By Tobias Gilk, MArch, MRSO (MRSC™), MRSE (MRSC™)
Welcome to the “Year of MRI Safety!”
Wait… you haven’t heard of the ‘Year of MRI Safety’?
Well, I suppose that’s OK since this is the first year we’ve done it, but now that it’s ‘MRI Safety Week’ (July 27 – August 1) we can call your attention to both the ‘Week’ and the ‘Year’.
But that expression on your face suggests to me that you’ve not heard of ‘MRI Safety Week,’ either…
You do know about radiation safety efforts, right? We’re widely taught about the risks of ionizing radiation (from Godzilla, to Chernobyl, to Homer Simpson’s work). In healthcare settings, we steer a wide berth around ionizing radiation emitted during X-ray and CT exams, and we have multitudes of standards for shielding and device performance, and professional programs such as Image Gently (reducing diagnostic radiation exposure in children) and Image Wisely (reducing diagnostic radiation exposure in everyone else).
Our engrained fear of ionizing radiation has helped us internalize the ALARA (As Low As Reasonably Achievable) aims of dose reduction, and have helped to reduce diagnostic radiation exposures by roughly 20% in a decade. Some radiation exposures are now so low that some patient shielding efforts offer no benefits and are being phased out. Metaphorically, we’re dramatically shrinking the fearsome ionizing radiation “Godzilla” to a small garden lizard.
But back to MRI, and why some of the associated safety initiatives may not have previously appeared on your radar. Unlike X-rays or nuclear medicine radioisotopes, MRI uses non-ionizing radiation (magnetic fields), which don’t have the (very, very small) risks of cellular damage that may produce cancer decades later. This absence of ionizing radiation, coupled with some clever marketing, resulted in MRI being labeled “the safe option” when various imaging choices were being considered.
However, the absence of ionizing radiation doesn’t mean the absence of risk. The “there is no ionizing radiation so therefore MRI is safe” follows a logical path similar to “driving cars can be dangerous so therefore skydiving (which doesn’t involve cars) is safe.” The marketing slogan of “the safe option” never fully considered that there might be different risks that were peculiar to this new modality… risks we should be aware of.
The fact of MRI’s peculiar risks was made painfully clear twenty years ago this year, in July of 2001, when a six-year old boy, Michael Colombini, died when a steel oxygen tank was brought into the MRI scanner room where young Michael was positioned to receive an MRI scan. The public nature of that accident set the radiology world on a course to better identify and communicate the risks associated with MRI, which include many other magnetic projectiles, but also MRI heating / burns, and conflicts with life-sustaining medical implants or devices.
While the radiology professional societies sat up and took notice, clinical practice has been patchy, at best, and regulation and accreditation (despite slogans of ‘quality and safety’) have largely failed to contain growing rates of MRI accidents. In the twenty years since the Colombini accident, MRI adverse events to the US FDA (reported under product code “LNH” and shown in red in the graph below) have grown at more than twice the rate of growth in MRI exams (shown in blue in the graph below).
Said plainly, in the US we’re injuring greater numbers and proportion of MRI patients today than we were in 2001 when the Colombini accident happened (and this data largely excludes negative MRI interactions with pacemakers, or medication pumps, or other medical devices, which are typically classified under the other medical device’s code… not MRI’s).
The above data, and the concerning trend-line it reveals, incites doubt -and sometimes hostility- from members of the radiology community. Partly this doubt arises from the growth in knowledge of MRI safety that has occurred over the past 20 years and the development of best-practice standards. ‘If we know better,’ the thinking goes, ‘surely we must be doing better.’ But this aphorism assumes that MRI risks have remained static. They haven’t.
MRI scanners today use stronger magnetic fields, more powerful gradient systems, and more radiofrequency energy than they did twenty years ago. MRI patients are larger, sometimes much more acute, with greater co-morbidities, and a much broader array of implants or medical devices accompanying / in them. And in this same time, insurance reimbursement rates for providers offering MRI exams have plummeted, forcing continuous ‘do more with less’ guidance for actually running MRI practices.
Yes, we do know more about MRI safety, but the changes arising from that new knowledge have been slower than the changes that increase the risks to MRI patients. We are getting better, but not fast enough.
Another reason people may be prone to cast doubt on the reality of growing MRI accidents is the fact that radiology is (in many areas) very closely regulated. Looking at the depth and breadth of radiation regulation to which healthcare providers are subject, it would be reasonable to assume that MRI was effectively rolled in there.
The overwhelming majority of rules regarding the safety of radiology services are geared towards ionizing radiation. Even regulation has been bamboozled by ‘the safe option’ PR campaign that makes MRI seem perfectly harmless. While there are extensive (and well observed) rules for MRI machines and their safety, the safety regulations for administering an MRI exam at a hospital or outpatient imaging center are almost nonexistent.
The FDA doesn’t have legal purview over the safety of the administration of an MRI exam. Most state licensure (both for hospitals and for the technologists who operate MRI scanners) falls prey to the “nonionizing = no risk” fallacy and require almost no mandatory MRI safety practices. Some accreditation programs have begun to scratch the surface, but only one of the major accrediting bodies has any explicit requirements for MRI safety training, and then only for the operator of the system (not for anyone else who works in the area or may have patient care responsibilities in MRI).
So what is a person concerned with patient safety supposed to do with this information? How do we ‘bend the curve’ of MRI accidents and make it safer and make it live up to its own PR slogan?
For the time being, we can’t depend on external controls. If we thought that the FDA, or state licensure, or enterprise / modality accreditation would help guarantee MRI safety for our patients or staff, we need to disabuse ourselves of that illusion. There is nobody out there who will be riding in to save us… not any time soon. It’s up to us.
Provide Advanced MRI Safety Training: It’s a bit of a ‘chicken-and-the-egg’ dilemma, but the absence of MRI safety regulation / standards has created an environment where MRI technologists and radiologists often start their jobs without formal MRI safety training, and may find themselves ill-prepared to appropriately address questions and concerns that are frequent parts of contemporary MRI patient care. It’s a frightening realization that some of the people being counted on to make these decisions have woefully inadequate training. Send your senior MRI techs, and MRI-oriented radiologists to get advanced MRI safety training. Having your key MRI safety people trained may help you identify better, faster, safer ways to provide MRI services.
Appoint MR Safety Officer, MR Medical Director, and MR Safety Expert: And speaking of ‘key MRI safety people,’ take the opportunity to officially designate individuals into roles of MRI safety responsibility and authority. You wouldn’t open a hot lab without a radiation safety officer (you wouldn’t be allowed to), so why doesn’t your site have an MR Safety Officer (MRSO)? So much of MRI safety pertains to clinical decision making, so have a designated chief MRI clinical decision maker, or MR Medical Director (MRMD). And as MRI safety situations get more and more complex, your site may very well want to lean on an MRI physicist to help move from pages of implant details and MRI system technical data sheets to clear and concise decisions about patient care… an MR Safety Expert (MRSE). Your site should have formally designated one of each of these.
Review P&Ps Against Contemporary Best Practices: With advanced MRI safety training and an org-chart that provides responsibility and authority for MRI safety for patients and staff, the next step is to make sure that your operational policies and procedures (P&Ps) harmonize with best practices, and that safety practices are clearly and effectively communicated from the most senior radiologist to the ‘travel tech’ providing weekend MRI scanning coverage for the next two months.
MRI accidents and injuries -even with the alarming growth- still represent a very small number of the total number of tens-of-millions of annual MRI exams… that’s part of the good news. The other point of the good news is that existing best practices, were they required and followed, would prevent almost all of the accidents that do occur. Yet we’re still at an important inflection point in MRI safety…
The growth in MRI adverse events, relative to number of exams, continues. If left unchecked, sooner or later we will see other high-profile MRI accidents and injuries, even fatalities, splashed across 24-hour news coverage. Today we healthcare providers and patient safety advocates have the opportunity to bend this accident growth curve, both by making meaningful changes at our own hospitals and imaging centers, and by asking more of the regulatory and accreditation bodies who we count on in so many other areas of healthcare.
Welcome to the “Year of MRI Safety.”