MRI safety and ethics in MRI environment The American College of Radiology (ACR) has developed a set of guidelines

to be used in the design of the MRI suite utilizing four zones: 1. Zone I. Any area freely accessible to the general public. It should lie outside the MRI suite but lead to its entrance. 2. Zone II. Serves as a buffer zone. Includes the reception and waiting areas. 3. Zone III. Areas restricted to MRI personnel and other individuals and equipment that have been properly screened. MRI personnel are in charge of supervision and safety of this room. Zone III Includes the MRI control room. The fringe field in this area is 0.5mT (5 gauss). A clear red line should be made visible. 4. Zone IV. This is the scan room itself. It should be marked with the necessary warnings and cautions pertaining to the magnetic field and should always be observable by the MRI personnel

The FDA has set limits of the strength of the main magnetic field at 8 T for adults and children and 4 T for infants less than one month old Effects of the Fringe Magnetic Field-Static (SMF) The magnet produces forces that interact with susceptible materials. The effect of the SMF may reach a distance far away from the magnet. The range of this fringe field depends on the following factors: 1. The strength of the magnet; FDA approves 3 T for clinical use while in research there are stronger magnets up to 10 T. 2. The distance away from the magnet; the effect decreases as we move away from the magnet. The invisible force line measured in gauss, the safe limit is set to 5 gauss. 1

3. Shielding; the perfect magnet shielding may reduce the effect of magnetic field to a limited area. There are two methods of sheildind:1-passive shielding by using steel to insulate the magnet from outside.2- Active shielding by using electrical current to counteract the unwanted magnetic fields 4. The degree of susceptibility of the material in the range of the fringe field. 5. The location in accordance to the center of the magnet. The effect is greater at the central line of the magnet at the openings of the bore. The magnet force interaction with susceptible material. Many biomedical utilities and devices are made of ferromagnetic material and are highly susceptible such as Iron, Nickel, Cobalt, and other alloys. Although stainless steel is not ferromagnetic there can be some devices that are made of stainless steel with some alloys that make it unsafe for MRI usage. The magnetic force has two main effects when interacted with susceptible materials: 1. Physical attraction 2. Physiological interaction 1. Physical attraction The strong magnetic force creates an environment in which ferromagnetic objects could become projectiles. Objects may be pulled into the magnet with great force creating dangerous projectiles. Any object, regardless of size, could be considered dangerous. Small objects such as paper clips and hairpins have a terminal velocity of 40 mph when pulled into a 1.5 T magnet. All objects and instruments should be tested before being brought into the magnet room, and any device made of or containing metal parts should be verified in writing that they are safe for MRI. 2. Physiological interaction with electronic devices: Magnetic force may interfere with Electronic and physiologic devices by inducing voltage or interfere with the function of the device, for example neuorostimulator may be turned off by the referring doctor before admitting the patient to the magnet room, on the other hand patient with cardiac pace maker must be out of the 5 gauss line which is mostly lies at the door of the magnet room. Biological effects As yet, no long term adverse biological effects of extended exposure to the magnetic field associated with MRI have been documented injuries, or even death. Effects and safety of Radio Frequency Pulses RF is an energy sent to the body. The Transmitter coil produces the RF which enters the body. The range of frequencies is from 10 to 200 MHz. Some of the RF will be absorbed by the body tissues and transformed into heat. The amount of heat that is absorbed by the body is measured by Specific Absorption Rate (SAR). Watt/Kg is the unit of SAR. The MRI system controls SAR level and it will prohibits scan when SAR level is above the permissible level. RF may induce electrical current in the body, this result in the generation of heat. 2

The presence of any conductor inside the body may concentrate the electrical current and produce heat due to resistance of the tissues heat may cause local burns Specific Absorption Rate (SAR) The ability of patient to dissipate heat during MRI depends on many factors such: 1. The type of oil, 2. RF pulse amplitude, 3. Ambient room temperature, 4. Air flow through the bore, 5. The type of sequence, 6. Number of slices, 7. TR and TE, 8. Saturation pulses, 9. Volume of tissue being scanned. Some parts of the body have very limited ability to dissipate heat that includes the cornea and the testicles. Heat deposition increases with higher magnetic field. The FDA guidelines for maximum Specific Absorption Rate (SAR) exposure, released in 2003, are A. 4 Watt/kg averaged over 15 minutes for the whole body, B. 3 Watt/kg averaged over 10 minutes for the head, C. 12 Watt/kg per gram of tissue over five minutes for the extremities Effects of rapidly changing magnetic field According to Faradays law of induction, changing magnetic fields may cause induced electrical current in conductors within the body. The gradient magnetic force strength increases away from the isocenter. There are a variety of conductors in the body, blood vessels, muscles and nerves, rapidly changing magnetic field especially in EPI sequence may cause nerve stimulation or muscle tissue to excite. The FDA limits the exposure to Time-varying magnetic fields by using the Faradays Law of induction equation db/dt =dV, where db is the magnetic field change (which is caused by the gradients), dt is the change overtime, and dV is the change in voltage that result from altering the magnetic field over time. Metal Implanted devices Metal Implanted devices presents two problems, first it may distort the images due to its susceptibility, second it may absorb energy and raise the temperature of the surrounding tissue, smaller implanted metallic objects may be moved by the torque induced by the magnetic field. Biostimulation Devices The safe limit by FDA limits the Electronic implanted devices to 5-Gauss as maximum limit. The magnetic field may change its mode of operation or even stop it. These devices may 3

include but not limited to Cardiac pacemakers/pacemaker wires, electronically, magnetically, or mechanically activated implanted devices Absolute contraindications to MRI There are several absolute contraindications to MRI: A. Cardiac pacemakers/pacemaker wires. B. Electronically, magnetically, or mechanically activated implanted devices. C. Metallic orbital foreign bodies. D. Tissue expanders. E. Ocular prostheses. F. Dental implants. Relative contraindications include: A. Intracranial vascular clips. B. Extra-cranial vascular clips. C. Intravascular coils, filters, and stents. D. Heart valves. E. Middle ear prostheses. F. Penile prostheses. G. Shrapnel/foreign bodies. H. Halo vests and fixation devices. Devices that are relatively safe to study include A. Surgical hemostasis clips (after a 2-3 month post-surgery delay) B. Orthopedic prostheses, pins, rods, and plates C. Dental fillings and orthodontic braces D. Intrauterine devices (IUDs) and contraceptive diaphragms Acoustic hazards. Fast switching of the gradients during scanning produce noise that may exceed 99 db in the bore, this high level of sound may cause hearing impairment. The noise level is higher with EPI sequences. Psychological hazards, People may develop claustrophobia, feel irritable, and may panic during the exam. These hazards may be caused by confining into small space and noise Laser light is used by the technologist to set the center point; laser light may have negative effects on the eyes Pregnant Patient safety: a. Magnetic Field Data currently available about hazards of magnetic field on fetus/embryo does not show any contraindication to scan pregnant patient, however, this current information does not exclude future discovery of potential hazards of magnetic field on pregnancy.

b. MRI Contrast medium Contrast medium may cross blood barrier into placenta. Some adverse effects are possible. Contrast medium used in MRI should not be used for pregnant patient or breast feeding patient without the consent of MR medical director. Contrast medium side effects: A. Nausea and/or vomiting. B. Slight transitory increase in bilirubin and blood iron. C. Mild transitory headaches. D. Hypotension. E. Gastrointestinal upset or rash. F. Anaphylaxis and/or respiratory problems. G. Death (2/500,000 injections). Contrast medium Contraindications: A. When scanning pregnant women. It is important female patients who are uncertain as to whether they are pregnant are required to have a screening urine or blood pregnancy test B. In women choosing to breast feed. C. In patients with hemoglobinopathies, hemolytic anemia, sickle cell anemia and hematological disorders D. In patients with renal disease (CrCl < 20 ml/min). E. In patients with an allergic history or diabetics. F. Patients with unstable angina or New York Heart Association functional class IV heart failure. G. Asthma. Burns Burns to patients may be caused by damaged coils or cables, cables loops, metallic tattoos, and metal implants such as prosthesis. Quenching Quenching is a sudden and massive expansion of liquid helium into gaseous helium due to the increase of heat from a sudden loss of superconductivity of the magnet. If the superconductor becomes resistive, it heats up. As it heats, it becomes more resistive. The result of such a situation is a quench. Quenches may be controlled, as when a magnet is ramped down. On the other hand, quenches may occur as a result of a lack of liquid helium or mechanical trauma to the cryostat that causes the conductor to come in contact with a warmer component of the cryostat. If this contact happens, an uncontrolled quench occurs, and the energy stored in the magnet is converted to heat. Much of this heat boils off the cryogens. However, some of this heat may raise the temperature of the cryostat and damage the superconductive windings. Such a violent quench can destroy a magnet. In the event of an unplanned quench, one may first hear a hissing noise caused by the release of helium, nitrogen, or both. Both gases can displace oxygen downward and cause asphyxiation Quenching is an emergency situation and the patient must be evacuated immediately and treated for any possible injuries. 5

MRI Safety Procedures Comprehensive safety policies and procedures must in place to ensure the safety of patients and personnel and it is the responsibility of a qualified person to assure the practice of the MRI safety procedures. Although MRI Screening form is an important safety procedure, the availability of a qualified knowledgeable interviewer is a must. 1. Limit and monitor access to the magnet. No one should pass the 5 Gauss line without being checked for Magnetic safety. 2. Use a detailed screening sheet for all subjects, patients, caretaker and personnel before entering the magnet room. 3. The screening sheet must be reviewed by a qualified and authorized interviewer who can approve or deny access to the magnet room and or have access for resources to clear any ambiguous condition. 4. checking the safety of devices include, manufacturer documentation and contact information, Implant card, peer-reviewed published information, web searches and consultation with designated safety experts such as MRI physicist, MRI Radiologist or licensed MRI technologist.

5. It is important to recognize the strength of the magnet when checking for the safety of implants. For Example, 1.5TMRI safe materials or implants may be not safe for 3T. 6. A second brief interview must be performed just before entering the magnet room to remind the subject of any unsafe implants or materials. 7. For a safe and diagnostic MRI exam, participants could be required to remove all clothes and jewelry and wear a gown clear of any metallic parts or contrast residues. 8. The screening form must be documented in writing with the participant and interviewers signature and date. 9. All items and devices that need to be entered to the magnet room should pass the Magnetic safety check.

Figure 1: Hand held ferromagnetic Detector

10. A sensitive ferromagnetic-detector may be installed at the door of the magnet room or a hand held device may be used to check for any ferromagnetic material. 11. In case of patient emergency, the scan may be aborted, patient must be pulled out of the magnet, provide medical help outside the magnet room as needed and call for help. 12. In case of quench, the helium may fill the magnet room and raise the pressure to a degree that makes it hard to open the door, this may be accompanied by a loud noise, the oxygen level may decrease, and cryogens may cause frostbite and asphyxiation. Technologist should calm the patient and try to enter the room; if not possible to open the door it is important to break the window to relieve the pressure. 13. Avoid Burns of the Patients Skin and internal tissues. To protect the patient from burns, the technologist must ensure the presence of adequate insulation between the skin of the patient and the cables and the sides of the magnet gantry. Also, the cable should be place placed straight, and loops must be avoided. Metal tattoos may be insulated by using an aluminum foil to cover the tattoos. To avoid metal implant heating, the technologist may use time separation between the sequences that may increase the temperature to give time for heat to dissipate. The technologist must monitor the SAR reading especially with the fast imaging sequences such as echo planner. 14. Noise Reduction Avoid acoustic hazard to patient and personnel. Loud noise may trigger claustrophobia, and it may be harmful to the patients hearing. Ear plugs must be provided to the patient, and the technologist may encourage patients to use them as patients are not familiar with the strength of noise. Headphones are very helpful to communicate with the patient during scanning, especially while using Flouro triggering in which the noise is very loud during scanning, and to provide music for patients.

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Figure 2: MRI compatible Headphones and ear plugs.

15. Consult MD for pregnant patient to get the MRI exam, and for nursing mother for having contrast media. 16. Avoid Peripheral Nerve Stimulation When using the ultrafast sequences such as Echo Planner Imaging (EPI), and due to the rapidly time varying magnetic fields, some patients may feel muscle twitching and tingling, and may see flashing lights in their eyes. The technologist can help reduce these effects by swapping the frequency encoding right to left, instructing patients to avoid loops by avoid crossing their hands and ankles, and to ask the patient to use the alarm to warn the technologist of any inconvenience. 17. Usage of Oxygen Supply for Patient in the Magnet Room. The supply of oxygen for the patient in the magnet room should be through an outside source, oxygen tube connection may be used to supply the patient with oxygen during the exam. In cases where oxygen outlet is not available, an MRI compatible certified oxygen cylinder may be used. The oxygen cylinder must be tested and verified for magnetic safety before it can be taken to the magnet room.

Figure 3: MRI safe fire extinguisher.

18. Monitor the helium range. 19. Monitor the SAR range. 20. Monitor the patient during scanning. 21. Communicate with the subject during scanning. Terminology and signs. It is fundamental to understand the terminology and definitions approved and use in MRI safety.

MRI Signs

Figure 4 MRI contraindicated devices

Figure 5 MRI safe device sign

Figure 6 MRI safe Oxygen Cylinder sign

Figure 7 MRI safe and non safe sign

Figure 8 MRI Strong Magnet Field

Brown, Jeffrey J, Thomas Schrack, Alan H. Stolpen and Daniel Thedens, MRI for Technologists Technical Considerations of MRI, 2006 Magnetic Resonance Technology IP - MRI Patient Information, www.mrtip.com/serv1.php?type=pin&sub=1 - 78k -, Received November 24, 2007. MRI Safety Patient Questionnaire, www.mr-tip.com/serv1.php?type=pin&sub=1 - 78k -, received November 24, 2007. Parkside Magnetic Resonance Center - Preparing Your Patients for MRI, www3.americanradiology.com/library/CLINICAL/mriclinical.pdf www.mrtip.com/serv1.php?type=pin&sub=1 - 78k -, received November 24, 2007. Safety in Medical Imaging Procedures, www.radiologyinfo.org/en/safety/index.cfm?pg=sfty_mr - 23k, received November 24, 2007.

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