Safety Guidelines regarding excessive heating and burns

From BrainImagingCenter

In general, magnetic resonance (MR) imaging is considered to be a relatively safe diagnostic modality. However, the use of radiofrequency coils, physiologic monitors, electronically-activated devices, and external accessories or objects made from conductive materials has caused excessive heating, resulting in burn injuries to patients undergoing MR procedures. Heating of implants and similar devices may also occur in association with MR procedures, but this tends be problematic primarily for objects made from conductive materials that have elongated shapes such as leads, guidewires, and certain types of catheters (e.g., catheters with thermistors or other conducting components).

Notably, more than 30 incidents of excessive heating have been reported in patients undergoing MR procedures in the United States that were unrelated to equipment problems or the presence of conductive external or internal implants or materials [review of data files from U.S. Food and Drug Administration, Center for Devices and Radiological Health, Manufacturer and User Facility Device Experience Database, MAUDE, http://www.fda.gov/cdrh/maude.html and U.S. Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Report, (http://www.fda.gov/CDRH/mdrfile.html)]. These incidents included first, second, and third degree burns that were experienced by patients. In many of these cases, the reports indicated that the limbs or other body parts of the patients were in direct contact with body radiofrequency (RF) coils or other RF transmit coils of the MR systems or there were skin-to-skin contact points suspected to be responsible for these injuries.

MR systems require the use of RF pulses to create the MR signal. This RF energy is transmitted readily through free space from the transmit RF coil to the patient. When conducting materials are placed within the RF field, the result may be a concentration of electrical currents sufficient to cause excessive heating and tissue damage. The nature of high frequency electromagnetic fields is such that the energy can be transmitted across open space and through insulators. Therefore, only devices with carefully designed current paths can be made safe for use during MR procedures. Simply insulating conductive material (e.g., wire or lead) or separating it from the patient may not be sufficient to prevent excessive heating or burns from occurring.

Furthermore, certain geometrical shapes exhibit the phenomenon of "resonance" which increases their propensity to concentrate RF currents. At the operating frequencies of present day MR systems, conducting loops of tens of centimeters in size may create problems and, therefore, must be avoided, unless high impedance is used to limit RF current. Importantly, even loops that include small gaps separated by insulation may still conduct current.

To prevent patients from experiencing excessive heating and possible burns in association with MR procedures, the following guidelines are recommended:

1. Prepare the patient for the MR procedure by ensuring that there are no unnecessary metallic objects contacting the patient's skin (e.g., metallic drug delivery patches, jewelry, necklaces, bracelets, key chains, etc.).
2. Prepare the patient for the MR procedure by using insulation material (i.e., appropriate padding) to prevent skin-to-skin contact points and the formation of "closed-loops" from touching body parts.
3. Insulating material (minimum recommended thickness, 1-cm) should be placed between the patient's skin and transmit RF coil that is used for the MR procedure (alternatively, the RF coil itself should be padded). For example, position the patient so that there is no direct contact between the patient's skin and the body RF coil of the MR system. This may be accomplished by having the patient place his/her arms over his/her head or by using elbow pads or foam padding between the patient's tissue and the body RF coil of the MR system. This is especially important for those MR examinations that use the body coil or other large RF coils for transmission of RF energy.
4. Use only electrically conductive devices, equipment, accessories (e.g., ECG leads, electrodes, etc.), and materials that have been thoroughly tested and determined to be safe and compatible for MR procedures.
5. Carefully follow specific MR safety criteria and recommendations for implants made from electrically-conductive materials (e.g., bone fusion stimulators, neurostimulation systems, etc.).
6. Before using electrical equipment, check the integrity of the insulation and/or housing of all components including surface RF coils, monitoring leads, cables, and wires. Preventive maintenance should be practiced routinely for such equipment.
7. Remove all non-essential electrically conductive materials from the MR system (i.e., unused surface RF coils, ECG leads, cables, wires, etc.).
8. Keep electrically conductive materials that must remain in the MR system from directly contacting the patient by placing thermal and/or electrical insulation between the conductive material and the patient.
9. Keep electrically conductive materials that must remain within the body RF coil or other transmit RF coil of the MR system from forming conductive loops. Note: The patient's tissue is conductive and, therefore, may be involved in the formation of a conductive loop, which can be circular, U-shaped, or S-shaped.
10. Position electrically conductive materials to prevent "cross points". For example, a cross point is the point where a cable crosses another cable, where a cable loops across itself, or where a cable touches either the patient or sides of the transmit RF coil more than once. Notably, even the close proximity of conductive materials with each other should be avoided because some cables and RF coils can capacitively-couple (without any contact or crossover) when placed close together.
11. Position electrically conductive materials to exit down the center of the MR system (i.e., not along the side of the MR system or close to the body RF coil or other transmit RF coil).
12. Do not position electrically conductive materials across an external metallic prosthesis (e.g., external fixation device, cervical fixation device, etc.) or similar device that is in direct contact with the patient.
13. Allow only properly trained individuals to operate devices (e.g., monitoring equipment) in the MR environment.
14. Follow all manufacturer instructions for the proper operation and maintenance of physiologic monitoring or other similar electronic equipment intended for use during MR procedures.
15. Electrical devices that do not appear to be operating properly during the MR procedure should be removed from the patient immediately.
16. Closely monitor the patient during the MR procedure. If the patient reports sensations of heating or other unusual sensation, discontinue the MR procedure immediately and perform a thorough assessment of the situation.
17. RF surface coil decoupling failures can cause localized RF power deposition levels to reach excessive levels. The MR system operator will recognize such a failure as a set of concentric semicircles in the tissue on the associated MR image or as an unusual amount of image non-uniformity related to the position of the RF coil.

The adoption of these guidelines will help to ensure that patient safety is maintained, especially as more conductive materials and electronically-activated devices are used in association with MR procedures.

PERTINENT REFERENCES

Bashein G, Syrory G. Burns associated with pulse oximetry during

magnetic resonance imaging. Anesthesiology 1991;75:382-3.

Brown TR, Goldstein B, Little J. Severe burns resulting from magnetic

resonance imaging with cardiopulmonary monitoring. Risks and relevant

safety precautions. Am J Phys Med Rehabil 1993;72:166-7.

Chou C-K, McDougall JA, Chan KW. Absence of radiofrequency heating from

auditory implants during magnetic resonance imaging. Bioelectromagnetics

1997;44:367-372.

Dempsey MF, Condon B. Thermal injuries associated with MRI. Clin Radiol

2001;56:457-65.

Dempsey MF, Condon B, Hadley DM. Investigation of the factors

responsible for burns during MRI. J Magn Reson Imaging 2001;13:627-631.

ECRI, Health Devices Alert. A new MRI complication? Health Devices

Alert. May 27, pp. 1, 1988.

ECRI. Thermal injuries and patient monitoring during MRI studies. Health

Devices Alert. 1991;20: 362-363.

Finelli DA, Rezai AR, Ruggieri PM, Tkach JA, Nyenhuis JA, Hrdlicka G,

Sharan A, Gonzalez-Martinez J, Stypulkowski PH, Shellock FG. MR

imaging-related heating of deep brain stimulation electrodes: In vitro

study. Am J Neuroradiol 2002;23:1795-1802.

Hall SC, Stevenson GW, Suresh S. Burn associated with temperature

monitoring during magnetic resonance imaging. Anesthesiology 1992;76:152.

Heinz W, Frohlich E, Stork T. Burns following magnetic resonance

tomography study. (German) Z Gastroenterol 1999;37:31-2.

http://www.MRIsafety.com

International Electrotechnical Commission (IEC), Medical Electrical

Equipment, Particular requirements for the safety of magnetic resonance

equipment for medical diagnosis, International Standard IEC 60601-2-33,

2002.

Jones S, Jaffe W, Alvi R. Burns associated with electrocardiographic

monitoring during magnetic resonance imaging. Burns 1996;22:420-1.

Kanal E, Shellock FG. Burns associated with clinical MR examinations.

Radiology 1990;175: 585.

Kanal E, Shellock FG. Policies, guidelines, and recommendations for MR

imaging safety and patient management. J Magn Reson Imaging 1992;2:247-248.

Keens SJ, Laurence AS. Burns caused by ECG monitoring during MRI

imaging. Anaesthesia 1996;51:1188-9.

Knopp MV, Essig M, Debus J, Zabel HJ, van Kaick G. Unusual burns of the

lower extremities caused by a closed conducting loop in a patient at MR

imaging. Radiology 1996;200:572-5.

Knopp MV, Metzner R, Brix G, van Kaick G. Safety considerations to avoid

current-induced skin burns in MRI procedures. (German) Radiologe

199838:759-63.

Kugel H, Bremer C, Puschel M, Fischbach R, Lenzen H, Tombach B, Van Aken

H, Heindel W. Hazardous situation in the MR bore: induction in ECG leads

causes fire. Eur Radiol 2003;13:690-694.

Nakamura T, Fukuda K, Hayakawa K, Aoki I, Matsumoto K, Sekine T, Ueda H,

Shimizu Y. Mechanism of burn injury during magnetic resonance imaging

(MRI)-simple loops can induce heat injury. Front Med Biol Eng

2001;11:117-29

Nyenhuis JA, Kildishev AV, Foster KS, Graber G, Athey W. Heating near

implanted medical devices by the MRI RF-magnetic field. IEEE Trans Magn

1999;35:4133-4135.

Rezai AR, Finelli D, Nyenhuis JA, Hrdlick G, Tkach J, Ruggieri P,

Stypulkowski PH, Sharan A, Shellock FG. Neurostimulator for deep brain

stimulation: Ex vivo evaluation of MRI-related heating at 1.5-Tesla.

Journal of Magnetic Resonance Imaging 2002;15:241-250.

Schaefer DJ. Safety Aspects of radio-frequency power deposition in

magnetic resonance. MRI Clinics of North America 1998;6:775-789.

Schaefer DJ, Felmlee JP. Radio-frequency safety in MR examinations,

Special Cross-Specialty Categorical Course in Diagnostic Radiology:

Practical MR Safety Considerations for Physicians, Physicists, and

Technologists, Syllabus, 87th Scientific of the Radiological Society of

North America, Chicago, pp 111-123, 2001.

Shellock FG. Magnetic Resonance Procedures: Health Effects and Safety.

CRC Press, LLC, Boca Raton, FL, 2001.

Shellock FG. MR safety update 2002: Implants and devices. Journal of

Magnetic Resonance Imaging 2002;16:485-496.

Shellock FG. Radiofrequency-induced heating during MR procedures: A

review. Journal of Magnetic Resonance Imaging 2000;12: 30-36.

Shellock FG. Reference Manual for Magnetic Resonance Safety: 2003

Edition, Amirsys, Inc., 2003.

Shellock FG, Slimp G. Severe burn of the finger caused by using a pulse

oximeter during MRI. American Journal of Roentgenology 1989;153:1105.

Shellock FG, Hatfield M, Simon BJ, Block S, Wamboldt J, Starewicz PM,

Punchard WFB. Implantable spinal fusion stimulator: assessment of MRI

safety. Journal of Magnetic Resonance Imaging 2000;12:214-223.

Smith CD, Nyenhuis JA, Kildishev AV. Health effects of induced

electrical fields: implications for metallic implants. In: Shellock FG,

ed. Magnetic resonance procedure: health effects and safety. Boca Raton,

FL: CRC Press, 2001; 393-414.

U.S. Food and Drug Administration, Center for Devices and Radiological

Health (CDRH), Medical Device Report (MDR)

(http://www.fda.gov/CDRH/mdrfile.html).

• The files contain information from CDRH's device experience reports on devices which may have malfunctioned or caused a death or serious injury. The files contain reports received under both the mandatory Medical Device Reporting Program (MDR) from 1984 - 1996, and the voluntary reports up to June 1993. The database currently contains over 600,000 reports.

U.S. Food and Drug Administration, Center for Devices and Radiological

Health (CDRH), Manufacturer and User Facility Device Experience

Database, MAUDE, (http://www.fda.gov/cdrh/maude.html).

• MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996.