Well, in case your imaginations have only wrapped around the aftermath, and not the incident, I’ve just recently come across another visual aid that might just help you with the complete picture. Imagine a pair of scissors, an MRI, and a pumpkin…

MRI + scissors + pumkin = Do Not Try This!

Now, the screen shot, above, taken from the video doesn’t do the moving picture justice. I encourage you to take a look at it for yourself. But before you do it is vital to remember that this isn’t just a hypothetical. This accident and many, many other MRI projectile accidents – with, thankfully, less catastrophic outcomes -  occur all the time.

This isn’t simply a gee whiz scientific demonstration. This represents the real nature of projectile threats. It is at our (and our patients’) own peril that we relegate these to intellectual curiosities instead of cautionary tales.

So, with that prelude, you can find the video here.

I hope that every single MRI is adequately protected against similar sorts of accidents. This protection should include, in nearly every instance, ferromagnetic detection screening of patients, visitors, and equipment.

Click here for Tobias’ Twitter Profile

Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams

The review has been requested by Robert Russo, MD, with Scripps Research Institute. A copy of Dr. Russo’s request can be viewed here.

The public comment period is open through July 28, 2010, and I strongly encourage anyone with questions or concerns about the safety of MR imaging for patients with implanted cardiac devices (Dr. Russo correctly points out that CMS’ restriction fails to speak directly to implanted cardio-defibrillators, or ICD’s) to offer their comments to CMS.

The full explanation of the current restrictions on MR imaging of pacemaker patients (also aneurysm clip patients, and pregnant patients), as well as the instructions for reviewing other public comments or submitting your own, can be found here.

Click here for Tobias’ Twitter Profile

That’s right, the FDA has updated it’s MRI accident figures available online through the MAUDE database. We were alarmed and astonished when we thought that the rate of increases in MRI accidents was only 270% (from 2004 to 2008). Turns out that the FDA must have found additional accident reports that were in a stack of junk-mail, or got lost between the sofa cushions, which means that the rate if adverse events went up, significantly, in 2008 from the prior calculation.

Somehow, when I did the analysis last year (in 2009) of the 2008 numbers, it was apparently 11% shy of the final total. When we add the (previously uncounted) adverse events, the actual rate of accident growth is 310%!!!

Between 2004 and 2008, MRI Accident Rates Increased 310%

That’s right, in 2008 we were more than 4 times as likely to injure someone during an MR exam than we were just four years earlier!

What would happen in your town if:

• Traffic accidents quadrupled in 4 years?
• Rates of violence in schools quadrupled?
• Divorce rates increased 4x in 4 years?

Alarm bells, that’s what! People for certain would not be complacent.

There would be efforts to figure out why, and fix whatever was going wrong. Reduced speed limits or more traffic enforcement? You bet! Counselors in the schools and demands for greater teacher and parent involvement? Darn right! Lay and religious leaders reassessing the very nature of the marital institution in our society? Abso-friggin-lutely!

So, with an exploding rate of MRI injuries and adverse events, what is being done to identify and curb the source of these incidents? [cue cricket sounds]

NOTHING!

Apart from the continuous efforts of a small cadre of MR safety advocates, whose cries have (apparently) fallen on deaf ears, there are no substantive accreditation, licensure, or regulatory actions that have reversed the trend of the last several years.

The silver-lining may be that the increase from 2008 to 2009 was very modest. Perhaps we’re leveling-off, or perhaps, like 2004, this is just a momentary pause before we skyrocket upwards again. And given the FDA’s marked upward adjustment of the 2008 numbers, it may wind up being another year before we can feel confident about the 2009 accident report numbers.

Click here for Tobias’ Twitter Profile

If you’d like to watch it, it’s in 3 parts. The first of 3 is available here (requires QuickTime viewer).

Click here for Tobias’ Twitter Profile

Just a few months ago a service engineer was replacing a fan-blower assembly in an MRI unit (a part that is notoriously ferromagnetic). Working alone in the suite in the evening, after the regular staff had left, the engineer had finished early… or that’s what the security guard thought when he called to her and got no reply.

Turns out that she had been struck and pinned to the MR scanner by the blower assembly, and was unconscious, if not already dead, when the guard checked to see if she was still there.

This tragic story is something of a departure from my typical mantra of patient and staff safety. Yes, this was a trained individual who knew about the risks of the MR environment and materials she was working with. And yes, this was a vendor, and not a hospital worker or patient. But this is a repeatable condition, and an accident which, because there have been MRI accidents involving such a tremendous variety of ferromagnetic materials, deserves a little analysis for a ‘lessons-learned’ output.

One of the (theorized) main contributing factors to this accident is the design of the magnet room. Since the advent of active shielding, we’ve seen MRI rooms go from the size of racquetball courts to office cubicles. In this case, the clearances around the magnet were uncomfortably tight, and what space there was between the magnet and the walls of the suite was purportedly infringed by shelves, storage and clutter.

By failing to provide an appropriately-sized room to accommodate not only the MRI unit itself, but also the service and storage needs, the layout may have substantially increased the likelihood of an accident.

And while conventional screening methodologies wouldn’t have helped in this particular scenario (the object already in the MRI room), it’s not like this is the only strange thing that has been brought into a MRI room to be ‘sucked’ into the scanner. Yes, we all know about oxygen tanks (well, apparently we don’t, as there was another one reported recently, here), but they aren’t all!

Personal computers, iPods, filing cabinets, desk chairs, anesthesia machines, cribs, gurneys, wheelchairs, dollies, staplers, power tools, axes, roller skates, ‘sand’ bags, hampers, mop-buckets, and the list goes on, and on, and on… All of these, and many, many more objects have found their way into MRI scanner rooms. Sometimes the people involved, like in the circumstances surrounding the recent fatality, know that they’re taking a risk. But at least as often the accident occurs because the person is unaware of what they’re doing.

The magnets don’t take vacations. They’re not on just when ‘taking the picture’. They’re not turned off for the night when the last patient is done for the day. The risks are omnipresent, which demands that we are equally vigilant about providing the appropriate protections for everyone and everything that approaches the MRI room.

In the weeks ahead, I hope to have information for you about some of the efforts in the works that may help codify some of these expectations at the point of care. Suffice it to say that right now, for the first time in the U.S., substantive consideration is being given to explicit MRI safety requirements at the point of care. This is still all in the formative stages, and lots of work remains to be done. But perhaps when it is, there’s an umbrella drink and sandy beach with my name on them.

Click here for Tobias’ Twitter Profile

About fifteen years ago, there was a fire at a medical office building in Stockton. The smoke was so thick that the firefighters searching the building didn’t see the MRI warning signs on the door they went through. Once inside the room, one firefighter felt his pike (a long stick with a hook at the end used to pull apart loose materials to look for fire) pulled to the MRI scanner.

Immediately recognizing the hazard, the firefighter went and told the incident commander of the risk. But before a warning could be broadcast to the other firefighters, a different fireman, this one with an axe on his belt, approached the MRI scanner and was pulled, bodily, to the scanner by the attractive forces acting on the axe-head.

Fortunately, no serious injuries resulted. (click here for an article on this incident)

Fast-forward to March of 2010, when Stockton MRI goes up in flames.

Stockton, California, MRI Center on Fire.

This time, the firefighters’ hoses, axes and pikes are supplemented with their acute awareness of the hazards of MRI. No firefighter will enter the MRI scanner room without confirming that the magnet is not at field, first. The fire, which didn’t originate in the scanner room, will be fought from all locations except the magnet room.

Apparently, however, one of the MRI’s at the center was in cahoots with the MRI from the fire 15 years earlier, and desperately wanted its very own firefighter souvenir. According to the newspaper report, the magnetic field from the MRI within the building pulled an axe out of the hands of a firefighter who was working on the roof of the imaging center!

As before, the accident did not result in any injuries. Unlike the prior incident, this MRI was denied its own firefighter souvenir .

The moral of this story is that if you’re a firefighter, be very cautious of the MRI’s in Stockton, California. In fact, since we don’t know how far this MRI conspiracy goes, it might be wise for geared-up firefighters to be extraordinarily cautious near all MRI’s!

Click here for Tobias’ Twitter Profile

This past weekend I had the privilege of participating in OSU MRI conference. I was able to sit-in on a number of the presenters, plus I presented, and was asked to sit-in on a panel discussion on safety with Bill Faulkner and Candi Roth. The conference provided me the opportunity to hear from a number techs regarding their most recent Joint Commission surveys, and I was encouraged by what they had to say.

My (longstanding) prior criticism of the Joint Commission and their MRI patient safety survey efforts have centered around one simple fact… they didn’t do anything with respect to MRI safety. JCAHO hasn’t ever had MRI-specific standards or survey criteria, but I was certain that the 2008 release of Sentinel Event Alert #38 on MRI accidents and injuries would change that, instantaneously (a SEA being the Joint Commission’s ultimate patient safety warning). It didn’t.

I was certain that the change to the Joint Commission’s 2009 changes to their Environment of Care (EC) standard which specifically invoked Sentinel Event Alerts would immediately change their survey methods. Reports I received from JCAHO accredited providers who were surveyed in the first half of 2009 indicated that I was to be disappointed again. But at the OSU conference, the clouds parted and glorious beams of hope shot down from the sky and landed on me.

Yes, I did hear several of the expected ‘their shadow never crossed our doorway’ stories of JCAHO surveyors ignoring MRI. There were also the accounts of ‘checked fire extinguisher and walked out.’ As little as one year ago, I would have expected that to be the end of the list, but several people came up to me and recounted recent surveys in which Joint Commission surveyors asked about…

• Screening forms
• ACR four-zone separations
• MR Conditional equipment
• Infection control procedures
• Emergent / code procedures, and,
• Ferromagnetic screening

One person told me of how the surveyor spent more than 30 minutes in their department, tracing the entire sequence of the screening and care of an MRI patient.

These heartening stories of surveyor attention to MRI were the minority, but given that JCAHO surveys occur on a 3-year interval, that there was any change in the status quo in the past year is likely an indicator of a significant prioritization of MRI safety at the Joint Commission.

The hazards of MRI come from the fact that – as soon as you step into that room – the fundamental laws of physics change, without any outward indication. Non-ferromagnetic objects still fall down, but ‘gravity’ works in a different direction for magnetic materials. This simple, invisible truth requires a host of MRI-specific safety protocols. Application of generalized hospital-wide patient safety standards to MRI hasn’t worked terribly well (as in, not at all) in the past, so I can’t tell you how encouraged I am by this recent news.

If one is truly interested in patient safety, and has been critical of others for a lack of attention to these issues, there is no sweeter sound than to hear that you are wrong. When weighed against the benefits to be realized by MRI patients, staff and providers from enhanced safety (fewer accidents), any swelling of my personal ego is of zero importance. I hope that the degree of my wrongitude only grows from here going forward.

‘On the Joint Commission,’ I should add. I do have my weekly PowerBall lottery ticket, and I would very much love to be right on that.

Click here for Tobias’ Twitter Profile

In nearly concurrent moves, the Joint Commission (JC) unveils their just-developed Advanced Imaging (AI) accreditation program, the FDA is clamoring for new authority to regulate medical device safety (or gearing-up to use authority that it’s been hiding for safe-keeping, that isn’t exactly clear to me), the US Congress whips together a set of hearings on the issue, and, at those hearings,  the American College of Radiology (ACR) recommends that the Feds expand the scope of the AI accreditation requirement to include radiation therapy and to apply the expanded accreditation requirements to hospitals, too.

Whew, that’s a lot of ground covered for radiology in just the last few weeks! Wait a minute… who is that sitting in the backseat? Who has been drug through all of the hullabaloo about radiation exposure and patient safety without once having been considered, individually? MRI, that’s who.

So congress is alarmed at the lack of regulatory oversight on ionizing modalities, such as CT or beam therapies, hmm? The ACR couldn’t get to the hearings fast enough to recommend that the Congress mandate both deeper and broader accreditation requirements (which the ACR would be pleased to provide, by the way). The argument in favor of these enhanced accreditation requirements is that the patchwork body of existing state requirements are simply inadequate to protect patient safety.

What was the reaction to the fact that there are zero (and I’m not being dramatic here… I mean zero) requirements at state or federal levels for physical safety around MRI systems? Or what was the reaction to the fact that the FDA’s own data shows a near-four-fold increase in the number of MRI accidents in recent years? What about the fact that in states like Missouri, where I was born, don’t even require any credentialling of technologists who administer MRI exams? (Seriously, in Missouri you have to have vastly more proof-of-competence to give someone colored highlights in their hair than administer their MRI exam.)

MRI Accidents As Reported To The FDA

What was the reaction? None. Nada. Zilch.

Why? Because MRI has just been ‘along for the ride,’ apparently.

Regulation:

It’s important to realize that the bulk of radiology’s regulatory oversight grew out of federal standards for ionizing radiation protection of workers on the Manhattan project. Those standards became the template to be adopted and adapted by the individual states. The FDA, which regulates the approval of radiology equipment as diagnostic or therapeutic device, has left the oversight of the safety of the administration of that exam / procedure to the states.

What resulted was a patchwork of mix-matched state regulations governing ionizing radiation devices that use X-rays (such as CT and mammography), and radioisotopes (such as in nuclear medicine and many therapies).

In the 80′s, MRI came along. Since MRI didn’t use ionizing radiation, it was almost as if the absence of regulation was seen as ‘proof’ that MRI was safe. Neither hospitals nor the equipment manufacturers were interested in promoting regulation for this new modality, and quite honestly most state authorities and elected officials didn’t really understand what MRI was (and their inaction probably saved us from some very bad legislation at the time… look no further than the contemporary European Physical Agents Directive to see what ill-informed regulation can do to MRI).

Accreditation:

Let there be no mistake about it, MRI accreditation efforts have been driven primarily by payors. Apart from the last few weeks, the overall accreditation program balance between image quality and patient safety has leaned heavily towards the side of image quality. Let’s use the ACR’s MRI accreditation program as the example…

To be accredited by the ACR for MRI, there is a long list of quality controls that have to be implemented regularly. And since image interpretation is largely a qualitative skill, the ACR went so far as to develop a specialized imaging phantom to distill otherwise-subjective quality differences into objective tests (can you see the proper number of spokes on the phantom image?). There are logs, tests, data-collection, reports, all necessary to help assure that the machine is capable of producing pictures of a minimum requisite quality.

ACR Phantom Showing Radiating 'Spokes' Of Contrast Dots

At the same time that the ACR has made such remarkable efforts at standardizing measures of quality, they have largely ignored even their own MR Safety Committee’s request to include physical safety criteria in the MR accreditation program.

In 2006, during the MR Safety Committee’s working session to develop what became the ACR Guidance Document for Safe MR Practices: 2007, the Safety Committee, unanimously, issued a formal request to the College to include the standards developed by the Safety Committee as a part of the MR accreditation program. Four years later, there is no objective evidence that this formal request has been taken seriously.

Both the ACR and the other primary imaging accrediting body, the Intersocietal Accreditation Commission (IAC), assert that their standards for MRI accreditation are serious and robust, yet neither have identified how their MRI safety standards have successfully responded to the nearly 300% increase in MRI accidents in the last several years. If these accrediting bodies are serious about MRI safety, how can the reconcile the alarming MRI accident growth with their wet-noodle protections?

I have left the Joint Commission out of this evaluation of accreditation standards because – prior to this year – the JC has not offered a single modality-specific accreditation standard for MRI, or any other imaging device. From an MRI patient safety perspective, they’ve been virtually a non-factor, even though their accreditation services cover thousands of providers across the US that offer MRI services.

So today, MRI is lumped-in with CT and PET as a part of the AI accreditation program. And AI accreditation is largely seen as the way to address the headline-grabbing concerns about ionizing radiation exposure.

To be perfectly clear, I support greater attention to standards and safeguards for ionizing modalities, but I find the omission of any mention of MRI safety in the current conversation surrounding the Advanced Imaging accreditation program as an indictment of the earnestness of this as a patient safety campaign.

I think that accreditation should follow the path that the ACR has laid out, and I don’t begrudge them their efforts at positioning themselves as the preferred accrediting body for this expanded role. However, I think that a little ‘truth in advertising’ is called for (one could even call it a quid pro quo).

The ACR (and IAC, who I imagine is equally interested in expanded mandatory accreditation) should balance their own indisputable self-interest in new accreditation requirements with some substantive action on objective MRI physical safety requirements. Standards for MRI safety have literally been ‘laid at their doorstep,’ now all they have to do is adopt them.

If we fail to look at the escalating rates of accidents and injuries in MRI and address them as a part of the broader ‘radiology safety’ conversation; if we focus solely on ionizing radiation to the exclusion of all else, then we will again ignore the giant magnetic elephant in the room… the one that represents the alarming rate at which we’re increasingly injuring MRI patients.

Click here for Tobias’ Twitter Profile

Much to my surprise (and delight), this is happening with the new Guidelines for Design and Construction of Health Care Facilities (or Guidelines, for short). Though the 2010 edition of Guidelines has only been published for about a month (and the publisher has been struggling to catch up on back-ordered copies), two states have already adopted the 2010 edition as their requirements for licensure.

That’s right, in less than a month, the states of New Jersey and Georgia have already moved to the new 2010 edition of Guidelines, complete with its wholly rewritten section on MRI suite design and safety. What does this lightning-fast adoption of the new edition of Guidelines foretell for the other states and authorities (like the Joint Commission) that use Guidelines for their standard?

"As go Georgia and New Jersey, so goes the rest of the nation..."

“If the Guidelines code is updated every 3 – 4 years, why is this update so significant for MRI suite safety and design?”

Excellent question. The answer lies in what hasn’t been in the past 25-years worth of Guidelines, and that is any sort of design standard pertaining to safety for the MRI suite. Clinical MRI has been around that long, and yet the last edition of the standard (released in 2006) had nothing about MRI safety. If you just compared the number of words in that prior edition, there was nearly 5 times as much guidance for laundry facilities as there was for MRI.

And though it may not be significant from an MRI safety standpoint, a number of authorities – the Joint Commission among them – still reference the 2003 edition of Guidelines! Given the pace of healthcare developments, it’s hard to imagine anything remaining unchanged over a 7-year period. Georgia and New Jersey are just the first in what appears to be a multi-jurisdiction sprint to the new standards (some just staying current, others playing ‘catch-up’).

“What does this mean for MRI suites and the hospitals and imaging centers that build them?”

Among other things, it means that the verbatim cut-and-paste templates from the MRI equipment vendors are now insufficient for state licensure approval (I contend that they, alone, have been insufficient on many levels, but until now state licensure hasn’t been one of them). MRI suites will now have to be designed to respond to the new line-of-sight, access-controls, and ferromagnetic screening requirements in the 2010 edition of Guidelines.

Architects, engineers, equipment planners and facility managers are all having the performance bar raised relative to MRI safety design provisions. Here’s just one section of the new requirements for MRI suite design in the 2010 edition of Guidelines:

2.2-3.4.4.2 Design configuration of the MRI suite

(1) Suites for MRI equipment shall be planned to conform to the four-zone screening and access control protocols identified in the American College of Radiology’s “Guidance Document for Safe MR Practices.”

(2) The layout shall include provisions for the following functions:

(a) Patient interviews and clinical screening
(b) Physical screening and changing areas (as indicated)
(c) Siting of ferromagnetic detection systems
(d) Access control
(e) Accommodation of site-specific clinical and operational requirements

While I was expecting the roll-call of states adopting the contemporary 2010 edition of Guidelines to begin late this spring, or even this summer, I’m very pleased that this has bested my expectations. This means that as of right now, the new MRI safety standards are already required at the state level in Georgia and New Jersey… months ahead of schedule. We may actually see a very sizable number of authorities moved to the current version by this summer, the time I had expected the first adopters to announce.

Click here for Tobias’ Twitter Profile

The other two have had modality-specific accreditation programs for years, so what was the TJC going to do? Well, they’ve released their accreditation criteria, and one of the most wonderful surprises is that MRI safety is more prominent than it is in either of the other two ‘imaging’ accrediting bodies!

That’s right, the ACR, despite having been the name behind three publications of the ‘White Paper on MR Safety’  (now the ‘Guidance Document for Safe MRI Practices’), has no physical safety standards for their MRI accreditation program. And at last check, ICAMRL didn’t even have the contemporary terminology for MRI safety-tested medical devices in their standards. So, in an amazing ‘come from behind’ showing, TJC has now bested the veteran agencies in patient safety protections.

From the perspective of MRI patient safety, one of the most wonderful things is the addition to the Joint Commission’s Environment of Care (EC) standard. In this updated version (effective immediately), TJC explicitly mandates MRI safety protections:

Excerpted from EC 02.01.01, EP 14

At a minimum, the organization manages safety risks in the magnetic resonance imaging (MRI) environment associated with the following:
- Patients who may experience claustrophobia, anxiety, or emotional distress
- Patients who may require urgent or emergent medical care
- Metallic implants and devices
- Ferrous objects entering the MRI environment

OK, I might have chosen a slightly different list, but these four items nail some of the greatest environmental threats to the safety of patients and staff in the MRI suite. And given that it’s the first requirement from an accrediting body (the recent MRI safety changes to the healthcare building code, Guidelines, are regulatory / licensure requirements), I’m more than happy to give JCAHO a little slack.

If you would like to download your own PDF copy of the changes to the ambulatory accreditation program’s Environment of Care standards, which includes the explicit MRI safety requirements, identified above, please click here.

In a nutshell, these new standards echo many, many prior recommendations, including JCAHO’s own, for MRI safety. Namely, these are to plan for emergent situations, screen patients more effectively for contraindications, and screen for ferromagnetic materials.

With the new EC standards it is no longer acceptable to simply say, ‘yeah, we have a policy and procedure manual that outlines how to handle each of these.’ Now, as a part of regular accreditation, providers will have to provide risk assessments and explain how their actions are proportionate responses to those risks.

Earlier in that same EC standard, it makes specific mention to seeking external sources of information to establish risks and responses. For MRI, that list would likely include the ACR Guidance Document, the VA’s MRI Design Guide, the ASHE monograph ‘Designing and Engineering MRI Safety’, the ECRI Institute’s Top-10 Medical Technology Hazards, and perhaps even the MHRA MRI risk assessment.

What recommendation is common to all of these industry-standard-setting publications (that explicitly addresses one of the 4 new EC requirements)? The use of ferromagnetic detection systems.

As you conduct your risk assessments, and determine a path to MRI safety and regulatory conformance, I hope that you’ll contact the people at Mednovus regarding their ferromagnetic MRI screening systems. When your next state or accreditation surveyor comes around, you’ll be so very glad you did.

Click here for Tobias’ Twitter Profile