MR Safety in Clinical Practice - t2star.com

MR Safety in Clinical Practice

Wm. Faulkner, BS,RT(R)(MR)(CT),MRSO(MRSC )

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Kristan Harrington, MBA,RT(R)(MR),MRSO(MRSC )

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www.t2star.com/faulkner/MRSO_Course

Rank Danger: 1 - 10

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Rank Danger: 1 - 10

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Rank Danger: 1 - 10

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Mitigating Risks

Understanding the RisksReduce/Eliminate the Risks

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July 2001

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Courtesy Tobias Gilk

It is estimated that less than 20% of

incidents are reported

Between 2000 and 2013

- MR utilization increased 114%- Reported incidents increased 487%

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Courtesy Tobias Gilk

"Show me another industry where the more we know about risks and the more we know about prevention, the worse we do in terms of protecting people from the known risks”

- Emanuel Kanal, M.D.

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American Board of Magnetic Resonance Safety

ABMRS

MR Safety Credentialing for:MR Medical Director (MRMD)MR Safety Officers (MRSO)MR Safety Experts (MRSE)

www.abmrs.org9

Founding Board MembersEmanuel Kanal, MD (Chair)Max Amurao, PhD (Vice-Chair)Tobias Gilk, M Arch (Secretary / Treasurer)Wm. Faulkner, B.S.,R.T.(R)(MR)(CT), FSMRTJohn Nyenhuis, PhDJoe Schaefer, PhDTerry Woods, PhDDavid Grainger (International Non-voting)Cormac McGrath, PhD (International Non-voting)Donald McRobbie, PhD (International Non-voting)Siegfried Trattnig, MD (International Non-voting)

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CredentialingThe MRMD certification is designed for physicians, such as radiologists, who have responsibility for the safe administration of MR exams.

The MRSO certification is designed for those with a supervisory MRI safety role at the point of care. While not exclusive to technologists, this role is most frequently be filled by an MR technologist.

The MRSE certification is designed for those in an expert, technical consulting role who may help determine the safety of complex conditions. While not exclusive to MR medical physicists, this role is most frequently filled by a medical physicist.

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ContentAll three of the certifications share a common content syllabus, which can be found on the ABMRS website. Each of the three certifications will have different emphases for different topics, or knowledge domains, from that syllabus. At the current time, the ABMRS has not developed study materials beyond the content syllabus. The ABMRS does recommend familiarizing yourself with existing MR safety standards documents (e.g. the ACR Guidance Document on MR Safe Practices: 2013, and IEC 60601-2-33), and MR system manufacturer documentation.

Other than best practice documents, regulatory structures, and MR system documentation, the ABMRS does not endorse any third party materials for exam preparation

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“Together with MR Site accreditation, the formation of the ABMRS now completes the logical extension of creating a system to certify not only the hardware, software, and siting of an MR scanner, but also the individuals who are formally organized for and charged with ensuring the safety of those who will be exposed to clinical and research magnetic resonance facilities.”

www.abmrs.org

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Safety Incident at Your Facility

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What’s the standard?

What’s required?

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ACR Physicist’s Checklist19

20Issue 38: Preventing accidents and injuries in the MRI suite | Joint Commission

http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_38.htm?print=yes[9/20/2010 11:53:56 AM]

Sentinel Event Alert February 14, 2008

Issue 38, February 14, 2008

Preventing accidents and injuries in the MRI suiteMagnetic resonance imaging (MRI) was applied to health care in the late 1970s to provide never-before-seen two- and three-dimensional views of body tissue and structure. Today, more than 10 million MRI, or MR, scans are done in the United Stateseach year. (1) While the capabilities of the MRI scanner are well-recognized, its inherent dangers may not be as well known.The following types of injury can and have occurred during the MRI scanning process:

1. “Missile effect” or “projectile” injury in which ferromagnetic objects (those having magnetic properties) such as ink pens,wheelchairs, and oxygen canisters are pulled into the MRI scanner at rapid velocity.

2. Injury related to dislodged ferromagnetic implants such as aneurysm clips, pins in joints, and drug infusion devices.3. Burns from objects that may heat during the MRI process, such as wires (including lead wires for both implants and

external devices) and surgical staples, or from the patient’s body touching the inside walls (the bore) of the MRI scannerduring the scan. (2)

4. Injury or complication related to equipment or device malfunction or failure caused by the magnetic field. For example,battery-powered devices (laryngoscopes, microinfusion pumps, monitors, etc.) can suddenly fail to operate; someprogrammable infusion pumps may perform erratically; (3) and pacemakers and implantable defibrillators may not behaveas programmed.

5. Injury or complication due to failure to attend to patient support systems during the MRI. This is especially true for patientsedation or anesthesia in MRI arenas. For example, oxygen canisters or infusion pumps run out and staff must either leavethe MRI area to retrieve a replacement or move the patient to an area where a replacement can be found.

6. Acoustic injury from the loud knocking noise that the MRI scanner makes.7. Adverse events related to the administration of MRI contrast agents.8. Adverse events related to cryogen handling, storage, or inadvertent release in superconducting MR imaging system sites.

Five MRI-related cases in the Joint Commission’s Sentinel Event database resulted in four deaths and affected four adults andone child. One case was caused by a projectile; three were cardiac events, and one was a misread MRI scan that resulted indelayed treatment.

In 2005, Jason Launders, MSc, a medical physicist with the ECRI Institute, conducted an independent analysis of the FDA’sMAUDE (Manufacturer and User Facility Device Experience Database) reporting database over a 10-year time span, whichrevealed 389 reports of MRI-related events, including nine deaths: three related to pacemaker failure; two to insulin pumpfailure; and the remaining four events related to implant disturbance, a projectile, and asphyxiation from a cryogenic mishapduring installation of an MR imaging system. More than 70 percent of the 389 reports were burns; 10 percent were projectile-related; another 10 percent were “other events, including implant disturbance; 4 percent were acoustic injuries; 4 percent werefire-related; and 2 percent were internal heating-related.

The most common patient injuries in the MRI suite are burns and the most common objects to undergo significant heating arewires and leads. Other objects associated with burns are pulse oximeter sensors and cables, cardiorespiratory monitor cables,safety pins, metal clamps, drug delivery patches (which may contain metallic foil), and tattoos (which may contain iron oxidepigment). Less common injuries involve pacemakers. The American College of Radiology (2) recommends that implanted cardiacpacemakers and implantable cardioverter/defibrillators should be considered a relative contraindication for MRI. Any exceptionshould be considered on a case-by-case basis and only if the site is staffed with individuals with the appropriate radiology andcardiology knowledge and expertise. (2)

While only one missile-effect case has been reported to the Joint Commission, they are more common than is generallyrecognized. Many people—including health care workers—are unaware that the magnets in the MRI scanner are always “on” andthat turning them “off” (quenching) is an expensive and potentially dangerous undertaking, involving the controlled release ofcryogenic gases that can be deadly if released into a contained area. As a result of the magnets, many of the objects pulled intothe MRI scanner are cleaning equipment or tools taken into the MRI suite by housekeeping staff or maintenance workers.

Risk reduction strategiesConventional metal detectors have been used to help identify metal objects in and on patients, but they are not 100 percentaccurate and can give false-positives and false-negatives.(4) Furthermore, metal detectors cannot alert personnel to all objectsthat are subject to heating, malfunction or failure during an MRI scan. (5) However, the recent availability of ferromagneticdetectors may help in screening patients for objects left on their person, according to Dr. Emanuel Kanal, chair of the ACR’sMagnetic Resonance Safety Committee. A recent study concludes that ferromagnetic detectors have 99 percent sensitivity. (6)

A report on projectile cylinder accidents in the American Journal of Radiology (7) recommends strategies to prevent missile-effect accidents, including implementing protocols that allow maintenance and housekeeping personnel to enter the MRI suiteonly after proper safety education and when no patient is in the suite. A number of preventive measures for hazards in the MRI-environment are recommended by Dr. Kanal (8) and are supported by the ECRI Institute (9), including:screen-grab 1.9.17

SEA 38 “Retired”

Joint Commission Checklist21

Terminology Safety ZonesPersonnel

MR PersonnelLevel 1Level 2MR Medical DirectorMR Safety Officer

Non-MR Personnel

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Zones and Access Restrictions26

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Personnel Designation

Level 1

Those who have passed minimal safety educational efforts to ensure their own safety as they work within Zone III

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Level 1 MR personnel are not permitted to directly admit, or be designated responsible for, non-MR personnel in Zone IV.

Pg 5: ACR Guidance Document:

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Level 2

Those who have been more extensively trained and educated in the broader aspects of MR safety issues, including, for example, issues related to the potential for thermal loading or burns and direct neuromuscular excitation from rapidly changing gradients

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Level 2

It is the responsibility of the MR medicaldirector not only to identify the necessary training, but also to identify those individuals who qualify as level 2 MR personnel

Pg 5: ACR Guidance Document

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Level 2: MR Medical Director

It is understood that the medical director will have the necessary education and experience in MR safety to qualify as level 2 MR personnel


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Non-MR Personnel

Non-MR personnel will be the terminologyused to refer to any individual or group who has not within the previous 12 months undergone the designated formal training in MR safety issues defined by the MR safety director of that installation.

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Secured Access

Zone III regions should be physically restricted from general public access by, for example, key locks, passkey locking systems, or any other reliable, physically restricting method that can differentiate between MR personnel and non-MR personnel.


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Secured Access

Only MR personnel shall be provided free access, such as the access keys or passkeys, to Zone III.

There should be no exceptions to this guideline. Specifically, this includes hospital or site administration, physician, security, and other non-MR personnel


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Secured Access38

https://www.jointcommission.org/ambulatory_buzz/show_me_the_data/

Secured Access

Non-MR personnel should be accompanied by, or under the immediate supervision of and in visual or verbal contact with, one specifically identified level 2 MR person for the entirety of their duration within Zone III or IV restricted regions.

Pg 5: ACR Guidance Document:

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A respiratory therapist was wheeling around a ventilator to the 'backside' of a magnet. It was known that the vent was supposed to stay a minimum distance away from the magnet, but as the respiratory tech was looking for an outlet to plug the vent in, their focus was not on where the vent was rolling around within the room.This was not a small hospital. This was not a hospital that doesn't have a serious focus on MR safety issues. This was a hospital where the restrictions (conditions) of use for a device were not followed, which could be any site, really.

Controlled Access

Surgery

Intensive Care Units

Hot Lab

MRI

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Controlled Access

Surgery

Intensive Care Units

Hot Lab

MRI

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Training

Level 1

Level 2

AnnualAccess tied to training

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Who is responsible for the safe executionof an MRI procedure?

It HAS been well defined in court

It’s the radiologist / MR Medical Director

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“Captain-of-the-Ship”

Captain-of-the-Ship Doctrine is a principle of medical-malpractice law, holding a surgeon liable for the actions of assistants who are

under the surgeon's control but who are employees of the hospital, not the surgeon. The surgeon as "the captain of the ship," is directly responsible for an alleged error or act of alleged negligence because

he or she controls and directs the actions of those in assistance.

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Who is the captain of this ship?

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Who is the captain of this ship?

The Radiologist

MR Safety in Clinical Practice - t2star.com

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