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MRI Accident Data:
You Don' t Know More Than You Think You Do.
By Tobias Gilk
In Kansas City, an area plastic surgeon made national news by being the focus of a running expose on a local television news station, having left an old personal computer on his curb for trash pickup with reams of patient data, including before and after pictures, still on the hard drive. Perhaps it was in an effort to avoid just this sort of debacle that a radiologist was determined to erase the contents of an old hard drive. But where, oh where, could a radiologist find an electromagnet strong enough to erase a computer hard drive?
“No,” said the technologist when asked by the radiologist if they could take the computer into the MRI room to erase it. However, once the technologist was distracted with other activities, the doctor ignored the technologist’s prohibition and took a box containing the soon-to-be-discarded computer into the magnet room. The MRI pulled the box from the physician’s grasp and stuffed it into the bore of the magnet. Or rather, it was on its way to enter the bore but was prevented from fully doing so by the patient who was on the table at the time!
The patient and computer box were wedged into the opening and the magnet was ultimately quenched to extricate the patient and the computer with the now-erased hard drive.
This event, along with thousands of similar inadvertent, imbecilic and incomprehensible MRI accidents will only be retold in this sort of forum, as anecdotes to amuse and inform. Even in those incidents when a person is injured (which was reportedly not the case in this instance), the vast majority are swept under the carpet.
Take, as an example, the FDA’s database of medical device accidents. Over a 10 year period the FDA catalogued a total of 389 incidents in MRI facilities across the US (an average rate of less than one incident per state per year). Contrast this with the data from the Pennsylvania Patient Safety Authority which, over just a 16-month period, tallied 88 MRI incidents from those facilities which are subject to mandatory state reporting. Fortunately, every MRI incident in the Pennsylvania database over that period was a ‘near miss’ which did not result in injury, but the gross disparity between the FDA’s data and that of just the state of Pennsylvania, leads one to seriously question the accuracy and value of the FDA’s numbers.
This concern is not limited to only armchair statisticians, either. Dr. Emanuel Kanal, FACR, Chair of the ACR’s MR Safety Committee, believes the FDA database represents less than 10% of MRI injury accidents based on anecdotal accounts and his own experiences, called as an expert witness for injury-related litigation. Dr. John Gosbee, a director with the VA’s National Center for Patient Safety, has compared the FDA’s data with that collected internally to the VA and believes that the FDA’s public record captures something closer to 1% of the number of actual events.
ECRI, a non-profit healthcare consulting group, conducted a small survey of MRI facilities. Fully 60% of those responding indicated that their facility had experienced a projectile accident. But because projectile accidents are not necessarily the product of a malfunction of an FDA approved MRI, the FDA is very ambiguous about whether these accidents are required to be reported.
So what is the upshot of underreporting of accidents in the MRI suite by one or two orders of magnitude? Patients, staff, clinicians and regulatory bodies are vastly underestimating the accident-risks in MRI suites. This leads many to shrug-off accident prevention tools, such as the ACR’s 4-zone principle, effective suite design and ferromagnetic detection as economically unjustifiable.
In other areas of our lives if the risks went up ten-fold we would make significant changes. What if there were ten times the current number of burglaries in your neighborhood? How about ten times the known number of assaults at your child’s school? These examples sound more like crime waves than simple miscalculations, don’t they? What if we’re really underestimating by a factor of 100 instead of 10, as Dr. Gosbee theorizes, how strongly would that impact our behavior?
Unfortunately, without accurate accident data in a public venue, individuals and facilities have little choice other than to trust in the information and opinion of experts in the field. The consensus of many experts seems to be that accident rates are rising and that increasing patient age and acuity, coupled with the increasing use of interventional MR imaging, are setting the stage for rapid growth in the rate of accidents.
Given the potential for significant revenue loss and enormous repair bills from MRI accidents, a very modest increase in the perceived level of risk and facility liability would justify significant patient safety improvements.
If you are looking for an assessment of your MRI facility’s safety risks and ways to minimize your liability exposure, please contact us.
You're reading the MRI Newsletter, which means you're plugged-in to the industry's leading source for information on MRI suite safety and design. Contact Robert Junk, AIA or Tobias Gilk for information on how we can help you develop your next MRI project.
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