Safety Training

1. 1. Before a research study partcipant enters the magnet room, a screening form must be completed by the subject and reviewed by the certified user who will be performing the MRI exam.
   2. Any person not receiving an MRI as part of a research study or any person not previously screened and trained in the CBBI procedures may not enter the MRI room without approval from CBBI staff. (maintenance workers, custodial staff, etc.)
   3. Before entering the magnet room, all pockets are to be emptied of: watches, pagers, wallets, pens, pencils, hair clips, jewelry, keys, coins, and any other possible projectiles.
   4. The person being scanned must be wearing MRI safe attire. 

Scrub tops and bottoms are provided for this purpose.

1. 1. The magnet room door should be kept closed at all times except when entering or exiting the room.

Keeping the door shut tightly will reduce RF noise during imaging.

1. All persons scanned must wear ear protection. I f they decline, the exam must be canceled.
2. Never scan with an unplugged surface (or body flex) coil in the bore of the magnet.
3. Use of any research equipment, coils, or supplies not supplied by the MRI facility must be approved by an MR Safety Committee or appropriate official.
4. All investigators and operators must clean up after themselves. Return all equipment to its proper place. The room should be kept neat and tidy. Do not lay coils or phantoms on the floors.
5. Please report all malfunctioning or damaged equipment to the center manager immediately.
6. All studies should be archived immediately after the exam is complete. Data may remain on the system for up to 7 days (or some agreed upon time) unless disk space becomes critical, in which case, the oldest studies will be removed first. 
7. All users must be familiar with code procedures and calling 911 if a medical emergency should arise.
8. Users must never leave their subjects unattended in the magnet. 

Magnetic Field

It is important to remember when working around a superconducting magnet that the magnetic field is always on. Under normal working conditions, the field is never turned off. Therefore, it is important to be aware of safety issues regarding ferrous objects that can act as projectiles and watching out for patients who may have contraindicated devices implanted in their bodies. There are two units used to describe magnetic field strength. They are Tesla and Gauss:1 Tesla equals 10,000 Gauss.

Keep doors closed.

The doors leading to the magnet room should be closed at all times except when entering or exiting the room. This will prevent people who do not belong in the room from wandering into the room.

Consent and Screening Procedures

Consent Forms

Every research study particpitant will need to sign a consent form. Research often involves the use of non-FDA (Food and Drug Administration)-approved MRI sequences on volunteers. These sequences are important to the advancement of the science of MRI. The research participants must be informed that these non-approved sequences are being performed and consent must be given. In addition, the consent form must be signed by the Principal Investigator or his/her designee.

Screening Forms

As stated earlier, the magnet has a very strong magnetic field surrounding them, which has the potential to attract certain types of metal. The magnetic field can also interfere with the normal operation of electronic devices. For these reasons, a detailed health history for every person that enters the magnet room is necessary. This includes all staff members, investigators and volunteers. The repercussions associated with a volunteer, or staff member being injured because of negligence on the part of the scanning investigator could be severe and could cause all research to be halted at this facility. Screening forms must be completed by every person entering the magnet room .In the event that a staff member has an accident or surgery where a metallic foreign object or electronic device is implanted into their body, the staff member would be restricted from going into the magnet room until the metallic/electronic object can be cleared for safety purposes. It is up to the staff member to be aware of such circumstances and to report any such events to their direct supervisor.

Subjects who return for other MRI exams must fill out a new screening form for each visit. Every screening form must be signed by the subject and the certified user who is performing the scan. Keep in mind that all subjects who are providing information regarding their health history must be conscious and coherent. Any gaps in memory or lack of information about a surgical procedure is grounds for canceling the subject. If there is ever any question about the past health history of a subject regarding metal in their body, it is required that the MRI exam be canceled or rescheduled until the question can be investigated thoroughly. 

There are several types of contraindications that would prevent a subject from having an MRI scan. Metallic implants and foreign bodies as well as the physical condition of the subject will be discussed in this section. All subjects are required to remove any clothing that has metal on it. Scrubs are provided for the subject to change into. All subjects and staff members must empty their pockets of any loose metallic objects (e.g., hair pins, safety pins, coins, keys, ID badges, wallets, credit cards, banking cards, lighters, pocket knives, scissors, stethoscopes, hemostats, etc.) before entering the magnet room

Surgical implants

There are hundreds of metallic implants that can be surgically placed into a person’s body for various reasons. Some of these implants are ferrous and may be attracted to the magnetic field. Some may be electronic in nature, in which case, the magnetic field can interrupt the normal operations of the device. By placing an electronic device in the magnetic field, a current may be induced in the conducting wires of the device, which could possibly burn the subject. 

Accidental Metallic Foreign Bodies

Occasionally, a subject may have been injured by a piece of metal that punctured his/her body in some way, shape, or form. Common causes of this type of injury are bullets, buckshot, pellets, or BBs. Other frequent causes are metal slivers that fly off by those who grind, sand, or cut metal. These metal slivers often fly into the eyes, hands, or face (and it is likely that the people working in these areas are completely unaware because these metal slivers are so fine). Also, people who have been involved in wartime activity may have pieces of shrapnel or other metal fragments in their body. Any of these circumstances must be investigated thoroughly to prevent injury to the subject.

Procedure to Clear Metallic Implants and Foreign Bodies

All medical devices and foreign objects must have clearance from the Center Manager or his/her designee(s) before proceeding. 

Pregnancy

It is the policy of the MRI department to not scan any pregnant subjects.

It is the policy of the MRI department that all pregnant staff members be restricted from the magnet room when radiofrequency pulses are on. Any pregnant ancillary staff member (e.g.,coordinators, research assistants) who does not need to be in the magnet room should stay out of the room unless there is an emergency with a subject. 

Radio-frequency and specific absorption rates

MRI employs radiofrequency (RF) pulses to disturb the alignment of protons in the nucleus of hydrogen atoms in the body. These RF pulses deposit heat into the tissues of the body. This heat deposition is termed specific absorption rate (SAR). SAR is measured in watts per kilogram and is a function of several variables, including: (1) the type of RF pulse used (90 or 180°); (2) the number of RF pulses in a sequence; (3) the pulse width; (4) the T_R; (5) the weight of the patient; and (6) the type of coil used. The FDA and IEC (International Electrotechnical Commission) have developed guidelines to regulate the acceptable amount of deposited heat. Currently all manufacturers of MRI equipment are permitted to submit their pulsing sequences to the FDA for SAR review.

Conditions in the Examination Room

The examination room should have an ambient temperature of 21°C ±3°C with a relative humidity of 50% to 70%.

Specific Absorption Rates:

Any pulse sequence exceeding 2W/kg Whole Body Average is considered “First-Level” and medical supervision is required. Prior approval from the center manager is required for any pulse sequence exceeding 2 W/kg Whole Body Average. 

Acoustic Noise

1. The FDA regulates the peak unweighted sound pressure level to be not >140 dB or the A-weighted r.m.s. sound pressure level to be not >99 dBA with hearing protection in place.
2. . IEC 60601-2-33 regulates that the peak unweighted sound pressure level is <140 dB.

NOTE: :It should be noted that subjects with thermoregulatory illnesses such as a fever, or diseases in which the patient is unable to sweat, may be compromised by heat deposition in MRI. Extreme care should be taken with these subjects to keep them cool during the exam. Choose sequences that do not result in high amounts of heat deposition. The eyes are also particularly susceptible to heat deposition.

CPR

It is a common practice of MRI facilities that all investigators, technologists, students, or other staff who will be conducting MRI experiments on humans are certified in cardiopulmonary resuscitation (CPR). Even though we offer classes, it is not a requirement.

Calling 911

In order to get emergency help, review the emergency contact numbers and follow the instructions of the dispatcher. Tell them the address right away. Remember to speak clearly and slowly so there is no misinterpretation of information.

Emergency Removal of the Subject from the MRI Scanner

If the investigator has placed a subject in the scanner and upon looking at the first set of
images notices a metallic artifact present, the investigator must follow the proper procedure
for removing the subject from the scanner and the magnet room.

1. Inform the subject that he or she is going to be removed from the magnet. Instruct
   him/her to remain perfectly still and to not sit up at any time.
2. Pull the table out of the scanner very slowly.
3. Move a gurney into the magnet room and place it next to the table.
4. Have the subject slide, without sitting up, onto the gurney.
5. Slowly pull the gurney straight away from the magnet without turning.
6. Once the doorway is reached, slowly turn the gurney and move it out through the doorway.
7. Once the subject is safely outside of the room, he/she may sit up.

NOTE: This procedure should also be used if the subject informs the technologist of a contraindicated metallic implant in his/her body after already being placed in the magnet

Extracting from the Magnet Room

1. Immediately remove the subject from the bore of the magnet.
2. Once emergency personnel arrive, DO NOT let them into the magnet room. Secure the subject out of the magnet room without endangering any personnel who have not been cleared to enter the room. Among other items, paramedics always have stethoscopes, scissors, and hemostats on them, which will turn into deadly projectiles if brought near the magnet. In addition, their health history is unknown and they may have contraindicated implants in them.
3. Inform the emergency personnel of the incident and stay close by to assist them with any questions they may have or items they may need.
4. After the subject is taken away by the paramedics, fill out an incident report

Quench

The term “quench” is used to describe the rapid boil off of the cryogens that keep the magnet cooled and in a superconducting state. Cryogens in this case is super-cooled liquid helium. Without cryogens, the magnet loses its magnetic field. Usually a quench is undesirable and is due to a malfunction within the system. In rare instances, a quench may be necessary to free someone from the magnet if they have been accidentally struck by a projectile ferrous object and pinned to the magnet. In each control room, there are “boxes” on the wall that enclose quench buttons that should be pushed in the event that the magnetic field must be manually run down. When a quench occurs, either spontaneously or manually, evacuate from the magnet room immediately to avoid being overcome by helium gas, should the room not vent properly. If manual quenching of the magnet is to be done, make sure the door to the scan room is left open to avoid a vacuum forming, which may seal the door shut. If the magnet quenches spontaneously, and the door does not open, break the window between the control room and the magnet room in order to get the subject and possibly yourself out of the room. Remember to stay low so that helium is not breathed in.

Projectile Injury

If a subject or staff member becomes pinned to the magnet by a ferromagnetic object, evaluate the situation quickly before taking any action. If the person is unconscious, bleeding profusely, at risk of losing a limb or extremity, or in severe pain, manually quench the magnet to bring down the field in order to release the object and the person. If the person is responsive and able to communicate his/her well being, leave him/her in the position until a service engineer can respond and ramp the magnet down slowly to avoid a full quench. If the latter is chosen, and the person then loses consciousness, or his/her condition worsens, immediately quench the magnet manually. Keep in mind that the cryogens are expensive to replace, so evaluate the situation carefully but never put cost above the life or well being of the subject. Once released, secure the subject out of the room and call 911 for emergency medical help.

Resonsible Parties

Any time a subject is scanned, the operator and ultimately the principle investigator are responsible for the given trial.

Bringing Computers up and Shutting Computers Down

Bringing the MRI computer up, or booting the computer, is a fairly simple procedure. (Review procedures) From this point on, in order to use the scanners, the scan time on the research magnets must be pre-approved.

Table Controls and Table Stop Buttons

The magnet is equipped with a table that moves into and out of the scanner by using the plasma controls on the front of the magnet gantry. (Review stop buttons and emergency evacuation)

Stereo/Headphones/Earplugs

All subjects are required to wear ear protection while undergoing an MRI exam. Earplugs
will be provided. Headphones are also provided. The headphones are also part of the noise reduction system that helps drown out the knocking noise of the gradients. For the high-field systems, if the subject refuses all hearing protection, the scan cannot be performed.

Communicating with the Subject While in the Scanner

It is important to maintain voice contact with the subject throughout the exam. The researcher or the technologist should routinely establish contact between each sequence. Speak to the subject while depressing the “speaking” button on the intercom.

Patient Alarm

Every subject should be given the patient alarm ball to hold in his/her hand during the
exam. The subject should be instructed to squeeze the ball if:

1. he/she needs to speak with the investigator or technologist in between sequences;
2. he/she wants to come out of the scanner immediately;
3. something is hurting.

Because the scanner cannot be put in a pause mode, stopping a scan to speak to the subject will require one to start the scan over again from the beginning. For this reason, it is wise to advise the subject to squeeze the ball only in situations of pain, injury, or claustrophobia. If the investigator or technologist is communicating with the subject routinely between sequences, the subject will be less likely to squeeze the ball in the middle of a sequence to ask a non-emergent question.

Removing Subjects from the MRI Scanner

If a subject requests to be removed from the magnet at any time, the investigator or technologist should do so promptly. Whether due to pain, illness, or claustrophobia, the investigator or technologist must never keep the subject in the MRI scanner against his/her will. If a subject asks to be brought out, communicate with him/her to determine the problem. Ask the subject if he/she can continue, if not, remove the subject immediately.

Starting/Stopping a Scan

Review procedures

Responsibility for Acquired Data, Archiving, and Deletion of Data

All investigators and certified users are responsible for the data acquired. Data must be archived immediately after the exam is complete in order to prevent loss by removal off the MRI system disks. Data may stay on the MRI system disks for up to 7 days. If the disks become full and deletion is necessary, the oldest studies will be removed first. Investigators and certified users may only remove one’s own data. One may not alter another researchers protocols. All other MRI data may only be removed from the system disks by CBBI staff.

(Review procedure for sending studies to OsiriX and moving them to the server.)