Level 1 MR Safety - E. Jackson CRCPD Meeting – Level 1 MR Safety, 2013 Safety Aspects and Challenges of Magnetic Resonance in Radioactive Materials Environments Edward F. Jackson, PhD Department of Imaging Physics 1 Introduction • Over the past three decades, MRI has clearly been demonstrated to be one of the most powerful imaging modalities and, if all appropriate safeguards are in place, one of the safest. • However, there are very real dangers associated with diagnostic MRI facilities. • The objectives of this presentations are to – provide a background on safety issues associated with each of the magnetic fields utilized in MRI, – provide an introduction to other safety issues, e.g., MR compatible/safe devices, safety screening procedures, cryogen gas issues, MR contrast agents, – discuss MR facility safety systems. 2 1 Level 1 MR Safety - E. Jackson Before we delve into MR safety…. ….an intro to how MRI works Introduction or MR101 Basic ingredients to form an MR image: – Non-zero magnetic moment nuclei Nuclear – Static magnetic field, Bo Magnetic – Radiofrequency field, B1 Resonance – Magnetic field gradients, Gx,y,z 4 2 Level 1 MR Safety - E. Jackson MR Scanner Block Diagram X-Gradient Amplifier Y-Gradient Amplifier Z-Gradient Waveform Generators Amplifier RF Amplifier Transcoupler Shim Control ADCs Host Computer Image Processor Console 5 Nuclear Magnetic Resonance • Only nuclei with non-zero magnetic moments can be imaged. • A non-zero magnetic moment occurs for odd numbers of protons and/or neutrons. • Most commonly, the nuclei have spin quantum numbers of 1/2, e.g., 1H, or 3/2, e.g., 23Na. 6 3 Level 1 MR Safety - E. Jackson Nuclear Magnetic Resonance Properties of some common nuclei with potential use in MR studies Nucleus 1 H C 19 F 23 Na 31 P 13 Spin 1/2 1/2 1/2 3/2 1/2 Natural Isotopic Sensitivity Gyromagnetic Abundance Relative to 1H (%)* ratio (MHz/T) (%) 42.57 99.98 100 10.71 1.11 1.6 40.06 100 83.4 11.26 100 9.3 17.24 100 6.6 *At constant field for equal number of nuclei. Note: The steady state magnetization depends on the square of , the gyromagnetic ratio 7 Nuclear Magnetic Resonance • Without an external magnetic field, the magnetic moments in a sample, or patient, are randomly distributed, i.e., there is no net magnetization. • In an externally applied field, protons, which have a spin quantum number of 1/2, have two allowed states: parallel or antiparallel to the applied magnetic field. |1/2 -1/2> |1/2 -1/2> |1/2 1/2> B= 0 Zeeman Splitting 8 4 B = Bo |1/2 1/2> Level 1 MR Safety - E. Jackson Nuclear Magnetic Resonance Bo N0- Mo N0+ 9 Small net excess of proton spins aligned with B0 yields net magnetization, M0. Nuclear Magnetic Resonance • To generate time-dependent transverse magnetization that can be detected, transitions between the two allowed energy states (for a spin 1/2 nucleus) must be induced. • The transitions result from the application of a time-varying magnetic field with energy equal to the difference in the energy levels, i.e., ΔE = = Bo where is Planck’s constant, is the gyromagnetic ratio, and Bo is the static magnetic field strength. 10 5 Level 1 MR Safety - E. Jackson Nuclear Magnetic Resonance • The Larmor frequency is given by: Bo • For protons in a 1.5 T field, the Larmor frequency is ~64 MHz. • The radiofrequency field is commonly known as the B1 field and, in addition to being applied at the Larmor frequency, must be applied perpendicular to the static field in order to induce the desired transitions => there is both a resonant frequency and a B1 field polarization requirement. 11 Nuclear Magnetic Resonance z Mo z 90o Pulsex Mxy y x y x 12 6 Level 1 MR Safety - E. Jackson Free Induction Decay Relative Signal Intensity 1 0.5 0 0 100 200 300 400 500 -0.5 -1 V (t ) 0 M 0 0 Time (ms) N 0 13 Spatial Orientation – The MR signals must be encoded in 3 dimensions – By convention: • z - slice selection • x - frequency-encoded • y - phase-encoded y x z – Note: The slice, frequency and phase encoding may be on any axis 14 7 Image compliments of Carl Keener, PhD 2 Level 1 MR Safety - E. Jackson Slice Selection – Gradient along z-axis modifies B0 to produce a range of Larmor frequencies which vary with position. – Max amplitudes ~10 - 50 mT/m 0 B0 z ( B0 zGz ) Gz -z z 0 Image compliments of Carl Keener, PhD 15 Slice Thickness • Slice thickness is determined by – Gradient strength Gz z – Bandwidth of RF pulse (B1) z ( B0 zGz ) z z2 Gz G2 G1 z1 16 8 Level 1 MR Safety - E. Jackson Slice Position Slice position is determined by the transmit “center frequency”. f0 - 1000Hz f0 f0 + 1000Hz - 1000Hz 0 + 1000Hz Gz z 17 Image compliments of Carl Keener, PhD Frequency Encoding To encode the spatial information in the x-axis, another gradient (Gx) is used: -x 0 x x = (Bo+ x Gx) <== one-to-one correspondence between frequency and position 18 9 Image compliments of Carl Keener, PhD Level 1 MR Safety - E. Jackson Frequency Encoding When the gradient is on: – frequencies vary along x-axis The signal is sampled while the x-gradient is on – frequency of signal encodes position along x-axis -x 0 x Image compliments of Carl Keener, PhD 19 Phase Encoding To encode the spatial information in the y-axis, a 3rd gradient (Gy) is used + y 0 - y 20 10 Image compliments of Carl Keener, PhD Level 1 MR Safety - E. Jackson Spin Echo Imaging Sequence TE 900 TR 1800 900 1800 RF ... ... ... ... ... Gslice Gphase Gfreq Signal k-space 2nd echo 1st echo 21 Reconstructing the Image image has been phaseencoded in one direction gradient applied before frequency-encoding & sampling 22 11 image has been frequencyencoded in other dimension gradient applied during sampling Image compliments of Carl Keener, PhD Level 1 MR Safety - E. Jackson Image Formation |2D FFT| Re[s(t,n)] S(,) 23 Now…. ….back to MR safety 12 Im[s(t,n)] Level 1 MR Safety - E. Jackson Levels of MR Safety Training • Safety training divided into two levels: – Level 1 • • • • maintain one’s own safety in a limited set of conditions limited experience / responsibility in the MR environment REQUIRED minimum level of training in order to work in MR environment Examples: nurses, (non-MR) technologists, state inspectors, non-MR facilities staff who must enter the MR scan rooms, etc. – Level 2 • • • • highly trained and experienced personnel work constantly in the MR environment level of training qualifies staff to train/oversee others Examples: MR technologist, MR radiologist, MR physicist, etc. • This presentation for Level 1 training 25 Kanal, Barkovich, et al., JMRI 37:501-530, 2013 Levels of MR Safety Training It’s important to remember that: – Level 1 MR Personnel can work in the Zone IV (MR scan room) environment, but only a Level 2 MR Personnel can approve the entry of other individuals or devices into Zone IV. 26 13 Level 1 MR Safety - E. Jackson Introduction Each of the magnetic fields used in MR imaging can be a source of safety concerns: – Static B0 field (always on!) • Physiological effects, projectile motion, medical device displacement and/or interference with normal operation – Radiofrequency B1 field (on during scanning) • Tissue heating, heating of conductors, interference with patient monitoring equipment – Gradient fields (on during scanning) • Peripheral nerve stimulation, excessive sound pressure levels, interference with patient monitoring equipment 27 Introduction Other safety issues in MR imaging include: – contrast agents – pregnant patients, technologists, and nursing staff – effects of MR scanners on patient monitoring equipment – cryogen gases 28 14 Level 1 MR Safety - E. Jackson MR Site Safety Issues / Access Control • ACR Guidance Document on MR Safe Practices: 2013 – Available at www.acr.org – Kanal, Barkovich, et al., J Magn Reson Imaging 37:501-530, 2013 – Recommends facility design with respect to the four zones, with increasing security / access control requirements. – Updated version of original white paper (2002), supplement (2004), and revision (2007). • Another good source of information on practical clinical MR safety is F.G. Shellock and J.V. Crues, MR Procedures: Biologic Effects, Safety, and Patient Care, Radiology 232:635-652, 2004. • Other MR safety references are provided at the end of this presentation. 29 2013 MR Site Safety Issues / Access Control ACR White Paper on Safety Zone Concept • Zone I Zone I 2007 – Open access • Zone II – Preparation and holding • Zone III Zone II Zone II – Carefully controlled by MR facility personnel. May be partially within 5 G exclusion zone. • Zone IV Zone III – Actual scan room. No admittance w/o documented training and screening. Zone IV • 30 15 Access to any space contained in the 5 G (0.5 mT) fringe field should be carefully controlled and that space must be posted. Level 1 MR Safety - E. Jackson An MD Anderson 3.0T MR Facility 31 An MD Anderson 3.0T MR Facility Note that the 5G fringe field (“exclusion zone”) is completely contained in the MR scan room (Zone IV). 32 16 Level 1 MR Safety - E. Jackson Static Field Safety Issues The primary safety concern from the Bo field is prevention of injury from ferrous objects becoming projectiles. – Examples of objects that have found their way into the bores of MR scanner magnets: hairpins, stethoscopes, forceps, oxygen cylinders, vacuum cleaners, electrical filter panels, floor buffers, a fork lift tine. – Facilities must carefully limit scan room entry to authorized personnel who clearly understand the dangers associated with such powerful magnets. Preferred siting is a single access door within clear view of the MR technologist. – Every individual (patients, employees, visitors) entering the scan room must first be screened. 33 Static Field Safety Issues 34 17 Level 1 MR Safety - E. Jackson Static Field Safety Issues 35 Static Field Safety Issues 36 18 Level 1 MR Safety - E. Jackson Static Field Safety Issues MR Scanner Fields – How Strong? • Magnetic Field Units: – – – – – – – Gauss (G) and Tesla (T) 1 T = 10,000 G Earth’s magnetic field is ~0.5 G (0.05 mT) Posted exclusion zone (pacemakers/neurostimulators): 5 G (0.5 mT) 1.5T MR scanner ~30,000 times Earth’s field 3.0T MR scanner ~90,000 times Earth’s field ~3,000 – 9,000 times the 5 G exclusion zone field strength • Force of attraction at 1.5T: – Near bore opening: can easily be ≥25-50x the weight of the object – Translational force, Fz, is proportional to B0 dB0/dz – Torque = –m H sin , where m is the magnetic moment, H is the magnetic field density, and is the angle between the magnetic moment and the field 38 19 Level 1 MR Safety - E. Jackson MR Fringe Fields – 1.5T Espree Field Strength vs Distance (1.5T Espree) 1600 5G Radial 5 1200 Field Strength (mT) Field Strength (mT) 1400 Field Strength vs Distance (1.5T Espree) 6 5G Axial 1000 800 600 400 4 3 2 200 0 y = 258.97x-4.3457 R 2 = 0.999 y = 65.63x-4.9078 R 2 = 0.9931 1 0 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 0.0 1.0 2.0 3.0 Distance (m) Axial 4.0 5.0 6.0 7.0 Distance (m) Axial Radial Radial Data extracted from shielded configuration Drawing 400-0000005597-2005-MR02-FBH-01 OR122 39 Static Field Safety Issues 40 20 8.0 Level 1 MR Safety - E. Jackson REMEMBER! The magnet is NEVER off! 41 Static Field Safety Issues A second concern is the movement/displacement of certain implanted medical devices and/or metal fragments (screening is essential!): – 5 G exclusion zone must be posted for persons with pacemakers and neurostimulators. – Pacemakers, neurostimulators, cochlear implants, and aneurysm clips are exclusion criteria for MR scanning in many MR centers. – Some ferrous temporary or permanent medical devices are exclusion criteria for patient scans. – Some body piercings are ferromagnetic (and even if they are not they can cause significant artifacts and, potentially, local heating!) 42 21 Level 1 MR Safety - E. Jackson Static Field Safety Issues MR safety of implanted medical devices and other metal objects: – Extensive lists summarizing the safety of a wide range of medical devices and metal objects (bullets, etc.) are available in the literature and, particularly, in F.G. Shellock and E. Kanal, Magnetic Resonance. Bioeffects, Safety, and Patient Management, LippincottRaven Publishers, 1996. This inexpensive paperback book (and its successors) are highly recommended for anyone involved with the support of a MR imaging facility. – Information can also be obtained from the FDA and at www.mrisafety.com (maintained by Shellock et al.) 43 Safety Reference Shellock & Kanal, pp.179-213 Magnetic Resonance. Bioeffects, Safety, and Patient Management. 2nd Edition, Lippincott-Raven, 1996 44 22 Level 1 MR Safety - E. Jackson MDACC Employee Screening Form 45 Static Field Safety Issues • Note that even non-ferrous metal materials, e.g., aluminum, are affected by such strong magnetic fields when they are moved through the field. • Due to magnetic field forces secondary to currents induced in the metal due to its motion in the static magnetic field (Lenz’s Law). 46 23 Level 1 MR Safety - E. Jackson Labeling of items that may go in Zone IV MR Safe NOTE: Items in Zone III (control room) that may be taken into Zone IV (procedure room) must be appropriately labeled in order to minimize the potential for an MR accident. MR Conditional Not MR Safe 47 MR Compatibility • Any tool or device that is brought into Zone IV (the MR scan room) must be known/labeled to be MR safe or must be tested by Level 2 MR Personnel before it can be taken into the MR scan room. • If there is ANY doubt about device compatibility, or anything dealing with MR safety or the MR environment, ASK! 48 24 Level 1 MR Safety - E. Jackson Static Field Safety Issues NEVER assume nearby unlabeled objects are MR safe!!! 49 A Brave New World… Brave new world potential dangers Interventional MR Systems MR–PET Systems 1.5T Supercon Magnet 3.0T Supercon Magnet 50 25 Level 1 MR Safety - E. Jackson A Brave New World… Brave new world potential dangers MR Systems in Radiation Therapy Univ Alberta 0.6 T / 6 MV Linac Viewray 0.35T / 3 x 60Co Philips / Elekta 1.5 T / Linac 51 All Supercon Magnets A Brave New World… Appropriate Caution Necessary • Each of these new types of facilities is an impressive technological advancement that promises to improve patient care and quality of life. • Each of these new types of facilities, however, brings individuals without prior MR safety training and experience into the MR environment, e.g., state inspectors, cleaning staff, non-MR radiologists, technologists, and physicists, etc. • As such, MR safety training and screening of these non-MR personnel is absolutely essential to protect these individuals, and others in the MR suite with them, from potential harm or even death. 52 26 Level 1 MR Safety - E. Jackson MR Safety Beyond being screened, what does this mean to non-MR workers who need to work (make measurements, inspect equipment, etc.) in the MR scan room (Zone IV)? – Different equipment might be needed (plastic levels, cloth measuring tape, etc.). – Don’t take ANYTHING into the scan room without first having a Level 2 MR Personnel check it! – Stop at the door to the MR scanner room. Check all pockets and take NOTHING in the room that isn’t absolutely necessary and, if necessary, checked first. 53 MR Safety If “something bad” happens, what do I do? – Unless the situation is life threatening, i.e., someone is pinned against the magnet, do NOTHING but report the incident. – Do NOT try to remove a ferromagnetic object that has inadvertently been attracted to the magnet. Danger to you and/or others, and the equipment, might result. – If the situation is, in fact, life threatening, a Level II MR Personnel, who should be in the facility monitoring your activities anyway, should activate emergency procedures. 54 27 Level 1 MR Safety - E. Jackson Static Field Safety Issues Physiological concerns: – There have been no documented permanent deleterious effects resulting from MR scanning. – Temporary effects typical all arise from the induced voltages in tissues due to the motion of charged substances through the strong magnetic field (v dB/dt; typically for B > 3T): • Magnetophosphenes - “flashes of light” • Vestibular function - “feeling of vertigo” • Taste perversions - “metallic taste” • Altered ECG waveforms - elevated T-wave (even at 1.5T) 55 Static Field Safety Issues With regard to any permanent deleterious physiological effects from the static field, Shellock and Kanal1 report: “…static magnetic fields up to 2 T produce no substantial harmful bioeffects, including no alterations of cell growth and morphology, DNA structure and gene expression, pre- and postnatal reproduction and development, visual functions, nerve bioelectric activity, animal behavior, visual response to photic stimulation, cardiovascular dynamics, hematologic indices, physiologic regulation and circadian rhythms, or immune responsiveness.” Similar findings have been reported in higher field strengths (≥4T). 56 28 Level 1 MR Safety - E. Jackson Static Field Safety Issues FDA Guidelines (7/2003): MR systems with main static magnetic fields greater than 8 Tesla (4 Tesla for infants <1 mo) are considered significant risk devices. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072688.pdf 57 Radiofrequency Field Safety Issues • At 1.5 T, the Larmor frequency is ~ 64 MHz => good penetration and possible source of tissue heating. • Tissue heating is primarily due to magnetic induction with a negligible electric field contribution. • Measure: the specific absorption rate (SAR) - W/kg. • The heating of the tissue is greatest at the periphery and minimal at the center of the body. Head equivalent phantom scans demonstrate significant changes in temperature during an MR only occur less than 4 cm from the edge and do not exceed 1-2oC for 1.0 and 2.5 W/kg scans for 30 minutes1. • Tissues that are poorly perfused, such as the orbits, require particular attention. 58 29 Level 1 MR Safety - E. Jackson Radiofrequency Field Safety Issues F.G. Shellock and E. Kanal, Magnetic Resonance. Bioeffects, Safety, and Patient Management, Lippincott-Raven Publishers, 1996 59 Radiofrequency Field Safety Issues The RF power required in MRI studies scales as the: – square of the static magnetic field for a given flip angle – square of the flip angle at a given static magnetic field – size of the patient – duty cycle of the RF pulses (# pulses per unit time) 60 30 Level 1 MR Safety - E. Jackson Radiofrequency Field Safety Issues • Considerable care must be taken to insure that no unnecessary conductors (including jewelry or other removable metal objects) are in the magnet bore during scanning. • All necessary conductors, e.g., surface coil leads and ECG leads, should be padded away from the patient, should not be allowed to loop, and should, to the extent possible, travel down the center of the magnet bore. • First, second, and even third degree burns due to poorly placed ECG leads or other non-MR compatible conductive devices have been reported. 61 Radiofrequency Field Safety Issues FDA Guidelines (7/2003): MR systems performing studies where the specific absorption rates are greater than a. 4 W/kg averaged over the whole body for any period of 15 min; or b. 3 W/kg averaged over the head for any period of 10 min; or c. 8 W/kg in any gram of tissue in the head or torso, or 12 W/kg in any gram of tissue in the extremities, for any period of 5 min; are considered significant risk devices. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072688.pdf 62 31 Level 1 MR Safety - E. Jackson Gradient Field Safety Issues Two concerns arising from the time-varying gradient magnetic fields: – Induced voltages from the time-varying magnetic fields can produce nerve stimulation, and can distort waveforms on patient monitoring equipment. – Auditory sound pressure levels produced by the rapidly switched gradient coils (due to the interaction of the gradient and static field coils) can be excessive. These levels can be up to 100 dBA at isocenter during fast scan techniques1. Hearing protection should be used by patients (and others near the magnet bore) during such scans. 63 Gradient Field Safety Issues FDA Guidelines (7/2003): MR systems producing scans with time rates of change of gradient fields (dB/dt) sufficient to produce severe discomfort or painful nerve stimulation are considered significant risk devices. Sequences producing peak unweighted sound pressure levels greater than 140 dB or A-weighted rms sound pressure levels greater than 99 dBA with hearing protection in place require an IDE. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072688.pdf 64 32 Level 1 MR Safety - E. Jackson Emergency Procedures/Systems Superconducting Magnet Field “Quench” – Recall that superconducting magnets are ALWAYS “on”. The static magnetic field is never off. Even if there is absolutely no noise being generated by the scanner, always assume the magnetic field is on. – In a life threatening emergency situation, e.g., someone pinned against the magnet or a ferrous object entering the bore along with the patient, the superconducting magnet can be “quenched”. – A quench is a sudden loss of superconductivity typically secondary to an increase in temperature in one section of the superconducting wiring that forms the main magnet. – During a quench, the static field strength is quickly lost (~20 sec - 1 min). – During the quench, virtually all of the liquid helium (4O K), which keeps the magnet in a superconducting state, is converted to very, very cold helium gas. 65 Emergency Procedures/Systems Life safety systems – Cryogen exhaust system – to provide a path for hundreds of liters of liquid helium, once converted to gas in a quench situation, to exit the facility. (~1000 m3 of gas; scan room is ~100 m3) – Emergency room exhaust system in case cryogen exhaust system fails. – Patient intercoms, “panic” switches, etc. – Emergency supercon magnet “rundown” systems => QUENCH. – Emergency power off (EPO) systems. – Patient monitoring equipment – must be MR compatible. – Anesthesia systems (MR compatible equipment AND cylinders) 66 33 Level 1 MR Safety - E. Jackson Emergency Procedures/Systems Emergency Systems – “Table Stop” buttons • Located on intercom (at operator console) and magnet housing. • Used to quickly stop the motion of the scan table. – Emergency room exhaust system (“Purge Fan”) in case the cryogen exhaust system fails fully or partially • Switches located near operator console and in the scan room (near main door) for all clinical MR facilities except the CABIR facility. 67 Emergency Procedures/Systems Emergency Systems (cont.) – Emergency power off (EPO) systems • Switches located near operator console, in scan room, and in equipment room. • Used in case of scanner-related electrical problems (arcing, smoke, etc.). • Shuts down power to the MR system (including the computers). – Emergency supercon magnet “rundown” systems • Switches located near operator console and in scan room. • Quenches superconducting magnet. • Very expensive recovery – to be used only in life threatening situations, e.g., individual pinned by ferrous object. 68 34 Level 1 MR Safety - E. Jackson CABIR 3.0T MR Facility Cryogen exhaust stack Emergency run down (quench) unit 69 MR and Pregnancy Pregnant Healthcare Workers – In 1990, Shellock and Kanal conducted a survey of all female MR technologists and nurses at most clinical MR facilities in the U.S.1 – Five categories analyzed: spontaneous abortion rate, preterm delivery (<39 weeks), low birth rate (<5.5 lbs), infertility (>11 mo to conceive), and gender of offspring. – Data indicated there were no statistically significant changes in the five areas studied for MR workers relative to other workers. 70 35 Level 1 MR Safety - E. Jackson MR and Pregnancy Pregnant Healthcare Workers (continued) – Shellock/Kanal recommendation1: Pregnant healthcare workers be permitted to continue performing MR procedures, to enter the scan room, and attend to the patient. However, the worker should avoid remaining in the scan room during actual operation of the system. (Based on conservative position, not any demonstrated adverse effects.) 71 Concluding Remarks • It takes constant vigilance on the part of every employee who works in or near the MR facilities to make the facilities safe for our patients, employees, and visitors. • Before entering Zone IV of ANY MR facility, employ a “time-out” at the door entering the MR scan room! 72 36 Level 1 MR Safety - E. Jackson REMEMBER! The magnet is NEVER off! 73 References 1. 2. 3. 4. 5. 6. F.G. Shellock and E. Kanal, Magnetic Resonance. Bioeffects, Safety, and Patient Management, 2nd edition, Lippincott-Raven Publishers, New York, 1996. http://www.mrisafety.com – “the list” of implants and devices http://www.acr.org - white papers on MR safety (2002), update (2004), revision (2007), and current (2013) F.G. Shellock and J.V. Crues, MR Procedures: Biologic Effects, Safety, and Patient Care, Radiology 232:635-652, 2004. E. Kanal, ed., Practical MR Safety Considerations for Physicians, Physicists, and Technologists, RSNA 2001 Syllabus FDA website guidance document: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm072688.pdf 74 37