With a few simple steps, the MRI environment can be free of danger.
Magnetic resonance imaging (MRI) has become a popular, effective, and robust diagnostic tool for many medical specialties. Indeed, it is uncommon for patients not to undergo this type of imaging at some point in their lives.
However, the increase in the number of MRI machines and the number of studies has come at a price. Patient safety continues to be an issue that causes clinicians, administrators, and technologists a certain amount of headaches.
Clinical screening has been at the forefront of MRI safety for the last 20 years or so, according to Tobias Gilk, president and director of MRI safety for Mednovus Inc. Most of this attention has been aimed at patients with medical implants, such as pacemakers, followed by operational safety. “A distant third has been the way we design and build safe MRI suites,” he said. “We really need to be looking at the issue of MRI safety holistically.”
In short, one way to make the MRI suite a safe zone in the hospital or imaging center is to build it correctly in the first place.
Building It Right
According to Gilk, many times he and his colleagues are called to help an organization develop a safe environment after the fact. “Our preference is to come in at the beginning of the project,” he said. “Unfortunately, more often than not we are called in retrospectively after there are technical or personnel problems associated with the machine.”
Being involved from the beginning is crucial for a number of reasons. First among them is the fact that—in Gilk’s opinion—”over the last several years, safety for the MRI modality has been getting worse.”
There are a number of reasons for this. The first is that the magnets are getting stronger and the magnetic fields are getting more tightly compressed, meaning that this strength is felt less gradually than with older magnet systems. The increasing use of MRI on sicker patients also causes safety issues. “About 15 to 20 years ago, MRI was used only to image the knees and heads of generally healthy patients,” Gilk said. “Today, it’s being used increasingly for stroke assessment and more emergent conditions. Many of these patients have more comorbidities, which need more care. Hospitals and imaging centers are also doing more exams overall. Both of these factors introduce more dangers. And these factors are not going to plateau anytime soon.”
Finally, with the increasing use of MR, Gilk notes that this has put huge stresses on training and accreditation of technologists. “A lot of machines are being used by nontrained and poorly trained people.”
But these factors are really only the most visible part of the problem. Economics play a role as well. According to Gilk, many facilities work very hard to get the full value of their investment, and, to that end, attempt to shave money off the final price tag for the new suite. With hospital space currently retailing at $350 per square foot, this price could quickly enter the $400,000 or more range.
However, facility planning has to be viewed as a long-term investment with cost-cutting measures weighed against the lifetime use of the physical facility. Hospital and radiology administrators have to look at their next step as they’re making their first one. This means that the administrators, clinicians, and technologists involved in the planning have to ask and answer a few important questions. “What were our needs 18 months ago, what are they today and beyond when this technology reaches obsolescence? What is the consequence of what we’re doing today?” Gilk said. “If the next step is a 3 Tesla machine—and you haven’t planned for that—then that $400,000 will have to be thrown away. We work with our clients to plan their immediate investment and their next step.”
And sometimes this investment can be compromised with the best of intentions. “[If I’m coming in after the fact,] I can usually tell the MRI vendor the hospital is using by the floor plan that is being used,” Gilk said. “A lot of times the hospital or imaging center will just copy and paste the floor plan offered by the vendor. There’s nothing fundamentally wrong with that, but when that happens nobody is taking into account the interventional nature of breast biopsies, lighting, space, blood and fluid issues—the latter require that there be a sink in the room. Copying and pasting without being informed will handcuff the facility. You may save a little money in the short term, but you can’t do what you want to do in 7 years or more.”
Facility planning has more to do with maximizing investment. One primary purpose is to make MRI suites safe for patients and staff. And while incidents continue to occur, according to Gilk, 99% of them can be avoided.
Among the facility-planning steps that can be taken to limit the possibility of mistakes is: the use of ferro-magnetic detectors as patients, medical staff, and administrative and support staff enter the room; improve the ability of technologists to see what is going on in the room; and—if the suite has direct access to a hallway—have effective locks in place to limit access.
While the facility can be designed to avoid most problems, it is still up to the clinicians and technologists to make sure that the room is used safely.
According to Emanuel Kanal, MD, FACR, FISMRM, AANG, director, Magnetic Resonance Services, professor of Radiology and Neuroradiology, Department of Radiology, University of Pittsburgh Medical Center (UPMC), safe access restrictions is one of the keys to dropping the number of MRI incidents. The other is education. “Access restrictions and education will both help us get to near zero incidents. But we’re not there, yet,” he said.
Kanal is one of the key authors of the American College of Radiology’s “Guidance Document for Safe MR Practices.” He also is a member of the speakers bureau and provides research support for Bracco Diagnostics and GE Healthcare, and provides research support for Berlex and Medtronic. Gilk was among the other co-authors of the document.
Among the document’s recommendations are that sites establish, implement, and maintain current MR safety policies and procedures. These policies and procedures should be updated regularly. The document also details how zoning and site restriction should be implemented.
While these are the recommendations, William H. Faulkner, RT (R), (MR), (CT), FSMRT, director of education, Chattanooga Imaging, Chattanooga, Tenn, notes that most sites do not have a well-defined safety program in place. “What we have to contend with is that the people who work with MR and who we’re reporting to often don’t have a clue [about the safety issues involved],” he said. “If you look at some of the accidents, you will find that the suite is not well planned; there is not an adequate focus on training; and because you can’t see, smell, or taste the magnetic waves—most people are oblivious to them.”
The lack of adequate training is a big problem for Faulkner. In his experience, he has seen training consist of students observing in the MR suite 2 days per week for a month and then taking a 4-day class. “And they end up having no clue what they’re doing,” he said. “No radiology manager is going to pull a technologist out of x-ray and have them read a book about how do an ultrasound and [expect them to be able to do the study]. I think [they do it with MR] because, when you watch a scan, it appears to be very easy. It’s automated. It’s very simple to do. But I can’t imagine why they would expose themselves to the liability issues with a poorly trained technologist.”
Although Kanal says that, overall, there are likely fewer injuries than in earlier years, injuries do still occur. “The number of incidents is very low, and virtually every time it’s a result of human error,” he said.
When incidents do occur, Kanal performs a methods analysis of what led to it, when possible. He has found that the culprit is not always caused by ferro-magnetic devices. Radiofrequency burns/thermal injuries and acoustic noise are also responsible for some injuries. Like Faulkner, Kanal has found that the problem is often not carelessness, but lack of knowledge. “In retrospect, I’ve been surprised that the level of knowledge of the personnel involved was not as high as I would have expected.”
Faulkner also pins the problem on systemic issues, shortchanging safety for higher throughput or simply because it appears to be onerous. “We talk about not having blanket policies, but people don’t want to be bothered by implementing them,” Faulkner said. “If you try to shortcut safety policies and procedures, it’s not a good idea.”
For instance, Faulkner points to one of the most common and, he suspects, underreported injuries—patient burns from the RF coil as a result of shortchanging safety procedures. According to him, many of these injuries occur when patients who are obviously too large for the bore are placed in the machine without protective covering. He notes that the typical nervous, sweaty patient is the perfect conductor for thermal energy. “In this case, the facility can get out its checkbook—it’s indefensible,” he said.
Injuries are not only a result of poor facility planning or lax safety procedures. In some cases, they are caused—unknowingly—by the patients themselves.
Getting to the Heart of the Matter
In Faulkner’s mind, a patient does not have to be ignorant about safety issues involved with MRI simply because they do not have a medical degree. For instance, few patients realize that the magnetic field is always activated. “It’s a logical assumption by the layperson that you would turn off the magnet when the machine is not in use,” he said. “We should educate the layperson about the MRI.”
And because of this lack of knowledge on the part of the patient—whose firsthand knowledge about MRI may be what they saw on the television show House—it can cause them not to realize that they may be putting themselves in danger by agreeing to have an MRI study.
This is because an increasing number of patients have medical devices that have ferro-magnetic components. Ignorance may keep a patient from revealing that they have breast implants, a pacemaker, or an IUD that may contain ferro-magnetic components, but lax safety protocols may contribute to a technologist not uncovering this fact.
According to Frank G. Shellock, PhD, adjunct clinical professor of Radiology and Medicine, Keck School of Medicine, University of Southern California; the Institute for Magnetic Resonance Safety, Education, and Research; and author of the Reference Manual for Magnetic Resonance Safety, Implants, and Devices, events related to implants and devices are mostly caused by an inconsistency in screening patients. “There’s a huge discrepancy in screening procedures [from facility to facility],” he said. “It’s not a requirement, and it’s not standardized.” He added that, though the ACR guidelines on MRI safety are useful, they do not provide comprehensive information for MRI screening procedures.
Shellock has seen the problem firsthand. He recently visited a facility where the screening questionnaire had only four to five questions, which he saw as completely inadequate. And as MRI use has increased, so has the use of medical implants and those that have undergone MRI testing. When MRI was first introduced to the medical marketplace, only 200 implants had been tested. Now, the number of devices is well over 1,800, not counting prototypes.
Like Faulkner and Kanal, Shellock blames the danger posed by implants on misunderstandings and misinformation as well as a lack of training or experience. “It’s obvious that there is not enough emphasis on training,” Shellock said.
And the problem is not just ferro-magnetic devices. Certain non-ferro-magnetic devices can heat up and cause burns on the inside of a patient’s body. Claustrophobia, more properly classed as “medical test anxiety” by Shellock, is another problem that needs to be addressed.
All of these are sources of potential injury of which the radiologist and technologist need to be aware.
Screening procedures need to be thorough and conducted each time that a patient comes to have a scan done. Faulkner notes a case in which a patient was screened on a Wednesday and came back for a follow-up scan on the next Monday. The technologist screened the patient, but did not do another interview with the patient, who had a pacemaker implanted in the interim.
While there are dangers associated with the increased use of MRI, the problems are easily solved.
Faulkner notes that there are numerous ways to improve MRI safety. Many of the answers exist already in the form of books, papers, and Web sites. But, fundamentally, it is necessary to implement safety training programs and continually update them.
Shellock agrees with Faulkner. “Are MRI accidents unavoidable? That’s not necessarily the case,” he said. “Most accidents are the result of human error. The machine itself is probably the safest instrument out there. If you have proper policies and procedures in place and standardize them, you’ll have a near perfect result.”
He also recommends that patients and nonmedical staff be fully apprised of the safety issues involved with MRI, including having videos available in both English and Spanish. “You should be as proactive as possible,” he said.
Faulkner also cautions facilities that are too focused on the bottom line to refocus on patient safety. “You can have a good business and make money, but at the same time, you have to realize that there are people you can’t scan because it isn’t safe,” he said.
C.A. Wolski is a contributing writer for Medical Imaging. For more information, contact .