Safety Screening Guidelines In order to ensure safety and quality care, Muscatine Radiology has developed the following

safety guidelines and patient management procedures. Policies have been developed based upon recommendations from the Safety Committee of the Society for Magnetic Resonance Imaging (SMRI), to provide standardized and consistent information for use by health care practitioners involved in clinical MR imaging, MR technologists, as well as other employees involved in patient safety, should be familiar with, and regularly consult the following publications for answers to safety related questions: Pocket Guide to MRI Procedures and Metallic Objects: Updated (annually), by Frank Shellock, PhD MAGNETIC RESONANCE Bioeffects, Safety, and Patient Management, by Frank Shellock, PhD, and Emmanuel Kanal, MD, both published by LippincottRaven Publishers. Another source for safety information is the International Magnetic Resonance Safety Central Web Site: http://www.Kanal.arad.upmc.edu/mrsafety.html and/or www.Mrisafety.com. CANDIDATES FOR SCREENING It is the policy of Muscatine Radiology that any person (1) scheduled or (2) planning to enter the MR scan room is to be thoroughly screened for contraindications to MRI. Part of the screening process involves completion of an industry standardized and approved safety screening checklist. Every individual will need to be cleared by an MRI technologist or Radiologist. Each case should be considered on an individual basis. Precautions should be taken with respect to any type of MR system regardless of field strength, magnet type, and the presence or absence of magnetic shielding. When safety questions arise, they are to be addressed by MRI Staff or Radiologist for further clarification. DEFRIBRILLATORS, PACEMAKERS and/or PACING WIRES Defibrillators, pacemakers and/or pacing wires are an ABSOLUTE CONTRAINDICATION FOR MRI. Even field strengths as low as 5 G may be sufficient to cause deflection programming changes, and closure of the reed switch, which converts a pacemaker to an asynchronous mode. In addition, patients who have had pacemakers removed may have pacer wires left within the body, which could act as an antenna and, by induced currents, cause cardiac fibrillation. It is Muscatine Radiologys policy NOT TO SCAN A PATIENT WHO HAS A DEFIBRILLATOR, PACEMAKER, OR PACING WIRES. CEREBRAL ANEURYSM CLIPS Some intra-cranial aneurysm clips are absolute contraindications in MR imaging. Clip motion may damage the vessel, resulting in

hemorrhage, ischemia, or death. Intra-cranial clips made of material known as titanium have been used and have proved safe for MR. Unfortunately there have been several cases documented where a clip was either MR compatible or thought to be and the clip moved during an MR scan resulting in death. It is therefore recommended by ISMRM that imaging of patients with aneurysm clips not be performed unless the clip has been tested for magnetic safety prior to insertion. For this reason Muscatine Radiology has adopted the policy to NOT SCAN A PATIENT WHO HAS CEREBRAL ANEURYSM CLIPS. ELECTRICALLY, MAGNETICALLY, OR MECHANICALLY ACTIVATED OR ELECTRICALLY CONDUCTIVE IMPLANTED DEVICES (i.e. pacemakers, cochlear implants, tissue expanders, ocular prosthesis, neurostimulators, bone growth simulators, magnetically held dental implants, implantable cardiac defibrillator, implantable drug infusion pump, among others) Patients with electrically, magnetically, or mechanically activated implants or who rely on electrically, magnetically, or mechanically activated life-support systems, must be identified during safety screening process. In many instances patients with these types of implants must not undergo MR procedures because of the risks associated with movements or dislodgement of the implant, MR incompatibility of the materials in the implant, or disruption of the normal operations of the implant, among others. Muscatine Radiology policy PROHIBITS SCANNING ANYONE WITH A CARDIAC PACEMAKER OR COCHLEAR IMPLANT. Other implants must be evaluated on a case-by-case basis. Recommended safety literature should be consulted for additional information. METALLIC FOREIGN BODY All patients or other individual with history of being injured by a metallic foreign body such as a bullet, shrapnel, or other type of metallic fragments should be thoroughly evaluated prior to admission to an area of MR systems. This is particularly important because serious injury may occur as a result of movement or dislodgement of the metallic foreign body as it is attracted by the magnetic field of the MR system. The relative risk of injury is dependent on the ferromagnetic properties of the foreign body, the geometry and dimensions of the object, and the strength of the static magnetic field of the MR system. Additionally, the potential risk for injury is related to the amount of force with which the object is fixed within the tissue and whether or not it is positioned in or adjacent to a particular sensitive site of the body such as a vital neural, vascular, or soft tissue structure. Please consult MR technologist, Radiologist, or recommended safety literature for additional information. INTRAOCULAR FOREIGN BODY Any individual with a high suspicion of having an intra-ocular metallic foreign body must have plain film radiographs of the orbits to rule out the presence of a metallic fragment prior to exposure to the magnetic field of the MR system. If an individual with a suspected ferromagnetic intra-ocular foreign body has no history of prior injury, no previous or present symptoms, and a plain film series of the orbits does not demonstrate a radiopaque foreign body, the risk of injury associated with exposure to MR system is considered to be minimal.

MUSCATINE RADIOLOGY POLICY ON ORBITAL X-RAYS It is the policy of Muscatine Radiology that individuals who indicate exposure to metal fragments as stated on the safety screening form will undergo plain film radiographs of the orbital area (eyes) prior to being allowed entry to the MR suite. MUSCATINE IMAGING POLICY ON METALLIC OBJECTS IN OTHER POTENTIALLY HAZARDOUS SITES In addition to being used to detect metallic objects in the ocular region, plain film radiography should be used as the standard of care when screening a patient for the presence of a metallic object located in other potentially hazardous sites of the body. EXTRA-CRANIAL VASCULAR CLIPS Five carotid artery vascular clamps after testing have showed deflection in the magnetic field. However, the deflection was mild when compared with the pulsatile vascular motion within the carotid. Extra-cranial clips tend to be surrounded by fibrous tissue or scar after surgery. It is recommended that MR is delayed until 6 weeks after surgery, but all studies should be evaluated on a case-bycase basis. Please consult recommended safety literature for additional information. HEART VALVE PROSTHESIS Several heart valve prostheses have been evaluated for magnetic susceptibility, and these showed negligible deflections in the magnetic field. The deflection is minimal compared with the normal pulsatile cardiac motion, therefore, although patients with most valvular implants are considered safe for MR, careful screening for valve type is advised because there are valves whose integrity could be compromised. Muscatine Radiology procedure includes obtaining information regarding the specific type of heart valve prosthesis and checking for MR compatibility in current safety literature prior to scanning. Please consult recommended safety literature for additional information. INTRAVASCULAR CATHETER, COIL, FILTER, STENT Several intra-vascular devices have been tested and some of these proved to be ferromagnetic. Although they have shown deflection in the presence of a magnetic field, these devices usually become imbedded in the vessel wall after several weeks, and are unlikely to become dislodged. Therefore it is considered safe to perform MR imaging on most patients with intravascular devices, provided a reasonable period of time has elapsed after implantation (usually 6 weeks). All patients are screened for intra-vascular catheter coil, filter, and/or stent prior to examination. Please consult recommended safety literature for additional information. OTOLOGIC IMPLANTS Muscatine Radiologys safety procedure includes screening for ear surgery. Patients with a cochlear implant are definitely CONTRAINDICATED FOR MRI. Some stapes implants are contraindicated for MRI so operative report must be reviewed to determine the type used prior to MR scanning. If prosthesis type cannot be identified, scan should not be performed. Please consult recommended safety literature for additional information.

PENILE IMPLANT Muscatine Radiologys safety procedure includes screening for penile implants and obtaining information regarding the specific type of implant and checking for MR compatibility prior to scanning. Please consult recommended safety literature for additional information. PREGNANCY PATIENTS Pregnant patients or those who suspect they are pregnant should be identified before undergoing MRI in order to assess the relative risks versus the benefits of the examination. MR imaging may be used in pregnant women if other nonionizing forms of diagnostic imaging are inadequate or if the exam provides important information that would otherwise require exposure to ionizing radiation. A pregnant patient should be informed that, to date, there has been no indication that the use of clinical MR imaging during pregnancy has produced deleterious effects. Muscatine Radiology prefers to refrain from scanning a patient in the first trimester of pregnancy since fetal cells undergoing division in the first trimester of pregnancy are more susceptible to the effects of the interaction of electromagnetic fields. All pregnant patients having an MR at Muscatine Radiology must be informed of the potential risk involved and must sign the Informed Consent for MRI During Pregnancy form prior to scan. Please consult recommended safety literature for additional information. TATTOOS (eyeliner and body) Patients should be screened for tattoos. There have been reported cases of eye irritation, local skin irritation, cutaneous swelling, or heating sensations at the site of the permanent colorings in association with MR procedure, probably caused from ferrous pigment in some tattoos. Also, some tattoos can cause image artifacts. Please consult recommended safety literature for additional information. INDUCED ELECTRICAL CURRENTS The potential for injury exists from induced electrical currents in conductive materials or devices such as gating leads, indwelling catheters with metallic components (Swan-Ganz, thermo-dilution catheters), guide wires disconnected or broken surface coils, certain cervical fixation devices, or improperly used physiologic monitors. Precautions must be taken to protect patients from injuries related to induced current. Cables must not be looped. Employees must be knowledgeable of and follow manufactures recommended guidelines for use of MR equipment and MR compatible monitoring equipment. Potential bio-effects of gradient magnetic fields from induced currents or voltages in the human body may result in power deposition and subsequent tissue heating, magnetophosphenes (electro-magnetically induced visual flashes of light), peripheral nerve stimulation, skeletal muscular contractions, or even cardiac arrhythmias. CLAUSTROPHOBIA Although claustrophobia does not seem to be a safety issue, it is a condition that commonly affects patients and which MR operators should appreciate. RF heating, gradient noises, and the confines of the magnet itself, add to the possibility of claustrophobic reactions. Controllable air movement within the bore of the magnet, along with good patient contact and education should help reduce claustrophobic reactions.

NOISE The use of earplugs or headphones is strongly recommended for patients since some may find the noise levels during an MRI examination unacceptable. OTHER SAFETY CONSIDERATIONS There are other possible hazards related to MR imaging: induction of electric current, excessive heating, noise, and the misinterpretation of an imaging artifact as an abnormality. EACH CASE SHOULD BE CONSIDERED ON AN INDIVIDUAL BASIS The precautions should be taken with respect to any type of MR system regardless of the field strength, magnet type, and the presence or absence of magnetic shielding. When safety questions arise, they are to be addressed by the MR technologist and/or Radiologist.

Dev. 06.12.06