NYU Langone Medical Center
Bernard and Irene Schwartz Center for Biomedical Imaging
SAFETY POLICY MANUAL
BERNARD AND IRENE SCHWARTZ CENTER FOR BIOMEDICAL IMAGING SAFETY POLICY
TABLE OF CONTENTS
B. THE RADIOLOGY RESEARCH COMMITTEE
C. SAFETY OFFICER
II. CBI SAFETY POLICY
B.MR SYSTEM SAFETY CONCERNS
Pulse Sequences and Coils
Human Clinical Studies
Non-FDA Approved Devices
Venipuncture and Injections
D. SAFETY STANDARDS FOR HUMAN MR STUDIES
I. CT IMAGING
J. SIGNS AND WARNINGS
L. HUMAN RESEARCH SUBJECTS
MRI SAFETY SCREENING FORM (PDF Format)
Bernard and Irene Schwartz Center for Biomedical Imaging is a research center,
which, with respect to safety, falls under the general auspices
of relevant institutional policies at NYU and other relevant policy-making
bodies of the state and federal governments. This manual serves
as a supplement to safety regulations and policy already established,
and is concerned only with safety policies unique to the Imaging
Center, principally due to its specialized facilities for studies
using magnetic resonance (MR) imaging and spectroscopy instruments.
Any categories not included in this document (e.g., the treatment
of biohazards, laboratory safety for chemicals, etc.) are referenced
to the relevant guidelines and policies governing other clinical
and research facilities at NYUMC. In the event of a conflict between
this document and these guidelines/policies, this document preempts
B. THE RADIOLOGY RESEARCH
The Safety Committee comprises individuals knowledgeable about experimental
procedures in MR, medicine, physiology, chemistry, physics, and
electronics. The Vice Chair of Research and the Director of the
Imaging Center or his designee will chair the Committee and appoint
members to the Committee.
The Safety Committee is responsible for the review and approval
of protocols for all research uses of the Imaging Center. This committee
supplements, and in no way replaces, the NYUMC Institutional Board
of Research Associates (IBRA). Research protocols should be submitted
to the Radiology Research Committee, after IBRA approval is obtained.
Research is not to be conducted within the Imaging Center, which
involves human subjects or animals without approval of both this
committee and the NYUMC IBRA or Institutional Animal Care and Use
The Safety Committee is ultimately responsible for safety within
the Imaging Center, and will perform the following safety-related
1. Review all protocols for conformance to the provisions of the
2. Revise the Safety Policy as needed; review the safety manual
periodically, and report any changes to the NYUMC IBRA.
3. Appoint a Safety Officer, who will report to the director of
the Imaging Center.
4. Convene as needed
In the event that an unsafe condition arises, or the safety policy
is violated, the Radiology Research Committee has the responsibility
to revoke approval of the protocol involved until the condition
is corrected. The Radiology Research Committee Chair and the Safety
Officer have this authority pro tempore.
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C. SAFETY OFFICER (SO)
The Safety Officer (SO) is a member of, and is appointed by, the
Radiology Research Committee. He/she is experienced in and knowledgeable
of the operation, safety hazards, and safety policy of the Imaging
Center. He/she has the authority to suspend any activity in the
Imaging Center that, in his/her judgment, violates the Safety Policy,
or otherwise constitutes an unsafe condition. He/she may transfer
this authority to an approved Operator of the facility. The SO will
perform the following safety-related tasks:
1. Ensure that the provisions of the Safety Policy are carried
out in the execution of approved laboratory protocols.
2. Advise the Radiology Research Committee as to needed changes
in Safety Policy.
3. Coordinate training concerning safe conduct in the Imaging Center
and execution of emergency procedures.
4. Verify that any personnel involved with any function of the Imaging
Center have completed the aforementioned safety
5. Maintain a permanent file of incident reports and any corrective
6. Ensure adequate distribution of this manual governing Safety
7. Maintain safety records of Imaging Center Operators.
8. Report occurrences immediately to the Director of the imaging
center, who will report the occurrences to the Research Committee.
9. Remain current on all new governmental and non-governmental safety
policies and recommendations.
An Operator of the Imaging Center will be certified as such once
1. Satisfactorily completed formal training on MRI, formal training
on safety, and hands- on training. The formal training on MRI may
be waived if adequate previous experience and/or course work in
MRI can be demonstrated.
2. Been approved by the Safety Committee as an authorized user.
A certified Operator understands that safe operation within the
Imaging Center and the administration of this safety policy is his/her
responsibility while he/she is present in the Imaging Center. Any
violation of this policy will be documented in writing by the Operator
and submitted to the SO within 24 hours of the incident.
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II. CBI SAFETY POLICY
Bernard and Irene Schwartz Center for Biomedical Imaging has installed three magnetic
resonance (MR) systems. The 3T systems have been approved by the
FDA for human examinations, and will serve as mixed-use systems,
serving a combination of clinical and research purposes. The 7T
whole-body system will be used for MRI imaging and spectroscopic
research studies involving human participants (volunteer patients
and healthy volunteers). All three MR systems fall under the purview
of the Department of Radiology. All three MR systems are included
in the following safety concerns. A high resolution x-ray computed
tomography (CT) system has also been installed in the Imaging Center.
B. MR SYSTEM SAFETY CONCERNS
1. Magnet Safety
The MRI magnet exerts a very strong attractive force on ferromagnetic
items such as iron and other metals. Oxygen tanks, wheel chairs,
stretchers and hand tools are examples of metallic items that should
never be brought into the magnet room. The magnetic attraction is
so strong that items such as these can be drawn forcibly into the
center, or bore, of the imaging system, resulting in injury to a
person and damage to the magnets.
Do not make assumptions about devices or equipment being safe.
For example, “sandbags” can sometimes contain metallic
pellets instead of sand. Err on the safe side; unless a device or
piece of equipment has been proven to be MRI safe, do not bring
it into the MRI areas.
The Magnets are ALWAYS ON. The magnetic force is always present,
even after hours of operation, and thus the attraction of metallic
objects is always present. The magnetic force varies very rapidly
with distance; by the time it is felt, it may be too late to keep
the object from being “snatched” into the magnet by
the magnetic force.
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2. Facility Safety
All groups using the Facility after hours and on weekends will
have at least one member present during all scanning sessions who
has been approved for operating the unit by the Manager of the Facility.
Training will include, but not be limited to: emergency procedures
– including safe machine shutdown, working within Machine
and FDA limits, maintaining records of machine usage, machine performance,
malfunctions and providing a safe working environment. In addition,
approved users must view the relevant safety films, and read and
sign off that they comprehend the policies and procedures related
to their research (human, animal, phantom, hardware, software, etc.)
Additional training may be required in order to be authorized by
a facility director to perform studies on human subjects.
The approved operator must also demonstrate to the facility manager
that they are capable of initiating the following emergency responses:
Code: Telephone 911
Hospital Security: 3-5038 business hours, emergency 3-3000, 24 hour
All groups will abide by Radiology Department policies for the
above emergencies. These are summarized in the Emergency Response
Policies and Procedures Manual. Emergency numbers will be located
next to every phone in the Imaging Facility.
Under NO circumstance is the tackle box or AED to be disturbed
for other than legitimate emergency use. Supplies for non-human
research are not to be taken from the clinical research supplies.
All cabinets used during the day will be locked during the evening
and weekend hours.
All groups are responsible for ensuring that those present follow
routine safety precautions with regard to metal objects, implanted
devices, foreign bodies, etc. It is required that a trained member
of the group review the safety procedures with new participants
prior to entering the console area. No one should enter the scanner
areas without having been cleared by the responsible member of the
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3. Human Subject Research
a. Research categories
The Safety Committee has divided human subject research into 3
Category 1: For Radiology faculty only: Limited human scanning
for testing and optimization of new experimental pulse sequences
and/or coils or image processing under a “software/hardware”
protocol. May use in-house consent forms kept by each of the scanners.
Does not require IDX documentation or MRN numbers. Images will not
go to PACS systems.
Category 2: Research studies carried out on patients and/or control
groups as part of pilot investigation or funded study. The study
results may be used to guide clinical decisions and /or treatment
as part of an approved IBRA study protocol. Investigators must provide
their own consent forms. Outside investigators must include the
participation of a radiologist if formal reports are required for
Category 3: Clinical trials: Studies are carried out on patients
and /or control groups through externally driven research that is
funded by pharma, e.g., Pfizer, EZ-M, Amersham or NIH. The study
results are used to guide clinical decisions and /or treatment as
part of the study protocol. Investigators must provide their own
consent forms. Outside investigators must include the participation
of a radiologist if formal reports are required for their studies.
All of the above categories must by part of an IRB-approved Human
Use protocol and every subject must sign an IBRA-approved consent
form before entering the magnet.
All Persons, whether they are healthy walk-in volunteers, normal
subjects, outpatients or inpatients participating in research studies
and /or clinical trials using Radiology facilities must have a medical
record number and be entered into the IDX or DECRAD system - the
exception is category one, hardware/software technical development.
b. Technical development studies involving human subject scanning
A global Human Use approval letter and consent form has been made
available under Dr. Joseph Helpern’s IRB approval to use for
technical developments involving limited human scanning for 7T and
below. A consent form and case report form must be filled out for
each scanning session. These forms are available at each scanner
for Radiology faculty only.
Scanning of volunteers under Dr. Helpern’s global approval
may be performed by MR Technologists or users authorized by the
facility manager. Researchers from outside Radiology must have their
own IRB approvals.
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4. Research Pulse
Sequences and Coils
a. Pulse sequences
All research pulse sequences that are to be used on human subjects
must be approved by the Safety Committee following the listed guidelines:
1. Documents will be submitted for approval at the Safety Committee
and include an IDEA simulation file. This file will be kept by the
2. All sequences need to be tested on a phantom before use on human
3. The PI of the study remains ultimately responsible for problems
associated with sequence development. All sequences should be tested
adequately prior to human subject use.
All research coils must be approved for safety by the head of the
RF coil lab or someone he or she authorizes for such approval. Research
coils include those built at NYU or other institutions. The only
coils that are exempted are those provided by the Scanner manufacturer
(Siemens) as product and that are used within the parameters and
protocols for which they were developed. Overriding the design or
modification of the product coil requires Radiology Research approval
and final approval of the RF Lab.
Human Clinical Studies
Authorization for performing studies in categories 2, and 3 must
be obtained from the Radiology Research Committee. To obtain authorization,
you must submit the application form, a copy of the dated consent
form, and the MRI protocol to Randa Hazar – email@example.com.
212-263-4814. Once submitted and approved, your application will
automatically be reviewed yearly and require only an updated stamped
IRB consent at the time of expiration. Approved studies are issued
a billing modifier for scheduling use if a protocol has been terminated
by the PI, the modifier will be deactivated.
MRI technologists will ensure that all of the screening and safety
procedures involved in conventional clinical MRI scanning are followed.
For hardware/software protocols, authorized users will ensure safety
procedures are followed. All persons entering the instrument will
be re-checked for metallic objects and provided with hearing protection.
They will also be asked if they signed a consent form.
Scanning technologists are required to have BCLS certification.
The BCLS certification should be renewed annually. This policy is
to allow skilled delivery of emergency care while 911 is dispatched
to the site.
All groups are responsible for maintaining security and restricting
unwarranted access to the facility. This includes basic safety in
the scanner area during use and securing the facility when not in
use. If a problem arises with an unauthorized person or persons,
scanning should stop and hospital security should be notified by
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6. Use of Non-FDA-approved Devices
Non-FDA-approved devices can only be used following designation
as non-significant risk by the IRB and approval by the Safety Committee.
Coils and pulse sequences must be approved according to the relevant
policies, as above. There must be reference in the protocol and
consent forms to a non-significant risk investigational device.
Devices and sequences to be used for applications which exceed the
FDA’s guidelines must be under an IDE from the FDA as well
as having approval from the IRB and Radiology Research Committee.
No formal reports are provided for research MRI’s unless
the investigator has a radiologist on board who will take responsibility
for the interpretation and dictation of a report through the Radiology
information system. This radiologist must be listed as a sub investigator
or a co-investigator of that particular protocol. This designation
will be made at the Safety Committee.
Venipuncture and Injection
Venipuncture and injection can only be performed by RNs, PAs, MDs
and others credentialed by the hospital for these procedures.
Only limited data are currently available on the use of 3T and
7T magnetic fields in pregnant women. Because the long term effects
on a fetus are still unknown, this cohort is to be excluded from
research using the 3T and 7T magnets. The investigator will provide
a urine pregnancy test for those patients uncertain of their status,
or they will be asked to reschedule the exam until their status
9. Animal Studies
Animal studies may be done after approval of the Safety Committee
and IACUC. For all animal studies we will need a copy of the “Animal
Transport Letter”, which allows transport of animals within
the University system. According to School of Medicine policy, animals
cannot be scanned or cohabitate in a clinical area where human subjects
are being evaluated simultaneously. Due to this policy, we will
try to schedule animal imaging late in the day – or schedule
animal imaging to coincide with phantom-based technical development
on other systems.
Researchers using animals are responsible for cleaning the magnet
room, bore, and carriage of any animal debris, or blood or waste
products. Clinical supplies are not to be used on animals.
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1. Potential hazards of MR Studies
Potential hazards to subjects during MRI examination include:
a. Static magnetic fields
b. Pulsed gradient magnetic fields
c. Radiofrequency electromagnetic fields
d. Acoustic noise
These are discussed further below.
2. Incidental hazards
Incidental hazards to Operators and patients in a restricted access
a. Implanted devices: The subject may have implanted objects which
might dislodge (e.g., an aneurysm clip), or malfunction (e.g., a
pacemaker), or become attached to the magnet (e.g., a metal pin)
in high static magnetic fields.
b. Flying objects: It is possible for a person to become trapped
between the cryostat and a magnetic object. If the object is fairly
massive, forces of up to 150 pounds may be generated for every pound
of ferromagnetic material. The person may thus be subjected to severe
force and mechanical stress, with resulting injury.
c. Quench: The cryostat of the magnet contains several hundred liters
of cryogens. If the magnet quenches, (i.e., makes the transition
from superconducting to resistively conducting) the liquid helium
in the innermost cryostat will boil off rapidly, and may displace
oxygen in a closed environment, leading to an asphyxiation hazard.
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D. FDA SAFETY STANDARDS FOR
HUMAN MR STUDIES
MR systems in Bernard and Irene Schwartz Center for Biomedical Imaging shall be
operated in strict adherence to existing guidance from the Food
and Drug Administration (FDA) for magnetic resonance diagnostic
devices. Safety standards for human studies are already established
for the 3T systems, since these systems have already received 510(k)
clearance. Safety standards for human studies using the 7T MR system
have been set with guidance from the relevant FDA documents, which
are appended to this Manual. These include the Safety Parameter
Action Levels document, which is referenced by the FDA document
entitled: Guidance for Content and Review of a Magnetic Resonance
Diagnostic Device 510 (K) Application. That original guidance (1988)
has been supplemented with additional guidance provided by the FDA,
including: (a) a 1995 FDA guidance regarding the rate of change
of magnetic fields over time (dB/dt), (see Gradient Switching, below),
and (b) a 1997 memo from the FDA Center for Devices and Radiological
Health, which clarifies the current guidance regarding static magnetic
fields. “Guidance for Industry and FDA Staff – Criteria
for Significant Risk Investigations of Magnetic Resonance Diagnostic
Devices issued July 14, 2003. In accordance with Blue Book memorandum
entitled “Significant Risk and Non-significant Risk Medical
Device Studies, http://www.fda.gov/cdrh/d861.html,” Magnetic
resonance devices operating within FDA guidelines up to 8T are considered
For further information please review the 2003 guidance for industry
and FDA staff entitled “Criteria for Significant Risk Investigators
of Magnetic Resonance Diagnostic Devices” at http://www.fda.gov/cdrh/ode/guidance/793.pdf
2. Static Magnetic
The 1988 FDA Guidance and Safety Parameter Action Levels indicate
that static field strengths of up to 2 Tesla comprise non-significant
risk to human subjects. The FDA has indicated more recently (1996/7)
that static field strengths up to and including 4.0 Tesla are not
considered significant risk (see attached memo from the FDA Center
for Devices and Radiological Health). Further, the FDA has already
approved research systems with field strengths up to 4.1 Tesla.
As with any human research study, those using magnets within the
Imaging Center will only be performed after approval from the Institutional
Review Board (IRB). If new limits on human exposure to magnetic
fields are defined in the future, the Imaging Center will immediately
comply with these limits.
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Safety parameter action levels on the rate of change of magnetic
field strength will be adopted as limits in our human studies. These
were established in 1988 as follows:
a. Demonstrate that the maximum dB/dt of the system is 6 T/second
or less: BELOW LEVEL OF CONCERN
b. For axial gradients: If dB/dt< 20 T/s for ? >= 120 ?s,
if dB/dt < 2400/? (?s) T/s for 12 ?s < ? < 120 ??s, or
if dB/dt < 200 T/s for ? ? 12 ?s, and For transverse gradients:
If dB/dt is less than 3 times the above limits for axial gradients:
BELOW LEVEL OF CONCERN
c. Demonstrate with valid scientific evidence that the rate of
change of magnetic field for the system is not sufficient to cause
peripheral nerve stimulation by an adequate margin of safety (at
least a factor of three): BELOW LEVEL OF CONCERN
The parameter dB/dt cited above must be shown to fall below either
of the two levels of concern by presentation of valid scientific
measurement or sufficient mathematical modeling and calculations
must be provided to demonstrate that the time rate of magnetic field
change (dB/dt) is of no concern.
Levels exceeding the above will be evaluated in terms of the likelihood
that they may produce painful nerve stimulation. The FDA Guidance
(1995) was developed specifically to consider the fact that many
clinical systems were capable of exceeding these levels of dB/dt.
It was originally considered that a warning level should be implemented
to guard against peripheral nerve stimulation, but it was concluded
that: “this warning level is not considered critical since
there are no harmful effects associated with mild peripheral nerve
stimulation” (FDA Guidance, 1995). The current guidelines
therefore include monitoring procedures to help avoid painful peripheral
nerve stimulation, without specific dB/dt limitations.
We will specifically consider any study that could exceed the level
of concern as identified in the 1988 guidance, and in those cases
implement the recommendations of the FDA for monitoring peripheral
nerve stimulation. Following the FDA Guidance (1995), our system
will generate a special notification below the lowest dB/dt level
at which peripheral nerve stimulation has been observed in volunteer
and clinical studies (in fact, we will use the level of concern
described in the 1988 Guidance to implement these notifications,
which is more conservative than the FDA guidelines). Deliberate
action by the operator will be necessary to proceed with a scan
in these cases. System operators will also receive special training,
and before any scanning procedure that might stimulate peripheral
nerves, operators will:
1. inform the patient/subject that peripheral nerve stimulation
2. describe the nature of the sensation to the patient/subject,
3. instruct patients/subjects not to clasp their hands, since this
may create a conductive loop which will increase the possibility
4. maintain constant contact with the patient/subject,
5. instruct patients/subjects to inform the operator if they experience
pain, or wish to stop the
6. procedure for any reason terminate the scan immediately when
a patient/subject requests that, and
7. complete a report of any incidents involving painful stimulation,
including a description of the associated
circumstances (imaging parameters, dB/dt value, level of pain, etc.),
and submit this report
immediately to the Safety Officer.
All consent forms for studies that might induce peripheral nerve
stimulation also will include language providing this information,
and operators will administer an exit questionnaire, using terms
and explanations for key symptoms (e.g., vertigo) in language that
patients/subjects can understand. A record of dB/dt value will also
be included with the image data, to help in analysis of levels of
peripheral nerve stimulation possibly perceived by subjects.
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Absorption Rate (SAR)
Safety parameter action levels on specific absorption rate (SAR;
i.e., possible heating associated with absorption of radiofrequency
[RF] energy) will also be adopted as limits in our human studies.
These are summarized as follows:
a. If SAR ?0.4 W/kg whole body:
and if SAR ? 8.0 W/kg spatial peak in any 1 gram of tissue,
and if SAR ? 3.2 W/kg averaged over the head: BELOW LEVEL OF CONCERN
b. The SAR parameter for RF heating cited above must be shown to
fall below either of the two levels of concern by presentation of
valid scientific measurement or calculation evidence sufficient
to demonstrate that RF heating effects (SAR) are of no concern.
5. Acoustic Noise
Acoustic noise levels must be shown to be below the level of concern
established by pertinent Federal Regulatory or other recognized
standards-setting organizations. If the acoustic noise is not below
the level of concern, steps to reduce or alleviate the noise perceived
by the patient must be taken.
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Access to the restricted area will be controlled, allowing access
only for personnel and patients or research subjects who have legitimate
reason to be in the restricted area. A securely locked door, with
only Operators having keys, or guarded entrance, are mandatory and
minimal safeguards. The purpose of controlling access is to control
the entry of ferromagnetic and other materials, which might cause
injury to patients, research subjects, personnel, or equipment.
1. Access will be restricted to those individuals authorized by
the Safety Committee. The Safety Officer (SO) has the duty to restrict
access to only those personnel, and to eject individuals acting
in an unsafe manner.
a. To assure their safety, NYU Security staff will have access
to restricted areas within the Imaging Center only under the supervision
of the SO or a qualified Operator. In the event of an emergency,
the Security Officer must attempt to contact the SO or a qualified
Operator before entering. Once contacted, the SO will direct the
Security Officer in safe methods to access the facility, and safe
procedures to follow once the restricted area is entered. All unauthorized
personnel are barred from the high field area.
b. Housekeeping staff will not have access to the restricted area
of the Imaging Center without Operator supervision.
2. Entrance doors will be kept closed and locked at all times.
a. Spring locks and door returns will be installed on the doors
to restricted access areas.
b. There will be one, and only one, ordinary method of entry and
egress to each restricted access area.
c. For the purpose of access in an emergency, a key will be kept
in a red security lock box with a glass door next to the door of
each restricted access area.
3 Magnetic objects will not be allowed into the restricted area
without approval of Safety Committee.
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1. The Imaging Center will be properly ventilated to evacuate excess
helium gasses. Ventilation will be adequate to provide fresh air
on a regular basis and to remove the heat load generated by the
2. There will be a separate helium discharge duct for each MR system.
1. The MR systems will be evaluated regularly for electrical hazards,
as detailed in the service agreements with the MR system manufacturers.
2. All modifications of the equipment will be performed only by
qualified personnel and will be properly evaluated in terms of electrical
3. Safety tests will be carried out on a regular basis with regard
to radiofrequency and magnetic field levels, as detailed in the
service agreements with the MR system manufacturers.
4. Patients, Operators, and other individuals will not have direct
contact with MR coil electronics.
5. Patients in MR systems will be connected to, at most, one electrical
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1. The transfer of cryogens and all handling of dewars and cryogenic
substances will be performed by a qualified Safety Officer with
experience in cryogens, using only non-magnetic equipment and containers
tested and designed for cryogenic use. In particular, transfer lines
should be made of latex, non-ferromagnetic metal or other shatter-resistant
2. Operators will wear suitable face and hand protection when transferring
3. Dewars shall be checked for correct pressure and ventilation
before and after liquid transfers.
4. Cryogenic transfers will be accomplished with a minimum of two
persons, at least one of whom is a qualified Operator.
5. All dewars, particularly liquid helium containers, must be kept
sealed and under a slight positive pressure at all times.
6. The restricted access areas will be vacated by persons other
than Operators during cryogenic transfers.
7. Each MR system will have in place a venting system, triggered
by high cryogenic flow rate, to carry cryogens out of the facility
rapidly if a quench should occur. In the event that a helium quench
does occur, any human subject (if present) must be removed from
the system, and with all other personnel be evacuated the area immediately.
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I. CT IMAGING
The high resolution CT system at the Center will be operated in
accordance with all relevant standards and guidelines, especially
in regard to risks associated with using ionizing radiation and
contrast agent administration.
J. SIGNS AND WARNINGS
Each restricted access area will be posted with conspicuous signs
advising of the existence of high magnetic fields. The signs must
contain warnings to wearers of pacemakers, as well as general warnings
against carrying magnetic materials into the facility. In addition
to warning signs, contact information for the SO and other backup
Operators will be posted conspicuously. This information will also
be provided to NYUMC Security.
1. The entrances to the rooms housing the magnets will be posted
with appropiate warning signs describing the hazards of entering
2. Anyone who is not an Operator and who wishes to enter a restricted
access area will be questioned and advised of the known hazards.
3. Patients and other potential research subjects will be fully
informed as to the risks, hazards, procedures, and possible emergencies
involved in their studies. The specific procedures for informed
consent fall under the purview of, and must be approved by, the
4. Signs will be placed near power breakers identifying these as
“Emergency Power Off” or “Emergency Stop”
5. Signs will be placed near emergency quench switches identifying
these as the “magnet emergency discharge” buttons.
6. Several signs will be posted informing all personnel and subjects
of proper procedures to be followed in the event of a fire.
7. Appropriate x-ray warning signs will be posted at the entrance
to the CT suite.
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a. Necessary equipment (fire extinguishers, etc.) will be provided
to manage all classes of fire. All equipment will be non-magnetic.
b. No flammable liquids in excess of five gallons will be brought
into the Imaging Center.
2. Fire with Operators on site
a. The Operator will know all of the fire emergency related procedures,
including a patient evacuation plan, and its proper execution.
b. In the event of a fire requiring outside response, the Operator
will perform an emergency quench of the magnet by activating the
emergency magnet shut-off.
c. In the event of a fire requiring outside response, the SO and
Operators will direct fire fighting operations until such time as
the magnetic field reaches zero.
3. Fire with no Operators on site
a. Once contacted, the SO or alternate Operator will instruct fire
fighting personnel and/or Security staff as to means of entry and
to the proper means of quenching the magnet if necessary.
b. For the purpose of access in emergency, a key to the restricted
access area door will be kept in a red security lock box with a
L. HUMAN RESEARCH SUBJECTS
The NYUMC IBRA has jurisdiction in all research involving human
subjects. General guidelines for human research studies in experimental
1. All subjects will be evaluated by the attending physician, principal
investigator, or designee, as to their physical and mental status
2. All subjects will undergo screening for metallic objects before
entering restricted access areas, and those with critical implanted
magnetic objects (i.e., aneurysm clips, pacemakers etc.) will not
be allowed in restricted access areas.
3. All subjects will be attended at all times while present in
the Imaging Center.
4. No human research will be performed without prior approval of
the NYUMC IBRA .
5. All human subjects (or legally authorized representative) will
sign an IRB-approved informed consent form before entering restricted
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It is the duty of the SO to report all violations of safety procedure
and accidents to the Director of the Imaging Center. The category
of the incident is classified below:
1. Incidents in which any person was injured.
2. Incidents requiring the emergency quench of the magnet.
3. Incidents involving damage to equipment.
4. Conditions that constitute a safety hazard but are not covered
by this safety policy.
5. Incidents in which an approved protocol was not followed, causing
an unsafe condition.
The SO is required to report incidents to the Chair of the Safety
Committee or to the Committee itself within the following time periods
for the different categories:
1 and 2: To the director or designee immediately.
3 and 4: To the director or designee within 24 hours.
5: To the Protocol Review Committee at its next meeting.
Any incident involving human subjects must also be reported to
the Institutional Review Board.
1. At least one Operator must be present when any MR system is
2 A qualified Operator will be on call at all times.
Nothing in the foregoing is to be interpreted as preempting the
legal and institutional responsibilities of the NYUMC Institutional
Review Board, regulations of New York State agencies, or such entities
and agencies as have purview over safety and research procedures
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