A child, rushed to the ER following a serious roadside accident, was assessed by doctors who determined an MR scan was in order.

But as the child entered the MR environment, a ferromagnetic detector went off, alerting staff that the child was carrying a metal object of some type. Upon finding no object on the outside of the child’s body, the staff determined that the child must have an implant.

Sure enough, the patient had been implanted with a programmable shunt, a procedure that neither the physician nor the staff was aware of. And while the doctor pressed for the operation to still go ahead as planned, the MR technologist refused.

“The technologist knew the information and preventing the child from going into the MR exam certainly prevented potentially a very injurious situation for that child,” Colin Robertson, the senior vice president of sales and marketing at Metrasens, a manufacturer of ferromagnetic detectors, told HealthCare Business News.

The detector going off and the doctor and technologist communicating their views and coming to a decision on how to proceed are good examples of how MR safety is supposed to work.

Yet, according to experts, the rate of MR adverse events increased by 500 percent from 2000 to 2009, a rate troublingly disproportionate to the 114 percent increase in overall scan volume.

What is the cause of these safety issues that put patients in danger at the point of care? The reasons are up for debate, though experts can agree on one thing: the rise in adverse events in MR rooms is a consequence of people making poor decisions.

Burns, projectiles and implants
Two-thirds of MR adverse events, excluding the presence of pharmaceuticals, pertain to burns. Yet, experts like Tobias Gilk, the chairman of the American Board of MR Safety and an MR safety trainer, say that researchers in this field do not devote nearly enough attention to this issue.

“If you ask MR departmental staffers what they spend the most time on in MR safety efforts,” Gilk told HealthCare Business News, “it’s on implant and device safety which is tremendously important but if you contrast the amount of energy spent on implant and device safety, identifying what the implant is, trying to find the manufacturer information, trying to make sure that that manufacturer information actually works with your MR system, that just eats up hours and hours of productivity for MR providers on a regular basis. Burns typically receive a very small minority of time, energy and attention at the point of care.”

Robertson, with Metrasens, echoes Gilk’s assessment and says the same inattention is also directed at projectile incidents, the second-most common type of adverse event in the MR environment. Another issue that contributes to this inattention he clarifies is the fact that physicians mainly only focus on incidents that involve patients rather than all MR-related incidents in general.

“It is generally acknowledged in the community that only a very small proportion of projectile incidents are actually reported,” says Robertson. “If it is a patient injury, a patient adverse event, generally those things are reported.”

The lack of focus in these areas is rooted in the protocols and guidelines handed down from senior staffers to new generations, many of which focus on the use of medical equipment and the effects they can produce in MR environments rather than outlining the specific causes of adverse events and the degree of attention they each require.

Gilk believes the issue of implants should continue to be studied extensively, but not at the cost of other areas of MRs. He asserts that the best option is to research and identify the aspects of MR environments that are leading to adverse events and how we can use our resources to prevent them.



“There hasn't been a very effective, contemporary effort to ask, 'OK, how are we injuring patients? What are the mechanisms that we could deploy that could reduce or eliminate those types of injuries,’ " he says. “[Accident] prevention really needs to begin with an understanding of how these injuries occur in the first place and what the frequency and the severity of different injury types are that we can begin to weigh the risks and benefits of spending a finite amount of resources that a provider has.”

Safety at what cost?
In the last 10 to 15 years, MR has become a common tool for examining high-acuity patients. This places a bigger burden on insurance companies to cover MR exams more frequently and for more patients.

To offset the costs of these additional procedures, insurance companies have resorted to changing their policies to decrease the amount of reimbursement they deliver to providers in exchange for MR exams, straining providers and forcing them to take measures of their own to offset the burden.

These may include cutting the number of staffers that oversee MR exams or turning to less experienced doctors and workers who will accept lower salaries. These decisions limit the quality of supervision in both numbers and expertise.

The problem is only exacerbated by continuous advancements in MR systems with many displaying stronger magnetic fields and faster gradient systems. If not supervised or handled correctly, these devices have the potential to inflict serious harm to patients and staff.

"We're slowly whittling away at some of the patient safety protections,” says Gilk. “None of the whittling is nefarious, it's not set out to make MR more dangerous, but that's some of the unintended consequence of technological advancements, MR as an imaging resource and response to some of the financial realities of declining reimbursements."

These changes can cost providers hefty medical and legal fees and more importantly, diminish the overall quality and quantity of protection and safety measures for patients – putting them at greater risk.

A false sense of security
The burden of cost for MR exams and the need for experienced staff has at least prompted some positive changes in the last few years, with providers exploring new ways to protect patient safety.

“There’ve been accreditations that are now reviewing processes, facility processes,” says David Geiger, vice president of Americas sales at ETS-Lindgren. “I’ve seen construction standards that are requiring the use of some of the tools to help prevent injuries and incidents. Today, there are a lot of talks, meetings and training. There’s a lot more exposure for folks to understand what they need to do.”

The need to enhance safety in the MR environment has spurred the creation and growth of many organizations offering courses and certification on the subject, an opportunity that many providers are jumping on to ensure the safety status of their institutions.

Though a positive change, the development of certification has created another problem in MR safety with providers believing that certification guarantees safety, and that’s the end of it.

"Many facilities will walk away from the accreditation process believing that the presence of accreditation is a demonstration of the site’s safe practices,” says Gilk. “While that may be true in other areas, historically, that has not been true with respect to MR. So the hallmark of a site that makes me nervous is one that insists, ‘We have joint accreditation or ACR accreditation and therefore, we don't need to worry.”

Gilk asserts that by obtaining certification, providers become overconfident that their facilities are safe without taking into consideration the changing and complex nature of the MR environment, such as training new hires and the need to update safety measures routinely.

This problem is what inspired him to help form the American Board of MR Safety, which provides accreditation for radiologists, technologists and medical directors, and has a 71 percent aggregate pass rate, much higher compared to the pass rates of other boards and organizations, according to Gilk.

“Since we determined that nearly all MR accidents are decision-making-related, poor decisions at the point of care, it became clear to us that what was needed was an organization whose sole focus was on the piece of the puzzle that seemed to be missing from all other organizations,” he says.

According to ETS-Lindgren’s Geiger, the best possible way to counteract the gradual degradation of safety protocols is to have a standard plan in place for keeping track of equipment and patient safety and making necessary updates.

"Create a process and train your employees on that process. Every patient does the same thing. Every employee does the same thing," he says. "You follow your process to a tee and that eliminates any issues for incidents. I think facilities that really don't have a clear process for how patients and employees move in and out of that space [MR rooms] is probably the No. 1 issue."



The limits of FDA guidelines
Providers, though perhaps overconfident in the safety that certification ensures them, may also be overly-cautious in other aspects of MR safety.

Sometimes, providers will refuse to perform scans on people with implants due to a lack of labeled conditions that specify whether their implants are compatible with specific models of MR machines.

According to Gilk, while the intention is to prevent adverse events from taking place, a situation like this hinders the ability to treat patients and highlights the need for guidelines that empower and equip end users with knowledge to make better judgment calls on what is safe and what is not in their own MR rooms.

“We need to do a better job of educating radiologists, rad techs and MR techs to understand when they are faced with a set of conditions that do represent a specific risk and when, even where there are no labeled conditions from the manufacturer, a set of conditions don’t represent a significant risk,” he says.

The problem is complex and exacerbated by the current state of federal guidelines. For instance, providers are unable to contact manufacturers and ask if a specific MR model will correspond well with an implant as manufacturers under FDA rules are prohibited from communicating this information.

Implant manufacturers, meanwhile, are not required by any law to label if an implant is safe for MR procedures unless the device is specifically designed and marketed for that purpose. They also do not have to provide information on what field strengths their products can handle or go back and update their product labeling.

This effectively hinders the ability for FDA guidelines to significantly enhance MR safety while also preventing hospital personnel from making decisions that could help protect or treat patients.

Ferromagnetic detectors: a key piece of the puzzle
Adverse events, though a consequence of MR technology and human decisions, can be largely prevented through the right form of screening.

But even the issue of how to screen patients properly is up for debate, especially regarding the use of ferromagnetic detectors. One particular issue concerns location.

"Many facilities would like to have what they call the last task effort on the magnet room door,” says Keith Kopp, the president and founder of Kopp Development, a manufacturer of ferromagnetic detectors. “And the function of that is if something got missed, if staff comes in that didn't plan on coming into the magnet room and for some reason they have to go in, there's a last ditch scanning.”

But Gilk says detectors by the door can create major safety hazards, and that a more suitable option would be to place the device a few feet away.

“When you do that, you inherently create a number of potential problems,” he says. “One of them is you’re right at the door and so therefore, if the alarm goes off and someone is actually walking forward, they don’t have the opportunity to stop until they’re three to five feet inside the room which may be a little too late, depending on the size of the room and extent of the magnetic field of that MR scanner.”

Another issue involves the features of ferromagnetic detectors. Many detectors are equipped to spatially locate door hinges so they can ignore ferromagnetic signals that come from them. There is, however, a concern that a metal object at the exact height of the hinge, in perhaps a pants pocket, may be ignored as well because of this feature.

Many systems are designed to tackle these issues, being able to detect the presence of objects, even those at the level of door hinges as well as alerting people to a potential problem as they approach the detector from a few feet away.

“Our systems, the way they work, is that they provide you with what we call visual early warning,” says Metrasens’ Roberson. “As you approach the door, it’s like a traffic system. Lights change from green to red at your eye level to show you if you have something that detectors sense.”

Detectors are also now equipped with systems that record and log information of any adverse events that take place so that managers can assess and determine any changes in protocol to ensure safe practices are in place.

"The key of any of these, our product, and frankly, any product in the hospital, is that the hospital implemented policies and procedures to integrate the detector into their system,” says Kopp. “Part of our training is we always state that this is a tool, a tool that will help you lower your risk of a projectile incident. But it won't fix anything.”

Not on its own, anyway.

Ferromagnetic detectors can do a world of good for patient safety in the MR environment, but if facilities really want to cut down on adverse incidents, they need to evaluate the entire culture of the facility from the top down.