This year, Geoff West, president and chief medical physicist at West Physics Consulting, noticed that several clients were calling in with requests for guidance on MRI safety. The Atlanta, Ga.-based company provides advanced imaging testing services and consulting to hospitals and imaging facilities, but they didn’t have a third party assessment and training service for MRI safety in place that could fulfill recommendations from the various U.S. regulatory and accrediting bodies. In fact, they found that no other company offered this service to MRI facilities. So after some careful planning, West Physics launched a multi-element MRI safety service in July.

“Most of the services we introduce are based on demand,” says West.

In essence, the report that West Physics generates is something facilities can hand inspectors to show that they have policies and procedures in place for MRI safety. As West points out, MRI safety has been getting more attention from regulators and accrediting bodies. For one, he says, the American College of Radiology will begin performing unannounced site surveys under the Medicare Improvements for Patients and Providers Act, checking if a facility is compliant with accreditation criteria, which includes safety for MRI and CT programs. In addition to the ACR, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the Joint Commission have all shown interest in stepping up efforts to ensure MRI safety. And at the state level, there are even more tangible signs of change.

The Wild West
While West Physics’ new MRI safety service is a step in the right direction, the fact that educational courses for safety exist in the first place highlights a missing component for what should have been a top priority for MRI environments all along.

“From a regulatory standpoint, MRI is the Wild West,” says Tobias Gilk, president and MRI safety director at Mednovus, Inc. and senior vice president of RADPlanning. “You would be hard-pressed to find a single regulatory requirement for physical safety in the MRI environment. They don’t exist on the federal level, they exist somewhat at the state level, and they hardly exist from accrediting bodies, even the ones who publish MRI best practice safety data.”

But there may be some valid reasons for the lapse in oversight. MRI safety expert Dr. Emanuel Kanal, director of magnetic resonance services and professor of radiology and neuroradiology at the University of Pittsburgh Medical Center, explains that the infrequency of accidents probably plays a part.

“MRI accidents are not common, and there are few injuries, which is a good thing. But these accidents and incidents are unnecessary and entirely avoidable. If they would be more common, then at least someone would step in and say this is unacceptable,” he says.

The increasing number of MRI procedures should also be taken into consideration. “In the U.S., we’re doing 30 million MRI exams on an annual basis. If your denominator is 30 million it doesn’t take a big numerator to wind up producing a lot of injuries,” says Gilk. In addition, magnet strength, gradient power and radio frequency transmissions in the machines have increased as a result of improvements in MRI technology, but those improvements could make the rare injury more serious.


According to data from MedWatch, the FDA safety information and adverse event reporting program, the number of complaints about MRI burns, thermal discomfort or direct thermal injury have skyrocketed since 1992. This was the same year the first sequences that increased power deposition in the machines were approved.

Gilk and Kanal reviewed two years’ worth of MRI accident data from the FDA and found that the majority of MRI accident fit into three categories: Burns, projectiles and hearing damage.

“I was surprised that these three accident types comprised more than 90 percent of all reported accidents and that these are almost universally preventable through existing best practice standards,” says Gilk.

Kanal, who was the chair of the ACR MR Safety Committee from 2001 through 2012, has performed dozens of MR site safety reviews. “Usually I am called in after the horse is already out of the barn”, he says. “Once the incident has already transpired, the powers that be call me in to review their MR safety and suggest guidance for future improvements. Only a few have the foresight to recognize how much more practical— and in the long run far less expensive—it is to call me in before a serious adverse event transpires, when it can be anticipated, avoided, and designed or defended against.”

Examples of recent accidents include: an infant receiving a burn so severe that she ultimately lost an arm; scissors flying out of a responding assistant’s pocket and getting embedded in the technologist’s head; and burns inside a patient’s brain that resulted in a comatose state.

While severe, those accidents weren’t fatal. But fatalities, while very uncommon, do occur. Perhaps the best known MRI tragedy is the death of 6-year-old Michael Colombini in 2001. He was taken to a New York area hospital for a routine MRI test after having a brain tumor removed. An oxygen tank, mistakenly taken into the room, was attracted by the machine’s 10-ton magnet magnetic field, went airborne propelling through the air at 20 to 30 feet per second and fracturing the boy’s skull.

Gilk says this death could have been prevented too—from the technologist being more aware of the policies and procedures for MRI safety to not storing oxygen tanks in the hall across from the magnet room.

“I hate to say this, and I hope I’m wrong, but that accident could occur today. From a regulatory, accrediting, and licensing standpoint, we are in the exact same position,” says Gilk.

States leading change
A technologist needs to be able to control who goes in and out of the MRI environment, but more importantly, what goes in and out. In other words, the room that houses an MRI machine shouldn’t be like any ordinary room.

Roughly 20 states have adopted guidelines for design and construction of new health care facilities that have the potential to benefit patients and providers. The model code includes MRI safety and physical environment protections. It requires things like the ACR 4-zone principal, which says MRI facilities should screen patients for both clinical and physical risks before they’re brought into the magnet room, and that a technologist needs to have a line of sight to the entrance to the magnet room in order to monitor who’s going in and out.

The state requirements are not retroactive, so they don’t require health care providers who have an existing MRI room to go back and make the safety changes. “But at least going forward, it’s moving in the right direction and hopefully we can get other states to sign on,” says Gilk.

Joint Commission steps in
Unlike ionizing radiation modalities, many states are lax on what’s required regarding training and licensing for the personnel operating MRI machines.

“In many cases, the state licensures are minimal, sometimes all you have to have is an R.T. [registered technologist credential]; not even basic safety or special training for MRI,” says Gilk.

However, in the last six to nine months, the Joint Commission— which accredits the majority of U.S. health care facilities—has taken a new approach to safety training for personnel as well as other aspects of MRI safety. Gilk says he’s hearing instances where Commission inspectors are showing up at MRI facilities for surveys and specifically asking for documentation that staff have been trained in MRI safety in the last year. (Although training is not required by the ACR, it’s prominently featured in its guidelines on MRI safety).

In addition to an interest in staff safety training, the Commission has zeroed in on elements of the ACR 4-zone principal in their recent surveys.


“They are asking providers to demonstrate how they handle these different safety protocols with tools, resources and documents,” says Gilk. Ferromagnetic detection systems, which have been around since 2005, are popular devices that comply with the ACR 4-zone principal. Kopp Development Inc. manufactures detection portals that not only screen individuals who enter an MRI room, but also show the location of dangerous ferromagnetic objects on the person.

“We have an extensive follow-up program with our customers every three months and I’ve heard lately that the Joint Commission is actually evaluating based on whether they [the facility] had detectors,” says Anna Srb, director of marketing and sales at Kopp. “And if they did, they got higher marks.”



Manufacturer ETS Lindgren, has also seen increased interest in its ferromagnetic detection device.

“Ferroguard has really taken off in the past three or four years,” says Craig Berg, director of Ferroguard Technical Sales at ETS-Lindgren.

CMS keeps mum
Last October, the FDA held a public meeting on MRI safety. But before it took place, CMS and the FDA had been in talks about what quality rules should be applied across radiology. This included things specific to MRI.

“The ultimate goal was that CMS would release these interpretive guidelines by the end of the year last year,” says Gilk.

But no one has heard anything since. Gilk speculates that the timing might not be right.

“My understanding is that there are a set of interpretive guidelines for radiology patient safety that are sitting on someone’s desk at CMS that haven’t been acted upon. I think the feds see this as the wrong time to implement any new regulations or interpretive guidelines. They want things to simmer down a little with the ACA [Affordable Care Act]. So if and when they will implement these is anyone’s guess.”

What’s really cost-effective?
As much as the industry wants to move in the right direction, current economic factors will undoubtedly get in the way of securing safe MRI envir onments across the board.

Expenditures that might normally get approved become harder to obtain when money is tight. This includes MRI safety devices, locks on doors, and educational opportunities for MRI technologists.

MRI safety device manufactures, like the ones interviewed for this story, are well aware of their customers’ concerns about money and have introduced ferromagnetic screeners at lower price points.

“Budgets are always a concern, but not implementing preventative measures can be more expensive when litigation, increased insurance premiums and professional reputation are considered if an accident does happen,” says ETS Lindgren’s Berg.

After involvement as an expert witness and consultant in more than 300 MRI safety-related legal cases to date, Kanal says that “prospective MR safety planning and implementation of basic MR safety policies is by far the safest and most cost effective outcome for all parties involved.”