Magnetic resonance imaging, страница 4

MR-Conditional: A device or implant that may contain magnetic, electrically conductive or RF-reactive components that is safe for operations in proximity to the MRI, provided the conditions for safe operation are defined and observed (such as 'tested safe to 1.5 Teslas' or 'safe in magnetic fields below 500 gauss in strength').

MR-Unsafe: Nearly self-explanatory, this category is reserved for objects that are significantly ferromagnetic and pose a clear and direct threat to persons and equipment within the magnet room.

In the case of pacemakers, the risk is thought to be primarily RF induction in the pacing electrodes/wires causing inappropriate pacing of the heart, rather than the magnetic field affecting the pacemaker itself. Much research and development is being undertaken, and many tools are being developed in order to predict the effects of the RF fields inside the body.

Other significant safety issues include:

• Projectiles: As a result of the very high strength of the magnetic field needed to produce scans (frequently up to 60,000 times the earth's own magnetic field effects), there are several incidental safety issues addressed in MRI facilities. Missile-effect accidents, where ferromagnetic objects are attracted to the center of the magnet, have resulted in injury and death.^[20] It is for this reason that ferrous objects and devices are prohibited in proximity to the MRI scanner, with non ferro-magnetic versions of many of these objects typically retained by the scanning facility. The magnetic field remains a permanent hazard — the superconductive MRI magnet retains its magnetic field at all times. The proliferation of ferromagnetic materials makes screening them out a significant challenge. New ferromagnetic-only detection devices are supplementing conventional screening techniques in many leading hospitals and imaging centers. A video of what happens when a ferromagnetic bottle of oxygen enters the vicinity of an MRI magnet can be viewed here [1], the bottle is violently sucked into the bore of the magnet and oscillates rapidly in midair until coming to rest at the center.

• Radio frequency energy: A powerful radio transmitter is needed for excitation of proton spins. This can heat the body significantly, with the risk of hyperthermia in patients, particularly the obese or patients with thermoregulation disorders. Several countries have issued restrictions on the maximum specific absorption rate that a scanner may produce.

• Peripheral nerve stimulation (PNR): The rapid switching (on and off) of the magnetic field gradients needed for imaging is capable of causing nerve stimulation. Volunteers report a twitching sensation when exposed to rapidly switched fields, particularly in their extremities. The reason the peripheral nerves are stimulated is that the changing field increases with distance from the center of the gradient coils (which more or less coincides with the center of the magnet). Note however that when imaging the head, the heart is far off-center and induction of even a tiny current into the heart must be avoided at all costs. Although PNR was not a problem for the slow, weak gradients used in the early days of MRI, the strong, rapidly-switched gradients used in techniques such as EPI, fMRI, diffusion MRI, etc. are indeed capable of inducing PNR. American and European regulatory agencies insist that manufacturers stay below specified dB/dt limits (dB/dt is the change in field per unit time) or else prove (via clinical studies) that no PNR is induced for any imaging sequence. As a result of dB/dt limitation software and/or hardware, commercial MRI systems cannot use the full rated power of their gradient amplifiers.

• Acoustic noise: Loud noises and vibrations are produced by forces resulting from rapidly switched magnetic gradients interacting with the main magnetic field, in turn causing minute expansions and contractions of the coil itself. This is most marked with high-field machines and rapid-imaging techniques in which sound intensity can reach 130 dB (equivalent to a jet engine at take-off). Appropriate use of ear protection is essential. Manufacturers are now incorporating noise insulation and active noise cancellation systems on their equipment.

• Cryogens: An emergency shut-down of a superconducting electromagnet, an operation known as "quenching", involves the rapid boiling of liquid helium from the device. If the rapidly expanding helium cannot be dissipated though external vents, it may be released into the scanner room where it may cause displacement of the oxygen and present a risk of asphyxiation. Since a quench results in immediate loss of all cryogens in the magnet, recommissioning the magnet is extremely expensive and time-consuming. Spontaneous quenches are uncommon, but can occur at any time.

[edit] Contrast agents

The most frequently used intravenous contrast agents are based on chelates of gadolinium. In general, these agents have proved safer than the iodinated contrast agents used in X-ray radiography or CT. Anaphylactoid reactions are rare occurring in approx 0.03-0.1%. ^[21] Of particular interest is the lower incidence of nephrotoxicity, compared with iodinated agents, when given at usual doses—this has made contrast-enhanced MRI scanning an option for patients with renal impairment, who would otherwise not be able to undergo contrast-enhanced CT. ^[22]

Although gadolinium agents have proved useful for patients with renal impairment, there has been a newly identified risk described in patients with severe renal failure requiring dialysis. A rare, but serious, illness affecting dialysis patients, nephrogenic systemic fibrosis, has been linked to the use of certain gadolinium containing agents: the most frequently associated is gadodiamide association with some other agents has been reported. ^[23] Although a causal link has not been definitively established, current guidelines in the United States are that dialysis patients should only receive gadolinium agents where essential, and that dialysis should be performed as soon as possible after the scan is complete, in order to remove the agent from the body promptly. ^[24] In Europe where more gadolinium-containing agents are available, a classification of agents according to potential risks has been released.^[25][26]

[edit] Pregnancy

No harmful effects of MRI on the fetus have been demonstrated. In particular, MRI avoids the use of ionizing radiation, to which the fetus is particularly sensitive. However, as a precaution, current guidelines recommend that pregnant women undergo MRI only when essential. This is particularly the case during the first trimester of pregnancy, as organogenesis takes place during this period. The concerns in pregnancy are the same as for MRI in general, but the fetus may be more sensitive to the effects—particularly to heating and to noise. However, one additional concern is the use of contrast agents; gadolinium compounds are known to cross the placenta and enter the fetal bloodstream, and it is recommended that their use be avoided.

Despite these concerns, MRI is rapidly growing in importance as a way of diagnosing and monitoring congenital defects of the fetus because it can provide more diagnostic information than ultrasound and it lacks the ionizing radiation of CT. MRI without contrast is the imaging mode of choice for pre-surgical, in-utero diagnosis and evaluation of fetal tumors, primarily teratomas, facilitating open fetal surgery, other fetal interventions, and planning for procedures (such as the EXIT procedure) to safely deliver and treat babies who have defects otherwise incompatible with life.

[edit] Claustrophobia and discomfort

Due to the construction of MRI scanners, they are potentially unpleasant to lie in. The part of the body being imaged needs to lie at the center of the magnet (which is often a long, narrow tube). Because scan times may be long (perhaps one hour), people with even mild claustrophobia are often unable to tolerate an MRI scan without management.

Management may include:

• Advance preparation

  • visiting the scanner to see the room and practice lying on the table

  • visualization techniques

  • chemical sedation

  • general anesthesia

• Coping while inside the scanner

  • holding a "panic button"

  • listening to music on headphones or watching a movie with a Head-mounted display while in the machine

• Modified scanner designs

  • open-bore design scanners.

Though open MRIs have increased in popularity as of late, they produce inferior scan quality because they operate at lower magnetic fields than closed MRIs.

• • upright MRIs (made exclusively by FONAR)

For babies and children, chemical sedation or general anesthesia are the norm. These MRI subjects are too young to be instructed to hold still during the scanning session. Obese patients and pregnant women may find the MRI machine to be a tight fit, and even someone without a history of claustrophobia may find the experience intolerable without sedation. Pregnant women may also have difficulty lying on their back without moving for an hour or more.

The noise associated with the operation of an MRI scanner (especially the audible noise associated with the gradient pulses applied to the subject) can also exacerbate the discomfort associated with the procedure.

[edit] Guidance

Safety issues, including the potential for biostimulation device interference, movement of ferromagnetic bodies, and incidental localized heating, have been addressed in the American College of Radiology's White Paper on MR Safety which was originally published in 2002 and expanded in 2004. The ACR White Paper on MR Safety has been rewritten and was released early in 2007 under the new title ACR Guidance Document for Safe MR Practices.

[edit] The European Physical Agents Directive

The European Physical Agents (Electromagnetic Fields) Directive is European legislation that has been adopted in European legislature. By 2008 each individual state within the European Union must include this directive in its own law.

The directive applies to occupational exposure to electromagnetic fields (not medical exposure) and was intended to limit workers’ acute exposure to strong electromagnetic fields, as may be found near electricity substations, radio or television transmitters or industrial equipment. However, the regulations impact significantly on MRI, with separate sections of the regulations limiting exposure to static magnetic fields, changing magnetic fields and radio frequency energy. Field strength limits are given which may not be exceeded for any period of time. An employer may commit a criminal offence by allowing a worker to exceed an exposure limit if that is how the Directive is implemented in a particular Member State.

The Directive is based on the international consensus of established effects of exposure to electromagnetic fields, and in particular the advice of the European Commissions's advisor, the International Commission on Non-Ionizing Radiation Protection (ICNIRP). The aims of the Directive, and the ICNIRP guidelines upon which it is based, are to prevent exposure to potentially harmful fields. The actual limits in the Directive are very similar to the limits advised by the Institute of Electrical and Electronics Engineers, with the exception of the frequencies produced by the gradient coils, where the IEEE limits are significantly higher.

Many Member States of the EU already have either specific EMF regulations or (as in the UK) a general requirement under workplace health and safety legislation to protect workers against electromagnetic fields. In almost all cases the existing regulations are aligned with the ICNIRP limits so that the Directive should, in theory, have little impact on any employer already meeting their legal responsibilities.

The introduction of the Directive has brought to light an existing potential issue with occupational exposures to MRI fields. There are at present very few data on the number or types of MRI practice that might lead to exposures in excess of the levels of the Directive. There is a justifiable concern amongst MRI practitioners that if the Directive were to be enforced more vigorously than existing legislation, the use of MRI might be restricted, or working practices of MRI personnel might have to change.

In the initial draft a limit of static field strength to 2 T was given. This has since been removed from the regulations, and whilst it is unlikely to be restored as it was without a strong justification, some restriction on static fields may be reintroduced after the matter has been considered more fully by ICNIRP. The effect of such a limit might be to restrict the installation, operation and maintenance of MRI scanners with magnets of 2 T and stronger. As the increase in field strength has been instrumental in developing higher resolution and higher performance scanners, this would be a significant step back. This is why it is unlikely to happen without strong justification.