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University of Bristol

MRI Local Rules &Procedures Version 1.1 November 2011

Contents

Document Version Notes ......................................................................................................... 1

The core document is version 1 ............................................................................................... 1

Approval for document use of version 1.1 ................................................................................ 1

Date document of Version 1.1 issue ........................................................................................ 1

Document review ..................................................................................................................... 2

Date of next document review .................................................................................................. 2

1 Introduction ....................................................................................................................... 3

2 Designated Controlled Area .............................................................................................. 4

3 Health and Safety Regulations .......................................................................................... 4

4 Specific Rules for Authorised Personnel ........................................................................... 5

5 Specific Rules for Unauthorised Personnel Requiring Access to the Controlled Area ........ 6

6 Emergencies in the MRI Facility ........................................................................................ 7

7 Examination Procedures for Research participants ........................................................... 9

8 Examination Procedures for Clinical Research participants ............................................. 11

9 Use of External Equipment within the Magnet Room ....................................................... 11

Appendix 1: Plan of the MRI Facility ....................................................................................... 13

Description of the MRI Facility ............................................................................................ 14

Appendix 2: Responsible Persons .......................................................................................... 15

Employing Authority ............................................................................................................ 15

Appendix 3: MR Authorised Personnel ................................................................................... 17

Appendix 4: MR Safety Screening Forms ............................................................................... 19

Definitions of Technical Terms ............................................................................................ 20

Second Screening Form ..................................................................................................... 21

Visitor Screening Form ....................................................................................................... 22

Rules for Administration of Screening Forms ...................................................................... 23

General ........................................................................................................................... 23

Initial Screening Form ..................................................................................................... 23

Second Screening Form .................................................................................................. 24

Appendix 5: General MRI Safety Precautions and Procedures ............................................... 26

Static Magnetic Field .......................................................................................................... 26

Time-Varying Fields (from switching of the gradient magnetic fields) .................................. 28

Radio-frequency (RF) Fields ............................................................................................... 29

Liquefied Helium ................................................................................................................. 30

Acoustic Noise .................................................................................................................... 30

Contraindications ................................................................................................................ 31

Appendix 6: Protocol for MR Examinations ............................................................................ 32

Screening and Scanning Procedure for Research Participants ........................................... 32

Appendix 7: Access to the MRI facility .................................................................................... 34

Appendix 8: Authorised MRI Scanner Operators Declaration ................................................. 35

Appendix 9: CRICBristol Research Flow Diagram .................................................................. 36

Appendix 10: Procedures for Research Studies ..................................................................... 37

Incidental findings in MRI Examination: Research participants ........................................... 37

MRI Data Handling Policy ................................................................................................... 38

Confidentiality ..................................................................................................................... 38

Data transfer ....................................................................................................................... 38

Data Analysis ...................................................................................................................... 38

Example MRI Information Form for Research Participants – fMRI ...................................... 39

Example MRI Information Form for Research Participants – Anatomical Imaging ............... 41

Clothing in the MRI Scanner ............................................................................................... 43

Appendix 11: Incident Reporting ............................................................................................ 44

Appendix 12: Emergency Contacts ........................................................................................ 45

Technical Contacts ............................................................................................................. 46

Appendix 13: SOP Cardiorespiratory arrest/medical emergency ............................................ 47

Appendix 14: Oxygen Policy ................................................................................................... 48

Appendix 15: Booking policy .................................................................................................. 49

Appendix 16: MRI scanning Out of Hours ............................................................................... 51

Appendix 17: Administration of intravenous gadolinium contrast agents policy ...................... 52

Appendix 18: Working in MRI during pregnancy ..................................................................... 53

CRICBristol MRI Local Rules & Procedures Version 1.1 Page 1 of 56

Document Version Notes

This document has been prepared after consultation of a wide-range of MR safety documents and procedures currently in place at similar MR sites. It is also based on the Authors’ experience of research scanning at several sites in the UK. The most important and relevant documents referred to in preparing these Rules and Procedures have been:

Guidelines for Magnetic Resonance Diagnostic Equipment in Clinical use, With Particular Reference to Safety. UK Medicines and Healthcare products Regulatory Agency (MHRA), issued December 2007.

American College of Radiology White Paper on MR Safety. AJR 188. 2007

The Aston Brain Centre MRI Local Rules and Procedure document previously prepared by the NJ Thai for the Aston University

CUBRIC MRI-Suite Safety Notes Rules and Procedures University of Cardiff, Version 12, 06/2007.

Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices. US Food and Drug Administration (FDA). July 14, 2003.

The core document is version 1

Version 1 reviewed by the GAG and approved for use by the CRICBristol Co Directors on 1st

July 2011

Approval for document use of version 1.1

Version 1.1 with minor amendments to reflect current operational procedures done by Aileen Wilson Lead Research Radiographer, checked and approved by Jade Thai Centre Manager

Additions to core document

Appendix 13: SOP for cardiorespitory arrest/medical emergency-reviewed and approved by GAG August 2011

Appendix 14: Oxygen policy reviewed and approved by GAG on 24th Nov 2011

Appendix 15: Booking policy and appendix 16: MRI scanning out of hours

Appendix 17: administration of intravenous gadolinium contrast agents reviewed and approved by GAG 24th Nov 2011

Appendix 18: working in MRI during pregnancy

Date document of Version 1.1 issue

30th November 2011


Document review

This document has been reviewed by the CRICBristol Governance Advisory committee. It is recommended that a review of these Local Rules and Procedures should be undertaken every two years. However, should there be significant changes to the working procedures, changes in legislation (or introduction of new legislation), or changes in best practice, an earlier review should commence.

Date of next document review

November 2013


1 Introduction

This document sets out the rules and procedures for work undertaken in the MRI suite (hereafter the “MRI facility”) located within the Clinical Research and Imaging Centre (CRICBristol) building

These Local Rules and Operating Procedures have been written to both clarify the normal mode of operation in the MRI facility, and for the protection of persons against hazards associated with the MRI equipment.

Full copies of these Local Rules and Operating Procedures are kept in the Centre Manager’s Office and the MRI facility Control Room.

The MRI facility contains a 3T Siemens Magnetom Skyra system, which is a superconducting, actively shielded magnetic resonance whole body scanner.

All persons whose work involves contact with the MRI facility (scanner operators, MRI support and technical staff, researchers conducting experiments) must familiarise themselves with these Local Rules and Operating Procedures and observe them in relation to their normal duties. It is the responsibility of all individuals conducting an imaging study or with responsibility within MRI facility at the time of operation, to ensure the health and safety of themselves, and research participants, and visitors.

The Health Protection Agency and the Department of Health have published the following documents relating to the use of Clinical Magnetic Resonance equipment:

“Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use”, Medicines and Healthcare products Regulatory Agency (MHRA), Department of Health, DB2007(03), December 2007; and

“Protection of Research participant and Research participants undergoing MRI Procedures”, Document of the Health Protection Agency, August 2008.

Copies of these documents are available for reference in the CRICBristol Academic Suite and MRI Control Room.

The Health and Safety at Work etc Act 1974 clearly defines the mandatory responsibilities and the statutory requirements under the Act, of the employer, of the employee and all who have access, including visitors, to the site of work.

The ultimate responsibility for the implementation and the maintenance of procedures to ensure the health and safety of all persons entering the MRI facility lies with the employer.

The day-to-day responsibility for aspects of safety, the participants/research participants scanned and all personnel who have access to the MRI facility is delegated to a “MR Responsible Person” as referred to in the referenced Department of Health document.

At CRICBristol, this will be the Lead Research Radiographer who will be responsible for MRI safety and is appointed to the role of Magnetic Resonance Safety Officer (MRSO). Further details of the “MR Responsible Person” can be found in Appendix 2, page 14 and the Emergency contact details of other key personnel can be found in Appendix 12, page 43.


2 Designated Controlled Area

2.1 The MRI equipment generates three types of electro-magnetic field: (i) a static magnetic field, (ii) a low frequency time-varying magnetic field and (iii) a radiofrequency electromagnetic field. Individuals undergoing an MRI examination will be exposed to all three types of field simultaneously, whilst others in the immediate vicinity will be exposed to a reduced level of static magnetic field only.

2.2 Access to the MRI facility is via doors, which are interlocked using swipe card access. A plan of the MRI facility with a detailed description of the Controlled Area is reproduced in Appendix 1, page12.

2.3 The MRI magnet is located within the Magnet Room. Essential hardware for the MRI scanner including the gradient and RF amplifiers are located inside the MRI Equipment Room. Both the Magnet Room and the MRI Equipment Room are sited inside a designated Controlled Area. The 5 Gauss (0.5mT) line of the magnetic field is within the Magnet Room. Only Authorised Personnel with the appropriate level of training may have free access to the Controlled Area.

2.4 All personnel who are not designated as Authorised Personnel, including staff and visitors, must complete the MRI Safety Screening Questionnaire (reproduced in Appendix 4, page 19) and should be accompanied and supervised by an Authorised Person at all times whilst they remain within the Controlled Area. Screening for MRI safety should be performed in the MR Preparation Area before entering the MRI facility.

2.5 No individual may enter the Controlled Area until they have completed the MRI Safety Screening Questionnaire to confirm that none of the contraindications to entry apply to them. Notices at the point of entry into the Controlled Area must be visible to remind individuals to check that they carry no ferromagnetic objects. This is particularly important for individuals who intend to work close to the MRI scanner, where such objects can behave as missiles, injuring people and damaging the equipment.

2.6 Currently, there is no conclusive evidence that electromagnetic fields used for MRI and spectroscopy can cause any detrimental effect to the well being of the embryo or foetus during pregnancy. However, to reduce the potential risks to the foetus from acoustic noise while the scanner is being operated, it is advisable to avoid entrance to the Magnet Room during the first trimester of pregnancy.

3 Health and Safety Regulations

The Health and Safety at Work etc Act 1974 clearly defines the mandatory responsibilities and the statutory requirements under the Act, of the employer, of the employee and all who have access, including visitors, to the site of work. A number of aspects of the Act are particularly relevant to the MRI safety.

The specific implications of the Act and of Guidelines issued by the Department of Health for Magnetic Resonance Diagnostic equipment in clinical use are as follows:

3..1 Only Authorised Personnel may have free access to the MRI facility. These are personnel who have satisfactorily completed training in their responsibilities and have gained an appropriate appreciation of the MRI diagnostic equipment and its safety requirements. Copies of the current list of


Authorised Personnel are kept in the MRI key logout book held in the CRICBristol Reception and in the Centre Manager’s Office, room number B.

3..2 All unauthorised personnel, including staff, research participants and visitors, may only enter the MRI facility under the direct supervision of an Authorised Person.

3..3 All persons who are contraindicated by the MRI Safety Screening Questionnaire are prohibited from entering the controlled area.

3..4 Ferromagnetic objects must not be taken into the Controlled Area. For example, standard hospital trolleys, wheelchairs, drip stands, tools, keys, and jewellery, as they present a projectile risk. These objects should remain outside the Controlled Area;

3..5 During the first trimester of pregnancy you are advised against entering the Magnet Room during scanning.

3..6 Personal belongings such as bank and credit cards, analogue watches and cameras should not be taken into the Controlled Area as they may be permanently damaged by the magnetic field. For logistical reasons such personal belongings should be deposited in the lockers outside the MR Preparation Area.

3..7 The doors to the Magnet Room and MRI Equipment Room should be kept closed at all times other than when Authorised Personnel need access to those areas. It is the responsibility of the scanner operator to ensure that, upon finishing a session, the Magnet and Equipment room doors are locked.

4 Specific Rules for Authorised Personnel

All Authorised Personnel should be conversant with, and be able to put into practice, the general rules and emergency procedures contained within this document. In addition, they should be conversant with the specific rules relevant to their work area.

Authorised Personnel are further classified as to their Level of Training, which determines their competency to use the MRI equipment. The competencies of each Level of Training are summarised in Appendix 3, page 17. Following training and assessment by two of the Operator Assessors listed in Appendix 2, page 15, Authorised Personnel should complete and sign the form appropriate to their Level of Training appendix 8 page 33). The operation, if any, of the MRI equipment by Authorised Personnel must be strictly confined according to these competencies.

Authorised Personnel should not undertake tasks/jobs that are beyond their level of training.

All Authorised Personnel have the responsibility to ensure that all visitors, research participants and other members of staff who enter the MRI facility are only allowed to do so subject to the general rules stated in Section 3. In particular, Authorised Personnel must ensure that persons fitted with a cardiac pacemaker, or who are otherwise contraindicated, do not enter the Controlled Area. The Authorised Person shall take full responsibility for an unauthorised person who enters the Controlled Area for the duration of their stay in the Controlled Area.

All Authorised Personnel have the responsibility to ensure that all visitors and other members of staff do not enter the Magnet Room unless they are under the


continuous supervision of an Authorised Person and are subject to the general rules stated in section 3.

During the normal working day (Monday to Friday, 0900-1700 hours) the responsibility for checking that it is safe for an individual to enter the MRI facility is taken by one or more of the relevant Authorised Personnel working in the MRI facility. See also Appendix 7, page 32 for guidelines on levels of access to the MRI facility afforded to personnel of different levels of training.

Authorised Personnel who are pregnant must inform the MRSO. During the first trimester of pregnancy, they should be given the choice whether or not to enter the Magnet Room, but may enter the Controlled Area including the MRI Control Room without detrimental effect. However, they may not remain in the Magnet Room during scanning. .

Action in breach of Local Rules and Procedures will result in an investigation and incident reporting. Appropriate measures after the investigation will be taken and this could result in MR authorised status being revoked.

5 Specific Rules for Unauthorised Personnel Requiring Access to the Controlled Area

5.1 All Unauthorised Persons eg porters, cleaners, Estates & Facilities staff, university staff and relatives accompanying research participants, and visitors requiring access to the Controlled Area must gain authorisation from, and be under direct supervision of, an Authorised Person before entry is permitted.

5.1.1 Before entry into the Controlled Area they should complete the MRI Safety Screening Questionnaire (see Appendix 4, page 19) and must place ferromagnetic objects and personal belongings in the lockers provided. For certain members of staff, it may be appropriate to complete the screening form on a monthly basis if repeated, periodic visits are necessary.

5.1.2 All unauthorised persons should not enter the Magnet Room unless requested to do so and only when accompanied by an Authorised Person.

5.1.3 Members of staff may accompany a research participant into the Magnet Room throughout the period of the examination provided they are subject to the general rules given in section 3.

5.2 Persons fitted with a cardiac pacemaker or any other electronically, magnetically or mechanically operated life saving device, or otherwise contraindicated by the MRI Safety Screening Questionnaire, should not be admitted into any part of the MRI facility.

5.3 Staff, including Estates & Facilities staff and other engineers who are not on the Authorised Personnel list but require access to the MRI facility for maintenance purposes, should first notify the MRSO and complete a UHBristol Permit to Work form before commencing any inspection or work.

5.3.1 All University staff requiring access into the Controlled Area will be required to complete the MRI Safety Screening Questionnaire (Appendix 4, page 19).

5.3.2 Persons in this category may gain access during normal working hours on admittance by an Authorised Person and subject to the general rules stated in section 3.


5.3.3 Persons in this category wishing to gain access to the Controlled Area outside normal working hours should notify the MRSO. In addition, they should be conversant with the general rules in section 3 and the emergency procedures in section 6.

5.3.4 All Cleaning Staff must be supervised by the MRSO when cleaning the Controlled Area and be subject to the general rules given in section 3. Only clearly labelled CRICBristol MR safe cleaning equipment can be used in the Controlled Area.

6 Emergencies in the MRI Facility

6.1 Quenching the Magnet using the Emergency Stop Button:

6.3.1 This action may be required in the event that a ferromagnetic object is brought into the vicinity of the magnet within the Magnet Room. The very strong magnetic field gradients will cause the object to be pulled very rapidly into the magnet with considerable force. Under certain circumstances severe injury may result if persons are struck by such objects.

6.3.2 In the event of needing to ‘ramp down’ the magnet quickly, the Emergency Quench Buttons are located in the Magnet Room and the Control Room.

6.3.3 The Emergency Quench Button should only be activated by an authorised person in circumstances where persons are in immediate danger and the presence of the magnetic field is still endangering the injured person.

6.3.4 When the magnet has been quenched by activating the Emergency Quench Button, cryogenic gases are very rapidly released and vented out of the building. The Magnet takes approximately 30 seconds to collapse to a safe, negligible field.

6.3.5 In addition to a quench being initiated by activating the Emergency Quench Button, there is a potential for a quench to occur spontaneously, however this is uncommon. This spontaneous quench is normally accompanied by a loud bang and sometimes the rapid release of large quantities of cold cryogenic gases into the Magnet Room. The cryogenic helium gas will liquefy oxygen out of the air; hence, both asphyxia and fire are real threats. During a quench, the oxygen levels in the Magnet Room may become dangerously low. The presence of the cold gases could cause cold burns, frostbite or hypothermia. It is important to evacuate everybody out of the MRI Controlled Area and particularly out of the Magnet Room as quickly as possible and restrict access to the Magnet Room until the arrival of the scanner service engineers. In the unlikely event that someone is trapped in the Magnet Room and the oxygen level is dangerously low keep the door of the Magnet Room completely open until the trapped person can be rescued. There is a risk of fire starting if there are naked flames or sparks in the Controlled Area.

6.3.6 Do not press the Emergency Quench Button unless the situation is life-threatening – a quench involves several weeks of down-time and is expensive. Persons initiating unnecessary quenches may be liable for these costs.


6.2 Medical Emergencies:

6.2.1 In the event of a medical emergency, the research participants must be taken out of the scanner immediately using the undockable table and brought into MR Lobby or the anaesthetic preparation room. The standard operating procedure for a medical emergency is described in appendix 13.

6.2.2 Under no circumstances must the resuscitation trolley or defibrillator be taken into the Magnet Room. Procedures such as defibrillation must be performed in the MR Lobby. Such a procedure must not be performed before the person is removed from the Magnet Room. Resuscitation equipment must never be taken into the Magnet Room.

6.3 Fire:

6.3.1 In the event of a fire within the CRICBristol, the alarm should be raised and all staff, research participants and visitors should be evacuated. On no account should any unauthorised member of staff enter the Controlled Area. The nearest fire escape to the assembly point is the CRICBristol main entrance. In the event of a fire all the swipe card doors are disabled and the fire doors automatically shut.

6.3.2 Call the Fire Service via Security emergency extension 2222 and inform the MRSO.

6.3.3 The Fire Service has been made aware of the MRI facility and the presence of the magnetic field; this information is held in a central database and available to local fire stations/crews. However, it cannot be guaranteed that in the event of a fire the attending Fire Officers will be aware of the special safety precautions necessary. In the event of a fire or fire alarm, the current scanner operator should await (in a safe location outside the building) the arrival of the Fire Service to ensure safety procedures are followed. In particular, the Fire Officers need to be informed of the dangers of entering the Magnet Room.

6.3.4 If the fire is in the MRI facility only an authorised person should push the electrical cut off button, the electrical cut off button is found in the control room and the magnet room.

6.3.5 If the fire is in the MRI facility, do not take any fire extinguishers into the Controlled Area unless you are sure they are MR Safe. The MR safe fire extinguishers are clearly labelled and located in the MR Lobby next to the magnet room door.

6.3.6 All fire extinguishers within the MRI controlled area are MR Safe and may be used within the Magnet Room. Fire fighting equipment from outside MRI Controlled area must not be taken into the Magnet Room whilst the magnet is energised.

6.3.7 Only Authorised Personnel who have received appropriate fire training should attempt to use the MR safe fire extinguishers and only if it is safe to do so.

6.3.8 Smoke detectors are fitted in all rooms of the MRI facility. If the fire alarms in the building sound with a continuous ring, the MRI facility should be evacuated even if no fire is evident – it may be a bomb threat. Assemble at the designated Fire Assembly Point which for the CRICBristol is beyond the


main entrance beyond the metal gates and brick wall on St Michael’s Hill by the CRICBristol sign and wait for permission to re-enter the building.

6.3.9 If a fire occurs outside of normal working hours, the Fire Service should be met by a Designated Person at the Main Entrance to the CRICBristol to provide any necessary keys etc to allow entry to the MRI facility. The Designated Person must not enter the Controlled Area under any circumstances unless an Authorised person is also present to supervise entry and only then, if instructed to so by the Fire Service.

6.3.10 Members of the Fire Service may only enter the Controlled Area under the instruction and supervision of a Senior Fire Service Officer who has been instructed in the relevant safety procedures required for access to the Controlled Area.

6.3.11 All the Fire Service’s fire fighting and auxiliary equipment may be used throughout the CRICBristol but NOT in the Magnet Room.

6.3.12 In the event of a fire in the Magnet Room which requires additional fire fighting equipment and/or the entry of personnel wearing breathing apparatus or carrying metallic objects, the magnet must be ramped down and stopped using the Emergency Magnet Quench Button.

6.3.13 The Emergency Magnet Quench Button should only be activated in the event of a severe fire within the Magnet Room.

6.3.14 When the magnet has been quenched using the Emergency Magnet Quench Button, cryogenic gases are released very rapidly and vented out of the building. The Magnet takes approximately 30 seconds to collapse to a safe, negligible field, at which point it is safe to enter with any metallic objects.

6.3.15 During the quenching procedure, small amounts of air may condense around the pipe-work venting the cryogenic gases. Because of a small risk of explosion from naked flames or sparks during this period, the Magnet Room door should be closed until 30 seconds have elapsed after activating the Emergency Magnet Quench Button.

7 Examination Procedures for Research participants

7.1 Imaging of research participants should only be carried out by persons trained in the safe use of the MRI equipment and who have obtained at least Authorised Staff User status as set out in Appendix 3 page 16

7.2 Research participants may only undergo an MR examination under protocols approved by either the appropriate NHS Ethics Committee or the University Ethics Committee.

7.3 Research participants undergoing an MR examination should only enter the MRI facility after the initial screening form has been completed (see Appendix 4, page 19), and when instructed to do so by an Authorised Person. The research participant must be able to demonstrate good comprehension and to be able to express informed consent. Normally, the research participant should sign to indicate written informed consent. In circumstances where the research participant is unable to sign but can indicate consent (eg, verbally), then the form should be signed by a friend or family member. A research participant protocol for MR examinations is given in Appendix 6, page 30.


7.4 Research participants who are children under the age of 16 can only undergo a MR examination after parental consent has been obtained. Parental consent must be given before the child research participant comes to CRICBristol. The Principle Investigator must consider the child capable of complying with the rigours of the scan and that they understand appropriate safety instructions (such as the use of the alarm-call button). A parent or guardian must accompany the child to the MRI facility. If the child is under 12 years of age.. The child and parent/guardian must give written informed consent for all research investigations. Children can only be scanned by Authorised Staff User or above.

7.5 Any personal effects or ferromagnetic objects belonging to the research participant should be placed in the lockers provided before the research participant enters the MRI controlled area. On no account must a person fitted with a cardiac pacemaker or otherwise contraindicated by the MRI Safety Screening Questionnaire be allowed to enter the Controlled Area.

7.6 Research participants should only enter the MRI Facility and Magnet Room when accompanied by an Authorised Person.

7.7 The MRI scanner should only be operated by an Authorised Person with ASU or APU status. There should be at least one other Authorised Person in the MRI facility with a minimum of level of MR safety training (i.e. a General User); while the research participant is in the MRI magnet bore.

7.8 For MRI scan operators, who are also University postgraduate students (APU), there should be at least one other Authorised Person in the MRI facility at least a ASU present, while the research participant is in the MRI magnet bore. At least one of the scanner operators present must be a full, rather than student operator. In general, and within normal working hours, it is expected that this role will be fulfilled by the Lead Research Radiographer.

7.9 Before proceeding with the study, the operator performing the scan should ensure that the MRI Safety Screening Questionnaire has been satisfactorily completed and that there are no contraindications which would prevent the MR examination from continuing. Guidelines for these contraindications are given in Appendices 4 & 5, page 19 & 23.

7.10 Two-way communication between the research participant and the operator should be possible at all times. In particular, the research participant should be within view of an operator at all times and the research participant should be able to attract the attention of the operator at all times using the "panic button" or by some other pre-arranged visual signal.

7.11 The operator should make all efforts to keep within the Specific Absorption Rate (SAR) limits set by the HPA (see Appendix 5, page24).

7.12 The operator should ensure that when the research participant enters the magnet bore, any cabling associated with monitoring equipment and RF coils are kept well away from each other and from the research participant and that there are no loops in any of these cables, which may give rise to burns.

7.13 Research participants requiring a wheelchair should be transferred onto the MRI compatible wheelchair (which is kept in the Lobby) before entering the Controlled Area. On no account should any other trolley or wheelchair be taken into the Controlled Area.


7.14 The time spent in the magnet bore by any one person must not exceed 90 minutes in any 24 hour period. Other than this, there is no restriction on the frequency with which a screened person may be scanned.

8 Examination Procedures for Clinical Research participants

The definition of clinical research participants here may include individuals who are currently hospital, research participants who have a greater than normal risk of having a further medical incident (eg, prior cardiac failure). Such individuals may only undergo MR examination under protocols approved by the appropriate NHS Ethics Committee. A research participant protocol for MR examinations is reproduced in Appendix 6, page 30 this must be modified to include any additional precautions and procedures approved by the NHS ethics committee.

MR studies with clinical research participants who have increased risk should only be carried out when there is a medically trained person available in the MRI facility. Imaging of clinical research participants should only be carried out by persons extensively trained and experienced in the safe use of the MRI equipment, i.e. Radiographer.

Clinical Research participants who are undergoing an MR study should complete a screening form prior to the examination in the presence of an Authorised Staff User, (see Appendix 4, page18). The clinical research participant must be able to demonstrate good comprehension and to be able to express informed consent. Normally, the research participant should sign to indicate written informed consent. In circumstances where the research participant is unable to sign but can indicate consent (eg, verbally), then the form will be signed by a friend or family member.

Before proceeding with the study, the Authorised Staff User performing the scan should ensure that the screening form has been satisfactorily completed and that there are no contraindications for the MR examination to continue (see Appendix 4, page 20).

Two-way communication between the clinical research participant and operator should be possible at all times. In particular, the research participant should be in view of the operator at all times and the research participant should be able to attract the attention of the operator at all times using the "alarm-call button" or some other pre-arranged visual signal.

The scanner operator should make all efforts to keep within the lower SAR limits set by HPA, IEC and ICNIRP (see Appendix 5, page 26). the SAR values will be recorded for each scan

In the clinical environment, pregnant patients are only scanned in emergency situations. with this in mind, and realising that research is not done on an emergency basis, pregnant women cannot undergo an MRI scan at CRIC Bristol

9 Use of External Equipment within the Magnet Room

Before the use of any peripheral equipment within the Magnet Room, prior documentation must be provided to the Centre Manager and or MRSO to confirm that it is MR compatible/safe at 3Tesla


The equipment must not enter the Magnet Room until the Centre Manager or MRSO, after consultation with the MR Physicist, Manufacturer or other expert body, has approved its use.

If the equipment has any likelihood of increasing the risk of harm to research participants, then studies requiring that equipment must gain specific approval from the appropriate Ethics Committee.


Appendix 1: Plan of the MRI Facility


Description of the MRI Facility The MRI facility within CRICBristol containing the MR system is a 3Tesla Magnetom Skyra system from Siemens Medical Solutions of Erlangen, Germany. The Magnet Room completely encloses the 5 Gauss (0.5 mT) line produced by the MRI scanner. The Controlled Area is further classified as being the “Magnet Room”, the “Control Room and the “Equipment Room”. The Magnet Room contains the strongest magnetic fields and hence is the most hazardous area of the MRI facility. The restrictions governing who may enter the Magnet Room and under what circumstances, are therefore more stringent than those for the Control Room. Within the Controlled Area, at certain points, the field strength is greater than the general safety limit of 5 gauss (0.5mT). Members of the public and staff should be excluded from the Controlled Area unless accompanied and supervised by an authorised member of staff after carrying out MRI safety screening. Clear visible warning signs are displayed at the entrance to the MRI facility with the following wording, “Warning, Strong Magnetic Fields; Restricted Area; No Unauthorised Entrance; Persons Fitted with Heart Pace-Maker Must Not Enter.”


Appendix 2: Responsible Persons

Employing Authority

University

Is the employing authority, which must be satisfied that the organisational arrangements exist for the safe installation and use of MRI equipment within its authority. The CRICBristol Co Directors are ultimately responsible for all internal controls including policies and procedures regarding safety and security. The Co Directors delegate responsibility for internal control to the Centre Manager. Standards and systems of internal control are designed, implemented and reviewed by the Co Directors to adequately safeguard all users (staff and participants) of the MRI equipment. Appropriate policies supported by evidence from regulatory bodies will be applied on a consistent and ongoing basis but will be subject to review. • As with all Health and Safety directives, all personnel have a personal responsibility to behave sensibly and ensure the well-being of themselves, their colleagues, participants in MRI examinations and any other visitors. • Some staff (i.e., Authorised Staff Users (ASUs) and Authorised Postgraduate Users (APUs) have additional responsibilities; these people are identified as part of the description of persons associated with the MR facility in Appendix 3. The CRICBristol Management Group (MAG) is responsible for writing the rules and procedures outlined in this document. However the Lead Research Radiographer carries responsibility for keeping abreast of any new legislation or external guidelines that may be relevant to internal procedures, advised by the MR Advisor in UHBristol Medical Physics and Governance Advisory Committee. The Centre Manager has overall authority for what may occur in the MRI facility, and is a member of the CRICBristol management Group, which collectively decides and reviews the working operational and safety strategy for the facility. On all substantive issues relating to operation of the MR facility, the Co Directors must be consulted and retain the right to suspend any activity. As Authorised Staff Users the Centre Manger and Lead Research Radiographer (LRR) must undergo the standard screening procedures. The Centre Manager and Lead Research Radiographer can be the sole occupant of the MR facility, so long as another member of staff is present in CRICBristol and knows that they are in the MRI facility. The Centre Manager and LRR have the right to review the classification of any person and, if appropriate, can re-classify that person, suspend their rights and access privileges if appropriate. The Centre Manager, and or LRR must be informed before any previously unclassified person is admitted to the MR Controlled Area. The Centre Manager and or LRR must be consulted before any new piece of equipment can be admitted to the MR Controlled Area. The LRR is the key operational person for managing and ensuring compliance in the MRI suite and has the same access privileges as the Centre Manager. The MR Safety Officer has the


day-to-day responsibilities for administering access privileges to other users. In addition, the MR Safety Officer is responsible for ensuring that Authorised Users have been properly screened and trained before being allowed to scan research participants. This person is responsible for ensuring that the rules and procedures set out in this document are adhered to at all times. The current MR Safety Officer (MRSO) will be the Lead Research radiographer. This person will spend most of their working day in the MR facility. Note that the MR Safety Officer does not have to be physically present for scanning or screening of participants to occur but either they, or the Centre Manager must be on site and within easy contact when such scanning is being carried out. MR Advisor Mr Ron Hartley-Davies This person is an expert in MR and MR Safety. This person will perform pre-acceptance testing of the system after installation by Siemens and their contractors. This person will be classified as an Authorised Staff user (ASU) when they are on our site.


Appendix 3: MR Authorised Personnel

MR Authorised Personnel (AP) with subcategories: There are three categories of Authorised Personnel: Authorised General User (AGU) Authorised Staff User (ASU) and Authorised Postgraduate User (APU). The key difference is in their rights and responsibilities. AGU has had safety training to work in the MRI facility but they are NOT trained as Scanner operators. Both AGU and APU cannot admit people to the Magnet Room and cannot scan participants without an ASU being present. Only if an APU is granted an employment contract with the University, can they be upgraded to ASU status by the Centre Manager or the MRSO.

General User

To obtain status as a General User, the appropriate training needs to be received from the Lead Research Radiographer or other appointed person. Before Authorised Person status as AGU is conferred, a person must undergo the following training and testing:

The form listing General User competencies is given below. This needs to be completed and signed before any individual can work within the MRI facility. AGU cannot operate the scanner but can screen research participants and work in the MRI facility with another ASU present.

1. They must know how to follow emergency procedures.

2. Training in removing an unconscious participant from the Magnet Room.

3. Viewing the current Siemens safety video.

4. Signed to say they have read and understood these Local Rules and Procedures

5. Successfully completing a written test on MR Local Rules and Procedures overseen by either the MRSO or Centre Manager.

Authorised Staff User (ASU) and Authorised Postgraduate User (APU) These are staff who are conversant with, and who agree and are able to put into practice, all the rules and emergency practices outlined in this document. They are responsible for screening participants and other visitors to ensure that it is safe for them to enter the Controlled Area, and they must supervise all non-authorised people at all times when in the Controlled Area. Records of screening are kept by the MRSO and held in the Control Room. Authorised User status is granted by the Centre Manager or the MRSO. A list of current authorised users will be kept on the shared drive and any additions/deletions will be reported to the CRICBristol management committee. Before Authorised User status can be conferred, a person must undergo the following training and testing:

1. Training in the operation of the scanner. 2. Training in the administration of screening questionnaires. 3. Training in First Aid (to the level of ‘appointed persons’)


4. Basic fire training (internal programme; content to be determined by the UHBristol Safety Officer)

5. Training in removing an unconscious participant from the controlled area. 6. Viewing the current Siemens safety video. (Attendance at a safety lecture given by a

suitably qualified person approved by the Management Committee (or viewing a video recording of such a lecture).

7. Reading the Guidelines for Magnetic Resonance Equipment in Clinical Use (December. 2007) published by the (MHRA).

8. Studying all relevant risk assessment forms (provided by the MRSO). 9. Thoroughly reading the local Rules of Operation and successfully completing a written

test, to be administered by the MRSO, covering the rules and procedures covered in this document.

10. These requirements apply to all persons, including members of the Management Committee.

Persons who satisfy all the above requirements but have little or no practical experience will initially be given Probationary Authorised User Status. Such persons will become full Authorised Users when they have been present at 10 scans and have operated the scanner on at least 5 of those occasions. This will be supervised and authorized by the Centre Manager or Lead Research Radiographer Authorised Persons must be screened at least yearly. They must also be trained in the use of any new equipment, software or procedures that may be introduced from time to time. The current list of authorised personnel, together with their qualifications, training and experience, will be made available on request to all relevant university ethics committees. Note that: Only an Authorised Person (AP) may: • Perform screening of MR participants, their helpers, other staff members and members of the general public, so that they may be admitted to the Outer Controlled Area. • Perform screening of MR participants such that they may be scanned using the MR system within the Inner Controlled Area. An AP may only scan participants if another AP is in attendance. An AP may only enter the Controlled Area in accordance with the rules outlined in Section 3 An AP must notify changes in their health status (surgery, pregnancy etc.) to the Centre Manager or MRSO who will re-screen them and makes changes to their classification (if appropriate).


Appendix 4: MR Safety Screening Forms

MAGNETIC RESONANCE IMAGING INITIAL SCREENING FORM

NAME OF PARTICIPANT.............................................................................. Sex: M / FDate of

birth……………………… Weight in kg……… or Stones/lbs Height in cm or m………………

Please read the questions on this screening form CAREFULLY. Your safety in the magnetic environment is

our primary concern. THIS IS VERY IMPORTANT. For a very small number of individuals, being scanned

can be uncomfortable, or endanger health or even life. The purpose of these questions is to make sure that

you are not such a person. The information you provide will be treated as strictly confidential and will be

held in secure conditions. If you are unsure of the answer to any of the questions, please ASK the person

who gave you this form or the person who will be performing the scan. Definitions of some of the more

technical terms are given overleaf. I wish to be screened by the same gender YES/NO*

Please answer all questions Circle answer

1. Have you been fitted with a pacemaker, artificial heart valve, cochlear implant or any other implanted device?

YES/NO

2. Have you any surgical clips, aneurysm clips, shunts or stents in your body? YES/NO

3. Have you ever had any metal fragments in your eyes? YES/NO

4. Have you been exposed in your life to metal debris as a result of welding, grinding, filing, sawing or drilling of metal either occupationally or recreationally?

YES/NO

5. Do you wear a hearing aid? YES/NO

6. Have you ever had any metal fragments, e.g. shrapnel in any other part of your body? YES/NO

7. Have you any surgically implanted metal in any part of your body (e.g. joint replacement or bone reconstruction)?

YES/NO

8. Have you ever had any surgery that might have involved metal implants of which you are not aware? YES/NO

9. Is there any possibility that you might be pregnant? YES/NO

10. Do you have a contraceptive coil (IUD) installed? YES/NO

11. Have you been sterilised using clips? YES/NO

12. Do you have any dental work (including dentures, crowns, bridgework, braces) in your mouth, other than simple fillings?

YES/NO

13. Have you ever suffered from any of: epilepsy, diabetes or thermoregulatory problems? YES/NO

14. Have you ever suffered from any heart disease? YES/NO

15. Do you have any tattoos? Do you have any permanent eye makeup? YES/NO

16. Are you wearing any skin patches? (eg. Nicotine ) YES/NO

I have read and understood the questions above and have answered them correctly.

SIGNED………………………………....................................... DATE…………………………

In the presence of ………………………………….. (Name) ………………………………….. (Signature)

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Definitions of Technical Terms

PACEMAKER: An electronic device that is surgically implanted in the research participant's body and connected to the heart to regulate the heartbeat. The safe operation of a pacemaker can be temporarily or permanently disrupted if a research participant goes near an MRI scanner.

COCHLEAR IMPLANT: An electronic medical device that bypasses damaged structures in the inner ear and directly stimulates the auditory nerve, allowing some deaf individuals to learn to hear and interpret sounds and speech.

ANEURYSM CLIP: A surgically implanted metal clip used to cut off blood flow through the neck of an aneurysm. An aneurysm is a deformity of a blood vessel in the body, which can swell and burst causing a haemorrhage.

SHUNT: A surgically implanted connector, which allows passage of fluid between two parts of the body. A common use of a shunt is to allow fluid to drain away from the brain, thus reducing pressure in the brain. May also describe a tube which allows blood to be moved from one part of the body to another.

STENT: A surgical implanted device that is inserted into a blood vessel to provide support, keep the vessel open and promote unblocked and enhanced blood flow. Sometimes used in other fluid carrying vessels in the body such as bile ducts etc.

THERMOREGULATORY PROBLEMS: Thermoregulation is the body’s in-built ability to keep all parts of your body at their correct temperature. Some illnesses prevent the person from properly controlling the temperature of their body. If you think you may have such an illness, please answer “YES” and discuss it with the person who gave you the form, or the person who is in charge of the scan.

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Second Screening Form

MAGNETIC RESONANCE IMAGING

SECOND SCREENING FORM

This form should be completed and signed immediately before your scan, after removal of all jewellery or other metal objects and (if required by the operator) changing your clothes.

NAME OF VOLUNTEER …………………………………………………Date of birth……………………………….

Sex: M / F

Please read the following questions CAREFULLY and provide answers. For a very small number of individuals, being scanned can endanger comfort, health or even life. The purpose of these questions is to make sure that you are not such a person.

You have the right to withdraw from the screening and subsequent scanning if you find the questions unacceptably intrusive. The information you provide will be treated as strictly confidential and will held in secure conditions.

Before you are taken through for your scan it is essential that you remove all metal objects including: Watches, Pens, Loose Change, Keys, Hair clips, All Jewellery, brassieres with metal fasteners, metallic cosmetics, Cash/debit cards

Please answer all questions Circle

your answer

1. Are you wearing or carrying any metal items such as those listed above? YES/NO

2. Have your answers to any of the questions in the initial screening form changed?

(The initial screening form must be shown to you before you answer this question.)

YES/NO

3. Have you been fitted with a pacemaker, artificial heart valve, cochlear implant or any other implanted device?

YES/NO

4. Is there any possibility that you might be pregnant? YES/NO

5. Are you currently feeling unwell (colds, flu etc.) or have you been unwell in the last week? YES/NO

I have read and understood the questions above and have answered them correctly.

SIGNATURE………………………………… DATE…………………………

FOR STAFF USE: CRICBristol UNIQUE IDENTIFIER:

I certify that the initial screening form and the consent form have been completed by the person named above and I have attached them to this form. The volunteer has been given the standard information sheet about MRI scans, together with any necessary scan-specific information, and has been given an opportunity to ask questions. I am satisfied that the volunteer is adequately informed and understands the content of the consent form. I have taken adequate steps to ensure that the volunteer has no ferro-magnetic metal in or on his/her person and I am satisfied that the scan can proceed.

SIGNATURE………………………………… NAME (print) …………………………………..

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Visitor Screening Form

MAGNETIC RESONANCE IMAGING VISITOR SCREENING FORM

FOR ACCESS TO THE OUTER CONTROLLED AREA ONLY. NO ACCESS TO MAGNET ROOM

NAME OF VISITOR: …………………………………………………

Please read the following questions CAREFULLY and provide answers. For a very small number of individuals, entering rooms in close proximity to an MRI can endanger comfort, health or even life. The purpose of these questions is to make sure that you are not such a person. The information you provide will be treated as strictly confidential and will be held in secure conditions. If you are unsure of the answer to any of the questions, please ASK the person who gave you this form. The person signing the form at the bottom will tell you whether you may enter the MRI suite. This can only be under the supervision of the person who signs at the bottom of this form.

Under no circumstances must you enter the magnet room itself.

I have read and understood the question above and have answered them correctly.

SIGNED………………………………… DATE…………………………

Please do not write below this line

The above person is cleared to enter the Outer Controlled area of the CRICBristol MRI Suite CRICBristol AUTHORISED PERSON:..........................................................

SIGNED .............................................................DATE: ....................................................

Please answer the following question Circle your answer

Have you been fitted with ANY of the following:

Pacemaker

Hearing Aid

Artificial heart valve

Implanted Cardiac Defibrillator

Neurostimulator

Any type of bio-stimulator

Implanted insulin pump

Cochlear implant

Any other electrical, magnetic or mechanical implanted device?

YES/NO

YES/NO

YES/NO

YES/NO

YES/NO

YES/NO

YES/NO

YES/NO

YES/NO

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Rules for Administration of Screening Forms

General

1. All participants and visitors must complete both the initial and second screening forms

before entering the Controlled Area. In cases where the research participant cannot complete the screening questionnaire or cannot understand the questions, a member of staff should go through the questions with the research participant and with an interpreter if necessary.

2. Completion of the screening forms must be supervised by an Authorised Person who must be satisfied that the participant has read the questions carefully and understands their importance.

3. The first screening may take place at another site before the participant travels to the MRI facility. This is designed to exclude people who may be at risk from either entering the Controlled Area, or being scanned.

4. The second screening form must be countersigned by an Authorised Person before the person enters the Controlled Area. The form should only be signed if all questions have been answered satisfactorily (see below). In the case of participants for scanning, the participant’s GP details must be completed and the participant must sign both screening forms and the consent form.

5. If the person answers “no” to all questions on both screening forms and the Authorised Person is satisfied that the person has given the questions due consideration, the person may be permitted to enter the Controlled Area.

Initial Screening Form

1. If the person answers ‘yes’ to any of the questions 1, 2 or 3, then the participant MUST NOT be allowed into the Controlled Area.

2. If the person answers ‘yes’ to question 5, the person must not be admitted to the Controlled Area until the device is removed. People with resulting hearing impairment can only be scanned if they can hear and respond to the intercom.

3. If the person answers ‘yes’ to any of the questions 6, 7, 8,or 9, then they cannot be scanned and should not enter the Controlled Area. If they answer ‘yes’ to question 10 or 11, they can only be scanned if the contraceptive coil or clip is on list of MR safe implants.

4. If a person answers ‘yes’ to question 12, which relates to dental work, they can be admitted to the Controlled Area. They can only be admitted to the Magnet Room, and then scanned, if one of the following can be ascertained by the Authorised Person responsible for the access/scanning: a) The dental work consists of simple fillings; b) The dental work is a crown or dentures, which can definitely be identified to be non-metallic; c) The dental implant is metallic but removable (for example braces) and is removed before entry to the Controlled Area. If it is not readily removable, the person should not be asked to remove it and scanning must not proceed.

5. If a person answers ‘yes’ to any of the questions 13 or 14 they may enter the Magnet Room but cannot be scanned as a research participant. In certain circumstances, these people may be scanned if they are part of a research project were appropriate ethical approval has been obtained.

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6. If a person answers ‘yes’ to question 15 they may enter the Controlled Area, but can only be scanned if they state that the tattoo was a standard one (not containing a metallic sheen) performed in the UK. If scanning proceeds they must be told to press the alarm-call button if any heating or discomfort is detected at the tattoo site. Should this occur, scanning should be stopped and a cold compress placed over the tattoo. The person must consent to the procedure and be aware of the risks.

7. If a person answers ‘yes’ to question 16 then they must remove the skin patch before entering the MRI facility.

8. If a participant has answered ‘yes’ to a question but is subsequently permitted to enter the Controlled Area, the facts and the basis of the decision must be documented and attached to the filed screening forms. Any material statements made by the research participant should be made in writing on the screening form.

9. Should any person respond positively to question 4 regarding exposure to metal debris as a result of welding, grinding, filing, sawing or drilling of metal either occupationally or recreationally, the person should be referred for ocular X-ray examination prior to being scanned.

If there is Any Doubt as to whether it is safe to proceed, the participant Must Not be allowed to enter the Controlled Area. Note that if someone is prevented from being scanned because of an answer on their screening forms, the person supervising the screening should explain the situation clearly, making clear that there is no cause for alarm, and cancel any MRI examination that has been arranged. They should also point out that rejection as a research participant does not necessarily mean that a future MRI scan for medical purposes would be unsafe and that they should be guided by the medical personnel concerned if such a need should arise.

Second Screening Form

1. If the participant answers ‘yes’ to question 1 then he/she should be asked to remove the item(s) in question, if that is practical, and then amend the answer and initial the change, or complete a fresh second screening form.

2. If the participant answers ‘yes’ to question 2, the initial screening form must be completed afresh and any affirmative answers acted upon in accordance with the rules above.

3. If the participant answers 'yes' to question 3, they must not be allowed into the Controlled Area.

4. A person answering ‘yes’ to question 4 they must not be scanned, but may be allowed into the Controlled Area for other purposes (eg a pregnant Authorised Person may enter to supervise research participants, but has the right to refuse to do so).

5. A person answering ‘yes’ to question 5 should not be scanned. This is because, in theory, people suffering from colds and flu may have reduced thermoregulatory control. In addition, scanning people whilst unwell has obvious disadvantages including the risk of sickness during the scan, cross-infection and reduced data quality.

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All of the Implants and devices should be checked as defined below:

1. Clarification of make and model from the research participant notes.

2. Use the manufacturer’s website.

Also cross-reference with Shellock website:

mrisafety.com

Go to “THE LIST” (left hand side, blue box)

“CLICK HERE to search the list”

Put name of the device in “Object Name”

Under “Result Status” enter “All”

Enter “Manufacturer Name” if known

Click the device in question in the “Object Category”

“search the database”

“The LIST” will then search the database for the implantable devices and will state if safe or unsafe and also give reference information

http://www.mrisafety.com/

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Appendix 5: General MRI Safety Precautions and Procedures Note: Participant/patients have died or lost their sight because they were not adequately screened.

Continued vigilance is needed to prevent harm to research participants or volunteers from bringing them inappropriately into the strong magnetic field, or by using scanning equipment carelessly. Accidents involving the missile effect of ferromagnetic objects in a magnetic field, and burns due to RF heat deposition still happen because of careless practice. All accidents and adverse incidents (including near misses) should be reported to the Centre Manger and/or MRSO (or, in their absence, the Co Directors) who will be responsible for investigating the incident and taking appropriate action. All accidents and incidents should be documented using the University incident/accident/near miss Reporting form Copies of the form can be found in the incident log book in the MRI Control Room and from the University of Bristol Safety Office webpage

http://www.bristol.ac.uk/safety/accidents.html

Any incident/accident/near miss regarded as having an impact on UHBristol requires notification to health and safety UHB and UoB incident/accident/near miss reporting form to be provided for their information and further investigation if deemed necessary.

Areas of potential safety concern are briefly reviewed below:

During an MRI examination, individuals being scanned and those in the immediate vicinity of the equipment will be exposed to a static magnetic field, a relatively low frequency time varying magnetic field and a radio-frequency (RF) field. Safety issues including biological effects, projectile hazards, compatibility of implanted devices, compatibility of ancillary equipment, peripheral nerve stimulation, muscle stimulation, acoustic noise, thermal heating, heat stress, current burns and contact burns must be taken into consideration before each MRI examination.

Potential safety risks occur if the MRI scanner is functioning incorrectly or has been modified in some way so as to render it unsafe. Installation of the scanner must be performed exclusively by the manufacturer and their contractors. As part of the installation process, the manufacturer will ensure that the scanner is operating within its standard parameters, which meet all regulatory requirements and limits. Once the scanner is operational, the medical physics department should be called to check the scanner and confirm the quality assurance and safety is satisfactory. In addition, regular site visits by the manufacturer service engineers will ensure that the scanner is operating within normal parameters. No modification of any hardware or software in the MRI facility is permitted unless clear instructions are given by the manufacturer’s service engineers or the manufacturer’s clinical support scientists.

Static Magnetic Field To date, no long-term harmful biological effects on human tissues have been demonstrated from the static magnetic fields used in clinical MRI at 3T. However, because of the risk of life-threatening malfunction of implanted devices with electronic components, all persons entering the vicinity of the MRI scanner must be screened. For example, there is a risk of malfunction of cardiac pacemakers at field strengths as low as 0.5mT.

With a shielded 3T system there are extremely steep fringe field gradients. Therefore a very high level of vigilance must be maintained to prevent anything being taken into the Magnet


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Room that might result in a projectile incident. Particular attention should be paid to the training of Authorised Personnel, as outlined in the MHRA guidelines.

The MHRA guidelines highlight that implantable medical devices, monitoring equipment, leads, etc should be checked for MR compatibility at 3T before use.

The 3T superconducting magnet is Permanently Activated even when the scanner is not being used for an examination. Hence, there is a need for caution and the potential hazards are summarised below:

The static field can interfere with cardiac pacemakers and other electrically, mechanically or magnetically active devices. Any person with a cardiac pacemaker or any other electrically, mechanically or magnetically active device must not be allowed entry into the MRI Controlled Area.

Embedded metal fragments, aneurysm clips or other implanted medical devices can move (be displaced) due to an attractive and/or torque force. This can cause injury to the research participant and/or damage to the implanted device. If an individual is identified as having a possibility of metallic fragments in the orbits,they cannot be scanned unless proven otherwise

Mechanical attraction of metallic, in particular ferromagnetic objects (eg scissors, pins, fire extinguishers etc) can become projectiles when accelerating towards the magnet and may hit the body of a person or the gantry of the scanner. This can cause fatal or serious injury to the person and serious damage to the scanner.

The static magnetic field has no known biological effect on humans. As far as is known, the static fields associated with MRI pose no risks to operating staff, so long as the appropriate screening and safety procedures are followed. However, National Radiological protection board (NRPB) guidelines state, as a precaution, that occupational static field exposure, averaged over an 8 hour period, should not exceed 0.2T to the whole body.

It is prudent to avoid unnecessary or excessive exposure to the static field, particularly in the case of pregnancy. To date, there has not been any study showing evidence of direct harm from the static fields associated with MRI to the mother or foetus during pregnancy. However, the consensus in the MR community is that pregnant women should only be scanned when there is a clear clinical benefit to either the mother or foetus. Pregnant staff should be allowed to work within the Controlled Area. However, pregnant women should not be in the Magnet Room during scanning.

Monitoring equipment that has ferromagnetic components can be affected by the static magnetic field and only devices that have been tested and demonstrated as being MR Conditional in the specified MR environment with specified conditions of use should be allowed entry into the Magnet Room.

The static field can cause damage to personal possessions such as analogue watches and credit cards. All possessions, which either may be damaged by the MRI system, or more importantly, may pose a projectile risk, must be secured in lockers external to the Controlled Area before the research participant is admitted entry to the Controlled Area.

Movement in the static magnetic field may cause some research participants acute vertigo-like sensations. This should be reduced by avoiding rapid movement in the Magnet Room. The sensitivity to movement induced sensations in the static field can

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vary between individuals. Research participants should be moved into and out of the bore of the magnet slowly as possible to avoid movement induced sensory effects.

Time-Varying Fields (from switching of the gradient magnetic fields) Rapidly switching magnetic field gradients are used to encode spatial position in the image. The hazards associated are summarised below:

The relatively low frequency (compared to RF fields) time-varying magnetic fields used for spatial encoding can potentially induce electric currents that could be sufficiently large in human tissues to interfere with the normal function of nerve cells and muscle fibres. Some research participants are particularly sensitive to PNS caused by certain MRI pulse sequences, which employ particularly rapid gradient switching. Usually, if peripheral nerve stimulation occurs it manifests as an uncomfortable tingling sensation, particularly in the extremities. In more serious, but extreme cases, the high rates of gradient field switching could lead to ventricular fibrillation. In scanners operating within IEC limits, ventricular fibrillation is prevented by restricting exposure to rates of change of magnetic flux density and the scanner is unable to switch gradients at levels higher than maximums set by regulatory bodies. The thresholds for PNS are much lower than for ventricular fibrillation, hence, while scanning particular care should be taken to ensure the feeling of uncomfortable or painful sensations caused by the induced current densities is minimised. An intercom and alarm-call system must be used so that the participant can report any uncomfortable peripheral sensations and stop the scan if necessary.

Heating can also occur in the vicinity of some implanted metal devices or objects, due to the induced electrical currents. The risk of injury caused by heating can be reduced by careful screening of research participants and by ensuring that they do not form any current loops with their bodies, ie no hand clasping or feet crossing.

All Research participants must be given an Alarm-Call Device, which when pressed will Sound an Alarm and Scanning must be stopped immediately. Research participants should be instructed to activate this alarm if any discomfort is felt. This means that only communicative and aware research participants who are able to understand these instructions should be scanned, unless there is in place additional MR conditional equipment for monitoring the research participant’s physiology (heart rate, temperature etc) during scanning.

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Radio-frequency (RF) Fields MRI involves the use of Radio-Frequency (RF) energy, which is applied to the body. RF fields are used to excite hydrogen nuclei in the body, in order to generate the MRI signal, which is detected and digitally recorded. The RF signals are applied and detected using coils placed in close proximity to the body-part being scanned The potential hazards associated with the RF fields used in MRI are summarised below:

Absorption of energy from the RF fields results in the increased oscillation of molecules and the generation of heat. This is compensated by dilatation of blood vessels which results in an increase in blood flow. The main concern is excessive cardiovascular strain resulting from thermoregulatory responses to body temperatures raised over a short period of time by more than 0.5oC. Research participants suffering from hypertension, pregnant women, the elderly and the very young, or research participants on drugs such as diuretics or vaso-dilators are of concern. Research participants exposed to short periods of RF at Specific energy Absorption Rate (SAR) of 1W/kg to 4W/kg will experience a tolerable heat load and rise in temperature of less than 1oC. The less heat tolerant group should be restricted to less than 0.5oC.

The RF pulses, if used improperly and indiscriminately, could cause extensive localised heating (and even tissue damage in extreme cases). The SAR is a term used to estimate the amount of RF dose received by the research participant, and is expressed as watts of power per kilogram of the research participant's body weight. SAR limits have been set for specific areas of the body (eg the head) and must not be exceeded. The scanner will limit the SAR so that RF deposition is within guidelines set by regulatory bodies (such as the IEC). For the SAR to be correctly calculated by the scanner software, it is critical to enter the research participant's correct height and weight and date of birth. Failure to do so may result in incorrect SAR limits being calculated, which may result in research participant heating or burns. The actual SAR applied to the body is dependent on temperature and humidity within the magnet bore. Scanning must not proceed if these are outside the manufacturer’s operating limits; hence routine maintenance of the cooling systems and air conditioning in the Magnet Room and around the MRI system is important.

Currents can be induced in metallic leads and electrodes (such as ECG leads) potentially causing burns in adjacent tissues. Electrical conducting elements, such as wires, must never be looped across the participant’s body or contact the participant’s skin. In addition, the research participant’s skin should never be allowed to touch either the sides of the RF coil, or the bore of the scanner. If necessary, padding (supplied by the manufacturer) should be used to prevent this.

Heating can occur from induced currents when a conductive loop is formed within the research participant’s body, eg by skin contact between the research participant’s thighs and feet, or arms. Care should also be taken to insulate the research participant from any metal (eg jewellery) that cannot be removed and to avoid the formation of potential conductive loops.

Certain types of cosmetic makeup contain metallic compounds; being most prevalent in eye makeup. These can potentially cause heating during scanning leading to discomfort or injury through burning. In addition, metallic makeup may significantly degrade the MR image quality. Research participants should be asked to remove all makeup which is metallic in nature, and in particular should be asked to remove all eye makeup.

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It has been known, in rare cases, for tattoos to contain metallic inks. Again, these can show potentially damaging heating effects during scanning. If research participants have tattoos and the presence of metallic inks is definitely confirmed then scanning should not proceed. If the tattoo is thought to be non-metallic, then the research participant can be scanned, but must be advised to press the alarm-call button if heating is felt in the region of the tattoo.

Liquefied Helium The liquefied helium used by the superconducting magnet also poses potential hazards, which are summarised below:

The equipment on top of the magnet, and pipes leading from it, can be extremely cold. Touching these surfaces can result in severe cold burns.

Sudden collapse of the magnetic field (‘quenching’) can occur without warning, causing immediate and violent boil off of very cold Helium gas. Asphyxiation of persons within the Magnet Room could occur during ‘a quench’, if the ventilation system fails to operate properly.

A quench might occur, either because it has been activated by the scanner operator during an emergency, or on a rare occasion it might occur spontaneously. A quench is generally accompanied by a loud bang and, sometimes, the release of large quantities of cold gas into the Magnet Room. The cryogenic helium gas will liquefy oxygen out of the air; hence, both asphyxia and fire are real threats.

During a quench, the oxygen levels in the Magnet Room may become dangerously low. The presence of the cold gases could cause cold burn, frostbite orhypothermia . It is important to evacuate everybody out of the Controlled Area and particularly out of the Magnet Room as quickly as possible and restrict access to the Magnet Room until the arrival of the scanner service engineers. In the unlikely event that someone is trapped in the Magnet Room and the oxygen level is dangerously low, keep the door of the Magnet Room fully open until the trapped person can be rescued. There is a risk of fire starting if there are naked flames or sparks in the Controlled Area.

In some emergency cases, the MRI operator may deliberately quench the system. Although most of the helium gas should be vented through the purpose built pipe, there is a risk that cold helium gas will remain in the Magnet Room. This can cause cold-related injuries and potentially cause asphyxiation as the helium displaces oxygen within the Magnet Room. Oxygen monitoring systems are installed and maintained to warn of any dangerous reduction of oxygen within the Magnet Room.

To minimise a large positive pressure in the Magnet Room due to Helium leakage it is recommended that the gas escape vents are annually checked by Estates & Facilities and any blockage removed.

Acoustic Noise During scanning, rapid gradient switching in MRI systems, results in high levels of noise being produced. It is essential, therefore, for all individuals to wear hearing protection while in the Magnet Room during scanning. Hearing protection must be provided to all staff, research participants and accompanying relatives within the Magnet Room while the scanner is

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operational. This will consist of magnet-compatible ear defenders (headphones) and/or disposable ear canal inserts.

The Control of Noise at Work Regulations 2005 stipulates that personal exposed to acoustic noise above 80dB should be offered hearing protection. Contraindications THE FOLLOWING PEOPLE MUST NOT BE SCANNED:

Individuals fitted with cardiac pacemakers, cochlear implants, neurostimulators or any other device that is electrically, mechanically or magnetically activated.

Individuals with metallic intra-ocular foreign bodies, or individuals with ferromagnetic non-MR compatible aneurysm clips.

Individuals who have had a penetrating injury to the eye involving metal even if it is confirmed to have been removed (as advised by the safety web site, mrisafety.com)

Individuals who have a prosthetic cardiac valve.

Advice must be sought from either the MRSO before scanning the following Categories of Subject:

Participants within 6 weeks of surgery where haemostatic clips have been inserted.

Participants with metallic implants (refer to Shellock and Kanal for compatibility of device).

Participants with a low tolerance to temperature change (these subjects must be monitored

during the scan using the pulse oximeter).


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Appendix 6: Protocol for MR Examinations

1. Healthy volunteers may only be accepted for a MR examination under protocols approved by the University or NHS Ethics Committee.

2. All volunteers should be assessed for contraindication against having the examination.

3. The purpose and nature of the examination should be explained to the volunteers.

4. The volunteers must have had the opportunity to ask questions.

5. The volunteers will be free to withdraw consent at any time.

6. Records of each volunteer and their examination will be kept in accordance with the Department of Health guidelines for magnetic resonance diagnostic equipment in clinical use.

Screening and Scanning Procedure for Research Participants

At Recruitment

Before being recruited to take part in a study, the potential Participant should undergo a preliminary screening for absolute contraindications to MRI scanning, ie cardiac pacemaker, aneurysm clip, metallic implants etc.

In CRICBristol

For safety and privacy during screening the Participant must complete the screening form in the CRICBristol MRI preparation Area or Reception meeting room.

The Experimenter should be available to answer questions whilst the Participant completes the screening form.

If the Experimenter is unclear about the safety implications of the Participant’s response to the screening form, the Scanner Operator or MRSO should be consulted.

Explain the purpose of the study and provide the Participant information of what to expect during the scanning process (noises, tasks etc).

Do not take the Participant into the MRI facility until the Scanner Operator is ready. The Participant should remain in the MR preparation Area. Give the completed screening form to the Scanner Operator. Highlight any potential risks from the screening form and from discussions with the Participant.

Before entering the MRI facility, ensure that the Participant’s pockets are empty. Remove hair clips, watches, jewellery, glasses, piercing etc. Leave items in the lockers. The Experimenter should take the locker key and keep it safe outside of the magnet room .

Do not leave the Participant unattended within the MRI facility. This is the responsibility of the Experimenter, not the Scanner Operator.

Do not leave the Participant unattended within the MRI facility. Do not take the Participant into the MRI facility if they have a pacemaker, aneurysm clip or metallic implants. Take the Participant back into the Reception Area after completing the

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screening procedure and explain to them why it may not be safe for them to undergo a MRI.

In The MRI Facility

The Participant should not enter the MRI facility until the Scanner Operator is ready

Do not leave the Participant unattended within the MRI facility.

The Scanner Operator will go through the screening form with the Participant.

The final decision as to whether the Participant may undergo MRI scanning rests with the Scanner Operator.

If the Scanner Operator is in doubt about the safety of scanning a Participant, the Participant should not enter the Magnet Room.

Responsibility for ensuring that stimulus presentation equipment is working and set up properly rests with the Experimenter.

Lack of an Ethics Code is a valid reason for refusal to scan the Participant. It is the responsibility of the Experimenter to ensure that a valid Ethics Code is provided.

The Scanner Operator will decide when the scanning session is finished. This is based on the time allocated to the study and is independent of whether the study has been completed. It is up to the Experimenter to book enough time to complete the study.

After scanning, the Participant should be taken back to the Reception Area and not remain within the MRI facility longer than is necessary.

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Appendix 7: Access to the MRI facility

It is extremely important to control the access of personnel and equipment into the MRI Controlled Area (see Appendix 1, page 13). The restriction and control of personnel and equipment into the Controlled Area forms the principal defence against MR related injury. The only means of access to the Controlled Area should be via the security doors, which can be opened by means of a swipe card . Appendix 1, page 13 shows a plan of the MRI facility and the extent of the Controlled Area.

Members of the public and staff should be excluded from the Controlled Area unless accompanied and supervised by an MR Authorised Person after satisfactorily completing the MRI safety screening form.

No person should work in the Controlled Area on their own when scanning research participants. No person may be placed in the scanner unless at least Two Authorised Persons are present and at least one of whom is an ASU.

No person, other than CRICBristol MR authorised staff (i.e. Centre Manger, Imaging Professor and MRSO), or the Siemens MRI engineers, UHBristol Medical Physics staff approved by Centre Manager or MRSO may enter the Magnet Room when alone in the MRI facility.

The boundaries of the MRI facility are clearly defined on the plan in Appendix 1, page 13. The outer door to the MRI facility must be kept closed at all times – even when the area is being supervised by an Authorised Person. Admission is by swipe card only. Only Authorised Persons will have swipe card access. Swipe card access is granted by the MRSO or Centre Manager.

UHBristol staff, or University of Bristol staff with an UHBristol honorary contract who are MR authorised will be granted swipe card access through their UHBristol staff card by the Centre Manager. They will be required to give their staff card number to the Centre Manager who will request security to activate the card for access to the MRI facility. Their staff card number will be kept in the MR authorised Persons record book held in the Centre Manger’s office.

All other MR authorised Personnel will be given a CRICBristol MRI zoned swipe card while they are working in the MRI facility. This swipe card must be signed in and out with the MRSO or Centre Manager.

When the MRI facility is not in use, the following doors must be kept locked:

Magnet Room door

Equipment/Cabinet Room door

Control Room door

Control and Magnet room doors are accessed by keys only. These doors are clearly identified in Appendix 1, page 13. Keys are kept in the CRICBristol Reception in a locked cabinet. Only an Authorised Person will be issued with the keys, which must be signed for in the accompanying log book. Upon return of the keys to reception, the Authorised Person must sign the log book to acknowledge the keys have been returned.

An additional set of keys are kept by the MRSO and Centre Manager.

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Appendix 8: Authorised MRI Scanner Operators Declaration

MRI Authorised Scanner Operators Training Declaration

Name.......................................................................................

I have watched the current Siemens MRI safety Video

Signed .................................................................Date.............................................

I have read and understood the CRICBristol MRI Local Rules and Procedures

Signed .................................................................Date.............................................

I have read and understood the University Radiation Safety Policy

Signed .................................................................Date.............................................

I have read and understood the MRHA guidelines

Signed .................................................................Date.............................................

I have attended the UHBristol fire safety training

Signed .................................................................Date.............................................

I have attended UHBristol first aid and resuscitation training

Signed .................................................................Date.............................................

The above named has taken and passed the MRI safety Exam and has been signed off for

level .............................MR Authorised Person

Signed ............................................... MRSO or Centre Manager

Date.............................................

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Appendix 9: CRICBristol Research Flow Diagram Diagrams can be downloaded from www.cricbristol.ac.uk

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Appendix 10: Procedures for Research Studies

Use the CRICBristol Flow diagram in Appendix 10 to identify research pathway for your study

Essential documents require by CRICBristol to begin research study

1. Ethics Approval letter from relevant NHS or University Ethics Committee. 2. Research governance registration with UoB or UHBristol R&D 3. Sponsor Letter 4. CRICBristol MR Risk Assessment form completed by the study Chief/Principle

Investigator

Incidental findings in MRI Examination: Research participants

CRICBristol does not have an incidental findings policy

1. The incidental findingsi policy of each MRI study at CRICBristol is the responsibility of the

Chief/Principal Investigator (CI/PI) leading the research project.

2. CRICBristol MR authorised staff will be able to advise the CI/PI at the project proposal stage on the most appropriate incidental findings policy for their study.

3. Each research project must submit their research project appropriate incidental findings policy to the relevant ethics committee approval.

4. The CI/PI will provide CRICBristol staff with a copy of the ethically approved incidental findings policy for their study.

5. Unless otherwise stated in the participant information sheet, qualified radiologists will not

normally review the MR scans of the research. Given this, it is unlikely that CRICBristol staff will become aware of any incidental findings on the scans.

6. In the unlikely event that CRICBristol staff becomes aware of unexpected or incidental finding as a result of a MR scan, they will notify the CI/PI who must implement the ethically approved incidental findings policy for their research project. 1 Incidental finding: unexpectedly identified abnormality that requires further investigation by a medical

professional found during a research MR imaging procedure.

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MRI Data Handling Policy

Confidentiality Subject to the requirements of legislation, including the Data Protection Act 1998, all information obtained about participants during an investigation is confidential unless otherwise agreed in advance. All MRI imaging data is anonymised before scanning in order to protect an individual’s identity.

Anonymisation is done by using coded information as the participant ID. The key to this code

is only accessible to members of the research team using that information.

This process should be detailed in the ethically approved research protocol and participant

information sheet/consent form, which must be adhered to.

Data transfer At the end of each scan session, the operator will transfer all anonymised data onto a University file server. Access to this is via User ID and Password. The console will be cleared of all scans monthly.

Data Security

All image data is only accessible to authorised users who have a user ID and password for a firewall protected server Data Analysis Data analysis will use a variety of methods. These will include Siemens programmes on the MRI console and computer based programs such as MATLAB, SPM, AFNI, DTIstudio, DTIslicer, LC Modelling and programs created/modified by the researchers. This data handling policy is in accordance with RCUK and NIHR guidelines

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Example MRI Information Form for Research Participants – fMRI

Functional Magnetic Resonance Imaging Information Sheet

Project title:

Functional Magnetic Resonance Imaging Volunteer Information Sheet These notes give some information about an MRI scan in which you are invited to take part. Functional MRI is a method for producing images of the brain. It involves placing the volunteer inside a large, powerful magnet which forms part of the brain scanner. In addition, MRI can be used to determine which parts of the brain are active during different tasks – this is known as functional MRI or fMRI. When particular regions of the brain are active, they require more oxygen, which comes from red corpuscles in the blood. As a result, the flow of blood increases. This can be detected as changes in the detected MR signals. These changes can then be converted by a computer into 3D images. This enables us to locate which parts of the brain are active during different tasks. As far as we know, this procedure poses no direct health risks. However, the Department of Health advises that certain people should NOT be scanned. Because the scanner magnet is very powerful, it can interfere with heart pacemakers and clips or other metal items which have been implanted into the body by a surgeon, or with body piercing items. If you have had surgery which may have involved the use of metal items you should NOT take part. If you are pregnant or think you might be pregnant you should NOT take part. You will be asked to complete a questionnaire (the Initial Screening Form) which asks about

these and other matters to determine whether it is safe for you to be scanned. You have the

right to withdraw from the screening and subsequent scanning if you find the questions

unacceptably intrusive (you can also request the screening to be carried out by someone

of your gender).You will also be asked to complete a second, shorter, screening form

immediately before the scan.

Note that only ferro-magnetic materials (e.g. steel) are likely to cause significant problems.

Normal dental amalgam fillings do not prohibit you from being scanned, but a dental plate or

braces which contain metal would, and you would be asked to remove it. You will be asked to

remove metal from your pockets (coins, keys).You will also be asked to remove articles of

clothing (in a dedicated changing room) that have metal fasteners (belts, bras, etc), as well as

most jewellery. Please bring suitable clothing with you for the scan. Sweatshirts and jogging

trousers are ideal.

The magnetic field can cause damage to personal possessions such as watches and credit

cards and such items should not be taken into the scanner, and should be placed in the

lockers provided in the lobby of the MR suite. The key will be placed a secure location by the

scanner operator and returned to you after the MRI scan.

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To be scanned, you will lie on your back on a bed on runners, on which you will be moved until your head is inside the magnet. The scanning process itself creates intermittent loud noises, and you must wear ear-plugs or sound-reducing headphones. We are able to talk to you while you are in the scanner through an intercom. If you are likely to become very uneasy in this relatively limited space (suffer from claustrophobia), you should NOT take part in the scan. If you do take part and this happens, you will be able to alert the staff by activating an alarm and will then be removed from the scanner quickly. It is important that you keep your head as still as possible during the scan, and to help you with this, your head will be partially supported with padded headrests. We shall ask you to relax your head and keep it still for a period that depends on the scan but may be more than one hour, which may require some effort on your part. If this becomes unacceptably difficult or uncomfortable, you should ask to be removed from the scanner. You may be asked to look at a screen through a small mirror (or other device) placed just above your eyes and/or be asked to listen to sounds through headphones. You may be asked to make judgements about what you see or asked to perform some other kind of mental task. Details of the specific scan in which you are invited to participate will either be appended to this sheet or else given to you verbally. Detailed instructions will be given just before the scan, and from time to time during it. The whole procedure will typically take about 1 hour, plus another 15 minutes to discuss with you the purposes of the scan and answer any questions about it which you may raise. You will be able to say that you wish to stop the testing and leave at any time, without giving a reason. This would not affect your relationship with the staff or University in any way. THIS IS NOT A MEDICAL OR DISEASE DIAGNOSTIC SCAN and therefore your scan will not be examined for abnormalities. The scan will not benefit you directly, and does not form part of any medical diagnosis or treatment. However, very occasionally, when we look at an MRI scan from a healthy volunteer, unexpected potential abnormalities are discovered and if appropriate your GP will be contacted. The staff involved in this training and feasibility test scanning do not have expertise in medical diagnosis, as they are not have the relevant specialist medical training. You should not regard this scan as a medical screening procedure. If you agree to participate you will be asked to sign the initial screening form that accompanies this information sheet, in the presence of an appropriate member of staff. It is perfectly acceptable for you to take time to consider whether to participate, or discuss the scan with other people, before signing. After signing, you will still have the right to withdraw at any time before or during the scan, without giving a reason. The images of your brain will be held securely and any identifiable information stripped from the scan. The information in the two screening forms will also be treated as strictly confidential and the forms will be held securely until eventually destroyed. Further information about the specific scan in which you are invited to participate may have been appended overleaf, if the person performing the scan has felt that this would be helpful. Otherwise, he/she will already have told you about the scan and will give full instructions prior to the scan. Please feel free to ask any questions about any aspect of the scan or the scanning procedure before completing the initial screening form. The purpose of the scans we have invited you to have is [study specific information to be

inserted here]

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Example MRI Information Form for Research Participants – Anatomical Imaging

Magnetic Resonance Imaging Information Sheet

Project title:

Magnetic Resonance Imaging Information Sheet These notes give some information about an MRI scan in which you are invited to take part.

MRI is a method for producing images of the body. It involves placing the volunteer inside a

large, powerful magnet, which forms part of the MRI scanner. Radiofrequency signals are also

used as part of the imaging process.

The MRI procedure poses no known direct health risks. However, the Department of Health

advises that certain people should NOT be scanned. Because the scanner magnet is very

powerful, it can interfere with heart pacemakers and clips or other metal items which have

been implanted into the body by a surgeon, or with body piercing items. If you are pregnant or

think you might be pregnant you should NOT take part. If you have had surgery which may

have involved the use of metal items you should NOT take part.

You will be asked to complete a questionnaire (the Initial Screening Form) which asks about

these and other matters to determine whether it is safe for you to be scanned. You have the

right to withdraw from the screening and subsequent scanning if you find the questions

unacceptably intrusive (you can also request the screening to be carried out by someone

of your gender).You will also be asked to complete a second, shorter, screening form

immediately before the scan.

Note that only ferro-magnetic materials (e.g. steel) are likely to cause significant problems.

Normal dental amalgam fillings do not prohibit you from being scanned, but a dental plate or

braces which contain metal would, and you would be asked to remove it. You will be asked to

remove metal from your pockets (coins, keys).You will also be asked to remove articles of

clothing (in a dedicated changing room) that have metal fasteners (belts, bras, etc), as well as

most jewellery. Please bring suitable clothing with you for the scan. Sweatshirts and jogging

trousers are ideal.

The magnetic field can cause damage to personal possessions such as watches and credit

cards and such items should not be taken into the scanner, and should be placed in the

lockers provided in the lobby of the MR suite. The key will be placed a secure location by the

scanner operator and returned to you after the MRI scan.

To be scanned, you will lie on your back or front on a narrow bed on runners, on which you will

be moved until your head or feet are inside the magnet. Whether you go in the scanner feet or

head first will depend on the body region being studied for the protocol being developed.

The scanning process itself creates intermittent loud noises, and you must wear ear-plugs or

sound-reducing headphones. We are able to talk to you while you are in the scanner through

an intercom. If you are likely to become very uneasy in this relatively limited space (suffer from

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claustrophobia), you should NOT take part in the scan. If you do take part and this happens,

you will be able to alert the staff by activating an alarm and will then be removed from the

scanner quickly.

It is important that you keep your body as still as possible during the scan, and to help you with

this, you may be partially supported with padding. We will ask you to relax your body and keep

it still for the period of the scan. If this becomes unacceptably difficult or uncomfortable, you

may ask to be removed from the scanner.

The whole procedure will typically take between from 20 minutes to 1 hour, plus another 15

minutes to discuss with you the purposes of the scan and answer any questions you may

have. You will be able to say that you wish to stop the testing and leave at any time,

without giving a reason. This would not affect your relationship with the staff or University or

the UHBristol NHS trust in any way.

THIS IS NOT A MEDICAL OR DISEASE DIAGNOSTIC SCAN and therefore your scan will not be examined for abnormalities. The scan will not benefit you directly, and does not form part of any medical diagnosis or treatment. However, very occasionally, when we look at an MRI scan from a healthy volunteer, unexpected potential abnormalities are discovered and if appropriate your GP will be contacted. The staff involved in this training and feasibility test scanning do not have expertise in medical diagnosis, as they are not have the relevant specialist medical training. You should not regard this scan as a medical screening procedure. If you agree to participate you will be asked to sign the initial screening form that accompanies this information sheet, in the presence of an appropriate member of staff. It is perfectly acceptable for you to take time to consider whether to participate, or discuss the scan with other people, before signing. After signing, you will still have the right to withdraw at any time before or during the scan, without giving a reason. The images we obtain will be held securely and any identifiable information stripped from the scan. The information in the two screening forms will also be treated as strictly confidential and the forms will be held securely until eventually destroyed. Further information about the specific scan in which you are invited to participate may have been appended overleaf, if the person performing the scan has felt that this would be helpful. Otherwise, he/she will already have told you about the scan and will give full instructions prior to the scan. Please feel free to ask any questions about any aspect of the scan or the scanning procedure before completing the initial screening form.

The purpose of the scans we have invited you to have is [insert study specific information]

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Clothing in the MRI Scanner

This document describes suitable clothing for research participants undergoing an MRI scan.

It is important that that the clothes you wear for the MRI scan contain little or no metal. The reason for this is the MRI scanner works using a very strong magnetic field, which will pull on any metal fastenings. As well as being uncomfortable, while the scanner is working the metal can theoretically be heated causing burns. Finally, and most commonly, the presence of metal can distort the images we collect, rendering them useless.

For these reasons, we would ask all research participants to come dressed according to the following guidelines, or to bring a suitable set of clothes to change into – in the MRI facility, adjacent to the scanner, we have a very private changing room, which includes secure lockers for valuables. Note that we do not require MRI research participants to change into hospital-type clothing and we do not provide a change of clothes for hygiene reasons.

Ideally, the clothing you bring should be comfortable without any metal whatsoever. An ideal solution is a sweatshirt and drawstring jogging trousers.

Note that the most important requirement is that the clothing of the top-half of your body contains no metal. In our experience, trousers containing a single metal zipper do not normally cause problems, but we would prefer research participants to wear/bring trousers without any metal fastenings. From a privacy point of view, it is desirable that trousers are worn by all research participants, including females.

Females will be asked questions about metal bra-straps, as these cannot be allowed in the scanner. Research participants wearing underwear, such as bras, containing metal will be asked to remove these items when they change into their clothes for scanning.

Some experiments require the research participant to view visual stimuli that are projected on a screen above their head. A mirror above the research participant’s eyes allows them to see the screen. Sometimes, the research participant’s hair will obscure part of the view. In these cases you may be asked to wear either a hair-net or shower-cap, which we will provide. Glasses/spectacles cannot be worn in the MRI scanner therefore if the research project involves visual stimuli participants will need to be contact lens wearers.

If you have any questions about this, or other issues regarding your scan, please contact the person who gave you this information

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Appendix 11: Incident Reporting

Incidents, including near misses, should be reported to the MRSO and or Centre Manager as soon as possible. They will investigate the seriousness of the incident and may wish to decide immediate actions. All accidents and incidents must be logged and reported using the University standard form; copies are found in the incident reporting folder in the MRI Control Room. Including guidelines on completing form and flow diagram, they can also be obtained from staff safety intranet. http://www.bristol.ac.uk/safety/accidents.html

ALL faults must be (i) reported to the MRSO or Centre Manager (see Appendix 2, page 15) at the earliest opportunity and (ii) documented in the Faults Book, which is kept in the Control Room.

If faults occur that prevent normal safe operation of the equipment, it must be taken out of service until repaired and passed fit for use by a competent person. Any work that is required to be untaken in the MRI facility Controlled Areas by Estates & Facilities staff or external contractors such as Siemens, it must be documented and those persons issued with a Permit to Work. The Permit to Work must be completed and signed by the MRSO or Centre Manager.

Should the use of equipment produce an accident, near miss or hazardous situation, operation must cease immediately until the cause is investigated and the hazard is removed.

To minimise inconvenience, faults should also be reported to all other Authorised Persons who may be intending to use the equipment in the following 48 hours.

In the event of a fault that prevents normal safe operation, the following must be observed:

The room must be signed out of use.

A “Do not use” sign must be fixed to the equipment.

The equipment must be signed over to the Siemens engineer and then signed back by the engineer once repaired and tested. Only then may it be signed back into use for scanning.

All accidents and other unforeseen incidents in the MRI facility must be reported. This includes, but is not restricted to:

1. Harm to the participant being scanned.

2. Projectile incidents (including minor ones such as coins).

3. Damage to equipment (which must be reported to member of the MRI Support Group on the technical contacts list (see Appendix 14, page 45) This list is also displayed in the MRI Control Room).

4. Any accident in the MRI facility – to staff or visitors.

5. Any problems with temperature/humidity and services such as electricity and water.

6. Any technical problems with the scanner, such as a failure to scan.


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Appendix 12: Emergency Contacts

MRI Scanner Emergency Contact Cascade

In the event of a serious emergency or fault occurring with the scanner, one of the following people should be contacted. Contact should be attempted from the top of the list downwards.

1. Aileen Wilson Lead Research Radiographer MRSO, Work Tel 0117 3421500

2. N Jade Thai – Centre Manager Work Tel: 0117 3421501

3. Risto Kauppinen Professor of Imaging Work Tel: 0117 928 8461

Note that in the event of a medical emergency involving someone in the MRI facility follow the arrest procedure. (appendix 13)

Ambulance

The Nurse-alarm call should be activated. An ambulance is called directly on 999 and security informed.

Security

Internal extension number within UHBristol 2222(Emergency); 2995(Non-Emergency

Type of Incident Name of Contact Telephone Number

Fire MRSO/Centre Manager

0117 3421503/ 0117 3421501

Quench MRSO /Centre Manager

0117 3421503/ 0117 3421501

First Aid MRSO 0117 3421500

Cardiac Arrest St Michael’s Hospital Resuscitation team

Use nurse alarm call located in Control Room/Magnet Room

Broken Scanner MRSO 0117 3421503

Broken Equipment MRSO 0117 3421503

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Technical Contacts In event of a technical fault a member of the MRI Support Group should be contacted and the error message from the MRI scanner should be logged.

MRI SUPPORT GROUP

Aileen Wilson-Lead Research Radiographer MRSO

Work Tel: 0117 3421503

Jade Thai – Centre Manager Work Tel: 0117 3421501 MEMO Philip Quirk

Work Tel 3422636

MR Advisor (medical physics) Ron Hartley-Davies

Work Tel 3423340

The MRI support group will contact Siemens to report the fault

Siemens UPTIME services Tel 08453002476, quoting system serial number 006-MR00025660

Estates & Facilities

In case of problems with MRI environment (Temp/Humidity) and/or services such as water and electricity, contact Estates & Facilities on 0000. This is during normal working hours, Out of hours, contact MRI Support Group.

CRICBRISTOL Internal Numbers

MRI Control Room 21519

Lead Research Radiographer/MRSO 21503

Centre Manager’s Office 21501

CRICBristol reception 21500

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Appendix 13: SOP Cardiorespiratory arrest/medical emergency

MRI SCANNER

STANDARD OPERATING PROCEDURE for the management of

CARDIORESPIRATORY ARREST (or other medical emergency) There will always be two people present in the MRI suite during scanning.

In the event of a cardio respiratory arrest (or other medical emergency):

Person 1 Person 2

1 undock the table Dial 2222 to call the

Resuscitation Team

2 wheel the patient out of the Magnet Room Clearly state which team you

need, i.e. adult, paediatric or

neonatal

3 commence BLS immediately State that access to CRICBristol

is via the corridor on level B, St

Michael’s Hospital

4 Lock the Magnet Room door

5 Take the appropriate,

resuscitation trolley, i.e. adult or

paediatric, to the scene

6 Wait at entry to CRICBristol on

the level B corridor to direct the

Resuscitation Team

7 Assist with resuscitation as appropriate Assist with resuscitation as

appropriate

Following the resuscitation, the leader of the resuscitation team will be

responsible for the post-resuscitation care & safe transport of the patient.

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Appendix 14: Oxygen Policy

CRICBristol Oxygen Policy

Oxygen is classified as a drug which requires a prescription in medical and research settings.

1. Administration of oxygen in research

a. The appropriately qualified person will be responsible for the oxygen management

b. All staff and research users should be aware of and comply with the relevant

University Hospital Bristol NHS foundation Trust policy for the Prescription and

Administration of Oxygen

2. Administration of Oxygen in emergency

a. A prescription is not required and oxygen can be given by an appropriately qualified

healthcare professional e.g. nurse, doctor, paramedic.

b. The person who administers the oxygen should document that oxygen was given in

the person’s source records e.g. medical records and or record log sheet located in

folder of resuscitation trolley

c. If cylinders have been used, inform CRICBristol staff so that they can ensure

cylinders which are low or empty are replaced.

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Appendix 15: Booking policy

CRICBristol MRI Booking Policy

Advance booking limit

3 months for patient groups, 2 months for other studies.

Regular bookings

Projects that require a regular timeslot each week (e.g. clinical populations, or large cohorts)

can request this from the CRICBristol Centre Manager.

The timing of the regular slot will be accommodated as far as practical, subject to the

limitations of radiographer provision.

Regular bookings may have to be changed in future to accommodate changes in radiographer

provision or scanner demand.

A maximum of four hours per project per week during core hours may be allocated in regular

bookings to any one project.

Cancellations

Cancelled bookings are chargeable. For any project, the first ‘chargeable’ cancellation will be

overlooked, but subsequent cancellations will be charged at the following rate:

Bookings cancelled less than 7 days before the scan will be charged at 50% of the scan fee

(excepting bookings made less than 7 days before the scan).

Bookings cancelled less than 24 hours before the scan will be charged at 100% of the scan

fee (excepting bookings made less than 24 hours before the scan)

The researcher should inform the operator and/or the CRICBristol Lead Research

radiographer ([email protected]) that the slot has been vacated.

The following are also chargeable cancellations:

Researcher failing to arrive, or arriving late for the scanning session.

Participants not passing MR screening (contra-indications should be checked prior to the

participant arriving for a scan).

Participants failing to meet any criteria for the experiment (e.g. failing a performance limit for a

task).

Covered slots that are unbooked 24 hours beforehand will revert to ‘No Cover’. It may be

possible to provide operator cover for this slot, but the operator should be contacted directly to

organise this.

mailto:[email protected]

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Core Hours are defined as:

Mon 10-5*, Tues 10- 5, Wed 10 – 5*, Thurs 10 – 5*, Friday 8 – 5

Operator Cover

Studies requiring an MR operator should book slots during the hours where there is MR cover

available. Operator cover is shown on the booking system.

Studies requiring operator cover outside the designated hours should arrange this with the

operators directly.

Bookings for more than 4 weeks in advance are considered provisional, to allow the operators

to plan leave.

Scan Timing

It is the responsibility of the researcher to ensure that the experiment can be completed within

the booked scanner time. Over-running is likely to result in the experiment being cut short.

The researcher should ensure that the participant is ready to enter the MR scanner at least 5

minutes before the start of the exam. This includes;

Initial and second screening forms have been completed.

The participant has removed all metal from their pockets, clothes, hair etc.

Consent form has been completed.

The experiment and MR procedure has been fully discussed with the participant.

Other Equipment

If your study requires additional equipment – e.g. Physiological monitoring, MR compatible

specialist equipment e.g. eye tracker, paediatric entertain box - please ensure that this

equipment is booked as well. This equipment is often used in other parts of the building, so a

booking of the MR scanner does not imply these components are included.

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Appendix 16: MRI scanning Out of Hours

STANDARD OPERATING PROCEDURE FOR MRI SCANNING OUTSIDE CORE HOURS

Introduction

These procedures are to ensure that appropriate operator and security cover can be provided

outside of the normal working hours of 9am to 5pm.

Procedure for researchers to follow to book out of hours scans

1. Request scan via the usual booking policy giving at least two weeks’ notice. Availability of

the room and staff will be checked and the researcher will be informed if the chosen date is

possible.

2. There must always be two authorised users during scanning. The researcher must therefore

ensure that one authorised user associated with that particular project is available for that day

and time. If there is no authorised user it may be possible to use a bank radiographer at an

additional charge.

3. On the scan date the researcher and participant will gain access through the front door once

the Authorised Advanced User is present.

Procedure for CRICBristol staff to follow:

1. Check that an Authorised Advanced User is available before confirming the booking.

2. Inform UHBristol security that scanning will be taking place by emailing Paul Wood,

[email protected] head of UHBristol security and Martin Reid

[email protected] with the date and time (hours) and names of who will be

present. They will then inform the operations team.

3. When the study is completed ensure that everyone has exited the building before setting the

security alarm system and locking the CRICBristol front door, by following procedure in

appendix 1 or 2 accordingly.

Procedure for Authorised Advanced User to follow on the day of the scan.

1. Arrive at least 30 minutes before the scan time in order to switch on and receive participant

and researcher.

2. Ensure that everyone signs in and out of the building in the log book at reception.



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Appendix 17: Administration of intravenous gadolinium contrast agents policy

For the Administration of Intravenous Gadolinium Based Contrast in MRI

The purpose of this document is to ensure the appropriate and safe use of Intravenous (IV)

Gadolinium based contrast media in research procedures.

STAFF: If IV gadolinium based contrast media is required for a research project it can only be

administered by a radiologist, clinician or a radiographer who holds the Society of

Radiographers Certificate of competence in Administering IV Injections .

PROCEDURE: The participants selected for the research project must have no history of renal

impairments and not be pregnant or breast feeding.

A clinician must be available in the CRICBristol MRI facility at the time of injection.

The PI has provided CRICBristol with results from a blood test (performed within 6months of

MRI scan) that participants’ eGFR is >30ml/min/1

Confirm participant is not pregnant or breast feeding

Checked participant has no significant allergies prior to injection.

Check emergency drugs are available on the resuscitation trolley.

Prepare a standard dose of the relevant contrast medium for injection using aseptic

technique.

Record the serial & batch number, type and dose of contrast given.

Observe the participant for 30 minutes after contrast injection for any related reactions.

CONTRAST AND DOSE

Gadovist is used in adults, adolescents and children aged 7 years and older.

Magnevist is used for children under 7 years of age and neonates.

(add other contrast agent suggested by CBD)

The recommended dose is 0.1 mmol per kilogram body weight (mmol/kg BW). This is

equivalent to 0.1 ml/kg BW of the 1.0 M solution.

ADVERSE REACTIONS: In the unlikely event of an adverse reaction to the contrast, the

participant should be removed from the magnet room and the resuscitation trolley brought into

the corridor immediately outside the magnet room, where the designated clinician can treat the

reaction as necessary. Given the risk of nephrogenic systemic fibrosis (NSF), researchers will

be advised to administer contrast only if eGFR (estimated glomerular filtration rate) is

>30ml/min/1.73m2. eGFR can be calculated using by entering cretin, age, gender and race in

the website www.renal.org/eGFRcalc/. We are currently not providing the service to measure

this in CRICBristol.

http://www.renal.org/eGFRcalc/

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Appendix 18: Working in MRI during pregnancy

Guidelines for Pregnant Staff Working in the MRI Scanner

There is no conclusive evidence that a static magnetic field can harm the developing fetus.

Pregnant users may enter the inner controlled area (magnet Room) but have the option of not

doing so in the first trimester of pregnancy.

There is also no conclusive evidence that varying magnetic fields can harm the developing

foetus. But pregnant users should not remain in the Magnet Room during the scan.

References

MHRA Guidelines

MRIsafety.com, Kanal

Revision date October 2012

http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON007427&ssTargetNodeId=575

http://mrisafety.com/search.asp?action=search&search_string=pregnancy

http://www.radiology.upmc.edu/MRsafety/search.asp?txtKeyWord=pregnant

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Operating Procedures have been written after consulting the following:

1. Protection of Research participant and Research participants undergoing MRI Procedures, Document of the Health Protection Agency, August 2008.

2. Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use, Medicines and Health Care Research Agency (MHRA), Department of Health, DB2007(03), December 2007.

3. ACR Guidance Document for Safe MR Practices: AJR 2007; 188:1–27

4. http://www.mrisafety.com/

5. The Control of Noise at Work Regulations 2005

6. Shellock and Kanal, Magnetic Resonance: Bio effects, safety and Subject Management ISBN 078 170 187-2. Published by Raven Press 1994.

7. MDA, Safety Notice-SN 2001 (27) Programmable shunts: risk of reprogramming during MRI/S procedures.

8. International Commission on Non-Ionising Radiation. Guidelines for limiting exposure to time-varying electric, magnetic and electro-magnetic fields (up to 300 GHz). Health Physics 74(4): 1998; 494-522.

9. International Electrotechnical Commission. Medical Electrical Equipment – particular requirements for the safety of magnetic resonance equipment for medical diagnosis. IEC 60601-2-33: 1995 revised 2002

10. HPA. Principles for the protection of research participants and research participants during clinical magnetic resonance diagnostic procedures. Documents of the NRPB 2(1):1991; ISBN 0859513467

11. HPA. Restrictions on human exposure to static and time-varying electromagnetic fields and radiation. Documents of the NRPB 4(5): 1993; ISBN 0859513661.


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