MRI Safety
MRI Safety
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Procedures should be in place to ensure that any and all adverse events, MR safety
incidents, or ‘ near incidents ’ that occur in the MR site are reported to the medical
director in a timely fashion and used in continuous quality improvement efforts.
It should be stressed that the Food and Drug Administration states that it is
incumbent upon the sites to also report adverse events and incidents to them via
their Med Watch program. The ACR supports this requirement and feels that it is
in the ultimate best interest of all MR practitioners to create and maintain this
consolidated database of such events to help us all learn about them and how to
better avoid them in the future
3. Safety tips
When sending out the appointment include any relevant safety information and
details of the examination – this will allay the patient’s fear of the unknown.
Try to ensure that the waiting area is calming and pleasant.
Before sending the patient an appointment, check with them – or the referring
clinician – that they do not have a pacemaker or other contraindicated implants; or
if all else fails, a skull and chest radiograph will show an intracranial aneurysm
clip and cardiac pacemaker
Carefully screen the patient and anyone else accompanying the patient into the
scan room. This should include questions about surgical procedures, metal injury
to the eye and pacemakers.
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4. RF heating for implant
Some metallic implants have shown considerable torque when placed in the presence
of a magnetic field. The force or torque exerted on small and large metallic implants
can cause serious effects, as unanchored implants can potentially move unpredictably
within the body. The type of metal used in such implants is one factor that determines
the force exerted on them in magnetic fields. While non - ferrous metallic implants
may show little or no deflection to the field, they could cause significant heating, due
to their inability to dissipate the heat caused by radio frequency absorption. However,
heating experiments have not shown excessive temperature increases in implants.
However, that if a particular implanted device (such as the MR conditional deep brain
stimulator) has specific criteria by which it should be scanned (specific field strength,
specific RF coil configuration, specific SAR limit, specific gradient limitation and
specific static field strength) these criteria must be adhered to. Cases of deep brain
burns have been reported in cases where criteria were ignored (1).
5. Implanted medical devices and other contraindications to scanning
Any implants or foreign body categorized onto three type:
MRI safe: there e is no problem for scanning
MR conditional: we must return to the documentation of the implants or
communicate with the manufacture to determine exactly under what conditions
the scanning will be safe, we weighting also in these cases between benefits and
harmful .
MRI unsafe: in this cases; it is forbidden to examine the patients under any
conditions and the patients will not exceed specific lines previously determine the
strength of the magnetic field e.g. patient with pace maker must not exceed the 5
gauss line under any condition if the type of the pace maker is categorized as MR
unsafe implant.
NB: The previous categories is generalized for patients, workers and publics.
6. MRI 4 zone
Zone 1- This zone has no detectable magnetic field and there is no restriction on
access. The public is free to move around without being screened. This zone would
include the waiting area and hallways outside of the restricted MRI hallways (2).
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Fig.3 MRI zone
Zone 2- This zone still has no detectable magnetic field but we do restrict access
because it is close to the MRI scanners. Patients, families, and visitors must be
escorted into Zone 2 (2).
Zone 3- This zone is only one door away from the MRI scanner, which always has
its magnetic field on. There could be a detectable magnetic field in this zone.
Patients, families, employees, and visitors must first be screened by either one of our
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MRI core staff or MRI safe staff and have on either an Orange Zone 3 MRI screened
sticker or Red Zone 4 MRI screened sticker to enter this area (2).
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12. Thermal injuries
There have been a number of burns and even fi res associated with exposure to the
RF fields in MRI. Several types of tattoo have been reported to exhibit heating which
has resulted in burns in patients who have undergone MRI. However, many of the
second - and third - degree burns were reported to have been associated with the
cables from the coils and contact with patient skin. In addition, some localized
thermal injuries to patients have been noted after imaging where there was no wire
in close proximity to the injury. Recently, the FDA released a public health advisory
about the risk of burns associated with medication skin patches (metallic drug
delivery patches).
13. Peripheral nerve stimulation
Time varying magnetic fields (TVMF) effects vary with the strength, speed and
duration of the gradient pulses. Biological effects that vary with current amplitude
include reversible alterations in vision, irreversible effects of cardiac fibrillation,
alterations in the biochemistry of cells and fracture union. As gradient amplitude
and speed increase, TVMF effects increase. For this reason, there are particular
pulse sequence types (EPI sequences such as perfusion, diffusion and blood oxygen
level dependent ,BOLD ) that pose an increased risk of TVMF effects. Effects
occasionally experienced during MRI examinations using echo planar techniques
include mild cutaneous sensations and involuntary muscle contractions. This
phenomenon is known as peripheral nerve stimulation. The FDA limit for gradient
fields used to be 6 T/s for all gradients. In this case, therefore, Δ B is 6 T and Δ T is
1 s. In addition, the FDA used to limit axial gradient fields to 20 mT/m/s and gradient
rise times to 120 ( μ s) microseconds. EPI sequences pose the greatest concern for
TVMF effects as strong gradients are switched rapidly during EPI acquisition. As
of July 2004, these limits have been increased so that gradient strengths are limited
to those below that ‘ sufficient to produce severe discomfort or painful nerve
stimulation.
14. Categories of personnel
the list below gives examples of typical categories of staff who will or may need to
enter the MR CONTROLLED ACCESS AREA/MR ENVIRONMENT in the
course of their duties. The choice of individuals, their number and their category
needs careful consideration before authorization is given.
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Category (A): MR OPERATOR Those wishing to operate, maintain or modify
the MRI equipment such as radiographers, radiographic assistant practitioners,
radiologists, scientific staff, technical staff, MRI service engineers and in
certain cases suitably qualified and trained research staff.
Category (B): Personnel who do not fall into category (A) but are present with
a volunteer or patient during scanning such as radiologists, anesthetists and
nurses.
Category (C): All staff who are required to enter the MR ENVIRONMENT
when scanning is not taking place, e.g. dedicated cleaning staff, estate
maintenance staff.
Category (D): All other staff who are required to enter the MR
CONTROLLED ACCESS AREA but will not enter the MR
ENVIRONMENT.
The following identifies specific topics for consideration in the training of various
categories of staff that need to enter the MR CONTROLLED ACCESS AREA in
the course of their duties.
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o They must have had full instruction in, and must understand, emergency
procedures arising from causes other than equipment failure.
o They must have had full instruction in, and must understand, the
screening process required, for all patients, volunteers, Authorized and
Unauthorized Persons and visitors, before granting permission to enter
the restricted area.
o They must have had full instruction in, and must understand, the local
regulations and procedures in connection with the MR diagnostic
equipment and its location.
o They must fully understand the significance of the MR CONTROLLED
ACCESS AREA, MR ENVIRONMENT and MR PROJECTILE ZONE
and be able to differentiate clearly between them. In particular they must
be fully conversant with:
The projectile effect.
The effect of magnetic field upon implants and prostheses.
The effect of magnetic fields upon personal effects such as credit
cards and watches.
o They must have had full instruction in, and must understand the
consequences and effects of quenching of superconducting magnets.
o They must be fully aware of the recommendations on exposure to MR.
o They must have had full instruction in, and must understand the
consequences of, the correct selection, fitting, and use of ear protection.
Training requirements for category (B) personnel
Personnel who do not fall into category (A) but are regularly present with a
volunteer or patient during scanning such as radiologists, anesthetists and
nurses.
Staff in this group should have an understanding of the hazards in the MR
ENVIRONMENT and how to minimize them. This category rates second only
to category (A) as a potential source of MR AUTHORISED PERSONNEL.
All requirements of category (A) also apply to category (B), except for those
that relate to the operation of the equipment.
Training requirements for category (C) personnel:
Staff who are required to enter the MR ENVIRONMENT when scanning is
not taking place. They must be fully instructed on the potential hazard of
ferromagnetic objects.
Certain members of this category may justify certification as a MR
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AUTHORISED PERSON. If members of this category become authorized
they should only be responsible for themselves and not be allowed to
supervise others.
Training requirements for category (D) personnel:
Staff who may enter the MR CONTROLLED ACCESS AREA but will not
enter the MR ENVIRONMENT should be aware of the location of the MR
ENVIRONMENT and its hazards.
15. Quench
Helium may escape from the cryogen bath accidentally or the process can be
manually instigated (by pressing a butt on) in the case of an emergency. As the
helium is vented from the cryostat, the windings of the main magnet cease to exhibit
superconductivity, and resistance in the conductor causes the current to stop
flowing. This in turn reduces the electromagnetic field to zero in the space of a few
minutes. Quenching may cause severe and irreparable damage to the
superconducting coils, so a manual quench should only be performed when there is
a clear danger to life or limb.
16. Projectiles
Ferromagnetic metal objects can become airborne as projectiles in the presence of a
strong static magnetic field. This is known as the missile affect , where an object
(such as an oxygen tank) becomes a missile. Remember, small objects such as paper
clips and hairpins, have a terminal velocity of 40 mph when pulled into a 1.5 T
magnet, and pose a serious risk to the patient and anyone else present in the scan
room. The force with which projectiles are pulled towards a magnetic field is
proportional to the strength of the magnetic field, the distance from the magnet, the
mass of the object and the material from which the device is made. There are many
medical devices and instruments that can inadvertently enter the MR scan room.
Oxygen tanks are also highly magnetic and should never be brought into the scan
room. However, there are non - ferrous oxygen tanks available, which are MR safe
and/or MR conditional. Immobilization bags should be tested with a hand - held
magnet, as some of these are filled with highly ferromagnetic steel shot rather than
sand. To avoid tragedies in the MR scan room from projectiles, all devices should
be tested and deemed safe prior to entering the MR scan room.
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Fig.6 The translational force is responsible for attracting ferromagnetic items
17. Pregnant patients
As yet, there are no known biological effects of MRI on the fetus. However, a
number of mechanisms could potentially cause adverse effects as a result of the
interaction of electromagnetic fields with developing fetuses. Cells undergoing
division, which occurs during the first trimester of pregnancy, are more susceptible
to these effects.
18. Pregnant employees
MR facilities have established individual guidelines for pregnant employees in the
MR environment. The safety committee of the ISMRM determined that pregnant
employees can safely enter the scan room, but should leave while the RF and
gradient fields are employed (during the time the scanner is running). Some
facilities, however, recommend that the employee stays out of the magnetic field
entirely during the first trimester of pregnancy.
19. Forces and torques acting on magnetic materials in static magnetic fields:
This include:
a. Translational (Projectile).
Translational force is that one causing ferrous objects to be pulled toward the
isocenter of the magnet. It is near zero at the isocenter.
b. Alignment (Torque).
This force cause the ferrous objects to turn and align with direction of the magnetic
field B0. Maximal torque force will be at isocenter, where field strength is the greatest
while the minimum is far away from the magnet.
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The previous forces depend on several factors and they are:
1- Strength of the magnet
2- Weight of the object.
3- Magnetic susceptibility of the object
4- Proximity of the object to the magnet (2)
20. Exposure limits for static magnetic fields
According to the International Commission on Non-Ionizing Radiation
Protection (ICNIRP) recommends that acute exposure of the general public should
not exceed 400 mT (any part of the body).
21. Potential risks of superconducting magnets and helium leakage
This include venting in superconducting magnets since these magnets offers a
potential risk or hazard of the cryogen. So attention should be paid to the provision
of the venting of the cryogens, including ensuring that the external vent pipes are of
the correct dimensions and in the case of a quench, able to withstand pressures above
that recommended by the manufacturers. Suitable low oxygen warning alarms should
be placed in the MR room and be regularly checked and maintained.
In addition to this department should adhere to the manufacturers recommendations
related to maintenance program.
Possible hazards of cryogens leakage include asphyxiation because of displacement
of oxygen, hypothermia and frostbite.
22. Risks in MRI II: MR gradients and RF
The main safety issue regarding the RF fields used in MRI are the thermal heating
that lead to stress that might lead to induced current burns and contact burns. The RF
will lead to power dissipation into the body which with time cause energy
accumulation and accordingly rise in body temperature. Frequencies above 0.1 MHz
heating effects predominates leading to a major consequence in MR imaging. The RF
distribution is not uniform and the main magnetic field inhomogeneity increase as
strength of the magnetic field increase. RF increasing the oscillation of the molecules
resulting in generation of heat.
When heating occurs in human tissue as a compensation for heating blood vessels
will make dilation and increase blood flow and hence dissipation for excess heat.
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electromagnetic and thermal characteristics differs for different organs, eyes for
example has little blood flow and lenses has none. Testes also separated from the
main volume of the body and have a lower temperature and they are sensitive to heat.
A rise of 1° is acceptable for healthy normal person. The actual rise in temperature
will depend on balance between absorbed and transferred energy depending on
ambient temperature, air flow, clothing and humidity all play a major role in the rate
of dissipation.
With regard to localized heating, it seems reasonable to assume that adverse effects
will be avoided with a reasonable certainty if temperatures in localized regions of the
head are less than 38°C, of the trunk less than 39°C, and in the limbs less than 40°C.(3)
23. Potential risks for humans with gradient fields
There are some elements in the MRI imaging that will lead to potential risks including
the main magnetic field.
The primary concern about the static or main magnetic field is possibility of potential
biological effect. The majority of studies show that there is no effect on cell growth
or morphology changes at 2 T filed strength.
The data also show that there is no evidence of leukemia or carcinogenesis, only there
were small electrical potential in major blood vessels that flow perpendicular to the
static filed.
Despite that there no biological effects has been observed at filed strength below 2T,
reversible effects have been noted on ECG including an increase in the amplitude of
the T wave can be noticed called Magneto-hemodynamic, or Magneto hydrodynamic
effect, figure.2.
Irritability.
25. Time varying magnetic field (magnetic field produce by the gradients)
The known gradients in the Gx, Gy, Gz directions induces electrical fields on the
patient. Current produced by time varying magnetic field is greater in the peripheral
tissues as the amplitude of the gradient is higher away from the magnetic isocentre
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In addition, acoustic nose produced by time-varying magnetic field gradients,
acoustic noise is measured in dB/dt. The FDA limits the acoustic noise to a maximum
of 140 dB/dt. This can be minimized by using earplugs by all patients, or MRI
headphones. Clinically significant temporary threshold shifts in patients and
volunteers undergoing MRI procedures are unlikely in most subjects for noise levels
below 85 dB.
26. Dependency of SAR from the static magnetic field
Specific absorption rate (SAR) is defined as the average energy dissipated in the body
per unit mass and time, and it is measured in W/kg and it is very important since it
regulates the amount of RF energy allowed per kilogram of patient body weight. The
FDA has ensured that too much RF energy should not be transmitted to the body.
FDA limits for SAR:
Whole body: 4W/Kg/ 15 -minutes exposure averaged.
Head: 3K/Kg/10 -minutes exposure averaged.
Head or torso: 8W/Kg/5 minutes /gram of tissue.
Extremities: 12W/Kg/5 minutes / gram of tissue.
SAR is calculated depending on the body weight, so it is important to enter the
patient’s right weight, (figure. 4)
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Each manufactures have SAR limitation. The DFA allows the manufactures to
maintain the SAR to 4W/K or less than that for the whole body. Or ensuring that any
given pulse sequence does not elevate the patient’s temperature by more than 1° C.
The ICNIRP guidelines for RF fields for each operating mode and additionally that
an upper temperature limit be specified for the experimental operating mode. (4)
27. Active devices:
Mechanically, electrically and magnetically operated devices may malfunction in the
presence of a strong magnetic field. This malfunction may not be obvious at the time
of examination but may subsequently have serious consequences. Examples include:
Cardiac pacemakers.
Cochlear implants.
Programmable hydrocephalus.
Shunts implanted.
Neurostimulation systems.
Implanted drug infusion pumps.
28. Non-active devices
There is a risk that implanted ferro-magnetic devices will undergo attractive forces
such that they can dislodge, causing serious injury or discomfort to the person
concerned. Such devices will be labelled as MR unsafe, MR conditional or MR
safe.
Examples include:
Coils.
Stents and filters.
Aneurysm clips.
Heart valves.
Orthopaedic implants.
29. MR-safety considerations in a clinical environment
There must be prober preparation for each patient before any MR procedure to
avoid any patient injury or burn and this include:
1- Consent form.
2- Patient history.
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3- Remove metallic objects like (jewelry, drug delivery patches with
metallic components).
4- use insulation material of 1 cm or thicker to prevent skin-to-skin contact
and the formation of closed-loops from touching body parts.
5- Only allow devices, equipment, accessories, that are tested to be MRI
safe to be in MRI room (ECG, electrodes).
30. Patient-related MR Safety (3 Tesla& 7 tesla)
a. Implantable medical and non-medical objects
Departments should ensure that the implant or device has been tested up to the
required field strength. For those listed as conditional at field strengths of 3T, or
7T departments should be fully aware of the conditions under which the device or
implant can be safely scanned in liaison with the MR safety advisor and
manufacturer. A record of all implants and their MR safety status should be
included within the local rules alongside processes for scanning patients with MR
conditional implants (2).
b. Projectile and attractive forces
The attractive force on a ferromagnetic object is proportional to the spatial gradient
of the magnetic field. This is normally steeper at higher fields particularly since
active shielding is used to reduce the extent of the stray fields around the scanner.
Therefore, objects including implants that have been found to be safe to use in the
presence of 1.5T systems may not be so with 3T, or 7T systems (2).
c. Specific Absorption Rate (SAR)
SAR increases quadratically with field strengths. When using RF-intensive pulse
sequences such as FSE, EPI and FLAIR then SAR limits can quickly be reached.
Extra precautions should therefore be taken to ensure patient safety.
Manufacturers have developed many SAR reducing sequences and staff should be
fully conversant with their use (2).
d. Peripheral Nerve Stimulation (PNS)
This effect is increased at 3T, or 7T and the radiographer should be aware of
methods to reduce this, both by means of patient positioning, sequence selection
and parameter manipulation if required (2).
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e. Scanning of pregnant patients at 3T or 7T
Departments need to carefully assess the risks and benefits prior to making the
decision to scan at the higher field strength; they should consider whether scanning
at a lower field strength such as 1.5T would adequately answer the clinical
question. The decision to scan a pregnant patient at 3T or 7T should be clearly
documented and the risks and benefits discussed with the patient (2).
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