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Safety First!
SAFETY IN THE MR ENVIRONMENT


ICAMRL DIVISION NEWS | Winter 2009

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Magnetic Resonance is often thought of as the "safe" diagnostic imaging modality since there is no ionizing radiation involved. However the potential to cause harm to patients, personnel and the equipment is very real if owners and operators are not knowledgeable about the environmental hazards that exist.

The Food and Drug Administration (FDA) approves MR scanners as medical devices, but offers no regulatory oversight. A mandatory reporting mechanism does not exist for documentation of MR accidents, although incidents occur on a frequent basis. These incidents generally go unnoticed unless the accident results in patient injury or causes damage to the equipment. The facility administrator and scanner operators are responsible for reducing the risk associated with the magnetic field.

Efforts are being made by The Joint Commission which, in February 2008, issued a Sentinel Event Alert: "Preventing Accidents and Injuries in the MRI Suite". The Joint Commission issues its Sentinel Event Alerts to identify specific events requiring the need for immediate investigation and response as they relate to unexpected occurrences involving death or serious physical or psychological injury, or the risk thereof. Such events are called "sentinel" because they signal the need for immediate investigation and response. The Sentinel Event Alert related to MR provides a summary of an independent analysis of the FDA's MAUDE (Manufacturer and User Facility Device Experience Database). indicating nearly 400 documented cases of MR-related accidents in the past ten years, with over 70 percent of the incidents due to patient burns and 10 percent from injuries due to projectile ferromagnetic materials brought into the scan room. There are five fatal cases documented in the Joint Commission's Sentinel Event database: one case was caused by a projectile; three were cardiac events and one was an interpretation error that resulted in delayed treatment.

The Joint Commission
Issue 38, February 14, 2008
Sentinel Event Alert: "Preventing Accidents and Injuries in the MRI Suite"

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 scanner during the scan.

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; some programmable infusion pumps may perform erratically; and pacemakers and implantable defibrillators may not behave as programmed.

5. Injury or complication due to failure to attend to patient support systems during the MRI. This is especially true for patient sedation or anesthesia in MRI arenas. For example, oxygen canisters or infusion pumps run out and staff must either leave the 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 MR scanner makes.

7. Adverse events related to the administration of MR contrast agents.

8. Adverse events related to cryogen handling, storage, or inadvertent release in superconducting MR imaging system sites. 1,3
 

MR personnel must have a healthy respect for the MR environment and be knowledgeable about the MR physics involved. The magnet is always on; therefore the potential for injury is always a concern. The three main components that contribute to a hazardous environment include the static magnetic field, the radio frequency and gradient fields. Adverse biological health effects to the body from these fields are negligible when all systems are functioning as designed; however, the potential risk for serious injury to the patient occurs when ferrous or mechanical devices are introduced into these fields. Objects may become projectiles when they try to align themselves with the magnetic field which is proportionally greatest at high field strengths. The greater the mass of the object, the faster it will fly into the bore and damage anything in its path. Burns to the patient can occur if care is not taken by the operator to ensure that wires are not looped, which may induce a current, and that the coil wires are not frayed. EKG leads must be frequently checked throughout the scan to prevent the likelihood of skin burns.

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