus without stated evidence grading.

A. Guidelines, Regulators’ Pages and Guidance

B. Surveys and Analysis of Reports

C. Professional-Society Poster

End of document — Incident Learning, Governance, Quality and Jurisdictions (S13) — MRIninja v1.0 — October 2026. Parent: MRI Safety master.