The Management of MR Scanner Safety in the SPMMRC
This document attempts to formalize the various scanner safety arrangements present in the MR Centre and to bring them more into line with the requirements of “Guidelines for Magnetic Resonance Diagnostic Equipment in Clinical Use” (MDA MRI Guidelines Draft April 2002). Nomenclature in bold type generally follows that of the MDA document and definitions are provided here.
1. Organizational Responsibilities :
The Head of School bears ultimate responsibility for all safety matters in the School and is assisted in this respect by the School Safety Officer. The Head of School delegates day-to-day responsibility [1] for MR Safety in the SPMMRC to a specified Responsible Person . The Responsible Person consults with MR Advisors , who are conversant with MR safety issues and in contact with safety committees and relevant professional bodies. Access to a Controlled Area is given only to an Authorized Person (SPMMRC and External staff with access to scanners). There must be a list of Authorized Persons together with details of their training and certification available to the Responsible Person . Unauthorized Persons , including carers escorting patients and the general public, must be accompanied by an Authorized Person , who is responsible for them whilst in the controlled area, must be Screened and have authority to enter the Controlled Area .
2. Definitions
2.1 Responsible Person Prof. P. G. Morris
Duties: To ensure adequate written safety procedures, ethical approvals, work instructions, emergency procedures etc are issued to all concerned after consultation with the MR Advisors and Authorized Persons .
2.2 MR Advisors : Link to List of People
Duties: Advise on safety aspects of clinical and scientific use of MR scanners with reference to safety committees, local ethics committee, NRPB and other professional bodies. To generate training materials, consent forms, questionnaires, safety record sheets etc for approval by the Responsible Person and the local ethics committee.
2.3 Authorized Persons :
SPMMRC and certain External Users with access to the machines.Duties: Day to day running and maintenance of the machines. Responsible for the safety of unauthorized persons in the Controlled Area.
Training: To join the certified list of Authorized Personnel it will be necessary to read and understand the MR Centre safety training materials and to pass a written test covering MR safety and record keeping. Annual Medical Assessment by registered medical practitioner may be required (MDA). External Users will be required to pass the written test each time a Magnet Hall Access Permit is issued (6 monthly max).
2.4 Scanner Operator :
An Authorized Person deemed sufficiently experienced and responsible to operate the scanner, having passed an additional test on MR safety and record keeping. Additions to the Scanner Operators list can only be made by an MR Advisor or the Responsible Person .
2.5 Experimenter :
An Authorized and Scanner Operator operating the scanner machine
Duties: To ensure all formalities are correctly completed and filed before a study is started.
2.6 Unauthorized Persons :
Carers and the general public
Duties: To remain under the control of an Authorized Person at all times in a Controlled Area .
Training: Screening by an Authorized Person
2.7 Controlled Area :
Anywhere within the 5 Gauss line, generally inside the key-coded magnet hall doors.
2.8 Screening :
Not to be confused with medical assessment, screening takes the form of verbal questioning, a written questionnaire and information about hazards signed by the individual and countersigned by the Authorized Person before entry to the Controlled Area is granted.
2.9 Medical Assessment
May be required (MDA) for Authorized Personnel (annually) and Volunteers. Performed by a registered medical practitioner.
2.10 External Users
Non SPMMRC research or clinical staff needing to be Authorized Persons .
3 Relevant Forms and information sheets
3.1 Volunteers/Patients: under the control of an Experimenter
3.1.1 Volunteer Information Sheet
Study-specific information describing the imaging technique, what is being investigated and why, what is involved for the volunteer and what are the risks.
3.1.2 SPMMRC Volunteer Safety Questionnaire
A set of specific questions with yes/no answers designed to ascertain whether there are any contra-indications for MRI. The form must be completed, verified and signed by an Authorized Person before scanning.
3.1.2 Consent Form
A study-specific form giving the project title and list of investigators followed by a list of what the patient/volunteer is consenting to. Should include a statement that the patient/volunteer may withdraw from the study at any time. Must be signed by the volunteer and counter-signed by the Experimenter.
3.2 Experimenters
3.2.1 Ethical approvals
Copies of the Ethics Committee Approvals and Sub-Approvals are held by the receptionist.
Detailed requirements are given in the annex attached.
3.2.2 Risk Assessments
No human experiment may be undertaken without a written risk assessment. Assessments are available per project and it is the Experimenters responsibility to ensure that the requirements of the risk assessment are fully complied with.
3.2.3 Scanner Safety Record Sheets
The relevant safety record sheet must be completed and filed in the 0.5T/3.0 T control room for each human subject. In it the Experimenter records details of the experiment and exposure times along with a check-list of other forms to be completed before the study commences.
3.2.4 Study Record Sheet
Records detailed study-specific information about machine set-up, number of scans etc. completed by the Experimenter.
3.3 Responsible Person/ MR Advisors:
3.3.1 Authorized Persons List
3.3.2 Scanner Operators List
3.3.3 Authorized Persons Test
3.4 External Workers/Contractors
3.4.1 Magnet Hall Access Permit
External workers including contractors and visiting scientists/clinicians are required to carry an up-to-date access permit signed by an Authorized Person after suitable training/instruction has been given. Validity may be not more than 5 days for contractors and not more than 6 months for External Users after they have passed the written Authorized Person test.
4 Available Training Material
4.1 Access to magnet halls instructions –
4.2 Visiting scientists instructions –
4.3 Cryogenics safety –
4.4 Risk Assessments –
4.5 Solitary working instructions – on-line (MR Centre access)
4.6 Sample forms available (attached)
4.7 The management of MR Scanner safety in the MR Centre (this document)
5 Data Protection Act
All data is kept in conformance with the data protection act, in the reception area and the records store room.
Update Log:
Updated March 2006
Updated March 2010 (changed 'competant person' to 'scanner operator')
