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SAFETY POLICY MANUAL

NYUMC CENTER FOR BIOMEDICAL IMAGING SAFETY POLICY MANUAL

TABLE OF CONTENTS

I. ORGANIZATON

A. INTRODUCTION
B. THE RADIOLOGY RESEARCH COMMITTEE
C. SAFETY OFFICER
D. OPERATORS

II. CBI SAFETY POLICY

A. INTRODUCTION
B.MR SYSTEM SAFETY CONCERNS
    1.Magnet Safety
    2.Facility Safety
    3.Human Subject Research
    4.Research Pulse Sequences and Coils
    5.Performing Human Clinical Studies
    6.Use of Non-FDA Approved Devices
    7.Human Venipuncture and Injections
    8.Pregnancy
    9.Animal Studies
C. HAZARDS
D. SAFETY STANDARDS FOR HUMAN MR STUDIES
E. ACCESS
F. FACILITIES
G. ELECTRICAL
H. CRYOGENS
I. CT IMAGING
J. SIGNS AND WARNINGS
K. FIRE
L. HUMAN RESEARCH SUBJECTS
M. INCIDENTS
N. GENERAL

III. MRI SAFETY SCREENING FORM (PDF Format)

I. ORGANIZATION

A. INTRODUCTION

The NYUMC 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 these.

B. THE RADIOLOGY RESEARCH COMMITTEE

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 Committee (IACUC).

The Safety Committee is ultimately responsible for safety within the Imaging Center, and will perform the following safety-related tasks:

1. Review all protocols for conformance to the provisions of the Safety Policy.
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.

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
Training.
5. Maintain a permanent file of incident reports and any corrective actions taken.
6. Ensure adequate distribution of this manual governing Safety Policy.
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.

D. OPERATORS

An Operator of the Imaging Center will be certified as such once he/she has:

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.

II. CBI SAFETY POLICY

A. INTRODUCTION

The NYUMC 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.

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 212-263-5120
Fire: 911

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 team.

3. Human Subject Research

a. Research categories

The Safety Committee has divided human subject research into 3 categories.

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 their studies.

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.

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 safety officer.
2. All sequences need to be tested on a phantom before use on human subjects.
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.

b. Coils

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.

5. Performing 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 – randa.hazar@nyumc.org. 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 calling 37790.

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.

7. Human Venipuncture and Injection

Venipuncture and injection can only be performed by RNs, PAs, MDs and others credentialed by the hospital for these procedures.

8. Pregnancy

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 is certain.

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.

C. HAZARDS

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 area include:

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.

D. FDA SAFETY STANDARDS FOR HUMAN MR STUDIES

1. Introduction

MR systems in the NYUMC 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 non-significant risk.
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 Field Strength

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.

3. Gradient Switching

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, or
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 may occur,
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 of stimulation,
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.

4. Specific 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:

Options:

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.

E. ACCESS

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.

F. FACILITIES

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 equipment.

2. There will be a separate helium discharge duct for each MR system.

G. ELECTRICAL

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 safety.

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 ground

H. CRYOGENS

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 material.

2. Operators will wear suitable face and hand protection when transferring cryogens.

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.

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 the area.

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 NYUMC IBRA.

4. Signs will be placed near power breakers identifying these as “Emergency Power Off” or “Emergency Stop” buttons.

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.

K. FIRE

1. General

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 glass door.

L. HUMAN RESEARCH SUBJECTS

The NYUMC IBRA has jurisdiction in all research involving human subjects. General guidelines for human research studies in experimental protocols are:

1. All subjects will be evaluated by the attending physician, principal investigator, or designee, as to their physical and mental status before entering.

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 access areas.

M. INCIDENTS

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.

N. GENERAL

1. At least one Operator must be present when any MR system is being used.

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 at NYUMC.

New York University Medical Center Center for Biomedical Imaging

SAFETY POLICY MANUAL

New York University Medical Center
Center for Biomedical Imaging