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MRI Accidents Prompt Attention From Regulatory Bodies

by Luke Molnar

The death of the 6 year old boy in a North American hospital when an oxygen cylinder was inadvertently taken into a MRI room was a touchstone for MRI safety. Subsequent investigations led to reports of increasing risk factors by safety bodies such as the US Food and Drug Administration (FDA), the American College of Radiology (ACR) and the Joint Commission.

Since, industry experts and representatives from a number of professional bodies have been outspoken on the issue of safety in MRI suites.

“The proliferation of MRI equipment and significant increases in both magnet strength and spatial gradients… has increased the number of accidents occurring in the MRI suite. Each accident and close call puts patients and staff at risk and carries the potential of damaging, if not crippling, over a million dollars worth of imaging equipment,” stated a member of ACR’s MR Safety Committee (taken from Patient Safety & Quality Healthcare, September/October 2006).

“…there is a strong ‘it couldn’t happen here’ mentality. …I don’t believe people are quite aware of the potential problems that can occur, the substantial severity that could occur.” said Emanuel Kanal, MD, FACR, FISMRM, AANG on Good Morning America, ABC News on 22 August 2005.

“We believe it likely that accidents and incidents in MR imaging are underreported,” argued Chaljub et al from a Study of the University of Texas Hospitals.

From 8 to 10 million MRI procedures are performed in US each year, the vast majority without complications (University of Pittsburgh Medical Center’s Department of Radiology). Nevertheless, since the device first went into use, there have been hundreds, perhaps thousands, of incidents where objects became magnetized and attracted to MRI machines.

In the UK, guidelines for MR equipment in clinical use were produced by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2002. In December 2007 these guidelines were updated to acknowledge the availability and use of ferromagnetic detection systems, detailing a number of advantages of their use as an ancillary screening device over standard metal detectors.

The MHRA safety guidance also refers to the American College of Radiology (ACR) White Paper as a useful reference document, itself updated in 2007.

In July, 2007 the FDA stated: “MR associated accidents, many of them life threatening or fatal are still occurring, causing continued concern in the radiology community.” The “ACR Guidance Document for Safe MR Practices: 2007” referred to by the FDA itself states…

“Ferromagnetic detection systems have been demonstrated to be highly effective as a quality assurance tool, verifying the successful screening and identifying ferromagnetic objects which were not discovered by conventional screening methods”.

Six-Year-Old Patient Killed in MRI Accident
An accident during an MR examination in 2001 resulted in the death of a 6-year-old boy at Westchester Medical Centre in New York-area when the machine’s powerful magnetic field attracted a metal oxygen tank that was mistakenly allowed to be inside the room, crushing the child’s head. The canister fractured the skull and injured the brain of the boy who was identified as Michael Colombini of Croton-On-Hudson, NY. He later died of the injuries sustained. The 10-ton magnet exerts a force that is about 30,000 times as powerful as Earth’s magnetic field. In layman terms, this is some 200 times stronger than a common refrigerator magnet.

Hospital Takes ‘Full Responsibility’
Westchester Medical Centre, which is located 15 miles north of New York City in Valhalla, accepted liability for the accident and the boy’s death. “The medical centre assumes full responsibility for the accident. Our sorrow is immeasurable and our prayers and our thoughts are with the child’s family,” the hospital’s president and CEO, Edward Stolzenberg, said in a statement. The hospital had reported the accident as required, and the state health department had sent investigators to the scene. The hospital said it was conducting its own inquiry as well. It is unclear who brought the canister into the room.

$2.9 Million Settlement Ends Colombini Case
Nearly nine years after the accident that killed then-six-year-old Michael Colombini, the lawsuit that resulted was settled for $2.9 million, a settlement that was likely both diminished by, and made possible by, a pre-trial motion which excused GE Healthcare as a defendant to the suit. The county-owned hospital, had immediately asserted its responsibility for the accident, settled the case on behalf of all of the remaining defendants, which included the head of radiology and the technologist who administered the boy’s scan. With the lawsuit resolved, it is hoped by many, including industry experts and professional bodies, that we can have abetter understanding of what contributed to the accident and what can be done in avoid future accidents.