New solutions, better training and regulation for reducing MR adverse events

September 12, 2022
by Lauren Dubinsky, Senior Reporter
Staffing shortages, an increase in imaging volume and a lack of standardization in training are just a few of the factors contributing to an increasingly dire predicament in the MR suite. HealthCare Business News checked in with some of the leading experts and vendors to find out why the situation is becoming so serious, and what can be done to improve safety and reduce adverse events at your facility.

“The thing that stands between those growing risks and a catastrophe is the vigilance of MR technologists,” said Tobias Gilk, a former chair of the American Board of Magnetic Resonance Safety (ABMRS). “As we put more and more strain on them and continue to ratchet up the risk factors, it's not a question of if, but of how terrible it will be when some horrific MR accident makes the news again.”

An accident in 2001 led to the death of a six-year-old boy whose skull was crushed after a metal oxygen tank was pulled into the MR bore. The cause of the tragedy was found to be a combination of communication failures and non-MR staff having access to the suite at Westchester Medical Center.

Although that was over 20 years ago, a look at FDA reports classified as “MR adverse events” shows that safety concerns are not in our rearview mirror. Gilk noted that accident rates have been growing at about two and a half to three times the rate of MR procedure volume since 2000.

“Fortunately, the number of MR accidents is still quite small, but if the growth in that is three times the growth in procedure volume, that is unsustainable,” said Gilk. “If we continue on the current course, we are going to wind up injuring and killing people in the United States with accidents that are completely avoidable, as almost all MR accidents and injuries are.”

Training is part of the answer
Only a handful of states have requirements for MR training and all that is needed is registered radiologic technologist RT(R) credentials. Gilk believes that one way to address the issues with MR safety is to rethink the model of how MR technologists are trained.

“We need a broader application of developing MR technologists who are purposely trained for working in MR and do it in a smarter way,” he added. “I think that we can bring those talented and competent MR techs to the employment market faster.”

Fortunately, the industry is making strides in this area. A company called ScanLabMR has developed a new method for MR training that leverages imaging simulation software to improve and assess clinical competence and scan quality.

In addition to the initial training, Brandon Taylor, director of MR safety at Metrasens, stressed the importance of ongoing education. MR technologists are constantly faced with new types of ferrous metals including magnetic eyelashes and metallic fibers in certain yoga pants.

“The complexities around strength of magnets and ferrous metals being introduced into the equation are ever-changing,” said Taylor. “Just even the social norms tied to our personal technologies — 20 years ago it was not common that everyone had a smart phone practically glued to their hand and a smart watch on their wrist.”

A 2019 case report published in the journal Radiology Case Reports described a 40-year-old patient who sustained second-degree burn injuries from wearing jogging pants during an MR exam. Prior to the exam, she was screened verbally, visually and with a metal detector wand to confirm that no ferrous material was present.

After the incident, the site imaged the pants on its own using high-resolution digital radiography and found no obvious metallic material. But when the staff contacted the clothing manufacturer, they discovered thin metal fibers might have been used to construct the vertical lines on the pants.

In recent years, clothing manufacturers have started to use metallic fibers in to prevent odor and bacteria, which will commonly be marketed as “anti-microbial” or “anti-bacterial.” To prevent future incidents, the authors of the report recommend that patients change into MR-compatible clothing.

According to the Joint Commission, over 70% of MR incidents are linked to thermal burns. Even certain kinds of face masks were recently found to have the potential to cause these burns when worn during MR exams.

In July, a research team at Cardiff University tested eight types of face masks and discovered that five of them contained magnetic components. The masks were found to have metal nose clips, metal staples to keep the ear straps in place and anti-microbial coating made of silver or copper.

It’s essential that MR staff is aware of these new types of threats, but they are not the only ones that need to be trained in MR safety. Keith Kopp, president of Kopp Development, thinks that personnel from other departments including code responders and ICU staff should know how to use ferromagnetic detectors (FMD).

“In our company, every time we are scheduling installation of our systems, we always ask to include all personnel who come in contact with MR department to participate in our product training,” he said.

Finding the right safety solutions for you
Whether it’s a stationary FMD mounted on the doorway or a hand-held scanner, having the right equipment for your facility can make or break your success. Gilk cautioned against purchasing a product from a catalog because individualized attention is important in this context.

“Deal with companies that provide training resources and materials about how to make the changes in a hospital's operational model to gain the greatest value,” he said. “The companies that sell products as if they're commodities are not the kind of partners that you want or need to get the greatest value out of a ferromagnetic detection system.”

Since every facility has unique needs and citing constraints, it’s important to assess the features and functions of each FMD on the market to find the right fit.

Kopp Development’s flagship capability is its FerrAlert FMD system’s ability to pinpoint the location of offending ferrous object. If a person with ferrous scissors in their right pocket walks through the HALO II PLUS system, it will notify staff with yellow or red lights.

If that is ignored and the person proceeds to enter the MR suite, the system will sound an audio alarm with flashing red lights at the exact height of the ferrous objects location. The location feature is especially important if the ferrous object is hidden or internal such as an implant.

Anna Srb, director of marketing and sales at the company, has received reports from customers who detected dental implants, ferromagnetic aorta clips and magnetic eyelashes when using the pre-screening FerrAlert SOLO system. She has noticed that when a customer cannot identify the object or location of it, they can become dismissive of the warning.

“When ferromagnetic detection systems do not show location of a potential ferromagnetic threat, it creates a state of confusion for the MR technologists and subsequently it also creates a distrust for ferromagnetic detection technology as a whole,” said Srb.

Some companies have developed FMDs that claim to be able to show the location of ferrous objects, but those products are still in their infant state. Srb came across their booths at a few recent trade shows and described these FMDs as not fully operational and unable to show the location of the detected ferrous objects.

Metrasens has two products, Assure and Screener, that comprise its Ferroguard Suite. Screener is for detecting small ferrous objects in Zone II and Assure is mounted to the wall outside the MR door in Zone III to detect large objects.

“An outswing shielded door has zero impact on the full function of the device, which allows us to be flexible regardless of environment,” said Taylor. “This allows for ease of adoption by staff and trust in the device.”

Assure features the company’s Smart Alarm technology that prevents alarms from sounding due to door movement and a person exiting the room. Findings from Metrasens’ Technology Center study found that this technology can reduce extraneous audible alerts by 85%.

Iradimed Corporation also puts a big emphasis on addressing alarm fatigue. The company’s new Trusense technology features highly sensitive sensors that only alert when ferrous threats are heading toward Zone IV doors.

“All ferromagnetic detectors do a good job at detecting moving ferrous metal, however, not all moving ferrous metal is a Zone IV threat and the constant alarming causes alarm fatigue,” said Kevin Jirka, marketing director at Iradimed.

When it comes to hand-held screening solutions, Aegys Group’s CEIA PD240CH family of FMDs is the only one capable of screening for all metal while simultaneously differentiating whether it’s ferrous or non-ferrous.

“This level of information is extremely important to MR technologists who are responsible for preventing not just projectile incidents and RF-induced heating injuries to patients, but also for image quality and artifact suppression,” said Joe Barwick, founder of Aegys.

The company also offers its TechGate Auto solution, which is a modular robotic arm that provides a physical protective barrier. Barwick explained that this approach is superior to plastic chains or a retractable belt because it automatically deploys when the MR suite door is open.

Barwick believes that since there are advantages and disadvantages to every safety solution, the optimal approach is to utilize multiple, complementary solutions. Each should work cohesively to mitigate the risk of major or catastrophic incidents.

“There is the Swiss Cheese model of accident analysis that typically equates major or catastrophic incidents to a series of breakdowns in the safety model, wherein the inherent weaknesses in each layered solution systematically line up like the holes in slices of Swiss cheese to allow the incident to occur,” he explained.

He added that hand-held screening devices are ideal for nonambulatory or nonresponsive patients and when locating metallic objects. Fixed FMDs in Zone III provide standardized screening functionality and can be located away from the MR entrance where there is adequate time and space to address the screening process.

To stress his point, he cited “To Err is Human: Building a Safer Health System” by the Institute of Medicine (U.S.) Committee on Quality of Health Care in America: “…the problem is not bad people in health care — it is that good people are working in bad systems that need to be made safer.”

What’s new?
In the last 12 months, the FMD companies have been hard at work making improvements to their existing products and developing revolutionary new ones.

Aegys made engineering updates to the TechGate Auto’s obstruction detection system. It mounted twin Keyence Class 2 Optical Lasers to the LED-lit barrier arm and incorporated functional algorithms that retract or engage the barrier arm only when the path is clear, and operate dynamically while the arm is in motion.

Metrasens’ research and development team has been working hard on a new product that will be unveiled at this year’s RSNA Conference and Expo in November. Although Taylor is not able to go into specifics ahead of the launch, he did divulge that it will “deliver on both performance as well as efficiency in managing projectile risks in the MR suite.”

Kopp Development introduced its most comprehensive safety solution, the FerrAlert Encompass Local Edition (LE). It can automatically log ferromagnetic entries, door openings, sensor alarm positions, and pause function as well as provide complete, verifiable data for JC inspections and American College of Radiology (ACR) compliance.

What’s more, it can conduct root cause analysis investigations and the reports can be shared throughout the hospital system. To Gilk, this is the most important feature of an FMD product.

“To my mind, the most important feature is the degree to which the site is willing and able to integrate the information that a ferromagnetic detection system provides into their workflow process,” he said. “There is no shortage of sites that talk about how the magnetic detector goes off all the time and they’ve just learned to tune it out.”

That information could be used to explain why the alarm is going off so frequently. It can serve as an information feedback loop to provide a quality control measure of how effective a site’s upstream screening processes are.

“Integrating the ferromagnetic detection system and the information that it provides in patient management and upstream screening is the secret sauce to the more effective deployment of ferromagnetic detection,” said Gilk.

We need safety regulations, and we need them now
Safety solutions can vary, but an area where standardization is needed is regulation. There is no shortage of regulation oversight for nuclear medicine, hot labs, fluoroscopy and ionizing radiation in general, yet MR has none of that when it comes to safety.

ACR has accreditation requirements but almost none speak to how people get injured in MR suites and what steps can be taken to prevent it.

“If you have a state license or an accreditation, whether it's Joint Commission or ACR or anybody else, don't assume that guarantees you're practicing safely,” warned Gilk. “Almost no specific preventions live in those accreditation requirements in any concrete of measurable way.”

Since ACR is both an accrediting organization and a professional society for radiology, they’re in a strange position. Maximizing safety may come at operational or financial cost to the owner of an imaging center, and if they are an ACR member that could spell trouble.

“They are beholden to their accreditation structure, but at the same time, they can't go too far as to alienate their professional membership,” said Gilk. “I think they've tried to thread that needle by publishing best practice guidance but have failed to directly incorporate that in their accreditation requirements.”

The Centers for Medicare and Medicaid Services (CMS) has the power to enforce a model set of standards, but may be unlikely to do so given the financial pressure that healthcare systems find themselves in. The culmination of hospital closures and effects of COVID forced radiology to take a back seat, but that may be starting to change.

“As we are emerging, at least, from the most acute problems with COVID, hopefully there will be a little more time, energy and resources devoted to radiology in general and MR in specific,” said Gilk. “We're going to have to see how that shakes out.”