This document is aimed at facilitating the implementation of a suitable organizational structure for ensuring Magnetic Resonance (MR) safety in and around MR imaging systems, suites, and their environment. These recommendations are applicable to both clinical and research MR settings. They represent the consensus of: the European Federation of Organisations in Medical Physics (EFOMP), the European Federation of Radiographer Societies (EFRS), the European Society for Magnetic Resonance in Medicine and Biology (ESMRMB), the European Society of Radiology (ESR), the International Society for Magnetic Resonance in Medicine (ISMRM), the Society for Magnetic Resonance Technologists (SMRT), the American Board of Magnetic Resonance Safety (ABMRS), and the Society for Cardiovascular Magnetic Resonance (SCMR).
The legal responsibility for MR safety may reside with an individual or with an institution. Operational responsibility may be delegated, however legal responsibility cannot. Within this document it will be assumed that ultimate operational responsibility lies with a single individual, herein referred to as the MR Medical Director (MRMD) or MR Research Director (MRRD), who may also be legally responsible. Their credentials, background, and training/education, may in some cases be defined by local or national laws, guidance, or institutional regulations. It is expected that a physician/radiologist acts as the MRMD/MRRD for the situation in which the entire MR examination is being directed by patient care concerns in a clinical setting.
Operational responsibility may also be delegated to other individuals to ensure that, in practice; the requirements for MR safety are in force and carried out. In particular this concerns the roles of an MR Safety Officer (MRSO), and an MR Safety Expert (MRSE). In the following it is assumed that the MRMD/MRRD and MRSO are of the organization conducting the scanning, whereas the MRSE may be external. If the MRSE is external then their role is advisory. If they are of the organisation, then the MRMD/MRRD may delegate technical (but not clinical) responsibility to them, in which case the MRSO may then report to the MRSE in the first instance, although ultimate responsibility will still reside with the MRMD/MRRD. In some countries the MRSE may have a legally defined operational role, in which case there will generally be a transfer of some (legal) responsibilities from the MRSO and/or the MRMD/MRRD to the MRSE.
The information in the next three sections lists the recommended responsibilities for management of MR safety for each of these three positions, whereby it should be noted that legal and statutory requirements may vary between nations and settings.
The MRMD/MRRD shall ensure the following:
- That the MRMD/MRRD oversees, either in person or via delegation to another appropriately licensed and/or qualified individual, the safe execution of the MR examination on each and every patient/human subject examined in the MR system(s) or MR site(s) under his/her jurisdiction at all times and without exception. One MRMD/MRRD may preside over more than one MR system.
- That the MRMD/MRRD and/or the responsible radiologist/physician (in the case of clinical patients) shall be available/accessible to the operators of the MR system at all times during which the MR facility is accessible.
- That at least one MRSE is identified who can advise, on an as-needed basis, regarding all matters and issues relating to MR safety.
- That at least one MRSO is designated and available/responsible for each MR system. One MRSO may be designated to be responsible for the proper execution of MR safety practices at one or more MR systems.
- That MR-specific policies and procedures pertaining to the safe operation of MR services are up-to-date, and are appropriate to the patient/research subject population(s), clinical/research applications, and MR equipment in use.
- That appropriate MR safety and quality assurance programs are implemented.
- That an appropriate system for record keeping and analysis of adverse events is implemented with the involvement of the MRSO and, if/as needed, the MRSE.
- That appropriate ongoing risk assessment is conducted for the MR facility.
- That an appropriate investigation (for example a root cause analysis) is performed for each reported MR safety adverse event for each site for whose safety the MRMD/MRRD is responsible and that records are kept of these analyses.
The role of MRSO is often carried out by the senior Radiographer , but other suitably trained individuals could also fill this role. Multiple MRSOs could be appointed, provided only one is in charge at a given time. His/her responsibilities include the following.
- To be readily accessible and available (e.g., to the operators of the MR system) at all times that the MR facility is accessible.
- Ensuring that proper policies and procedures for day-to-day MR safety are enforced .
- Developing, documenting, and introducing, in conjunction with and under the authority of the MRMD/MRRD, safe working procedures for the MR environment.
- Ensuring that adequate written safety procedures, work instructions, emergency procedures and operating instructions are issued to all concerned after full consultation with the MRMD/MRRD (and, if/as needed, the MRSE).
- Ensuring that appropriate measures for minimizing risks to health that arise from the use of or exposure to the MR equipment, as per the direction of the MRMD/MRRD, are implemented and monitored.
- Managing hazards posed by the MR equipment, and monitoring the measures taken to protect against such hazards.
- Ensuring that all Heads of Departments and senior medical staff members who are responsible for personnel who will be involved with the MR system are informed of the formal procedures for training and authorization.
- Ensuring that medical, technical, nursing and all other relevant staff groups (including ancillary workers) who may be exposed to the MR environment are educated appropriately on a regular basis as to the safety requirements and updated as necessary.
- Maintaining records of the personnel who have been educated appropriately as to the safety requirements.
- Consulting the MRMD/MRRD (and/or the MRSE) when further advice is required regarding MR safety.
- Reporting back to the MRMD/MRRD in a timely fashion any and all MR safety-related issues.
- Ensuring that there is a clear policy for the purchasing, testing, and marking of all equipment that will be taken into the MR-related critical areas.
- Providing and/or ensuring the provision of MR safety education and training in cooperation with, and as per the policies of, the MRMD/MRRD.
- Providing safety advice regarding the selection, procurement, and installation of MR-related equipment (in consultation with the MRSE, if/as needed).
- Providing safety advice on the modification of MR protocols (in consultation with the MRSE, if/as needed).
- Maintaining regular contact with other relevant groups or committees responsible for the safety and welfare of personnel on site, such as, but not limited to, the local ethics committee and the local safety committee.
This position is expected to serve as a resource for the MRMD/MRRD and/or MRSO. The MRSE is often an MR Physicist, but others with suitable technical MR expertise could also fill this role. The MRSE would not normally have a medical education and training and, hence, would neither be expected nor required to have any expertise regarding the safety of prescription medications or other non-MR medical procedures, such as the use of anesthetics, contrast agents, sedatives/anxiolytics, etc. It is understood that there may not be a sufficient number of individuals with the necessary qualifications to provide for the physical presence of an MRSE at each MR facility, and it may also not be necessary to have an MRSE at each site. Thus, the requirement herein is for ready access to the services and advisory assistance of an MRSE on an as-needed basis.
The MRSE roles include, but are not limited to, the following.
- Provide high level advice on the engineering, scientific, and administrative aspects of the safe use of MR equipment.
- Provide advice on the development and continuing evaluation of a safety framework for the MR environment.
- Provide advice for the development of local rules and procedures to ensure the safe use of MR equipment.
- Provide safety (including diagnostic effectiveness linked to safety) advice on the modification of MR protocols.
- Provide safety (including diagnostic effectiveness linked to safety) advice regarding non-routine MR procedures for individual subjects and specific subjects groups. This includes advice regarding safety related to implanted devices, metallic foreign bodies, tattoos and other similar issues.
- Provide advice on the choice of MR Safety programs and MR Quality Assurance programs, and evaluations and audits thereof.
- Provide safety advice regarding the selection, procurement, and installation of the MR system and related equipment, as well as on the quality control programs regarding their performance.
- Provide safety advice regarding acceptance testing and, prior to the first clinical or human research use of the MR equipment, provide advice regarding performance testing procedures and testing following any major maintenance procedure.
- Establish and maintain links with any appropriate district, regional and/or professional bodies.
- Report back to the MRMD/MRRD any MR safety-related issue(s)