CUBRIC MR Laboratories Procedures Document

Transcription

1 CUBRIC MR Laboratories Procedures Document Date 01 Oct 2017 Version 14 Document Version History: 16/11/05. Version 1 Drafted. 5/1/06, Changes made at the request of Peter Watkins from UMAL. 22/3/06, Changes made following a meeting with Mike Sobanski from OSHE. 09/04/06, Changes made by Derek Jones. 10/04/06, Changes made following meeting between Derek Jones, Krish Singh and Peter Halligan. 04/07/06 Changes made following review by Ethics Committee, School of Psychology. 17/08/06 Reviewed and verified against current standards by Mike Sobanski from OSHE 24/11/06 Changes made following discussion with Mike Sobanski from OSHE 15/08/15 CUBRIC 2; Complete revision and review by Peter Hobden, John Evans 20/09/17 Changes and updates made with Sonya Foley, John Evans, Peter Hobden 1

2 DOCUMENT CONTENTS INTRODUCTION BACKGROUND MR Safety 1. MR Controlled Areas 2. Personnel and Responsibilities 3. MR Safety 4. MR Accidents, Incidents, Near-misses 5. MR Safety Procedures, Policies & Guidelines 6. Incidental Findings 7. MR Emergency Procedures 8. MR Faults 9. MR Record-keeping 10. MR Maintenance & Testing APPENDICES Appendix 1: CUBRIC SIEMENS MAGNETOM PRISMA EAST, 3TE, Controlled Areas Appendix 2: CUBRIC SIEMENS MAGNETOM PRISMA WEST, 3TW, Controlled Areas Appendix 3: SIEMENS MAGNETOM 7T, 7T, Controlled Areas Appendix 4: SIEMENS 3T CONNECTOM 'MICROSTRUCTURE' 3TM, Controlled Areas Appendix 5: MR PERSONNEL DEFINITIONS Appendix 6: MR SAFETY-SCREENING Appendix 7: MR EMERGENCY PROCEDURES Appendix 8: SOPs and POLICIES Appendix 9: KEY CONTACTS DEFINITIONS REFERENCES 2

3 INTRODUCTION MR Facilities Covered by this Document: CUBRIC (School of Psychology) Maindy Road, Cardiff CF24 4HQ MR Equipment Covered by this Document: 3TW: "3T West" - Siemens Prisma 3 Tesla MRI Scanner CE-marked Medical Device 3TE: "3T East" - Siemens Prisma 3 Tesla MRI Scanner CE-marked Medical Device 3TM: "3T Microstructure" - Siemens CONNECTOM 3 Tesla MRI Scanner 7T - Siemens MAGNETOM 7 Tesla MRI Scanner *7T and 3TM are currently classified as Investigational Devices Document Purpose: 1. To prevent the risk of injury or harm at all times to all users and visitors of CUBRIC: CUBRIC Participants & Patients, Cardiff University staff, Cardiff University researchers, accompanying carers and relatives, University students, MR manufacturer employees, contractors and outsourced workers, as well as visiting members of the general public. 2. To prevent damage to the sensitive and expensive equipment sited within CUBRIC. 3. To provide a route map to MR standard operating procedures (SOPs), Risk Assessments, and all relevant Cardiff University Policies, Working Practices, UK Legislation, for all MR-related work, training, and all other activity in respect of the CUBRIC MR Suites located within CUBRIC. This document has been prepared after consultation of the latest and up to date MR safety guidelines, legislation and MR company guidelines. The most important and relevant documents referred to in preparing these policies have been: 1. American College of Radiology Guidance Document on MR Safe Practices 2013 Journal of Magnetic Resonance Imaging 37: (2013) 2. The Rules and Procedure document previously prepared by the Prof. KD Singh 3. Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices. US Food and Drug Administration (FDA). July 14, International Electro Technical Commission (IEC) 5. Relevant EU Directives and UK HSE/HPS/MHRA legislation documentations 6. MRI, Bio effects, Safety and Patient Management, Shellock Siemens Healthcare manufacturer documentation and MR user manuals 8. Cardiff University OSHEU CUBRIC Building Purpose: The primary role of CUBRIC is to provide world-class human research MR data for staff, researchers, collaborators and students, of Cardiff University. The majority of MR scans are performed on consenting volunteer Participants. However, clinical diagnostic Patient MR is also performed at this site. In this document, Participants refers to any volunteer consenting for an authorised and ethically-approved research study at CUBRIC. Patient refers to a consenting patient undergoing clinically diagnostic Medical Device MR imaging at CUBRIC. 3

4 Background - MR Safety MRI scanners create three types of electromagnetic fields in order to produce an image. Each of these fields has associated hazards; A strong, static magnetic field (B0) generated by a large superconducting magnet Time-varying magnetic field gradients (db/dt) Radio frequency (RF) fields Because of the generation of the fields by the MR scanner, the following hazards also need to be considered; Quench (The loss of helium and failure of the superconducting magnet) Acoustic Noise Electrical Safety To manage the hazards associated with the MR environment, it is required that MR Personnel follow a defined set of procedures to ensure that the environment is safe for themselves, their co-workers, Participants, Patients, and other non-mr personnel. The operation of the MR suites and scanners are therefore governed by the following general principles 1. Controlled Access to MR Areas. Access to MR areas is restricted according to an individual's personnel category (see below). Non-MR Personnel may only access these areas having been safety screened by the appropriate MR Personnel. (see relevant MR Safety-screening SOP). 2. MR Personnel Categories. Individuals are classed as either Non-MR Personnel, MR Personnel, or MR Operator Personnel, depending on their approved level of training. 3. Controlled Output of the MR system. The MR system can operate in three distinct 'modes', governed by the International Electro-technical Commission (IEC; (2015)), 'Normal Mode', 'First Level Mode' and 'Second Level Mode'. Operation of the MR scanner in higher modes is associated with an increased risk of physiological stress to the Participant/Patient. Static Magnetic Fields (B0) MR systems in CUBRIC which have static magnetic fields (B0) of 3 Tesla are: 3TW, 3TE, 3TM. The 7T MR system has a static field of 7 Tesla. The highest static fields are present at the centre of the magnet (isocentre). B0 diminishes accordingly at a given distance away from the scanner. Under normal circumstances, the superconducting magnet is permanently energised, therefore the static magnet field is regarded as always present. Static magnetic fields pose a potential health risk to individuals with certain implanted devices, or when carrying ferromagnetic objects or accessories, by one of the following mechanisms: Some metal objects in/on the body can experience a torque (twisting force) or become projectiles when placed in a static magnetic field. Injuries and fatalities have been caused as a direct result of the torque or projectile effect. Examples of objects and devices at risk from torque include (but are not limited to) certain models of aneurysm clips, certain vascular stents and clips, ferromagnetic metallic shrapnel, and ferrous metallic ocular foreign bodies. Any ferromagnetic object is a potential projectile in a field above 3mT. The presence of the magnetic field can interfere with the functioning of some devices resulting in a failure of the device upon exposure to the MRI environment. Examples of objects and devices at risk from this effect include (but are not limited to) certain models of cardiac pacemakers, cardiac defibrillators, cochlear implants or cerebrospinal fluid (CSF) shunts. This is potentially a risk for exposure to any static magnetic field greater than 0.5 mt. Access to areas with a static magnetic field of greater than 0.5 mt is restricted to ensure that no individual can inadvertently experience a static magnetic field of greater than 0.5 mt. 4

5 Time-varying Magnetic Field Gradients (db/dt): To spatially localise the MRI signal to form an image, the scanner uses a set of switched (i.e. varying in time) gradient (i.e. varying in space) magnetic fields. These magnetic fields are only present in the bore and the immediate vicinity of the scanner during scanning. The rapid gradient switching can induce electrical currents within the Participant/Patient's body, potentially causing peripheral nerve stimulation (PNS). PNS manifests itself as a tingling in the extremities or body trunk which may feel unpleasant, but is harmless to health. The probability of an individual experiencing PNS increases with both with increasing gradient amplitude and increasing switching rate. The maximum gradient coil switching rate & amplitude is set by an IEC standard (IEC ) and implemented via the MR scanner's software limits so that PNS should not occur in most Participants/Patients. However, PNS cannot be ruled out in all cases. Likelihood of PNS is higher at First Level, compared to Normal Mode. An intercom and alarm-call system must always be used so that the Participant/Patient can report any peripheral nerve sensations and the scan must be immediately stopped, if necessary. It is also vital that Participants/Patients do not form any electrical current loops with their bodies (e.g. no hand clasping or feet crossing) preventing/reducing PNS incidence and degree. Radio-frequency (RF) Power Deposition (SAR): These RF fields are pulsed during scanning to excite measurable MR signal. RF energies are generated and detected using RF coils. The frequency of the RF signals used in 3 T MR is around 128 MHz, and in 7 T MR approximately 300 MHz. RF energy is only transmitted during scanning. RF power deposition defined by the Specific Absorption Rate (SAR) into a Participant/Patient during scanning leads to tissue heating. RF fields used in MR can cause heating of tissue or conductive implants, if present. SAR is a term used to estimate the amount of RF power received by the Participant/Patient during scanning. It is expressed as watts of power per kilogram (W/kg) of the patient's body weight/part. From the power dissipated the heating effect of MRI sequences can be estimated and tightly controlled by the scanner RF control system. The RF field can also induce currents in any external metallic leads, electrodes (such as ECG leads) or other objects adjacent to body tissue, potentially causing thermal injury to the neighbouring body tissues. Therefore, electrically conducting elements, such as wires or cables, must never be looped across any part of the Participant/Patient body or in contact with their skin or MRI bore sides. In addition, the Participant/Patient skin should never be allowed to touch either the sides of the RF coil, conductors, or the bore of the scanner. Insulating padding must be used to prevent this occurrence. Participants/Patients will be given a manual alarm-call device, which when pressed, will sound an alarm and alert the operator to terminate the scanner sequence immediately. Participants/Patients should be encouraged to use this if anything untoward is felt, or if they wish to attract the attention of the MR Operator. For the SAR to be correctly calculated, it is critical to enter the Participant/Patient correct weight and height. Failure to do so will result in incorrect SAR value calculations, potentially resulting in Participant/Patient overheating. The actual amount of heat energy applied to the body is also dependent on the ambient temperature within the bore and magnet room. If the environmental conditions (temperature and/or humidity) are outside the normal operational range of operation, then scanning should be stopped and Siemens contacted. 5

6 MRI Quench: In rare circumstances, the liquid helium within the MRI scanner can boil off very rapidly as a cold gas. In some emergency situations, the MR Operator may be required to deliberately instigate an emergency quench. Although most of the helium gas is vented through a purpose built Quench Pipe, there is a risk that cold helium gas may leak into the magnet room and adjacent areas. This could potentially cause asphyxiation as the helium displaces room oxygen. Training of MR Operator Personnel includes a detailed explanation of the emergency procedures needed in the event of a spontaneous or instigated superconducting magnet quench. Oxygen monitoring systems will warn of any dangerous reduction of oxygen within the magnet room and also activate an emergency gas extraction fan function. Oxygen monitors and quench systems will be tested, serviced and replaced as required by the supplier. Participants/Patients and all other persons must be evacuated safely in the case of an oxygen alarm alert. (see CUBRIC ' MR Emergencies' SOP) Acoustic Noise: Rapid gradient switching of MR gradient coil systems may cause high levels of acoustic noise exposure (dba) during scanner gradient coil operation. It is essential therefore that all persons in the magnet room (including Participant, Patient, MR Personnel, or Patient Escorts) wear suitable hearing protection to reduce exposure levels to below 85dB(A) instantaneous exposure, in accordance with occupational and personal noise exposure levels set by UK HSE Noise Exposure Safety Directives. Participants/Patients may experience the highest noise levels (being closest to the MR gradient coils) and therefore must always wear acoustic defensive ear plugs (and/or protective headphones) at all times during MR scanning. Participants/Patients who are unable or unwilling to wear ear protection will not be scanned. An acoustic noise and magnetic field survey is performed on installation, and periodically as necessary. Electrical Safety: The MRI scanner peripheral systems, amplifiers, chillers and subsystems, are powered by a combination high voltage and high current electrical supplies. Servicing and safety of electrical systems is carried out by the respective manufacturer/supplier. 6

7 1. MR Controlled Areas Appendices 1-4 show plan diagrams of CUBRIC's Siemens 3T MRI Prisma East, Siemens 3T MRI Prisma West, Siemens 3T MRI Connectom and Siemens 7T MRI, building facilities and their respective MR Controlled Areas. The control of people and objects in and around these areas forms a principal part of the safety procedures. Building Zones and MR Controlled Area extents are coloured to indicate which building areas are within each respective Zones; Building Zone 1 (white), Building Zone 2 (green), MR Outer Controlled 3 (amber), MR Inner Controlled (red). Definition of CUBRIC Zones and MR Controlled Areas: Building Zone 1: Includes all CUBRIC building areas that are freely and safely-accessible by all persons, including the general public. Building Zone 2: The (university-controlled access) areas, interfacing between the publically-accessible Building Zone1, and the MR safety-screened MR Controlled Areas. MR Outer Controlled Area: Strictly controlled for access only by persons who have been formally and appropriately MR safety-screened to the correct clearance level prior to entry. (see CUBRIC 'MR Safety-screening' SOP) MR Inner Controlled Area: Room(s) containing an MRI scanner, plus any additional areas. This area(s) contain the highest static magnetic field strength. This area(s) is strictly controlled for access only by persons who have been formally and appropriately MR safety-screened to the correct clearance level prior to entry. (see CUBRIC 'MR Safety-screening' SOP) Magnetic and Radiofrequency (RF) Risks Associated with Respective CUBRIC Building Zones and MR Controlled Areas: Building Zone 1: No static or time-varying magnetic, or radiofrequency risks from the MR systems present. Building Zone 2: No magnetic or time-varying magnetic, or radiofrequency risks from the MR systems MR Outer Controlled Area: Magnetic field exceeds 0.5mT. Potential harmful magnetic-field device interaction risk. MR Inner Controlled Area: High (3T) or ultra-high (7T) magnetic fields present. High ferromagnetic projectile and/or torque risk hazards & high magnetic-field device interaction hazard at all times. Radiofrequency energy interactions risk hazard present. Associated risks may be present in all building Zones/MR Areas in the event of a magnet emergency or MR quench. High electrical voltage risks also present in Outer & Inner MR Controlled Areas associated with the MRI systems and sub-systems. Within MR Controlled Areas the static magnetic field strength is greater than the general public safety limit of 0.5 mt (5 Gauss), and therefore, all unscreened Personnel must be excluded from this area at all times. The MRI scanners does not, at any time, generate a static magnetic field of greater than 0.5 mt at any point outside of the MR Controlled Areas. Entry to all MR Controlled Areas requires formal documented MRI safety-screening clearance before entry is authorised by designated MR Operator Personnel. (see CUBRIC 'MR Safety Screening' SOP) 7

8 2. Personnel and Responsibilities The CUBRIC Director of MR is responsible for establishing all up-to-date MR safety guidelines, procedures, policies, Local Rules and safe working practices in all matters related to the use of MR at CUBRIC. They are also responsible for ensuring these are followed, implemented, maintained and regularly reviewed as required. Guidelines and safe working practices are implemented as local policies and procedures of work i.e. CUBRIC SOPs, Risk Assessments, Policies and Guidelines. All workers have a responsibility under UK Health and Safety legislation to ensure they act within the policies, procedures and guidelines as prescribed by their employer, professional bodies, and under UK Law. The employer (Cardiff University) is required to provide, enforce, and supply all required safety training and safety equipment appropriate to the working environment and to take all reasonably practicable measures to ensure that risk of injury or accident is brought to a practicable minimum. It is therefore imperative that all workers follow strictly the implemented guidelines, policies and procedures laid down by Cardiff University and the CUBRIC Director of MR. The consequences of not following procedures, policies or guidelines, may result in costly repairs and MRI scanner downtime, serious bodily injury or even fatality. In respect of CUBRIC MR-related personnel, the following categories are designated: Non-MR Personnel Any person who is not formally designated by the MR Safety Officer as MR Personnel. All MR Personnel are required to attend annual MR Safety Training. This category includes the general public, as well as any person who has not undertaken the CUBRIC MR safety training requirements within the previous 12 months. MR Personnel Those persons who have been formally designated as MR Personnel and have successfully completed (within the previous 12 months) training in the aspects of MR safety and practice. Their training will ensure their own safety, the safety of other Non-MR Personnel, and the basic safe use of MR-accessory equipment, as they work within and around the MR Controlled Areas. MR Operator Personnel Those persons who have been formally designated as MR Operator Personnel by the MR Safety Officer and have successfully completed (within the previous 12 months) comprehensive training in the safe use and operation of an MR system. Their training will also include safe operation of the MR systems, as well as first aid training, CPR and use of defibrillators, renewed biannually. (see CUBRIC 'MR Personnel' SOP) 8

9 3. MR Safety MR System Operating Levels Given the safety risks associated with the MR environment, a set of Operating Levels has been developed to regulate the relevant scanner outputs; static magnetic field, time-varying magnetic fields and radiofrequency fields. In these policies, we adopt the IEC definition of Operating Levels (IEC , 2015 standard) NORMAL MODE: Scanner outputs are at levels unlikely to cause physiological stress to the participant. No additional measures (above routine monitoring) are required while operating in this mode. FIRST LEVEL MODE (CONTROLLED MODE): Some scanner outputs are at levels which may cause physiological stress to the participant. Operating in this mode takes placed under the approval of the local Ethics Committee (School of Psychology, Cardiff University). Additional monitoring is required to ensure that the participant is not placed under any duress due to the scanner outputs, this could take the form of use of the alarm call ('squeeze ball'), physiological monitoring (e.g. pulse oximeter, respiratory bellows), frequent voice contact with the participant (in line with recommendations of MHRA, 2015). SECOND LEVEL MODE (RESEARCH MODE): Scanner output is restricted only to prevent harmful effects, but is more likely to cause physiological stress or discomfort to the participant. Scanning is only possible under explicit approval by the local Ethics committee, the MR safety Officer and the MR scanner vendor (Siemens). Access to Second Level Mode is restricted by the use of a vendorsupplied, time-restricted, password in accordance with the Research Agreement with the vendor. In line with the recommendations of MHRA (2015), a full risk assessment must be completed, and additional steps must be taken to minimise any potential distress to participants (e.g. scanning on phantoms only, scanning under medical supervision or other such restriction). The MR system output, as limited by the three Operating Modes are defined below (from IEC , 2015 standard); Static Magnetic Field, B 0 Switched Gradient Fields, db/dt Head SAR (W/kg) Normal Mode First Level Second Level <= 3 T < 0.8 (db/dt)threshold <= < B0 <= 4 T < 1.0(dB/dt)threshold <= 3.2 > 4 T >1.0 (db/dt)threshold > 3.2 The performance of the MR system to within the specified Operating Mode is restricted by the MR system using a combination of software and hardware limits. The 7 T System is only capable of operating in the Second Level (B0), as its static magnetic field is greater than 4T. Note that the US Food and Drug Administration (FDA) reclassified the use of static magnetic fields up to 8 T as a non-significant risk in June The Siemens 3T Magnetom Prisma MRI is classified as a Medical Device under UK Law. The Siemens 7T Magnetom, and Siemens 3T Connectom are classified under UK Law as Investigational 9

10 Devices. Participants/Patients will be encouraged to activate a call alarm if any untoward discomfort or claustrophobia is experienced. For MR studies which involve the use of sedating or anaesthetic drug administration, extra vigilance and medical officer is required as the scan subject may not be able to report any concerns to the MR scanner operator during the sedated procedure. The magnet and RF fields present in MR Controlled Areas can cause damage to personal accessories or devices (watches, bank cards, phones etc.). All Participants/Patients and MR Personnel, and all other persons entering MR Controlled Areas, must therefore store such accessories outside these areas before entering. Long Term and Occupation Exposure effects of MR For individuals without implanted devices, there are no known long-term detrimental health effects caused as a direct result of exposure to static magnetic fields (B0) at the levels present up to 8T (ICNIRP, Health Phys. 2009), higher than the maximum field present at CUBRIC. However, there may be some short-term reversible physiological and sensory non-harmful effects experienced by a minority of Participants/Patients, such as; metallic taste in the mouth, dizziness, or magnetophosphenes (perception of flashing lights). ICNIRP guidance is that individuals may be safety exposed to static magnetic fields up to 8T, provided it is in a controlled environment. The control of the environment is outlined in this Policy and associated Operating Procedures. As far as is known, static and time-varying magnetic fields (TVEMFs) associated with MRI pose no long term health risks to occupational staff, so long as the appropriate MR screening and safety procedures are followed. However, the UK Medical Devices Agency precautionary guidelines state (under precautionary principles only) that the static field exposure (averaged over any 24 hour period) should not exceed 0.2T/hour. All guidelines for workers (employees and students) exposure to the magnet fields associated with MR scanning must be complied with. Occupational exposure to db/dt can be reduced by CUBRIC MR safe working practices. Whilst MRI is conditionally excluded from legal enforcement of UK Physical Agents Directive (EMFs) limits, MRI EMF and magnetic field exposure levels must form part of a local EMF risk management strategy. Local Rules propose that no employee, worker or student shall stand within 1.0 metre of the end of the MR bore of any of the CUBRIC MR systems (Medical Devices or Investigational Devices) during magnetic gradient energising. Employees/workers/students who are concerned that they may or might exceed precautionary EMF 'Action Values' or 'Exposure Limit' guidelines must contact the MR Safety Officer. Where average B0 exposure to workers, students or Participants/Patients is likely to occur, an appropriate Risk Assessment must be carried out beforehand and specific authority sought from the MR Safety Officer/Ethics Committee before proceeding. There are no known long-term health effects caused as a direct result of exposure to radio frequency fields used in 3T (128MHz) or 7T (300MHz) MR, limited under IEC-limited Normal or Level 1 operating mode exposure levels (given that any such person exposed to such fields is not contraindicated for exposure for any other pre-existing reason e.g. presence of a contraindicated device or implant). However, RF exposure results in deposition of energy to the body in the form of heat. In addition, any metallic implant or device which may be present within or adjacent to the transmitting RF coil may potentially experience significant, even harmful, heating effects. The risks of harmful RF heating can be reduced or eliminated by safe MR working practices, procedures and policies. (see 'MR Occupational Exposure') 10

11 4. MRI ACCIDENTS, INCIDENTS OR NEAR-MISSES Potential safety risks occur if the MR scanner is functioning incorrectly or has been modified in some way so as to render it unsafe or outside limiting specification. Servicing of the MRI scanners will be performed exclusively by Siemens Healthcare and/or their contractors. As part of the installation and acceptance process an independent assessor will have ensured that the MRI scanners are operating to all IEC regulatory standards and limits. In addition, an acceptance survey of the scanner and the MR suites will have included a confirmation of the extent of the 0.5mT (5 Gauss) area, acoustic MR-generated noise, as well as checks on image quality. Regular service visits by the MRI manufacturer and QA checks ensure that the scanner is operating within normal parameters and legislative limits. No modifications of any MR equipment in the MR suite by persons other than those authorised by Siemens Healthcare will be permitted unless under strict Siemens Healthcare and Cardiff University Master Research Agreement. Additionally, while modifications to some levels of software that control MRI scanner operation are permitted as prescribed under the Research Agreement with Siemens Healthcare, it is imperative that the safety-checks embedded within such code (e.g. db/dt and RF power limits) are not over-ridden above IEC 1st Level Operating Mode for Participant/Patient MR scanning. All reportable incidents or near-misses, must be reported promptly (within 24hours) to the MRI Safety Officer (see CUBRIC 'MR Incidents') The static magnetic field (3mT or higher) may result in any unsecured ferromagnetic object becoming a projectile, potentially causing physical injury or even fatality to persons near or within the magnet bore. For this reason, unsecured ferromagnetic objects must never be allowed within the Magnet Room (MR Inner Controlled Areas). The principal defence against this risk is the rigorous enforcement of the controlled MR Areas in which all ferromagnetic objects are excluded or secured at a safe distance from the MR scanner. Training of personnel, and the rigorous application of safety procedures is vitally important. (see CUBRIC 'MR Safety Training ) The static magnetic fields, TVEMFs and RF fields generated by the MRI scanner may cause implanted electrical/magnetic devices (e.g. cardiac pacemakers) to malfunction, causing injury, or even fatality. Deaths and injuries have occurred in MRI centres worldwide to persons with such implants/devices because of the failure to implement and follow strict magnet safety-screening exclusion procedures in MR Controlled Areas. Therefore, all persons must follow and undergo strict MR safety-screening procedures and authorised clearance before they are considered for entry to the Controlled Areas. (see CUBRIC 'MR Safety-screening' SOP). Certain implants/devices are absolutely contraindicated for exposure to electromagnetic or RF fields and must be excluded at all times from MR Controlled Areas. Other implants and devices may be classified 'MR Conditional' or 'MR Safe'. MR safety nomenclature used in this document and applicable to CUBRIC signage and procedure is in accordance with the international standard ATSM (American Society for Testing & Materials) standards definition of signage in MR environments (see below). 11

12 ASTM MRI Definitions and Signage: 'MR-Safe': An object for which there is no known hazard in any MR environment. 'MR-Unsafe': An object which is known to be hazardous in all MR environments. 'MR-Conditional': An object which has been formally tested under specified test conditions, and for which there is no known hazard for a specific stated MR environment e.g. at a particular magnetic field strength, distance from a particular scanner, magnetic spatial gradient strength/slew rate etc. Specified terms must be clearly stated adjacent to the 'MR Conditional' sign. (see CUBRIC 'MR Signage', MR Device Testing Policies and SOPs) 12

13 5. MR SAFETY PROCEDURES, POLICIES & GUIDELINES There are strictly implemented policies, procedures and guidelines covering all MR-related activities at CUBRIC. These procedures, policies and guidelines of safe working practice are under-pinned by rigorous mandatory annual training requirements before authorisation to work in any MR-related activity. Detailed procedures, policies and guidelines can be found in the appropriate documentation: CUBRIC MR Policy Document CUBRIC MR Standard Operating Procedures CUBRIC MR Risk Assessments CUBRIC MR Published Guidance MR Operation: Only Siemens Healthcare MR Engineers, or MR Operator Personnel are authorised to operate the MRI or MR Sub-system equipment. MR Record-keeping: A formal record (MR Scanner Log Book) must be maintained of all persons who have undergone an MR scan procedure. The MR Operator must complete a record of the activity, date and scanning details for each Participant or Patient scanned. MR safety-screening forms for all persons entering MR Controlled Areas must be kept for 10 years. These records must be treated as confidential and held in a locked cabinet within CUBRIC in accordance with existing Data Protection Act legislation. 13

14 6. INCIDENTAL FINDINGS In the event that an MRI scan reveals an incidental or unexpected pathological/structural appearance, the CUBRIC MRI Incidental Findings Procedure must be carried out. (see CUBRIC 'MRI Incidental Findings' Policy). No offer of a copy (hard or digital) of the brain scan will be routinely made to any Participant/Patient. As a matter of policy, MRI scan pictures will not be provided to any Participant for a specified period of time following their MR scan. This is to allow sufficient time for CUBRIC s Incidental Findings Policy to be fully carried out, should an incidental finding have been seen. 14

15 7. MR EMERGENCY PROCEDURES Should any part of the MR system fail that may endanger any person (Participants, Patients, Employees, Students, Visitors) the examination must stop and the Participant/Patient must be removed safely from the MRI scanner and magnet room. If there is an electrical risk of damage to the equipment, an MR Operator Personnel must then electrically isolate the equipment by pressing one of the appropriate electrical red coloured stop buttons in the Control Room and/or Examination Room, (note this is NOT the quench button). No further scanning is permitted to take place until the fault has been corrected by Siemens Healthcare and the equipment formally certified for safe usage once again. (see CUBRIC 'MR Emergencies' SOP) Quenching of the magnet: is only expressly performed by MR Operator Personnel and only under the strict instruction to do so by the MR Safety Officer, or a CUBRIC Director, and (if time permits) only after careful consultation with the CUBRIC MR Director or the MR Safety Officer, taking into account the very real and serious risks associated with the quenching procedure. Emergency shutdown of the main static magnet field (quenching) may only be undertaken by authorised and suitably trained MR Operator Personnel, and only under strict authorisation and (if time permits) after due consideration of the relative risks and only in one of the two situations described below: 1. If a Participant/Patient or other person is in a life-threatening or injurious situation resulting directly from the magnetic field, and the person cannot be safely and quickly removed from the magnet field, quenching of the magnet should be considered. This is likely to be an extremely rare occurrence and is associated with additional associated risks to the trapped person and to those within and around the MR scanner (cold burns, asphyxiation etc.) 2. If the emergency services (e.g. fire service) require urgent and immediate access to MR Inner Controlled Areas with ferromagnetic equipment, the magnet MUST be quenched before access is granted. In this event, the Participant/Patient must be removed from the scanner and all other persons evacuated from the MR Areas, before the magnet is quenched. Quenching will not be required if fire service access is only needed to MR Outer Controlled Area. (see CUBRIC 'MR Emergencies') MR Medical Emergency (within MR Controlled Areas): In the event of a medical emergency occurring in the MR Controlled Areas medical help must be summoned immediately. (see CUBRIC 'MR Emergencies' SOP). The medically-affected person must be removed from MR Controlled Areas and into the designate nearest recovery area (see Appendices) or where magnetic fields are below 0.5mT (5Gauss). This procedure is to avoid the need to screen emergency health workers, for which there would not be practicable time in a medical emergency. CUBRIC Fire Emergency: In the event of a fire, the fire procedure the CUBRIC 'MR Emergencies' SOP and Cardiff University Fire safety procedures must be followed. If evacuation of the MR Areas is required, all persons (Participants/Patients, workers, students and visitors) must be removed from the scanner area, and evacuated to the designated fire evacuation safety meeting point, taking due care of the magnetic field. All doors must be secured on leaving, especially those that govern access to the Controlled Areas. 15

16 8. MR FAULTS All faults must be reported immediately to the MR Safety Officer and also documented in the Notifiable MR Faults Book/ Digitised Scanner Log. (see CUBRIC 'MR Faults' SOP) If MR-related faults occur that prevent normal safe operation of the MR or MR-related equipment, it must be taken out of service immediately until repaired and passed fit for use by Siemens Healthcare and the MR Safety Officer. A signed and dated Do Not Use sign must be fixed to the equipment until the equipment is re-authorised for safe usage by the MR Safety Officer. The scanners can be locked with a key of necessary. Should during use of MR or MR-related equipment produce an accident, near miss or hazardous situation, operation must cease immediately until the cause is investigated and the hazard is removed. All accidents must be reported to the MR Safety Officer, who will take the matter further with the University Safety Office, and/or RIDDOR/MHRA, and in the case of MRI equipment, Siemens Healthcare. To minimize inconvenience, operational faults will also be communicated to all MR Operator Personnel, who may be intending to use the equipment via electronic notification and/or the Notifiable Fault Log Book. (see CUBRIC 'MR Faults' SOP) 16

17 9. MR RECORD-KEEPING For each person scanned the following information must be recorded and retained for 10 years: Name, gender and date of birth Date of scan, CUBRIC ID and MR-generated scan number The name and address of the person s general practitioner (GP) Region of body scanned and type of coil(s) used Time spent in the magnet bore Scan data including series numbers, sequence type, as well as any non-standard variables not recorded by the MR system automatic log and DICOM headers. Weight and height SAR power dissipated may also be recorded, where prudent to do so CUBRIC MR Safety-screening Screening Forms and the Consent Form must also be retained for 10 years. All information should be held in a locked filing cabinet within CUBRIC in accordance with relevant Data Protection laws. 17

18 10. MR MAINTENANCE AND TESTING The MR equipment, MR sub-systems, helium re-liquification, helium levels, and chilling system, must only be serviced and maintained by Siemens Healthcare according to their normal servicing schedule. Manufacturer and local-user QA checks must be carried out routinely. (see CUBRIC 'MR QA Policy') The Oxygen monitor for the Magnet room must be tested, serviced and replaced according to the Manufacturer s requirements. Temperature and Humidity monitors for the magnet and MR equipment rooms must be tested, serviced and replaced according to the manufacturer s requirements. Water-cooling and chilling systems are serviced by contracted specialist maintenance suppliers. All MR equipment, MR-related sub-systems, RF coils and connectors, alarms and monitoring systems, must be inspected and checked before use. (see CUBRIC 'MR Operation' SOP) 18

19 APPENDICES APPENDIX 1: CUBRIC SIEMENS MAGNETOM PRISMA EAST, 3TE MR Controlled Areas Building Zone 1 Building Zone 2 MR Outer Controlled Area MR Inner Controlled Area Recovery Area 19

20 APPENDIX 2: CUBRIC SIEMENS MAGNETOM PRISMA WEST, 3TW MR Controlled Areas Building Zone 1 Building Zone 2 MR Outer Controlled Area MR Inner Controlled Area Recovery Area 20

21 APPENDIX 3: SIEMENS MAGNETOM 7T MRI, 7T MR Controlled Areas Building Zone 1 Building Zone 2 MR Outer Controlled Area MR Inner Controlled Area Recovery Area 21

22 APPENDIX 4: SIEMENS 3T CONNECTOM 'MICROSTRUCTURE' MRI, 3TM MR Controlled Areas Building Zone 1 Building Zone 2 MR Outer Controlled Area MR Inner Controlled Area Recovery Area 22

23 APPENDIX 5: MR PERSONNEL DEFINITIONS Category Director of MR Notes Designated Director for MR who has overall authority for what may occur in the MR Areas, and for all MR-related activity. The Director of MR is a member of the CUBRIC CUBRIC Management Committee, which collectively decides and reviews the working operational, strategy, and safety of all aspects related to MR. The MR Director must be consulted and retain the right to authorise or suspend any MR-related activity. The implementation of all safety policies and procedures is the responsibility of the MR Safety Officer, directed by the Director of MRI. The Director and MR Safety Officer are responsible for implementing appropriative MR safety training and have the right to review and issue the classification of authorised MR Personnel. MR Safety Officer/MR Lab Manager The key operational manager and expert for ensuring safety compliance in the MRI Areas and all MR-related activities. The MR Lab Manager has the responsibility for administering access privileges to authorised MR Personnel. In addition, they are responsible for ensuring that authorised MR Personnel have been properly instructed and trained. The MR Safety Officer is responsible for preparing, documenting, reviewing, and ensuring that all MR Policies and Procedures set out in this document are adhered to. MR Safety Advisor MR Participant MR Patient MR Personnel Non-MR Personnel MR Equipment Service Personnel General Public A consultant who is an expert in MR Safety. This person is responsible for acceptance testing of the MR systems after manufacturer installation. The MR Safety Advisor will also assist in regularly review with the Director of MR and the MR Safety Officer, of all MR-related working Policies and Procedures. Any incidents, hazards, or near misses will be reported to the Director of MR, MR Safety Officer and the MR Safety Advisor. Any person consenting to be part of a valid ethically-approved MRI research study at CUBRIC Any person consenting to be MR scanned for clinically diagnostic purposes at CUBRIC Any person who has been granted MR Personnel status by the MR Safety Officer. All MR Personnel must have mandatory annual MR safety training. Any person who does not have MR Personnel status. In practice this includes; Participants, Patients, escorts, trades personnel, visitors, general public etc. Trained service personnel or representatives of the equipment manufacturer (Siemens Healthcare) can operate the equipment for quality control testing, servicing and demonstration purposes. Such personnel may be admitted to the MR Controlled Areas by suitably authorised MR Personnel, on production of personal identification. These service personnel must be MR safety-screened as per CUBRIC s MR Safety-screening procedures. The general public who have no cause or reason to enter the MR Controlled Areas must be completely excluded from the MR Controlled Areas. 23

24 APPENDIX 6: MR SAFETY-SCREENING FORMS There are currently 2 MR safety-screening forms: - Outer Controlled Area MRI Safety Screening Form - Inner Controlled Area MRI Safety Screening Form Persons requiring access to MR Controlled Areas The MR safety screening process is multi-level. (see CUBRIC 'MR Safety-screening' SOP) 24

25 APPENDIX 7: MR EMERGENCY PROCEDURES MR Emergency Quench (see 'MR Emergencies' SOP) MR Low Oxygen Alarm (see 'MR Emergencies' SOP) Medical Emergency in MR Controlled Areas (see 'MR Emergencies' SOP) Fire Emergency in MR Controlled Areas (see 'MR Emergencies' SOP) Water Flood in MR Controlled Areas (see 'MR Emergencies' SOP) APPENDIX 8: MR SOPS, RAS AND POLICIES See relevant CUBRIC MR SOPs, Policies and Risk Assessments 25

26 APPENDIX 9: KEY CONTACTS CUBRIC Key Contacts: Prof. Derek Jones CUBRIC Director Prof. Richard Wise CUBRIC Director of MR Prof. David Linden CUBRIC Clinical Director (until Dec 2017) Dr Khalid Hamandi CUBRIC Clinical Coordinator Dr John Evans CUBRIC MR Safety Officer & MR Lab Manager Radiation Protection Adviser (MR Advisor) Cardiff University, OSHEU Research and Finance Manager CUBRIC Administration CUBRIC Centre Manager CUBRIC MR Radiographers Research Nurse Appointed for Jan 2018 contact 26

27 Definitions MR - Magnetic Resonance MRI - Magnetic Resonance Imaging RF - Radio-frequency waves B0 - Static magnetic field. Measured in units of Tesla (T) db/dt - Time-varying (gradient) magnetic fields SAR - Specific Absorption Rate; RF power absorbed per unit of mass Tesla - the unit of magnetic field. Abbreviated to T Gauss also a unit of magnetic field strength, 1T = gauss (G) Units; milli = 10-3 ; micro = 10-6 (e.g. 1 millitesla = 1 mt = T) 27

28 References Calamante, F. et al. MR system operator: Recommended minimum requirements for performing MRI in human subjects in a research setting. J. Magn. Reson. Imaging 41, (2014). FDA, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Guidance for Industry and FDA Staff. Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices, 20 June International Commission on Non-Ionising Radiation Protection (ICNIRP); ICNIRP Guidelines on Limits of Exposure to Static Magnetic Fields. Health Phys. 96, (2009). International Electrotechnical Commission (IEC); IEC (2015) / British Standard BS (2015) - Medical Electrical Equipment: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. (2015). Hebrank, F. X. & Gebhardt, M. SAFE-Model -- A new method for predicting peripheral nerve stimulations in MRI. Proc Intl Soc Mag Reson Med 8, 2007 (2007). Kanal, E. et al. ACR guidance document on MR safe practices: J. Magn. Reson. Imaging 37, (2013). Medicines and Healthcare Products Regulatory Agency (MHRA). Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use. Medicines and Healthcare Products Regulatory Agency (2015). Master Research Agreement (MRA) between Cardiff University and Siemens Healthcare (date...) Shellock FG, Reference Manual for Magnetic Resonance Safety, Implants and Devices: 2014 Edition, Biomedical Research Publishing Group, Siemens MAGNETOM Prisma Operator Manual MR System syngo MR E11, Print No. M , 2015 End. 28