0% found this document useful (0 votes)
31 views29 pages

Using MRI Safely - Practical Rules For Employees

The document outlines practical rules for safely using MRI technology, emphasizing the importance of adhering to safety measures to protect employees from electromagnetic fields and other risks associated with MRI. It discusses the background of the European Directive on electromagnetic fields and the collaborative efforts of various organizations in the Netherlands to develop these guidelines. The document serves as a framework for ensuring safe working conditions in MRI environments and highlights the need for ongoing education and training for staff involved in MRI operations.

Uploaded by

Hikmat Al Asmar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
31 views29 pages

Using MRI Safely - Practical Rules For Employees

The document outlines practical rules for safely using MRI technology, emphasizing the importance of adhering to safety measures to protect employees from electromagnetic fields and other risks associated with MRI. It discusses the background of the European Directive on electromagnetic fields and the collaborative efforts of various organizations in the Netherlands to develop these guidelines. The document serves as a framework for ensuring safe working conditions in MRI environments and highlights the need for ongoing education and training for staff involved in MRI operations.

Uploaded by

Hikmat Al Asmar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Using MRI safely

This document has been approved by


the following organisations:

Dutch Federation for University Medical Centers (NFU)


Dutch Society for Medical Imaging and Radiotherapy (NVMBR)
Dutch Society for Medical Physics (NVKF)
Dutch Hospitals Association (NVZ)
Radiological Society of the Netherlands (NVvR)
Holland Health Care Technology Association (HHT)

We’d like to thank the following organisations


for their collaboration:

Ministry of Social Affairs and Employment (SZW)


National Institute for Public Health and the Environment (RIVM)

PRACTICAL RULES
FOR EMPLOYEES

Holland HealthTech
Using MRI safely – practical rules for employees
MRI Working Group

Foreword the application of this technology,


which has been used in patient care
The European Directive on electro- for more than 25 years. This undesira-
magnetic fields, known as EMF Di- ble development was also confirmed
rective 2004/40/EC, was issued on 29 in various publications by the RIVM
April 2004. Originally, this guideline [National Institute for Public Health
was to be implemented in national and the Environment] and in an alert
legislation by no later than 30 April from the Gezondheidsraad [Health
2008. This meant that companies Council of the Netherlands]. Based
whose work involves the exposure of on extensive interventions by mem-
staff to electromagnetic fields would bers of the European Parliament, a
have to comply with the require- large number of scientific organisati-
ments of this directive. ons and above all numerous patient
groups, it was finally decided in April
In the original formulation of the Di- 2008 to postpone implementation of
rective, experts from the field were the Directive until 2012. In the con-
only involved at the margins. It only text of this postponement, both the
became clear in 2006 that the ex- content and the consequences of the
posure limits stated in the Directive Directive will be examined, looking
might inhibit the practical use of MRI in particular at avoiding restricting
in healthcare and research. This could the use of MRI in practice.
have wide-ranging ramifications for

2
The Netherlands has played an im- chairmanship of this working group.
portant positive role in the postpo- Mathieu Pruppers of the RIVM has
nement process. Those responsible supported me expertly as the secre-
within SZW [Ministry of Social Affairs tary. The Working Group has defined
and Employment] acknowledged the rules of conduct described in this
the negative effect of the Directive document in an exceptionally con-
on the use of MRI in patient care at structive and progressive way; the
an early stage. Based on their recom- Working Group believes that these
mendation, a working group was set will ensure that MRI can be used
up comprising representatives from safely in practice.
employers’ and employees’ organi-
sations plus a number of additional
experts, with the aim of developing
practical rules defining safe ways for
employees to work with MRI. These
practical rules could be the basis for Rotterdam, juli 2008.
drawing up an arbocatalogus [wor-
king conditions catalogue]. Because Gabriel P. Krestin
I was closely involved in the discus- Hoofd Radiologie Erasmus MC
sions about the Directive both in Past-president ESMRMB.
the Netherlands and at the Europe-
an level, I was asked to take on the

3
MRI Working Group

Index

1 Introduction 5
1.1 Background and Objectives 5
1.2 Concepts and definitions 6
1.3 Legislation and regulations in the Netherlands 7
2 Practical risks 10
2.1 Exposure to electromagnetic fields 11
2.2 Exposure to noise 12
2.3 Risks due to ferromagnetic projectiles 12
2.4 Risks from cryogenic liquids 12
3 Defined working situations 13
4 Types of effects 15
5 Precautions and rules of conduct 18
5.1 General precautions 18
5.2 Rules of conduct for working situation I 19
5.3 Rules of conduct for working situation II 21
5.4 Rules of conduct for working situation III 22
5.5 Test subjects – the voluntary basis 22
5.6 Education, training and instruction 23

Appendix 1 Members of the MRI Working Group 25


Appendix 2 Task and risk analysis for MRI staff 26

4
1 Introduction 1.1 Background and
Objectives
MRI, magnetic resonance imaging or
nuclear magnetic resonance tomog- To be able to work safely with MRI,
raphy, is a powerful diagnostic tool it is important that staff are aware of
that has been in use for 25 years now the safety aspects and handle them
in healthcare and for scientific stud- appropriately. Organisational and
ies. The use of MRI has major benefits technical measures are needed in or-
for the patients. It has now become der to reduce the potential hazards.
an essential part of the diagnosis and This document describes the various
treatment of illnesses and in medical safety aspects and the corresponding
research. Using magnetic and elec- practical rules. It has been drawn up
tromagnetic fields, MRI makes it pos- by the MRI Working Group, an ad hoc
sible to produce detailed images of working group of institutions with
the interior of the human body. MRI interests affected by the application
therefore plays a key role in the rou- of MRI in the Netherlands (please re-
tine treatment of numerous diseases, fer to Appendix 1 for an overview of
such as cancer, cardiovascular disease the members of the Working Group).
and neurological conditions. Further The purpose of this document is to
scientific investigations into the ap- protect all employees1 who are in-
plication of MRI to other illnesses and volved with MRI and to do so at the
into functional and interventional most practical level possible. This
applications are still forging ahead. document will be brought to the at-
MRI provides a much higher contrast tention of those who are involved
between soft tissues than CT (com- in the discussion about changes to
puter tomography) and, unlike CT, the EU Directive for the protection
does not use ionising radiation. of employees from the dangers of
exposure to electromagnetic fields.
This document is also the framework
for drawing up a working conditions
catalogue for handling MRI.

In order to produce a document


in which practical rules for staff in-
volved in MRI are described, a sum-
mary is given of the various situations

1 This document primarily considers occupational working conditions for employees. Safe use of MRI
has consequences for the way patients are handled; these are not covered in this document (e.g.
instructions for the patient, the use of upper and lower SAR limits, positioning of the patients, checking
for contra-indications, etc.). The description of good practice is limited to the ‘imaging of people and
animals’. 5
MRI Working Group

in which employees can be exposed the static magnetic field may not ex-
to magnetic fields due to the applica- ceed 0.5 mT (the field strength above
tion of MRI. The possible effects that which hazards can occur for medi-
could arise when working with MRI cal implants such as pacemakers). In
scanners are then listed. Finally, pre- clinical practice, the controlled access
cautions are recommended for each area is often the same as the scanner
of these effects, grouped according room. It is possible that the magnetic
to the working situations. field may be greater than 0.5 mT in
auxiliary areas below or above the
The Working Group is convinced that scanner area, and additional mea-
if the rules in this document are ob- sures are required in such cases.
served, the safety of staff during cur-
rent working practices and accord- Static magnetic field
ing to the current state of knowledge The static magnetic field is one of
is sufficiently guaranteed. Exposure the elements required to obtain an
limits have not been discussed in MRI signal. In an MRI scanner, this
this document, partly because of the field is generated with a solenoid
ongoing international discussions coil that is often made of a supercon-
about how high these limits should ducting material. When the magni-
be. tude and direction of the magnetic
field do not vary over time, then
this is referred to as a static mag-
1.2 Concepts and definitions netic field. In almost all MRI systems,
this static magnetic field is continu-
Scanner room ously present, i.e. 24 hours a day.
The room in which the MRI scanner is The magnetic field strength of MRI
located and in which usually only the systems varies from 0.2 to 1.0 T for
patient is present during scanning. open systems with a vertical static
magnetic field, and from 0.5 to 3.0 T
Controlled access area (around for the classical cylindrical systems
the scanner) with a horizontal field. Systems us-
According to NEN-EN-IEC standard ing 7 T are also in operation in the
60601-2-33, the controlled access Netherlands for scientific research.
area is the “area to which access is For comparison: the strength of the
controlled for safety reasons”. Outside earth’s (static) magnetic field is about
the controlled access area, this stan- 50 microtesla in the Netherlands,
dard states that the stray field from whereas the order of magnitude for

6
the strength of a refrigerator magnet ing coil. This can only be done at very
is a few millitesla. low temperatures, cooling the coil
with liquid helium (sometimes with a
Switched gradient fields secondary layer of cooling using liq-
As well as a static magnetic field, uid nitrogen).
switched magnetic fields are needed
in order to localise the MRI signal and
thereby generate an image. These 1.3 Legislation and
switched magnetic fields generate a regulations in the
linear field gradient and are therefore Netherlands
also referred to as “gradient fields”.
The gradient fields are switched on
and off in timeframes in the millisec- Under the Arbowet [Working Condi-
ond range, thereby producing a mag- tions Act], the employer will ensure
netic field in the kilohertz range. (with the cooperation of the em-
ployee) that the work does not have
Radio-frequency fields any negative effects on the health
In order to obtain the MRI signal, a and safety of the employee. The Ar-
radio-frequency magnetic field is re- bobesluit [Working Conditions De-
quired in addition to the static mag- cree] discusses the risks in greater
netic field and the switched gradient depth.
fields. The frequency of this magnetic
field depends on the strength of the The Working Conditions Decree
static magnetic field and the atoms states among other things that de-
used. For hydrogen under a field of vices that produce electromagnetic
1.5 T, this frequency is 63 MHz. Mag- fields must be properly manufac-
netic fields with these frequencies tured, must be in good working
are also known as radio-frequency order and must be located and as-
fields, or RF fields for short. sembled in such a way or screened
in such a way that damage to health
Cryogenic liquids as a result of electromagnetic fields is
The majority of MRI scanners have avoided as far as possible. In order to
a superconducting solenoid coil. To prevent or restrict exposure to noise,
generate a strong magnetic field, a it also states that appropriate techni-
high current must be passed through cal or organisational measures must
the solenoid coil. This is achieved be taken so that the risks of expo-
technically by using a superconduct- sure are eliminated at the source or

7
MRI Working Group

restricted to a minimum. If cryogenic Electromagnetic fields


liquids are present that could pres- The field strength above which elec-
ent a hazard to the health or safety tromagnetic fields are deemed to
of staff, due to the very low tempera- be hazardous in terms of the Work-
ture or the oxygen displacement ef- ing Conditions Decree is defined in
fect, then facilities must be provided European Union regulations. These
so that the dangers associated with include a large safety margin. For
those materials in the event of an un- staff in a working situation, Euro-
desirable incident are avoided as far pean Directive 2004/40/EC3 of 29
as possible. April 2004 defines limits. Those who
published comments about the pos-
The approach to occupational health sible restrictions on MRI if this direc-
and the occupational hygiene strat- tive were to be introduced included
egy for taking precautions consists the Gezondheidsraad4 [Health Coun-
of four steps, in order of decreasing cil of the Netherlands] and the Bel-
preference2: measures taken at the gian Hoge Gezondheidsraad [High
source, measures aimed at collective Health Council]. The latest date for
protection, measures aimed at indi- implementation of this directive in
vidual protection, and personal pro- the member states’ national legisla-
tection equipment. Combining the tion has now been postponed5 until
four different steps is also permis- 2012. European standards are being
sible. Practical rules can also make a prepared for situations requiring de-
contribution here. The Working Con- tailed evaluation, measurement or
ditions Decree also contains specific calculation to determine if the expo-
stipulations for particularly vulner- sure remains below the limit. The ex-
able groups who need greater atten- posure limits in the EU directive are
tion paid to them, such as employees based on recommendations by the
who are pregnant. ICNIRP (International Commission on
Non-Ionizing Radiation Protection)6,7.
The ICNIRP is working on new recom-

2 NTA 8050:2007 nl. (Nederlandse Technische Afspraak = Netherlands technical agreement) Guideline
for producing working conditions catalogues. Publication date: 01-Jun-2007.
3 Corrigendum to Directive 2004/40/EC of the European Parliament and the Council of 29 April 2004 on
the minimum health and safety requirements regarding the exposure of workers to the risks arising
from physical agents (electromagnetic fields). OJ 2004, L184.
4 Health Council of the Netherlands. Comments concerning possible MRI restrictions due to
implementation of an EU directive. The Hague: Gezondheidsraad, 2007; publication number
2007/17.
5 Directive 2008/46/EC of the European Parliament and of the Council of 23 April 2008 amending
Directive 2004/40/EC on minimum health and safety requirements regarding the exposure of workers
to the risks arising from physical agents (electromagnetic fields) (18th individual Directive within the
meaning of Article 16(1) of Directive 89/391/EEC). OJ 2008, L114/88-89.
8
mendations for static magnetic fields - risks must be excluded or
and (extremely) low-frequency elec- restricted as far as possible
tric and magnetic fields. (also meaning a safe design
and safe construction)
MRI equipment must comply with - in relevant cases, appropriate
the essential requirements that are measures will be taken,
defined in European Directive 93/42/ including alarm features if
EEC of 14 June 1993 (Medical De- necessary, to protect against
vices)8. MRI equipment must be de- those risks that cannot be
signed and manufactured in such a excluded, and
way that its use does not create any - the users must be informed
hazards for the clinical condition about any risks that may still
or the safety of the patients, nor for be present as a result of any
the safety and health of the users or, shortcomings in the protective
should such cases arise, any other measures
persons. The equipment must also
be used in the prescribed manner The IEC (International Electrotechni-
and for the purposes for which it is in- cal Committee) has issued a standard
tended. It should also be understood that defines safety procedures and
that any risks that may be associated threshold values for patients and
with its use must be acceptable, tak- staff for exposure to electromagnetic
ing account of the usefulness of the fields during MRI procedures. This
equipment for the patient, and com- standard, which is primarily intend-
patible with a high degree of pro- ed for the equipment manufacturers,
tection for health and safety. When has been published by the European
choosing the most suitable solutions and Dutch governments as a har-
for the design and construction of monised standard under the Medical
the equipment, the manufacturer Devices Directive9. According to this
must adopt the following principles standard, the static magnetic field
in the sequence given below: is limited in principle to 4 T. Above

6 ICNIRP. Guidelines on limits of exposure to static magnetic fields. Health Phys, 1994, 66(1) 100-106.
7 ICNIRP. Guidelines for limiting exposure to time-varying electric, magnetic, and electromagnetic fields
(up to 300 GHz). Health Phys, 1998, 74(4) 494-522.
8 Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ 1993, L169 of 12-Jul-
1993 pp. 0001-0043.
9 NEN-EN-IEC 60601-2-33:2002 en;fr. Medical electrical equipment - Part 2-33: Particular requirements for
the safety of magnetic resonance equipment for medical diagnosisMedical electrical equipment, Part
2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
Publication date 01-Nov-2002. This standard has now been modified by two amendments in 2005
and 2008 (NEN-EN-IEC 60601-2-33:2002/A1:2005 and NEN-EN-IEC 60601-2-33:2002/A2:2008); please
refer also to Commission communication (2001/C 319/05) and “New NEN norms” in the Staatscourant
[Dutch Government Gazette] (13 December 2002, no. 241 / page 47); the second amendment had not
yet been published as a harmonised standard under the Medical Devices Directive on the date upon 9
which this document from the MRI Working Group was finalised (see page 1).
MRI Working Group

that, according to the IEC, use on pa- through the day and on the given
tients or test subjects is permissible peak acoustic pressure. The average
as long as the consent of the local level to which the employee is sub-
Medical Ethics Committee has been jected during the day is hence an
obtained. important parameter. For example,
if the employee works for four hours
Noise a day at 90 dB(A) and four hours at
In 2006, the Working Conditions 75 dB(A), then the daily exposure is
Decree was modified regarding the above 80 dB(A).
exposure of employees to the risks
of noise10. This amendment was im- Cryogenic liquids
plemented as a result of European Policy rule 4.4-5 is applicable to the
Directive 2003/10/EC dated 6 Febru- use of cryogenic liquids, in order to
ary 200311. Noise in the workplace is prevent undesirable incidents when
harmful if the daily average exposure working with dangerous materials.
of an employee on a nominal work- This is based on article 4.4 of the
ing day of 8 hours or more is greater Working Conditions Decree, in which
than 80 dB(A)12 [or a peak acoustic the specific circumstances contribut-
pressure of 112 Pa13]. If this is the ing to elevated risk levels from these
case, the employer must provide ear materials are named, such as the ex-
protection and arrange for informa- tremely low temperature that can
tion and training. If the noise level is cause severe frostbite and the ex-
higher on a daily basis than 85 dB(A) pansion during evaporation, which
[or a peak acoustic pressure greater can displace oxygen and cause suf-
than 140 Pa], the employee must focation.
wear ear protection and the employ-
er must take protective measures.
Whether or not sound causes harm
depends on how long the employee
is exposed to a particular sound level

10 Decree dated 25 January 2006 amending the Working Conditions Decree, containing rules relating
to the exposure of employees to the risks of noise. Staatsblad [Dutch Bulletin of Acts, Orders and
Decrees] 2006, number 56, 1 25.
11 Directive 2003/10/EC of the European Parliament and of the Council of 6 February 2003 on the
minimum health and safety requirements regarding the exposure of workers to the risks arising
from physical agents (noise) (Seventeenth individual Directive within the meaning of Article 16(1) of
Directive 89/391/EEC). OJ 2003, L42, 38.
12 The daily exposure is expressed in dB (decibels). For filtering, the A filter is generally used, which
corresponds to the sensitivity of the human ear; this is therefore referred to as dB(A).
13 The peak acoustic pressure is taken to mean the unweighted acoustic pressure that is measured
with a noise level meter in the peak hold position, expressed in Pa. This uses a frequency weighting
according to the C filtering. This measurement allows the maximum value (peak acoustic level) of brief
10 or momentary noise signals to be measured.
2 Practical risks immediately outside the ends of
the MRI scanner’s magnet core than
In the application, development, or the fields in the centre of the scan-
maintenance of MRI systems, em- ner, and it decreases rapidly with
ployees may be exposed to various distance from the system. The stray
types of risks, namely those result- field from the static magnetic field
ing from exposure to magnetic fields is always present, whereas the stray
and to noise, and as the result of fer- fields from the switched gradient
romagnetic projectiles, and risks de- fields and the RF fields are only pres-
riving from cryogenic liquids. ent during scanning.

The stray field from the static mag-


2.1 Exposure to netic field is present all around the
electromagnetic fields magnet, and exposure is directly
related to the distance from the
magnet. If a person moves within this
During scanning, three types of mag- magnetic field, electrical currents are
netic fields are present: the static induced in the body. The employee’s
magnetic field, the field generated by speed of movement is important in
the switched gradient fields (in the determining the strength of these
kHz range) and the radio-frequency currents.
(RF) field (in the MHz range). These
fields have to have a particular value In practice, the stray field from the RF
in the centre of the MRI scanner in fields directly outside the scanner is
order to ensure the desired picture so small that it cannot cause any ef-
quality for the diagnostic images. fects. It would only be possible for ef-
The most significant risks are the cur- fects to be conceivable if an employ-
rents induced in the body by move- ee’s body (or part thereof ) were to be
ment through the static field and by in the centre of the scanner during
the gradient fields, and the heat that scanning. This situation can occur in
the radio-frequency field can impart hospital practice if a staff member
to the body. accompanies a patient (a child) in the
scanner during scanning, or if a mem-
For all three types of field, there are ber of staff from an MRI manufacturer
stray fields around the magnet to has to be inside the system during
which an employee can be exposed. scanning for trouble-shooting opera-
This stray field is considerably lower tions, for example to trace a fault.

11
MRI Working Group

The situation as regards the switched pends on the location and can reach
gradient fields needs examining levels of greater than 80 dB(A) in the
with greater care. These stray fields majority of systems. NEN3418 is gen-
are also considerably lower immedi- erally adopted as the measurement
ately outside the system than are the protocol.
fields in the centre of the system, but
it is nevertheless possible that these
stray fields might cause effects. This 2.3 Risks due to
depends on the scanning technique ferromagnetic
being used, because the strength projectiles
and the switching speed of the gra-
dient fields can vary.
In the static magnetic field of an MRI
Finally, a new technique is being de- scanner, there is the risk of ferromag-
veloped: MRI-guided interventions. netic items flying around. Employ-
This is a technique in which e.g. a ees could be injured as a result of an
physician or other professional prac- item turning into a projectile, or get
titioner carries out interventions trapped between the magnet and
with the help of MRI imaging, such the ferromagnetic material. This can
as taking biopsies, introducing cath- only happen in the scanner room it-
eters, and so forth. This may mean self.
that it is necessary for the employee
to be close to the magnet core dur-
ing scanning, with hands or head in 2.4 Risks from cryogenic
the switched gradient field and the liquids
RF field.

There is a risk of freezing effects be-


2.2 Exposure to noise cause parts of the magnet are highly
cooled. Under normal operational
The switched gradient fields create situations this does not engender
noise in the scanner room due to vi- hazardous situations for employees
brations in the gradient coils. This de- (other than the MRI maintenance
pends on the mechanical construc- staff ), because these parts are locat-
tion of the system and the length ed out of reach on top of the magnet.
of the exposure. The noise level de- If the magnet quenches14 in excep-

14 The term ‘quench’ refers to the process in which the superconductive coils of the magnet become
resistive. This converts the energy of the static field into heat, which causes part of the liquid helium
(and the liquid nitrogen, if present) to be vaporised. This large amount of gas is vented outside
through a special pipe, known as the quench pipe. There is a quench button to activate this process in
12 emergency situations.
tional circumstances, then parts of constructed in such a way that no
the sides of the magnet can become condensed air can drip onto the pa-
cold. This can clearly be seen from tient or employees in the event of a
the ice deposition and the formation quench.
of a “cloud”. The evaporating cryo-
genic liquids are vented outside via All the working situations mentioned
the quench pipe. Gaseous helium is here are the cases in which employ-
only released into the scanner room ees are present within the controlled
(with the concomitant danger of suf- access area and, in the majority of
focation) in those quenches where cases, in the scanner room. No spe-
this pipe leaks or is blocked. cial measures are applicable out-
side the controlled access area. The
working situation in which the con-
3 Defined working trolled access area extends outside
situations the scanner room is only discussed
tangentially here. This then refers to
adjacent work areas that are directly
The scanner room does not restrict related to the MRI application and to
the stray field from the switched which access is restricted for safety
gradient fields, but the strength of reasons, such as rooms for access,
this field is so low outside the scan- administration, operating the equip-
ner room that it can no longer have ment, and waiting. These rooms are
any effect. The stray field from the RF only accessible after controls (in-
fields is shielded by the ‘Faraday cage’ cluding screening and instruction)
that is constructed around the scan- and have the necessary warnings on
ner room and sometimes around the view.
scanner itself. The noise levels outside
the scanner room will in general be The relevant distinction between the
lower than the legal limits. If not, ad- various situations is the question of
ditional measures will be necessary whether or not scanning is being
for the adjacent rooms. The risks due performed, and where the employ-
to cryogenic liquids are also present ee is at that time. This means that
outside the scanner room. For this, three working situations can be dis-
the only checks required are that the tinguished for staff whose activities
quench pipe does not vent into areas have to be carried out in the vicinity
where staff could come into contact of MRI equipment.
with it and that the quench pipe is

13
MRI Working Group

I The situation in which a staff - the static magnetic field


member has to carry out work in (including moving within this
the scanner room while scanning field)
is not taking place. - the switched gradient fields
In this situation, the employee - the RF fields
can be exposed to risks as a result - noise
of: - ferromagnetic projectiles, and
- stray fields from the static - cryogenic liquids
magnetic field (including moving
within this field) Areas for working situation I are in
- ferromagnetic projectiles, and principle accessible to any employ-
- cryogenic liquids ee, as long as they have been both
screened (for metal objects, metals
II The situation in which a staff implants, active medical implants,
member has to carry out work etc.) and have been given instruc-
in the scanner room during tion about the potential risks. Staff
scanning. who can only occasionally be in this
In this situation, the employee situation and therefore require spe-
can be exposed to risks as a result cial attention to be paid to them are
of: e.g. internal and external emergency
- stray fields from the static service staff (fire brigade, first aiders),
magnetic field (including moving people who are being trained (work
within this field) experience staff etc.), cleaning staff,
- stray fields from the switched guards and security staff, and visitors.
gradient fields Working situation I is also applicable
- stray fields from the RF fields to staff who have to carry out activi-
- noise ties in the scanner room of a small
- ferromagnetic projectiles, and bore system15 such as an MRI system
- cryogenic liquids for experimental animal research.

III The situation in which a staff Areas for working situation II are only
member is partly or entirely accessible to staff who have been
inside the scanner during screened (for metal objects, metals
scanning. implants, active medical implants,
In this situation, the employee etc.), who have been given instruc-
can be exposed to risks as a result tion about the potential risks, and
of: who are strictly required in the scan-

15 A small bore system is an MRI scanner with a magnetic core of less than approximately 30 cm in
diameter. Such systems are mostly used for scanning small experimental animals and for scanning the
14 limbs of human beings.
ner room during scanning, due to Working situation III is applicable
the activities to be carried out. Work- when an employee:
ing situation II is also applicable to - is entirely or partially within
staff members who have to be close the scanner for intervention
to the magnet of a small bore system work17
during scanning, for example in or- - is in the scanner together
der to start an infusion. with a patient as part of
their work, for example
For each type of employer (hospital, when accompanying a child,
scientific research institute or MRI or
manufacturer), consideration must - has to be inside the scanner
be given to staff with the following e.g. to track down a fault
occupations and/or duties:
A Hospital A member of staff will be treated as
- radiological technologist a pregnant employee as soon as she
(radiographer)16 has reported to the employer that
- physician she is pregnant. Consideration may
- anaesthesiology staff be given to excluding a pregnant
member employee from working situations II
- nurse and III as a precautionary measure.
- technical or medical
researcher
- maintenance staff 4 Types of effects
- patient supervisor
B Scientific institute The term ‘effects’ is interpreted in a
- operator / biotechnician wide sense in this document, i.e. cov-
- researcher ering everything that could be asso-
- maintenance staff ciated with exposure to all the iden-
C MRI manufacturer tified risks. It is moreover important
- applications specialist that not all physical and biological
- researcher effects lead to transitory or perma-
- developer nent effects on health.
- system tester
- production staff member The ICNIRP distinguishes three types
- maintenance staff of effects that electromagnetic fields
can have on health (their terminol-

16 As of 17 April 2008, the new professional term for medical nuclear science workers, radio-diagnostic and
radio-therapeutic technicians in Dutch is MBB’er (Medisch Beeldvormings- en Bestralingsdeskundige
= medical imaging and radiation expert).
17 It is possible that people will in future carry out MRI interventions on experimental animals. In terms
of the exposure of the employees, these situations are comparable with working situations II and III 15
respectively.
MRI Working Group

ogy is given in parentheses)18. Firstly, This document categorises the ef-


effects that can be objectively deter- fects according to two character-
mined with measurement devices istics. The first is the degree of cer-
(results), such as heating or injury as tainty with which an effect can be
a result of ferromagnetic projectiles. determined, i.e. whether it is an ob-
Secondly, indications that can be jective observation (a result or sign)
determined by experts such as doc- or a subjective one (a symptom). The
tors (signs). Thirdly, effects that are second characteristic is associated
experienced subjectively by the per- with the question of whether the ef-
sons exposed (symptoms). Examples fect is transitory, i.e. disappears im-
of these would be flashes of light or mediately when exposure ends, or
dizziness. may inflict permanent harm.

A subdivision widely used in the The effects on the employee differ


literature is into thermal and non- according to the various working
thermal effects. However, this no- situations. The following effects can
menclature is confusing. The effect be distinguished for each identified
itself is not thermal, but the chain risk.
of bodily processes capable of
leading to the final effect starts with Electromagnetic fields
heating. 1. Static magnetic field
a objective, possibly
Another subdivision commonly ad- permanent harm: disruption
opted in the literature is between of the functioning of active
direct and indirect effects. Direct ef- implanted medical devices
fects derive from direct links between (AIMDs) such as pacemakers
electromagnetic fields and bodily or infusion pumps
processes, such as muscle stimula- b objective, possibly permanent
tion. Indirect effects arise through harm: injury as a result of
the way an object is affected and its attractive or torsional forces
effect in turn on the body. Examples on ferromagnetic objects
of the latter are burns due to cloth- within the body
ing containing metal (that is heated c subjective, transitory:
by the radio-frequency field) and dis- dizziness / vertigo, nausea,
ruption of a pacemaker’s function- metallic taste and/or light
ing. flashes (phosphenes)
These effects only occur

18 ICNIRP. General approach to protection against non-ionizing radiation. Health Phys, 2002, 82(4):540-
16 548.
when the staff member tickling. The threshold at
moves within the static which this occurs varies from
magnetic field, with the one person to another.
speed and direction also b objective, transitory: muscular
being important. The fact contractions
that the static magnetic As a result of nerve
field outside the magnet stimulation, muscular
is not homogenous is also contractions can arise which
important. There is also may be painful (subjective).
variability in individual c objective, possibly
sensitivities to these effects. permanent harm: disruption
The stronger the magnetic of the functioning of active
field is, the more often such implanted medical devices
effects are reported. (AIMDs) such as pacemakers
d subjective, transitory: or infusion pumps
cognitive effects
Examples are a possible 3. RF fields
worsening of hand-eye a objective, possibly permanent
coordination and memory harm: direct heating of tissues
effects. Unlike other well- (although the effect itself is
documented effects, these transitory)
are only based on a few Tissue heating can cause
references in the literature. It burns and therefore give rise
is thought that these effects to permanent injury.
are caused by the above- b objective, possibly permanent
mentioned effects, such as harm: injuries as a result of
dizziness and nausea. There heating (although the effect
is also variability in individual itself is transitory) of metals or
sensitivities to these effects. implants containing metals,
wires, piercings, tattoos,
2. Switched gradient fields permanent makeup, etc.
a subjective, transitory: nerve This heating can cause burns
stimulation and therefore give rise to
Stimulation of the peripheral permanent injury.
nervous system in the limbs, c objective, possibly permanent
head and torso. The first harm: disruption of active
sensation observed is a slight implanted medical devices

17
MRI Working Group

(AIMDs) such as pacemakers 5 Precautions and rules of


or infusion pumps conduct
4. Noise
a objective, transitory: ringing
in the ears 5.1 General precautions
b objective, permanent: hearing
damage In line with the essential require-
ments imposed on MRI equipment
5. Ferromagnetic projectiles by the Medical Devices Directive, the
a objective, possibly permanent MRI scanner itself has a number of
harm: injuries as a result of intrinsic safety features. Clinical MRI
loose ferromagnetic objects systems have internal monitors to
becoming projectiles, or of ensure that the RF level is so low that
getting trapped between direct heating of tissues (3a) remains
the magnet and loose below 1 °C, that muscular contrac-
ferromagnetic objects tions (2b) are avoided, and that pe-
ripheral nerve stimulation (2a) should
6. Cryogenic liquids not generally be experienced.
a objective, permanent harm:
frostbite The difference between working
b objective, permanent harm: situation I and the other working
suffocation due to lack of situations guarantees that staff who
oxygen do not have to carry out activities
that must necessarily be done in the
scanner room during scanning are
protected against exposure to (stray
fields) from the static magnetic field,
the switched gradient fields and the
RF fields, as well as against noise. The
scanner room (or the controlled ac-
cess area) must therefore be made
recognisable as such by the applica-
tion of warning signs.

The key measure that can be taken in


all the working situations is to keep

18
as far away from the scanner as pos- fore advisable to automate infusions
sible. The greater the distance, the of anaesthetics, medications or con-
lower the exposure to the electro- trast liquids during scanning as fully
magnetic fields. As a precautionary as possible and to place operating
measure, it can also be recommend- consoles, anaesthesia equipment
ed that people do not remain in the and so forth as far away from the
scanner room longer than strictly magnet core as possible. It should
necessary, that additional measures also be noted here that the mini-
are taken to minimise exposure, and mum distance that should be kept
that awareness of the possible ef- depends strongly on the strength of
fects is encouraged. the RF field and the switched gradi-
ent field that the system can gener-
For exposure to the static magnetic ate. In practice, a distance of more
field in particular, in all the working than approximately 1m is sufficient
situations, an extra control measure to prevent the switched gradient
is that the changes in magnetic flux fields from having any effect. There is
density can be minimised by moving in practice no effective personal pro-
slowly through those areas where the tection equipment available yet for
static magnetic field gradient (dB0/ shielding against the switched gradi-
dx) is greatest, so that the product of ent fields. Marking out the 1m limit
the speed (dx/dt) and the field gradi- on the floor of the scanner room can
ent (dB0/dx) produces the smallest help make people aware of the risk.
possible value for the flux change
(dB0/dt). Within 1m of the aperture The following sections contain addi-
of the magnet core, the gradient of tional rules of conduct for the three
the static field is at a maximum and different working situations. Appen-
the employee must therefore move dix 2 lists the measures to be taken,
slowly. The gradient of the field is grouped by the type of area, working
much less at the sides of the mag- situation and type of activity.
net.

For both the RF field and the switched 5.2 Rules of conduct for
gradient field, the exposure can only working situation I
be minimised by keeping at a dis-
tance from the MRI scanner and by
avoiding tasks near to the magnet In this working situation, the impor-
core as much as possible. It is there- tant effects are those resulting from

19
MRI Working Group

the static magnetic field, ferromag- alternatives must be available for


netic projectiles, and cryogenic ma- e.g. wheelchairs, stretchers, clean-
terials. ing trolleys and anaesthesia trolleys.
Less obvious objects that must be
Static magnetic field avoided are metal jewellery, cloth-
To prevent disruption in the func- ing (wired bras, belts), footwear, keys
tioning of AIMDs (1a) and the at- and cigarette lighters. For the staff
traction of ferromagnetic materials themselves, it is important to know
in the body (1b), staff who enter the that watches can be damaged and
scanner room must be screened for that cards containing chips or mag-
AIMDs and ferromagnetic implants; netic strips can be wiped. The opera-
these are contraindications. These tor has the job of instructing every-
criteria are in principle the same as one who enters the scanner room.
the contraindications for patients Outside working hours, this instruc-
with regard to the static magnetic tion must also be arranged for staff
field. such as cleaners. The fire brigade and
security staff must be given separate
Dizziness, nausea, metallic tastes instruction and non-magnetic gas
and light flashes (1c) can occur when cylinders and fire extinguishers must
moving close to the scanner. Moving be present. Staff must be taught
slowly around the scanner – particu- the circumstances under which the
larly when the head is moving – can quench button should be activated.
keep these effects as small as pos-
sible. The cognitive effects (1d) can Cryogenic liquids
also be kept to a minimum by mov- In the event of a quench, the staff
ing slowly. Staff must be instructed and patients or test subjects must
about these effects and the associ- leave the scanner room as quickly as
ated rules of conduct. possible. When doing so, they must
take care that they do not touch any
Ferromagnetic projectiles parts on which ice has formed and
Employees may not bring any objects do not use naked flames, because of
into the scanner room that contain the danger of fire due to condensed
ferromagnetic components19. These oxygen. Maintenance staff, the fire
can become uncontrollable projec- brigade, and the security services
tiles that can injure staff and patients must be informed as quickly as pos-
severely and could damage the MRI sible. For these staff members, ad-
scanner severely. MRI-compatible ditional instruction on working with

19 De ontwikkeling van nieuwe ferromagnetische detectorpoortjes is veelbelovend. In het ACR


20 document (zie voetnoot 20) wordt het gebruik van deze nieuwe technologie aanbevolen.
cryogenic liquids and the specific threshold value is attained for less
maintenance procedures for the MRI than 50% of the population8,9. This
scanner is essential. For example, the nerve stimulation can be felt clearly
large clouds of “smoke” may initially by the most sensitive individuals.
look like a fire, but fire extinguishing Nerve stimulation that produces in-
measures could cause a great deal of tolerable muscular contractions or
damage. Staff must be taught what that can affect the heart muscles only
to do in the event of a quench. occurs with fields that are at least ten
times stronger, and these are pre-
vented by the safety circuit.
5.3 Rules of conduct for
working situation II It is recommended that exposure
should be limited as much as pos-
sible to prevent any effects.
All the points mentioned above for
working situation I are applicable Noise
here, plus the following extra rules If the daily exposure during scanning
of conduct. When screening employ- is above 80 db(A), the employer must
ees, there must also be a check of provide ear protection. If e.g. a level
contraindications for the switched of 86 db(A) is only “experienced” for a
gradient fields and the RF fields. In total of one hour a day, then it is not
this working situation, the effects mandatory because the daily dose is
resulting from stray fields from the in this case 77 dB(A). When work is
switched gradient field and from carried out at these kinds of daily ex-
noise are important. The effects of posures, the employer must provide
stray fields from RF fields are prob- the employees with the opportunity
ably not significant in this working of a periodic hearing test (e.g. once
situation for the current generation every four years) so that incipient
of MRI scanners. hearing damage can be detected
early. Staff may refer to the occupa-
Switched gradient fields tional health service or expert for
Instruction must comprise elucidat- this.
ing the ‘peripheral nerve stimulation’
effect (2a and 2b) and keeping away
from the scanner. A clinical MRI sys-
tem has a safety circuit to limit pe-
ripheral nerve stimulation so that the

21
MRI Working Group

5.4 Rules of conduct for zondheidsraad [Health Council of the


working situation III Netherlands] Electromagnetic Fields
committee3, staff members must en-
sure that they limit their time near
All the points mentioned above for the scanner as much as possible and
working situation II are applicable that they maintain as much distance
here, plus the following rules of con- as possible from the scanner.
duct. An employee in this working
situation will only receive an RF dose As a precautionary measure, it is rec-
that could lead to effects during MRI ommended that exposure should be
intervention, or an occasional one limited as much as possible so that
during maintenance. effects are prevented.

RF fields Going into the scanner with a patient,


To avoid direct heating of tissues (3a), for example when accompanying a
the clinical MRI system has a safety child, is strongly discouraged. This
system that limits the RF output in does not apply if the manufacturer
such a way that the local heating of has listed this method as an “intend-
the tissues is less than 1°C, the power ed use” and has therefore prevented
input into the entire body is less than the specific aspects of undesired in-
4 W/kg, and to the head is less than teractions of RF fields with the pa-
3.2 W/kg8, 9. tient or the accompanying person by
means of a special scanner design.
To avoid injury as a result of local
heating of metals or implants and
so forth containing metals (3b), em- 5.5 Test subjects – the
ployees who enter the scanner room voluntary basis
must be screened for contraindica-
tions to RF effects and the effects of
the switched gradient fields. These The question of the voluntary nature
criteria are in principle the same as is very important for an employee
the contraindications for patients. who is acting as a test subject. An
employee entering an MRI system as
For the exposure to RF fields, an aver- part of the optimisation of MRI pro-
age may be taken over an exposure tocols or testing new MRI protocols
duration of 6 minutes. In line with is not part of the employment con-
the recommendations of the Ge- tract or public law appointment. This

22
is because the employment contract issues discussed in this document
or public law appointment does not and the practical rules needed. This
provide a basis for the infringement training must match the local situa-
of personal integrity that is involved tion and can be arranged e.g. by the
in acting as a test subject. Moreover, clinical physicist or MR physicist.
the Working Conditions Act states
that the employer must avoid psy- Clinical MRI scans will generally be
chosocial work stresses. The employ- carried out in hospitals or MRI cen-
ee is clearly in a dependent position tres. This means that the clinical in-
with respect to the employer, and vestigations will be performed by
feeling obliged to act as a test subject qualified radiological technologists16.
in order to maintain a good work- They will have been trained in how
ing relationship could cause stress. to deal with patients and in the inter-
Stress is deemed to be a psychoso- pretation of anatomical images. This
cial work burden. Test subjects must background also means that they
be recruited passively (no compul- will be familiar with the operation of
sion) and must be properly informed equipment such as X-ray and irradia-
about the possible risks. Handling of tion equipment. Since the arrival of
any incidental findings (reported or MRI, the basic principles of MRI have
not) must also be explained clearly also been included in the initial train-
to the test subject beforehand. It is ing of the radiological technologists,
desirable that the ‘agreement’ be- also covering the safety aspects.
tween the employer and the em-
ployee should be recorded in writing One possible way for technnolo-
by means of an informed consent gists working with MRI to obtain the
form. required extra training regarding
safety issues is by following a post-
HBO [higher vocational education]
5.6 Education, training and MRI course. This course emphasizes
instruction the theory and techniques required
to be able to perform the optimum
examinations. This addresses the
Given the central role of the technol- risks and effects of electromagnetic
ogist/operator on the work floor in fields once again, plus the major im-
implementing the working methods portance of screening everyone who
indicated here, such employees must enters the scanner room properly.
be trained regarding the MRI safety

23
MRI Working Group

Staff who do not belong to the group Staff members who do not belong
mentioned above and who carry out to the groups mentioned above and
their duties in working situation I who may have to carry out their du-
must be screened by the qualified ties in working situations II or III must
technologist/operator and informed also have followed a training course
about the potential risks. If there are about safety. Given the importance
practical reasons why this is not pos- of safety, MRI operators must regu-
sible, these employees must follow a larly receive refresher training re-
separate safety training course. This garding safety aspects (for further
training must be tuned to match the information, please refer to the ACR
local situation, the equipment at the Guidance Document 200720).
site, and the activities performed.

20 ACR Blue Ribbon Panel on MR Safety (Kanal et al.). ACR Guidance Document for Safe MR Practices:
24 2007. American Journal of Roentgenology, 188:1–27, June 2007.
Appendix 1
Members of the MRI
Working Group

G. P. Krestin, MD, PhD S. Geers-van Gemeren


Radiological Society of the Netherlands Medical Imaging
Netherlands (NVvR) and Radiotherapy Association
c/o Erasmus MC – University (NVMBR)
Medical Center Rotterdam, M. B. M. Hofman, PhD
Radiology (Working Group Dutch Society for Medical
chairman) Physics (NVKF)
P. C. J. Leijh, PhD c/o VUMC Amsterdam, Physics
Netherlands Federation of and Medical Technology
University Medical Centres D. G. Norris, PhD
(NFU) FC Donders Centre for
c/o Leiden University Medical Cognitive Neuroimaging
Center H. Engels, PhD
P. Stubbs Philips Healthcare, MR Safety
Dutch Hospitals Association Director
(NVZ) A. Vermeulen
c/o Medical Center Ministry of Social Affairs and
‘Haaglanden’ Employment
A. van der Star, MSHE Working Conditions Directorate
Netherlands Federation of M. J. M. Pruppers, PhD
University Medical Centres National Institute of Public
(NFU)] Health and the Environment
c/o UMC Grongingen, AVM/ (RIVM/LSO, Working Group
Quality Development secretary)
Department

25
26
type of room Working situation activity risk measures
adjacent working areas Various, no MRI ap- access, longer presence, sMF * < 0.5 mT none
and corridors, outside the plication walking routes
controlled access area
MRI Working Group

technical areas, outside Various, no MRI ap- maintenance release of cryogenic gases protect the quench pipe; warning
the controlled access area plication signals; detection if required
sMF< 0,5 mT none
Appendix 2

MRI staff

controlled access area: Area where access is access sMF> 0,5 mT screening; instruction; access con-
area outside the scanner restricted for safety trol; warning signals;
room reasons
administration; operation sMF> 0,5 mT none
waiting sMF> 0,5 mT none
cleaning sMF> 0,5 mT none
controlled access area: Working situation I: accessing the room to moving in a sMF instruction; move slowly
scanner room situation in which a staff position or fetch the
ferromagnetic projectiles special tools; screening; instruction
Task and risk analysis for

member has to carry patient, or to get people


out work in the scanner out of the scanner room burning by liquid helium/ visual inspection; instruction
room while scanning is in the event of a quench, nitrogen
not taking place or for maintenance
release of helium quench pipe; ventilation
Working situation II: monitoring / accompan- moving in a sMF instruction; move slowly
situation in which a staff ying the patient
gF* scanner switching restrictions;
member has to carry
screening; instruction; keeping at a
out work in the scanner
distance; limit duration of exposure
room while scanning is
taking place RF * SAR scanner monitor restrictions;
screening; instruction; keeping at a
distance; limit duration of exposure
burns screening (incl. clothing, loose metal
objects)
noise ear protection equipment
ferromagnetic projectiles special tools; screening; instruction

* sMF = static magnetic field, gF = switched gradient fields, RF = radio-frequency fields


type of room Working situation activity risk measures
controlled access Working situation III: situation interventions on moving in a sMF instruction; move slowly
area: scanner room in which a staff member is the patient
gF scanner switching restrictions; screening; instruction;
(cont.) partly or entirely inside the
keeping at a distance; limit duration of exposure
scanner while scanning is be-
ing performed RF SAR scanner monitor restrictions; screening; instruction;
keeping at a distance; limit duration of exposure
burns screening (incl. clothing, loose metal objects)
noise ear protection equipment
ferromagnetic projectiles special tools; screening; instruction
repair moving in a sMF instruction; move slowly
gF scanner switching restrictions; screening; instruction;
keeping at a distance; limit duration of exposure
RF SAR scanner monitor restrictions; screening; instruction;
keeping at a distance; limit duration of exposure
burns screening (incl. clothing, loose metal objects)

noise ear protection equipment


ferromagnetic projectiles special tools; screening; instruction
burning by liquid helium/nitrogen visual inspection; instruction
release of helium quench pipe; ventilation
preventive mainte- gVF scanner switching restrictions; screening; instruction;
nance keeping at a distance; limit duration of exposure
RF SAR scanner monitor restrictions; screening; instruction;
keeping at a distance; limit duration of exposure
burns screening (incl. clothing, loose metal objects)

noise ear protection equipment


ferromagnetic projectiles special tools; screening; instruction

27
Using MRI safely

This document has been approved by


the following organisations:

Dutch Federation for University Medical Centers (NFU)


Dutch Society for Medical Imaging and Radiotherapy (NVMBR)
Dutch Society for Medical Physics (NVKF)
Dutch Hospitals Association (NVZ)
Radiological Society of the Netherlands (NVvR)
Holland Health Care Technology Association (HHT)

We’d like to thank the following organisations


for their collaboration:

Ministry of Social Affairs and Employment (SZW)


National Institute for Public Health and the Environment (RIVM)

PRACTICAL RULES
FOR EMPLOYEES

Holland HealthTech

You might also like