FAQs
Frequently asked questions
 

IN BRIEF, WHAT ARE NMR AND MRI?

_As brief as possible ...


HOW MANY MR MACHINES ARE THERE?

_In the early 1980s, there were 12 machines, and everybody knew
the others. Then it went like this: ...


ARE THERE OTHER THAN MEDICAL APPLICATIONS OF MR?

_Basically, (N)MR used not to be a medical tool. The details ...


IS MR IMAGING A SAFE PROCEDURE OR ARE THERE SIDE EFFECTS?

_At present, exposure to MR examination procedures below 2.0 Tesla is considered safe for patients and personnel. Operation at up to 8.0 T is not considered significant risk. There is no convincing evidence of any long-term or irreversible subacute effects of MR imaging or spectroscopy. There are, however, acute hazards ...


HOW DID MAGNETIC RESONANCE IMAGING DEVELOP?

_A little bit about MR history ...


I DO NOT UNDERSTAND ALL THE ACRONYMS USED FOR
RAPID MR IMAGING BY DIFFERENT COMPANIES. IS THERE A LIST?

_Classification of rapid MR pulse sequences ...


CAN YOU PROVIDE AN OVERVIEW OF MR CONTRAST AGENTS?

_Classification of MR contrast agents ...


 

FAQs

How safe is MRI?

July 30, 2001
Child Dies in MRI Machine

By THE ASSOCIATED PRESS • Filed at 2:42 p.m. ET

VALHALLA, N.Y. (AP) -- A child undergoing an MRI exam received a fatal head wound when the machine's powerful magnet pulled a metal oxygen canister inside, the Westchester Medical Center said Monday.

The child, whom the medical center would not identify by name, sex or age,died Sunday.

The hospital said the child was sedated following an operation Friday and was inside the machine when the 10-ton electromagnet drew the canister.

Edward Stolzenberg, president and chief executive of the medical center, said the hospital assumes full responsibility and "will do anything it can to ease the family's grief.''

Investigations are under way by the medical center and the state Health Department.

  _Commentary: Collateral damage
  

 

 

Introduction

Any new method in medicine, be it diagnostic or therapeutic, must be thoroughly checked for possible adverse side effects. More than 100 years ago, x-rays represented a major step forward, but then sobered radiologists and the public after the hazards of ionizing radiation were detected. No ionizing radiation is involved in MR imaging. However, because of the known problems with x-rays and radioisotope examinations, magnetic resonance imaging and spectroscopy have been intensively examined for possible dangerous side effects. To date, there is no proof of permanent damages to patients or staff caused by the magnetic or radiofrequency fields of commonly used clinical MR equipment.

During the last century, several hundred papers focusing on the effects or side effects of magnetic or radiofrequency fields have been published. They range from anecdotal reports about therapeutical applications of magnetic fields as published by Zhang et al. [48] to reports on unwelcome side effects, such as Beischer’s study [11].

This overview cannot cover all potential sources of hazards. Numerous reviews of the literature have been published recently, e.g., by Shellock and Kanal [42], by Persson and Ståhlberg [32], and by Magin, Liburdy, and Persson [25].

Several of the side effects associated with MR are unique to this kind of medical diagnostic tool; others are similar to hazards of other diagnostic methods. Possible hazards can arise from or be connected to:

• static magnetic fields;
• varying magnetic fields (gradient fields);
• radiofrequency fields;

and specifically:

• devices necessary to operate the imager (such as cooling gases) or to ensure the quality of life of the patients (such as intracorporal implants and extracorporal monitors);
• conducting loops such as electrical leads or accidental anatomical positions of the patient.

These hazards can affect patients, personnel, and other persons within the field of the magnet. They can be categorized as acute and subacute.

Acute Hazards

Acute hazards are created by the static magnetic field usually covering an ellipsoid region around the isocenter of the magnetic resonance imager. The range of this fringe or stray field depends on the field strength of the system, the type of magnet, and the kind of shielding used.
Ultralow- and low-field magnets possess a limited stray field of sometimes less than one meter radius from the isocenter. The stray field of large-bore, high-field systems may cover a radius of 15 or 20 meters, unless the magnet is heavily shielded.


Danger and prohibition symbols and signs used in MR installations

danger — strong magnetic field

danger — high-frequency electromagnetic field

active implants and metallic implants, such as pacemakers, prohibited

loose ferromagnetic objects prohibited

metal body implants prohibited

magnetic media such as credit cards, diskettes, magnetic tapes prohibited

mechanical watches, cameras and similar devices prohibited


External Objects and Devices

Projectiles. The most imminent danger for both patients and personnel in the magnetic field of an imaging system may result from ferromagnetic objects such as scalpels, scissors, pens, and even sand bags (not filled with sand but with iron shot) and gas dewars, which can be attracted by the magnet and thus behave like projectiles.

To prevent such accidents, the installation of a metal detector through which everybody has to pass before entering the MR suite has been recommended, but is rather cumbersome.

Every person working or entering the magnet room or adjacent rooms with a magnetic field has to be instructed about the dangers. This should include the intensive-care staff, and maintenance, service and cleaning personnel, as well as the crew at the local fire station.

The best protection against this danger is not to allow personnel other than those directly involved in patient examinations, i.e., the operator and the radiologist, into the magnet room. Constant education of everybody involved is also vital.

Monitors and respirators. The dependence on physiological monitoring, on mechanical respiration, and electric infusion pumps during MR examinations renders difficulties, and in certain instances does not allow such an examination.

However, with the development of appropriate monitoring and life-support equipment during the last few years, dependence is no longer a contraindication of MR imaging. Details on monitoring can be found in an article by Kanal and Shellock [20].

Contrast agents. Paramagnetic, superparamagnetic or ferromagnetic magnetic resonance contrast agents or other substances which have to be injected or applied in another way may present risks similar to those in any other invasive technique such as x-rays, particularly in patients with kidney diseases. The clinical experience of administering gadolinium-based or other agents intravenously to patients has shown that these agents are generally safe and well-tolerated. Only very few severe anaphylactoid reactions and cases of glottis edema have been reported.

Still, all necessary precautions for intensive-care treatment have to be considered when injecting such contrast agents, particularly in patients with a history of allergy or drug reaction [38].

With at least two contrast agents a rare, but serious syndrome (Nephrogenic systemic fibrosis – NSF) has been observed in patients with severe kidney failure. It involves fibrosis of skin, joints, eyes, and internal organs, and can be fatal [28]. When contrast agents are used according to the given guidelines and regulations such side effects are extremely unlikely.

A precautionary 24-hour suspension of breast-feeding was generally recommended following the administration of gadolinium-containing contrast agents. However, it has been proposed that this suspension be reduced to 12 hours [18].

MR Equipment

Noise. The noise created by the switching of the gradients is an additional source of inconvenience and, possibly, ear damage for the patient and, occasionally, personnel. This noise is comparable to very heavy traffic. Noise levels increase with field strength.

Disposable earplugs for the patient are recommended in high-field systems. Noise-cancelling systems and special earphones are available, and active acoustic control systems are being developed [26].

Cooling gases. In superconductive magnet systems, helium and nitrogen are used as cooling gases. In the case of a quench, gases are released to the outside. Under normal circumstances, the gases should escape through a pipe system and not reach the magnet-room atmosphere. However, accidentally some gas could be released into the magnet room.

In this case, there are two potential dangers. Frostbite can be induced because the gases are extremely cold. Secondly, nitrogen is to be considered hazardous, in particular under pressure (whereas there is no danger of direct intoxication from helium). All personnel and patients must evacuate the area immediately and return only after proper ventilation of the magnet room. Oxygen monitors with an audible alarm, situated at an appropriate height within the magnet room are recommended safety devices [42].

Patient-Related Devices

Implants. A particular danger is presented by small metallic surgical implants. Hemostatic or other clips in the CNS can move in their position. Dislocation by magnetic attraction or torque presents a risk of hemorrhage. In other parts of the body, we consider this to be a minimal risk, because after the healing phase of six to eight weeks, fibrosis and encasement of the clip help to keep it in a stable position. The label stainless steel is not a guarantee for non-ferromagnetic steel.

Implants that involve magnets such as magnetic sphincters, stoma plugs, dental implants, etc., can be demagnetized by the MR imager. They should be removed prior to the examination.

An extensive overview of the behavior of implants is given by Shellock [41], including a list of several hundred devices which are not prone to dislocation. It also lists a selection of those metallic implants, materials, and foreign bodies that are potential risks for patients undergoing MR imaging examinations.

Foreign bodies. Occult ferromagnetic foreign bodies incorporated in accidents are dangerous, in particular those close to the eyes. The patient's history may help to rule out such foreign bodies. Many patients, however, do not remember such accidents. In case of doubt, x-rays should be taken prior to MR imaging.

Ferromagnetic makeup and tattoos cannot only distort MR images, but also can be irritated and makeup can even be pulled into the eye by magnetic forces. Makeup should be removed before the examination, if possible.

Pacemakers. Research on the influence of magnetic and radiofrequency fields upon cardiac pacemakers reported that the RF radiation of the MR imager might disturb the function of demand pacemakers by closing the reed relay and switching to the asynchronous mode; varying magnetic fields may mimic cardiac activity. Magnetic attraction can provoke motion of the pacemaker in its pocket and thus move the conducting lead. Therefore, pacemaker patients or other persons bearing pacemakers should not be examined in, or come close to, an MRI or MRS system, although recently some exceptions have been described for new-generation pacemakers [44].

Pavlicek et al. reported a threshold for initiating the asynchronous mode of a pacemaker at 17 Gauss [31]. The national regulatory boards decided to limit the threshold for access to MRI areas to 5 Gauss. It seems advisable to mark this area by signs or lines on the floor.

It is of special interest for the observer of bureaucratic procedures that the 5-Gauss limit is ten times higher than the average earth magnetic field, but lower than the magnetic field in electric trains such as subways (up to 7 Gauss). The fields measured on the surface of the receiver of a telephone are 35 Gauss and of an audio headset 100 Gauss.

Similar considerations hold for pacemakers used for stimulation of the carotid sinus or intracorporal insulin pumps, for instance. Here, no adverse effects have been observed [38]. However, interference in electronic cochlear implants and ferromagnetic mechanical stapedial replacements has been reported [17].

Prosthetic heart valves are not considered to be dangerous in low fields. Patients should not undergo MR imaging in high fields if valve dehiscence is clinically suspected [45].

Wires, other metallic objects, and skin contact. Wire configurations such as pacemaker lead wires, ECG and plethysmographic cables, and surface-coil connections can act as antennae. Gradient and RF fields may induce current into these wires and thus cause fibrillations and burns. This presents a risk to the patient and must be eliminated prior to the examination.

This holds in a similar way for all clothing containing metallic threads or components, as well as all metallic objects such as eye glasses, jewelry, hairpins, buttons, watches, bracelets, prostheses, etc. All of these objects must be removed prior to the examination.

The patient’s skin should not be in contact with the inner bore of the magnet. Large-radius wire loops should not be formed by leads or wires that are used in the magnet bore during imaging procedures.

If the patient’s arms and legs are not completely covered with clothing, insulating material must be placed between the legs and between legs and magnet. Leg-to-leg and leg-to-arm skin contact must be prevented in order to avoid the risk of burning due to the generation of high current loops if the legs or arms are allowed to touch.

IUDs. Most of the commonly used intrauterine contraceptive devices (IUD) do not move under the influence of the magnetic field, do not heat up during sequences usually applied for pelvic imaging, and do not produce major artifacts in vitro or in vivo. Thus, patients with either all plastic or copper IUDs can be safely imaged with magnetic resonance [27].

Joint and limb prostheses. Generally, such prostheses present no risk. However, they can introduce image artifacts. If possible, they should be removed prior to the MR examination.

Skin patches. Pharmaceutical products in transdermal skin patches may cause burns due to the absorption of RF energy. Such patches must be removed prior to MR examinations.

Other Considerations

Sedation. MR has become an important tool in pediatric imaging. Since some infants and children are unable to cooperate with the examiners, there is an increased demand for sedation.

Some infants sleep soundly through an MR examination, particularly if they have eaten; however, many infants and children up to eight years require sedation, even if they are accompanied by their parents into the scanner room. In most instances, teenagers can be treated like adults.

Details on sedation and procedures can be found in the literature [3, 4, 20].

Claustrophobia. This is a very real psychological danger for some patients. Claustrophobia and other psychological stress situations have been reported severe enough to interrupt the examination in about 1-4% of cases. In this respect, small and wide-bore MR imagers are advantageous because the percentage of claustrophobic incidents drops significantly. Explanation of the imaging procedure and the equipment prior to the examination helps to reduce claustrophobia significantly.

The possibility of the patient falling from the examination couch and hypotonic syndrome (due to heat, motionless horizontal lying for a certain time, and psychological agitation) are additional hazards.

Pregnancy. There is no evidence that MR can harm the fetus or embryo — MR imaging is used for fetography, particularly for imaging the brain. An epidemiological study by Kanal, et al. concluded that data collected from MR imaging technologists were negative with respect to any statistically significant elevations in the rates of spontaneous abortion, infertility, and premature delivery [21]. As a safety precaution, MR scanning should be avoided in the first three months of pregnancy. MR imaging is indicated for use in pregnant women if other nonionizing forms of diagnostic imaging are inadequate, or if the examination provides important information which would otherwise require exposure to ionizing radiation such as x-ray or CT. Similar considerations hold for pregnant staff of a magnetic resonance department. Mainly for psychological reasons, it might be a wise precaution that pregnant staff members do not remain in the scan room during actual scanning; however, they are allowed to prepare and position the patient, administer contrast agents, and scan and film.


Contraindications for MR imaging and spectroscopy. Never forget that the magnetic memory of credit and similar cards, as well as magnetic devices such as tapes, will be erased by MR magnets. Leave home without them or leave them outside the magnet room.

Absolute Contraindications

electronically, magnetically, and mechanically activated implants:
cardiac pacemakers
ferromagnetic or electronically operated stapedial implants
hemostatic clips (CNS)
metallic splinters in the orbit

Relative Contraindications

electronically, magnetically, and mechanically activated implants:
other pacemakers, e.g., for the carotid sinus; insulin pumps and nerve stimulators; lead wires or similar wires
non-ferromagnetic stapedial implants
cochlear implants
prosthetic heart valves (in high fields, if dehiscence is suspected)
hemostatic clips (body)
makeup and tattoos
congestive heart failure
pregnancy
(claustrophobia)


Legal Requirements

In the early 1980s, a number of national health and radiation protection boards first established recommendations concerning magnetic resonance imagers and spectroscopic units [15, 19, 34, 35]. All limits set by them were recommended levels, not mandatory ones.

Legal requirements in some European and Asian countries exist; some of them are without any scientific background, imposed by economic lobbies rather than learned societies. Others have no connection to reality or clinical routine [19, 30].

In the meantime, however, some manufacturers started using field strengths beyond 2.0 T, different pulse sequences, and gradient-switching procedures without any reported ill effects. Thus, these recommendations are partly outdated.

Adjustments made do not cover all possible medical applications of MR imaging, although the US-American Food and Drug Administration (FDA) extended the designation of ‘nonsignificant risk’ to MR systems with field strengths of up to 4.0 T in 1997 [5b] and 8.0 T in 2003 (4.0 T in neonates younger than one month) [5c].

However, there is no sufficient evidence that imaging at fields higher than 2.0 Tesla is risk-free. Until reliable scientific studies about the effects of ultrahigh fields are available, MR equipment operating at fields higher than 2.0 Tesla should be purchased with caution.

For legal reasons, the owner of MR equipment has to ensure that the equipment does fulfil the local requirements. In some countries, the regulations are more stringent than in others; in other countries, they are nonexistent. These requirements must be guaranteed by the manufacturer because the user in general is unable to check power output, gradient strength, or even field strength. This guarantee must cover authorized hardware and software updates after the initial installation. Specially designed computer programs usually supervise the power output of MR systems and will not allow or will interrupt any imaging or spectroscopy procedure exceeding those limits considered safe.

Subacute Hazards

The subacute risks of magnetic and RF fields have been intensively examined for a long time.

There are some publications associating an increase in the incidence of leukemia with the location of buildings close to high-current power lines with extremely low-frequency (ELF) electromagnetic radiation of 50-60 Hz [47], and industrial exposure to electric and magnetic fields [29]. However, a transposition of such effects to MRI or MRS seems unlikely.

According to the National Radiological Protection Board of the United Kingdom [36], the available experimental evidence weighs against electromagnetic fields acting directly to damage cellular DNA, implying that these fields may not be capable of initiating cancer in a manner that parallels that of ionizing radiation and many chemical agents. The results of some animal and cellular studies suggest the possibility that electromagnetic fields may act as co-carcinogens or tumor promotors, but taken overall, the data are inconclusive.

In the following paragraphs, we shall discuss some possible subacute hazards.

Static Magnetic Fields

In every MR examination, a large static magnetic field is applied. Field strengths for clinical equipment can vary between 0.2 and 3.0 T (2,000 and 30,000 Gauss); experimental imaging units have a field strength of up to 17.5 T, depending on the equipment used. In MRS, field strengths up to 12 T (120,000 Gauss) are currently used. No permanent hazardous effects of static magnetic fields upon human beings have yet been demonstrated [8].

However, there have been no long-term studies following persons who have been exposed to a static magnetic field.

Budinger calls the following five biophysical mechanisms into question whereby static magnetic fields might influence biological processes or an organism’s behavior [14]:


Changes in enzyme kinetics. Up to 45 Tesla, no important effects on enzyme systems have been observed.

Orientation changes of macromolecules and living-cell subcellular components. The result of replicable experiments on the orientation effects of retinal rods in fields of 1 Tesla, the alignment of sickle cells at 0.35 T, and the orientation of certain bacteria and animals might be explained by the physical torque rather than the sensing of the turning torque by nervous tissue.

Nerve conductivity. As early as 1893, the first results of experiments about a possible influence of static magnetic fields upon nerve tissue were obtained [6]. These and all later experiments showed negative results. There are apparently no effects on the conduction of impulses in the nerve fiber up to a field strength of 0.1 T generated by either changing the electrical resistance or the potential of the excitation [1, 2]. Theoretical examinations argue that fields of 24 T are required to produce a 10% reduction of nerve impulse conduction velocity [23].

A preliminary study has indicated neurological effects in subjects exposed to a whole-body imager at 4.0 T [41]. Here, additional research is necessary.

Cardiac changes. A field-strength-dependent increase in the amplitude of the ECG in rats has been observed during exposure to homogeneous stationary magnetic fields. The minimum level at which augmentation could be observed was 0.3 T; at 2.0 T, the increase was by an average of 400%.

The augmentation in T-wave amplitude occurred instantaneously and was immediately reversible after exposure to the magnetic field ceased. There have been no abnormalities in the ECG in the later follow-up [16]. The authors suggest that augmentation of the signal amplitude in the T-wave segment may result from a superimposed electrical potential. At field strengths of between 7 and 10 T, no arrhythmia could be proven [10].

According to the national radiation protection and health agencies, it is unlikely that cardiac fibrillation would occur as a result of induced flow potential in the major blood vessels or heart chambers at this level of field intensity.

No circulatory alterations coincide with the ECG changes. Therefore, no biological risks are believed to be associated with them.

Magnetohydrodynamic effects. A blood pressure increase of 28% is predicted theoretically for a field of 10 T. This is claimed to be caused by interaction of induced electrical potentials and currents within a solution, e.g. blood, and an electrical volume force causing a retardation in the direction opposite to the fluid flow. This decrease in flow velocity must be compensated for by an elevation in pressure. At 1.5 T, no significant changes are expected; at 6.0 T a 10% pressure change is expected [14, 46].

In addition to Budinger's reflections, the following points are valid for discussion:

Genetic effects. There have been several reports that static magnetic fields may provoke genetic mutations, changes in growth rate and leukocyte count and other effects [37]. The results of these experiments could not be reproduced [40]. Inhibition of growth rate of Eschericha coli induced by low-frequency magnetic field could be shown. Nevertheless, some authors claim it be unlikely that mutagenic effects are introduced by fields lower than 1.0 T [24]. No reports have been published that persons exposed to magnetic fields, including personnel at MR departments, have a higher incidence of genetic damage to their children than found in the average population.

We believe, however, that this research needs further investigation and that pregnancy should be considered a relative contraindication for MRI and MRS. Taking into account that clinical MR imaging devices operate at field strengths of between 0.2 and 2.0 T, caution demands further experiments at higher field strengths.

Membrane transportation and blood sedimentation. Other potential hazards from static fields include, for instance, membrane transportation and blood sedimentation induced by the field. As Mansfield and Morris pointed out, static magnetic field gradients of 0.01 T/cm (100 G/cm) make no significant difference in the membrane transport processes. The influence of a static magnetic field upon erythrocytes is not sufficient to provoke sedimentation, as long as there is a normal blood circulation [24].

As discussed above, many results presented in publications about effects of static magnetic fields are contradictory and cannot be explained by biophysical or biochemical mechanisms. In some cases, the effects observed must be attributed to other causes which had not been considered by the researchers in the setup of the experimental protocol. Critical considerations of such experiments can be found in a number of reviews [14, 32]. However, the data available are not comprehensive enough to assume MR imaging and spectroscopy are absolutely safe.

Varying Magnetic Fields

Varying magnetic fields are necessary for the localization of nuclei with magnetic properties within the sample.

A well described effect of varying magnetic fields is the so-called magnetic phosphenes [16], which were first observed some 90 years ago [7]. They are attributed to magnetic-field variations and may occur in a threshold field change of between 2 and 5 T/s. Phosphenes are stimulations of the optic nerve or the retina, producing a flashing sensation in the eyes. They seem not to cause any damage in the eye or the nerve.

Varying magnetic fields are also used to stimulate bone-healing in non-unions and pseudarthroses. The reasons why pulsed magnetic fields support bone-healing are not completely understood [9].

Rapid echo-planar imaging and high-performance gradient systems create fast-switching magnetic fields that can stimulate muscle and nerve tissues.

The mean threshold levels for various stimulations are 3,600 T/s for the heart, 900 T/s for the respiratory system, and 60 T/s for the peripheral nerves. Guidelines in the United States limit switching rates at a factor of three below the mean threshold for peripheral nerve stimulation.

Radiofrequency Fields

Radiofrequency pulses are used in MR imaging for the excitation of the nuclei. RF fields may interact with both tissues and foreign bodies, such as metallic implants, in the patient. The main result of this type of interaction is heat.

The higher the frequency, the larger will be the amount of heat developed; and the more ionic the biochemical environment in the tissue, the more energy that will be deposited as heat [22, 36]. This effect is well-known for homogeneous model systems, but the complex structure of various human tissues makes detailed theoretical calculations very difficult, if not impossible.

The specific absorption rate, SAR, helps to estimate RF heating effects. It increases with field strength, radiofrequency power and duty cycle, transmitter-coil type and body size. In high and ultrahigh fields, some of the multiple echo, multiple-slice pulse sequences may create a higher SAR than recommended by the agencies.

Hot spots may occur in the exposed tissue. At present, it seems unlikely that such hot spots in the body exist, but to avoid or at least minimize effects of such theoretical complications, the frequency and the power of the RF irradiation should be kept at the lowest possible level.

In several in vitro and in vivo experiments, no threatening increase in temperature could be shown [13, 23]. Even in high magnetic fields, no local temperature increase greater than 1°C occurred. The highest skin temperature increase described reached 2.1°C [42]. Eddy currents may heat up implants and thus may cause local heating. In vitro worst-case experiments performed with a large and very thin thermally insulated aluminium sheet at 1.5 T after 15 minutes of exposure showed a temperature rise of only 0.08°C.

According to the specific FDA criteria for SAR limits, the SAR must not be greater than:

• 4 W/kg averaged over the whole body for any 15-minute period;
• 3 W/kg averaged over the head for any 10-minute period; or
• 8 W/kg in any gram of tissue in the extremities for any period of 5 minutes.

Some European countries have issued SAR restriction too. No common denominator has been found.

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