Editor’s Note: This article is the second in a three-part series on MRI facility safety. The first segment discussed the three major safety hazards: missile effects, biostimulation device interference, and cryogenic gas venting.

The accidental—and entirely preventable—death of a pediatric patient in 2001 in a New York hospital focused new attention on safety problems in MRI and, specifically, on access to and control over the magnet room. Many of the subsequent recommendations on making the MRI suite safer concentrate on staff training and supervision (see the accompanying sidebar).

But, as medical architect Tobias Gilk points out, “There is still a sort of vacuum around who is responsible for MR site design.” Gilk, an associate architect with medical design firm Junk Architects, PC in Kansas City, Mo., adds, “With all the talk of MR safety, the facility aspect remains in a lot of ways the most overlooked and underdeveloped aspect of any kind of comprehensive take on the issues.”

Overcoming Inertia
One key reason for that has been radiology’s previous focus on ionizing radiation. “There’s a whole series of regulations regarding exposure to radiation, and that has an indirect but definite consequence on imaging facility design. Most states have certain design requirements only for CT, x-ray, PET, and anything else that emits ionizing radiation,” says Gilk. Because MRI works without ionizing radiation emissions, neither the federal nor most state governments regulate site and construction design. “It’s partly a question of inertia. [The MRI community] needs to admit that we can’t just keep doing things the way we have been, because precedence is not working in our favor.”

One problem is that radiology decision makers generally believe their facilities are getting more safety information and protection provided by their vendors than they really are, he adds. Historically, MRI owners and operators have leaned on scanner vendors for information about installing and running this expensive, complex technology. However, Gilk says, “system developers and vendors don’t clarify issues beyond the control room, equipment room, and gantry room. But MRI environmental and operational issues can pose a much greater hazard than other clinical operations—partly because the MRI equipment itself, and the clinical practices, are so relatively safe.”

He points out that original equipment manufacturers “already absorb a good deal of liability exposure” simply because they sell their systems as heavily regulated medical devices or appliances. Unfortunately, though, Gilk says that often means hospital and clinic administrators view these powerful behemoths “like $2.5 million toaster ovens. [In their view], an MRI scanner may require a lot of specialized equipment, but still, it’s something you just plug into the wall.” This perception that MRIs are “only appliances,” he says, “fails to recognize a number of safety issues crucial to MRI facility design and operation.”

Identifying Needs
In Gilk’s experience, people who best understand MRI safety concerns—clinicians—are often two or three levels removed from purchase and installation decision making. Those with the best sense of daily operations typically don’t speak directly with the architect or engineer but instead submit questions and information through various administrative channels.

Thus, MR siting details frequently become what Gilk calls “the leftover conversation.” The technologists with the most direct responsibility for patient care, for instance, may first submit ideas to a lead technologist, who acts as a liaison with a departmental manager, who then deals with a construction manager—perhaps an independent contractor—who may report to the financial manager.

Says Gilk, “The techs in the trenches may have expressed expectations about how the site design will address specific safety issues, but by the time those concerns reach the site designer, they’ve been diluted or even dismissed. It’s like the kids’ game of ‘telephone.’ By the end, nobody [at the executive decision-making level] really understands why those clinical concerns are important. They become items that can be easily jettisoned.”

When that happens, the MRI operator is virtually playing Russian Roulette with both staff and patients, Gilk says. “They’re running what they feel are acceptable risks, because their perception is that the risks are small—and I think the perception doesn’t match reality. [Nonclinical] people underestimate what the risks really are.”

The Cost of Safety
“Patient safety is always a major concern, but it would be foolish to suggest that financial considerations are not sometimes a major factor,” Gilk admits. “We’ve occasionally been a little dismayed at the lukewarm reception to issues presented strictly in terms of patient safety. People become a bit more attentive when you start talking about the risk of damage to the equipment.”

For those clients, Gilk emphasizes that safety is not a secondary aspect that can be added on at some point in the future—usually after a near disaster. Instead, he highlights something most administrators will understand: Even an incremental increase in patient throughput can reap tens of thousands of dollars of additional revenue over the course of a year, and designing an MRI with safety in mind facilitates patient throughput. “In our experience, integrating patient safety into the entire process makes every [other activity] easier and more efficient… So from even the purely economic standpoint, you have to ask how many extra scans over the course of a month, or a year, or over the 10-year life span of the equipment, will improving workflow patterns make possible?”

Gilk views MRI safety as having three interconnected components: clinical, operational, and facility aspects. He believes recognizing them and building them into the design process creates a layout that actually makes it more intuitive for diagnostic imaging personnel to provide the top-level care without any additional effort.

Identifying Hazard Zones
The 2001 American College of Radiology (ACR) White Paper on MR Safety introduced de facto guidelines by categorizing four zones within the MRI suite, with ascending designations to indicate increasing hazards:

• Zone I includes all publicly accessible areas beyond the reach of the MR magnetic field—think parking lots, entryways, reception desks, etc.

• Zone II denotes “the interface” where patients come under the direct supervision of the MR personnel for screening, history, insurance questions, and the like, but are still shielded from significant risk.

• Zone III encompasses the areas that may be affected by the scanner and should be strictly controlled by the MRI staff. This zone includes the control room and patient holding rooms, but could also extend to adjacent non-MRI areas.

• Zone IV is the scanner room. “By definition,” says the ACR, “Zone IV will always be located within Zone III.”

While all this sounds fundamental, Gilk says, “the White Paper doesn’t provide easily digestible data for designing an MRI facility—or even a very effective tool for evaluating existing facilities.

“What [the White Paper] does extremely well is identify what the hazards are and lay out the screening and access control principles … but it doesn’t take the next step and say, ‘Here’s how you take this design intention and apply it in bricks and mortar in the real world.’ So it takes quite some time and attention to try to extrapolate … the relevant pieces of information that facilitate efficient MRI design.”

Fortunately, he says, “the ACR safety principles can be applied in a very flexible way.” Whether designing a new suite from the ground up or retrofitting improvements within an existing floor plan, achievable solutions exist to mitigate recognized safety hazards.

Determining Existing Issues
Gilk understands that many facilities are hamstrung by poor design inherited as a legacy: “No White Paper is going to change where the walls and doors are located.”

If yours is a multimodality facility, the first step can be ensuring that the MRI magnet is in fact appropriately contained. The easiest way to determine whether the system’s fringe field—the magnetic field spread—affects outside systems is with a professional-grade Gauss meter. Compare the magnetic field reading within the various rooms of the MRI suite against the environmental power specifications for the other equipment.

“Whenever we’re doing multimodality radiology facilities, we’ll pick apart the specifications for every single piece of clinical equipment that’s being sited nearby the MRI, including floors above or below,” says Gilk. It’s a good starting point for every MRI suite evaluation.

Another common problem with existing MRI suites is blocked views within the control room. Many control rooms are virtually sealed boxes once the door is shut. But the technologist needs to observe not only the patient but also any other personnel who may have reason to enter the magnet room. This situation particularly crops up when a facility upgrades its scanner to one that is larger or differently configured than the previous one. Frequently, the system has to be placed wherever it will fit, without a lot of forethought given to the physical limitations on the operator.

But, Gilk notes, “the technologist needs to be able to easily see something besides the side of the machine.” As the ACR White Paper advises, “…all MR installations should provide for direct visual observation … to access pathways … [and to] directly observe and control, via line of site or via video monitors, the entrances or access corridors … from their normal positions…”

Gilk also sees a lot of facilities that have outgrown their original physical plant. As their patient volume builds, they add more staff and upgrade their computer systems, but now they’re trying to squeeze all those changes into the same space using the same workflow patterns. “A badly designed facility actually builds in a conflict between patient safety and patient throughput,” he says. “And too many facilities are designed for the scanner, rather than to follow an efficient [human] process. We think it’s most important to take a look at what the different steps [of each task] are and lay out the facility to respond to the flow. Doing that really makes it easier for technologists to do their job well than to do their job poorly.”

Retrofitting Efficiency
Being willing to tweak the work process often means some simple alterations can reap enormous safety gains, says Gilk. When helping a client retrofit an existing site to meet ACR guidelines, his firm first maps out the scan process, creating a step-by-step flowchart from patient sign-in to departure. Then he’ll take the suite floor plan “and erase all the room names, except for the magnet room and control room, and lay the flowchart over the spaces available.”

Gilk says eliminating the old expectations of what a particular space is supposed to be allows both the operator and the designer to rethink the intended process. This fresh approach allows everyone in the decision team to “figure out how best to work with what you’ve already got. So … even when presented with a less than ideal layout, [you can determine] how to provide the appropriate level of intervention [and] achieve the greatest result.”

Clients are surprised to find that “a lot of times the best improvement simply means an extra wall and a locked door. For instance, to improve access control if there’s no secured point that keeps people away from the magnet, maybe all that’s needed is a new door. Maybe that door needs to be placed in a little-used corridor where it doesn’t impact any existing functions. Or maybe it just means installing a window into a wall so the operator can track who’s coming and going.”

In other cases, he continues, starting from the point of the patient flow process rather than the magnet leads to revamping how people use all the available space. “Maybe improving safety means reassigning patient holding or patient screening as part of some centralized outside patient services so you can offload that function to another location. Or maybe you can put benches into the bathrooms to use them as changing rooms, so you can optimize the use of the space you do have and don’t have to create new spaces for dedicated functions.”

To those who protest that MRI staff won’t welcome change, Gilk responds, “It’s more effective to set up the suite so that it supports their work within the necessary spaces, rather than trying to convince or coerce people to use best practices in a facility that actually makes that more difficult… If you design your facility plan to respond to the workflow process, you can enhance both throughput and patient safety.”

Coming Soon?
While Gilk would like to see the ACR make meeting its White Paper safety standards part of the accreditation process, doing so remains strictly voluntary. “ACR accredits the technologists and the performance of the device. ACR credentialing doesn’t address the safety issues that can be mitigated through physical facility design,” he says.

However, given how swiftly MRI technology has advanced and its use spread, Gilk projects that emerging pay-for-performance proposals, which call for reimbursement based on measures of appropriateness and clinical quality, will eventually bring insurers into the discussion. Noting that payors are already exhibiting concern over MRI overutilization and market saturation, he anticipates less emphasis on “traditional slash and burn tactics” to curb rising reimbursement levels. Instead, expect insurer contracts to require imaging facilities to meet new, more uniform, more stringent credentialing standards, beginning with the physical plant. With new attention focused on patient safety following the Valhalla accident in both the popular press and clinical journals, he predicts, “some payor will say, ‘We don’t want to pay for an ER visit for a patient who got hurt during a [medically necessary] scan.’”

— J. K. Bucsko is a freelance healthcare and technology writer based in Westville, N.J., and frequent contributor to Radiology Today.

The following list recaps the main points of the ECRI’s original hazard alert advisory. (For the full document, see “Patient Death Illustrates the Importance of Adhering to Safety Precautions in Magnetic Resonance Environments”; ECRI, August 6, 2001; www.ecri.org/include/docs/hazard_mri_080601.pdf.)

• Appoint an MR safety officer.

• Define formal safety policies and procedures. Train all staff who work in or must enter the MRI environment. Review staff compliance regularly.

• Treat the scanner magnet as always ‘On.’

• Delineate zones of influence surrounding the magnet. Restrict access to areas where the magnetic field strength tops 5 Gauss.

• Maintain a list of medical devices and equipment that have been tested and labeled MR-safe or MR-compatible. Adhere to vendor restrictions regarding equipment, devices, and components. Test equipment with a handheld magnet before allowing it into the MR room.

• Screen all patients, every time.

Be sure wheelchairs, gurneys, carts, IV poles, oxygen tanks, and other necessary medical apparatus used when delivering patients to the magnet room are nonmagnetic and contain no magnetic parts. Always check for stowed or hidden objects.

— JKB

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