Accidents with MRI machines avoidable, and lawsuits are now no-win
Some facilities still not working to prevent accidents
A renewed focus on safety issues with magnetic resonance imaging (MRI) machines has upped the ante for risk managers, says the leading authority on this issue. The risk is so clear, the potential consequences so enormous, and the risk reduction strategies so clearly defined, he says, that a risk manager will find it nearly impossible to defend a malpractice case brought after an MRI accident.
The foremost authority in MRI safety is Emanuel Kanal, MD, chair of the Magnetic Resonance Safety Committee with the American College of Radiology (ACR) in Reston, VA. Kanal is a professor of radiology and neuroradiology at the University of Pittsburgh and director of magnetic resonance services at the University of Pittsburgh Medical Center. Kanal, who helped develop the guidelines that now are the standard for MRI safety,1 tells Healthcare Risk Management that MRI safety should be a major liability concern.
"At this stage of the game, we have very little excuse. If there is an event today, there's not much of a defense," he says. "It is so strongly in the interest of the institution to realize that, if just about anything happens with the MRI that injures a patient, we will be found at fault."
Plaintiff's attorneys are familiar with the guidelines that are available to health care providers, and they will use them against you, he warns. "If your defense is someone saying he thought someone else was in charge of site access or that someone else was supposed to check the patient's pockets, the plaintiff's attorney is just waiting for you to say that so they can pull out the guidelines," Kanal says. "They will show that the guidelines spell it out very clearly, and they will ask why you didn't follow them. What are you going to say?"
Kanal says the recent warning from The Joint Commission reaffirmed that the issue of MRI safety should be high on the priority list for risk managers. The Joint Commission recently issued a Sentinel Event Alert that urges hospitals and ambulatory care centers to pay special attention to preventing accidents and injuries that can occur during MRI scans.2 In the Alert, The Joint Commission notes that more than 10 million MRI scans are performed each year in the United States.
Mark R. Chassin, MD, MPP, MPH, president of The Joint Commission, says the most common types of injuries are burns, while some of the more devastating accidents are caused by everyday objects that become missiles when brought into the MRI scanner's magnetic field. "MRI technology represents an important advance in diagnostic medicine, but special care must be taken to protect patients," he says. "The increasing use of MRI scans as a diagnostic tool, coupled with stronger MRI technology, suggests that the risk of accident and injury may increase."
Chassin and Kanal express concern that health care professionals still do not take the risk of MRI injury seriously enough, even after hearing about terrible accidents caused by poor MRI safety procedures. "There is still a steady stream of phone calls to my office and e-mails to my account from plaintiff's attorneys looking into these cases," Kanal says. "We have some sites that have dramatically learned from the mistakes of others, by restricting access and educating everyone associated with the MRI and by being very careful with the uninitiated. We have others who have done nothing."
FDA database shows many incidents
The Food and Drug Administration (FDA) has received nearly 400 reports of MRI-related accidents over the past decade, Chassin says. More than 70% of the accidents were burns, while 10% of the injuries occurred when metal objects such as ink pens, cleaning equipment, and oxygen canisters were pulled into the magnetic field of the scanner.
The best known MRI accident, and probably the worst on record, led to many of the safety standards now promoted by The Joint Commission, ACR, and other groups. In that incident, a 6-year-old boy died at the Westchester Medical Center in Valhalla, NY. As he was undergoing an MRI exam, a staff member brought a metal oxygen cylinder into the room, trying to aid an anesthesiologist who could not get oxygen from the fixture in the MRI room. The machine's powerful magnet pulled the oxygen tank through the air and into the machine, fracturing the boy's skull. The boy was sedated when he was struck, says Kanal, who led the post-accident investigation and the effort to develop safety guidelines.
The hospital's root-cause analysis identified a wide range of systemic failures including poorly trained staff, and it instituted several policy and procedure improvements. The New York State Department of Health fined the hospital $22,000 for 11 safety violations, the maximum allowable under state law for that number of violations. The health department also criticized Westchester for not reporting or adequately investigating a similar accident in 1997. In that case, an oxygen tank struck the MRI machine, but no patient was present.
The ACR MRI safety committee headed by Kanal was formed in direct response to that tragedy, within a few days of the child's death in 2001.
Restrict access to MRI area
Kanal says risk managers should focus on restricting access to the MRI site and educating the staff and physicians who work with the machine.
"If those two things could be addressed, I think there would be a tremendous reduction in MRI incidents across the country," he says. "These guidelines are as practical as they can be. It's just up to the providers to put them in place."
Risk managers should establish facility-specific policies and procedures for MRI safety based on the ACR guidelines, Kanal says. But once you do that, you must be able to ensure that the policies and procedures are followed. Thus, you must name a safety director for the MRI site.
"It's amazing how often that doesn't happen," he says. "You have to have this one person who is in charge of safety for the site and who can ensure that people are adequately trained."
The ACR guidelines are based on those previously developed at the University of Pittsburgh under Kanal's direction, and he notes that they are based almost entirely on reports of actual incidents. The guidelines address real concerns with MRI safety, not theoretical risks, he says.
Kanal and Chassin point out that some commonly used techniques to avoid MRI accidents may be insufficient. For instance, some health facilities use metal detectors to help identify metal objects in and on patients, but these devices don't always detect metal items. They also produce a lot of false-positives, which can lead staff to being less vigilant when the detector goes off.
Kanal emphasizes that, even if the issue of MRI safety previously was just the purview of radiologists, it isn't anymore. The risks and responsibilities are clear, he says. "Risk managers can either play a significant role up front, or they will play a very significant role after the fact," he warns.
References
1. Kanal E, Barkovich AJ, Bell C, et al. ACR guidance document for safe MR practices: 2007. Am J Roentgenol 2007; 188:1-27.
2. The Joint Commission. Preventing accidents and injuries in the MRI suite. Sentinel Event Alert 2008; Issue 38. Accessed at: www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_38.htm.
Sources
For more information on MRI safety, contact:
- Emanuel Kanal, MD, Professor of Radiology and Neuroradiology, University of Pittsburgh (PA). Telephone: (412) 647-3530. E-mail: [email protected].
- Mark R. Chassin, MD, MPP, MPH, President, The Joint Commission, Oakbrook Terrace, IL. Telephone: (630) 792-5000.
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