Q&A: MRI accidents are rare, preventable—but safety standardization and certification are key

HI: Can you give us a little background on your work in MRI safety? What led you to focus on this for a large part of your career? 

Kanal: My background in medical school—as well as training in surgery then subsequently internal medicine and then radiology—has always focused on patient and healthcare practitioner safety issues. When MRI was released as a clinical tool in the mid-1980’s, I naturally focused not only on its imaging physics but also its risks and safety issues, that are singularly unique to this diagnostic imaging modality. I was therefore already quite active in the field of MR safety for 15 years when, in 2001, a 6-year-old boy named Michael Colombini was killed by a ferrous oxygen tank brought into an MRI scan room. The American College of Radiology asked me to head a Blue Ribbon panel on MR safety, with the two stated objectives of a) investigating what kind of safety incidents were occurring in MR centers throughout the world and performing root cause analyses to determine why they were happening; and b) determining what steps we might collectively undertake to decrease the incidence of these MRI-related adverse events.

In its research this Blue Ribbon panel—the precursor of the ACR MR Safety Committee—found that almost 95% of MR-related adverse events could be prevented by focusing on two objectives: 1) Better site access restriction; and 2) ensuring adequate MR safety education on the part of the MR practitioners—namely, the MR technologists and radiologists.

We published a white paper on MR safety, whose numerous updates became the ACR Guidance Documents for Safe MR Practices. These were initially issued in 2002 and then updated in 2004, 2007, 2013 and 2019. In 2020 these were re-written from the ground up as the ACR MR Safety Manual. Throughout each iteration of that document, those same two major objectives—adequate site access restriction and MR safety education for all MR practitioners—have remained the underlying bedrock for all MR safety recommendations.

MRI safety incidents earn a lot of attention, but I’m sure they’re rare. Is that true, if you address those two concerns, you could eliminate practically all accidents?

If we want to stop these injuries from happening, we need better site access restriction and better MR safety education of the practitioners of MR. If someone is injured in and from an MR scanner or in the MR environment, it is virtually always 'our’ fault—pilot error—and it is almost always an injury that could have been avoided and did not have to happen.

It's just like an operating room, where OR personnel oversee safety and site access. If anyone tries to enter the operating suite when not appropriately attired or prepared, we all recognize that they will be stopped by the OR nurses and personnel at the front desk. Nobody just walks into an OR; strict site access restriction is always maintained. Unfortunately, many MR safety incidents, accidents, and injuries occur because of precisely that, someone simply entering—unmonitored and unchallenged—the MR environments and areas where the invisible, yet potentially harmful and very strong, MR-related energies are found.

Until the entire industry adopts the attitude that this is a controlled space—just like an operating room—MR safety incidents and accidents and injuries will continue to occur. Indeed, the MR environment should actually be more carefully controlled than an operating room. In the OR environment the predominant concern is infectious disease control, where a patient may or may not become infected if adequate site access restriction and safety education is not mandated. In an MR environment, it is almost guaranteed that incidents and accidents and injuries will occur—including some that can be literally life and limb threatening if adequate site access restriction is not maintained at all times.

Can I give you a couple examples of incidents that earned a lot of attention? One was a prisoner with a metal shackle around her waist—it seems like common sense that would be a problem with a big magnet in the room. Is this still an education issue?

Such an MR-related injury can only transpire if either a) the site did not know that this was a potential problem and that they would need to prospectively screen for such metallic objects prior to permitting the individual access to the MR environment; or b) they were aware of the potential danger, but did not perform either an adequate screen or adequate site access restriction. Option “a” today is exceedingly unlikely: Everyone recognizes that large pieces of metal shackles can pose a serious physical injury threat if brought near the powerful magnetic fields of a typical clinical MRI scanner/magnet. Therefore, as is almost always the case, option "b"—or failure of adequate site access restriction—is far more likely to have been the proximate cause of such an injury.

Other examples are patients being shot with their own guns they somehow get into the MRI machine. Is this all an access restriction issue?

Yes, it’s again one of those two things: Either the person carrying the gun was not adequately restricted from entering the site or the site MR personnel were not aware that the gun posed a safety issue in the MR environment—and they let him or her bring it into the MR room or suite. Once again, we would be hard pressed to find anyone at any MRI site who would not prospectively recognize that guns pose serious safety risks if brought near the powerful magnetic fields of typical MRI scanners. Once again, this brings us to the overwhelmingly likely mechanism of this injury: Another example of a failure of maintaining adequate site access restriction.

One thing we noticed is that, in some cases, regulators appear to virtually ignore safety incidents—or at least, there isn’t much of an investigation into their cause. Is this an issue that licensing and more oversight could solve? 

Interesting question. Are you asking me to speak to the regulation? 

Yeah, exactly. 

Certainly the companies who make MR scanners are regulated as to how their machines operate, how much energy their machines can transmit per unit time, etc. But, there is almost no regulatory oversight of the individuals who operate the MR scanners themselves—namely, the MR technologists and the radiologists who oversee the safe execution of this medical imaging procedure known as MRI.

What do the regulations or laws of our country—or its states—today say about the MR safety education for these MR practitioners? What knowledge or curriculum must those who oversee MR imaging studies have? What certification is required of today’s MR safety practitioners before they are permitted to either operate MRI scanners, or serve as physicians or radiologists who oversee those who operate MRI scanners? Essentially, none.

There are multiple states that do not require a radiologic technologist certification to operate an MR scanner. The MR site owner—or owners—may be charged with overseeing safety in that environment, but there are no regulations, per se, regarding such critical issues as a defined MR safety curriculum, MR safety certification, or demonstrated-minimum, documented training. There are merely voluntary guidance documents issued by societies, such as those of the ACR. There is no shortage of MR safety texts and articles—I have authored several of these myself—but there are no mandates or actual requirements that MR operators demonstrate—or document minimal competency—in MR safety practices, nor regulation that requires any type of formal, objective, standardized certification regarding MR safety education.

A long time ago, the Secretary of Health and Human Services was Tommy Thompon. At roughly the time frame when Michael Colombini was struck and killed by an oxygen tank in an MR scanner, I asked him what his feelings and opinions were regarding some level of regulatory oversight for MRI environments—similar to that which exists for sites using ionizing radiation on humans. Paraphrasing, his response essentially was, "if you keep your own house in order, there's no need for regulatory oversight. But if these types of tragedies continue to recur, we're going to step in and regulate you."

X-rays and nuclear medicine—and all diagnostic tests that utilize ionizing radiation on humans—have regulatory oversight in the U.S. Why? When human tissues are exposed to X-rays, serious patient injury, and even death, can result. Yet, X-rays are a type of energy that is silent, undetectable and invisible. One may not even detect that they are being accidentally exposed to life threatening X-ray irradiation until it is too late. Society has therefore decided that their usage should be regulated to help protect both patients who might be exposed to such energies, as well as healthcare practitioners working with such dangerous energy sources.

The MRI process uses not one, but three different and powerful energy sources. Each one has the potential to cause harm to humans—and in some rare cases, even serious injury and death. These energies are also generally invisible and undetectable to the one who is being exposed to them. Yet, there is no regulatory oversight for the practitioners operating these MR scanners.

If you want to use X-rays on humans in the United States, you must be able to document that you had formal training in the safe utilization of ionizing radiation. You can even pass tests and become certified by the American Board of Radiology. There is no equivalent safety education—or training—in MR imaging today, except for the voluntary certification pathway through the American Board of MR Safety.

Does the responsibility then fall on patients and consumers to investigate who they’re seeking care from?

Most patients may not even know if their primary care doctor is board certified. And the fact is, an MD who is licensed to practice medicine and surgery in that state can absolutely—100%—operate an MR scanner, and either perform MR imaging or oversee the safe execution of an MRI examination on patients, regardless of prior MR safety training, education, experience—or complete lack thereof.

And on top of that, it seems like a lot of these facilities may have a doctor “running” the facility on paper, but they’re often owned by investment firms with no knowledge of patient care. 

Correct. Many MR scanners and imaging centers are owned by corporate or business entities, investors, and the like. As I stated numerous times before, there is no requirement to demonstrate that one has been educated in—or passed any tests in, or was certified in—the safety of the operation of the MR scanners in that institution or site. They do not have to satisfy any requirements that demonstrate their understanding of the safety issues related to MR environments.

However, it is important to bring up the following—and I believe that this may surprise you: I believe that one of the main reasons that MR safety formal education and certification are not required today is because MRI is generally so very safe. Why do they regulate ionizing radiation? Because every single exposure carries de facto—a very small, but definite, finite, real—risk of causing cancer. Once we understood that, it was regulated. When it comes to magnetic resonance imaging, one may hear people discussing how dangerous it is and how many people are injured from this modality, but it is actually the exact opposite that is true. All statistics document how rare it is for there to be an injury in MRI environments. MR is impressively safe, and injuries in MR environments only rarely—or even very rarely—occur.

In my opinion, one of the major contributors to the present unregulated nature of this modality is indeed just that—injuries so rarely occur. But if that is the case, then indeed why are we focusing so much attention on MR safety? Because—in the unlikely and rare incidence in which a patient or healthcare worker MR-related injury does occur—the chances are overwhelming that it was entirely preventable. Further, these very rare events can be minor—or they may be life or limb threatening, and especially when they are serious or severe in nature, you can bet they will find their way to the evening news and eventually become widely publicized.

They earn media attention because they’re shocking and seem like stupid mistakes, is that what you mean? They tend to make headlines. 

Exactly, they tend to make the news because, what makes them stand out is, they're so very often the result of human error—nearly 100% of MR safety related injuries and accidents are preventable. Very few other types of medical accidents are 95% preventable.

If a patient has an allergic reaction to a drug, it may well be litigated. However, if it can be shown that the physician followed appropriate care guidelines in prescribing that drug and made the right diagnostic and therapeutic decisions—even though patient injury may have resulted—it is overwhelmingly likely that they will establish that medical malpractice did not transpire. However when it comes to MRI-related accidents and injuries, almost all are attributable to human errors—errors on the part of those who were supposed to be overseeing the safe execution of that MR imaging examination. And virtually all of these injuries could have been prevented had the healthcare practitioner taken some clear and simple preventive steps.

As with anything involving human error, you will never prevent every safety incident, accident—or even injury—from happening. But, you most definitely can seriously reduce their frequency with education and adequate site access restriction.

So, in your opinion, are certification and education the only solutions to reducing that element of human error?

In my opinion, certification and standardization are key. When I spoke to Tommy Thompson, I was very much pushing for us to regulate ourselves. Now, after decades of experiencing how our society has managed safety in MR environments, I have changed my opinion. Today I believe that some level of regulatory oversight would be helpful and appropriate in order for our society to improve our MR safety statistics.

The MR safety curriculum that I created is an attempt to provide some level of standardization for MR safety education internationally, and I have taught that curriculum to over 7,500 MR safety professionals worldwide who have attended my multi-day MR safety courses since 2014. Today that same curriculum serves as the basis for virtually all MR safety lectures, courses and texts, helping us achieve some level of educational standardization of an MR safety curriculum internationally.

In addition, I am a strong proponent for certification. In 2015 I founded the American Board of MR Safety for that very purpose. It serves as an objective third party, charged with creating and administering examinations, certifying that the examinees have successfully demonstrated at least minimal levels of knowledge, understanding, competency and proficiency in MR safety issues. In creating the American Board of MR Safety I invited an international panel of MR safety experts, physicists and physicians to generate hundreds and hundreds of test questions, covering the various topics in MR safety and the numerous energies used in the MRI process.

Today, thousands have taken the American Board of MR Safety examinations and have been certified for the positions of MR Medical Director, MR Safety Officer and/or MR Safety Expert. These three positions were codified in a consensus document published in the peer-reviewed publication the Journal of Magnetic Resonance Imaging in 2016. This consensus document basically said that, if one is going to perform magnetic resonance on humans—whether in clinical or research settings—there should be oversight by these three positions: an MR medical director, an MR safety officer and an MR safety expert. This consensus document was unanimously authored by eight medical societies, and it defines what those positions are and what their responsibilities are in MR environments.

I am the co-author of that document as well. This is my attempt to both standardize our approach to safety in the MRI environment, as well as to certify MR safety practitioners. Since anyone can simply claim to be an MR "safety officer," such certification from an objective board of internationally recognized experts in the field helps document that at least minimal levels of MR safety knowledge and proficiency were demonstrated by the one who is certified by the American Board of MR Safety.

Although it is called the American Board of MR Safety, it is fully active internationally at this point and its examinations have been administered at multiple international venues. Further, more than a third of its board members are non-US based.

And as of now, this is still entirely voluntary?

Today, such certification by the American Board of MR Safety is entirely voluntary, and we want to encourage such certification. For example, one can certainly be treated by a physician who is not certified by the American Board of Medicine—or Surgery, or Pediatrics, or Radiology—and one may legally practice medicine and/or surgery without having ever been board certified. But, many insist on such board certification for themselves or—for some hospital systems—their employees, and many knowledgeable patients insist on such certification for the physicians that will be treating them.

It is this same model that we followed in creating the American Board of MR Safety, to certify those who voluntarily wish to become that much more knowledgeable and capable about safety in MR environments as they oversee the safe execution of MRI examinations on their patients.