Guess what? Today is one of my somedays! Or, I should say, today promises to be one of my somedays (there’s the cautious vein running through my optimism).

Today the FDA announced that they are hosting a public workshop on MRI Safety! Faced with staggering growth in MRI accidents and a diaspora of state, accreditation, professional and regulation organizations (who either can’t or won’t acknowledge the role that they each could have played in preventing the dramatic increase in accidents), the FDA is assembling a public workshop not unlike the one that fostered unprecedented cooperation among industry, providers and regulatory bodies to address ionizing radiation exposure concerns in ionizing medical imaging.

Like the ionizing predecessor, the challenge for the MRI safety workshop will be twofold… first, getting stakeholders (who disavow being stakeholders with a responsibility) to work together will be like herding cats. Fortunately, there are a few of us crazies [ahem] zealots, er enthusiasts who won’t forsake this opportunity and will help marshal the kitten rodeo. Second, and more critical, will be the commitment to actually doing something!

“Try harder” or “Improve tech education” or “Develop a policy” have all been tried to death! The ‘we promise we’ll do better in the future’ line, without specific, measurable criteria, has been the staple of MRI safety improvement efforts over the course of time in which we’ve seen the rates of MRI accidents grow to five times what they were just a few years ago. The promise to ‘do better’ is wholly inadequate. The promise to ‘measure up’ to an explicit standard is what we need.

Alarming Growth In MRI Accidents

This planned meeting – or more specifically, the progress that it represents – is long overdue, as is this contribution to this forum.

If you would like to participate in this upcoming FDA meeting, scheduled for October 25th – 26th, 2011, please sign up soon on the FDA’s registration website, here.

I hope to see you in DC, herding cats and agitating for standards for the safety of MRI patients and staff!

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So, here is the justification my new nPSG, using the Joint Commission’s own words…

PPS (a Joint Commission publication) Feb, 2007 – “Safety in the MRI suite is both vitally important and unusually challenging to implement because of the invisibility of of the threats coupled with the increasingly common presence of objects that MRI can act upon with disastrous results.”

SEA #38, Preventing Accidents and Injuries in the MRI Suite, Feb, 2008 – “The Joint Commission offers the following recommendations and strategies to health care organizations for reducing  MRI accidents and injuries:” [Ten explicit objectives follow]

EoC News (a Joint Commission publication) May, 2009 – “In January 2009, the Joint Commission issued Standard EC.02.02.01, Element of Performance (EP) 1, which lists Sentinel Event Alert among the sources of information to assist in proactively identifying safety and security risks associated with the environment of care.”

EC.02.01.01 – “The organization identifies safety and security risks associated with the environment of care. Note: Risks are identified from internal sources… …and from credible external sources such as Sentinel Event Alerts.”

EoC News (a Joint Commission publication) May, 2009 – “…[W]e do ask each organization to look at the literature — any credible external sources, such as Sentinel Event Alerts — and put into place those things that can help prevent a safety incident involving their patients.” — John Fishbeck, R. A., Associate Director, Department of Standards, The Joint Commission.

SEA #38, Preventing Accidents and Injuries in the MRI Suite, Feb, 2008 – “Implement systems to support safe MRI practice such as written protocols and checklists and periodically review, and assess compliance with your organization’s MRI policies, procedures and protocols.” — paraphrasing Dr. Emanuel Kanal, FACR, FISMRM

Admittedly, a good editor could take my own words and re-purpose them to say something that I would find antithetical, but that’s not what I’ve done here. While I suspect that voices within the Joint Commission might be quick to come up with qualifications / rationalizations as to the un-enforceability of MRI safety, I can’t imagine that they would actually disagree with words that they themselves have spoken, written or published on the subject.

What follows are the 2011 nPSG’s which follow, fairly directly, from the hazard description above:

• nPSG.11.01.01 – Accredited Health Care Organizations that provide MR services must perform a risk / hazard analysis for those services in accordance with EC.02.01.01.
• nPSG.11.01.02 – Provide access restrictions, and both clinical and physical screening, for all persons prior to being granted access to the controlled access areas of the MRI suite, in accordance with the ACR Guidance Document for Safe MR Practices: 2007 and the ACR 4-Zone model described therein.
• nPSG.11.01.03 – Appoint a dedicated MR safety officer with responsibility and authority for implementing and enforcing MR safety procedures.
• nPSG.11.01.04 – Provide and document MR safety training for all MR staff at least annually.
• nPSG.11.01.05 – Use only portable equipment tested and approved as ‘MR Safe’ or ‘MR Conditional’ as appropriate to the MR environment.
• nPSG.11.01.06 – Provide ferromagnetic (only) detection screening for persons and objects prior to admission to controlled access areas within the MRI suite as stipulated in nPSG.11.01.02.
• nPSG.11.01.o7 – Provide padding in accordance with MR equipment manufacturer recommendations to isolate patients from RF coil elements or from conductive materials in proximity to the patient (including the skin-to-skin contact of the patient’s own tissues) during the MR exam.
• nPSG.11.01.08 – Provide hearing protection for all persons in the MR examination room during the MR exam, verifying proper fit before initiation of the exam.

These 8 nPSG’s, if enforced, could actually slash the number of MR accidents dramatically! A retrospective analysis of MRI accident reports to the FDA indicated that more than 92% of MRI clinical adverse events are burns, projectiles and hearing damage. Adherence to these 8 steps could nearly eliminate MRI accidents and injuries!

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I was invited to present a paper at the American College of Radiology’s meeting on quality and safety held October 22 – 23 in Phoenix, Arizona. Actually, the invitation came in response to an abstract of a paper that hadn’t been written yet [not to self, don't promise papers you've not yet written again].

While the FDA’s adverse event data was clearly never intended to be useful to the outside world (we eliminated over 50% of the events from consideration, primarily because of too little narrative), it did provide a great snapshot of the diversity of accidents. We wound up with 104 useful event reports from an 18 month period of reporting.

We then compared each of these 104 events against the criteria in both the ACR Guidance Document and the Joint Commission Sentinel Event Alert #38. What we found gave us tremendous encouragement… encouragement tempered with some very unpleasant contemporary realities.

Stunning: Our review found that the ACR Guidance Document for Safe MR Practices: 2007 had explicit, actionable criteria that could have interdicted 80% of the 104 tested adverse events! And that doesn’t even include the general provisions for safety such as technologist training, or situational awareness.

The TJC Sentinel Event Alert (SEA) #38 fared somewhat less well, with a 49% effectiveness, though preventing half of the MRI adverse events that are occurring is certainly nothing to scoff at!

Frustrating: Neither the ACR nor the Joint Commission currently have any… ANY… explicit standards for MRI safety, despite the fact that each organization has published best-practice standards that promise to be 80% and 49% effective (respectively) in mitigating MR specific hazards in the MRI suite!

So the conclusion of the presentation offers a challenge to the ACR, the Joint Commission, DNV, and the IAC, to adopt explicit MRI safety standards as a requisite element of accreditation.

If you would like to view the presentation, please see the video (below).

http://www.youtube.com/watch?v=O4zsQ1Yh15A

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

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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.

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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.

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The National Council on Aging just released a study which details these alarming numbers. The matter-of-fact language of their release did nothing to diminish my welling fear as the study went on to detail chronic failures in our healthcare system to educate, alert, and prevent the dangers inherent in MR imaging of medical implant patients. Here are a few of the particulars:

• Medical implant patients over age 65 have between a 50% and 75% chance of requiring imaging during the useful life of their implant.
• While 90% of physicians knew of MRI risks for some pacemakers, over half of doctors say that they aren’t informed about imaging limitations when a patient is implanted.
• Nearly a third of patients who receive medical implants are not informed of MRI restrictions.
• After exposed to the MRI risks to their implant, nearly 20% of these device patients experience some sort of problem or malfunction with their implant.

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

The near universal opinion (98%) of healthcare providers is that they require additional information and training on these MRI safety risks.

Let’s hope that regulatory (FDA and States) and accreditation (JCAHO, ACR, and IC) bodies for MR imaging look at ways that they can take a more active role in promoting education and protecting these patients.

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You see, back in 1983 when GE was going through their pre-market approvals with the FDA for their first commercial clinical MRI system, they indicated that MRI suite safety minimally required ferromagnetic detection pre-screening. The only problem was, it hadn’t been invented yet!

During R&D the physicists at GE discovered that the MRI scanner could be tuned in such a way to create something of a ‘worm hole’ and permit time-travel. Anyone who has spent 2 or 3 hours in an MRI, only to have their wristwatch tell them they’d only been in it for 30 minutes, won’t have a hard time believing that there’s still some vestige of time-warp still left, even in contemporary MRI scanners.

What did the GE physicists see during their clandestine time-traveling jaunts into the 21st century? We suspect that they saw MRI’s everywhere – hospitals, imaging centers, strip malls – and each and every one of them was protected by ferromagnetic detection pre-screening devices. When they returned to 1983, it seemed such a natural thought, to protect patients, staff and these marvelous machines, that the requirement for ferromagnetic detectors actually made it into their safety submittals to the FDA.

Admittedly, I’m taking (more than a little) artistic license here. What GE actually stated in their November, 1983 ‘Hazard Analysis’ that accompanied their MRI device application to the FDA was that metal detection (for prevention of ferromagnetic projectile accidents) was a “minimum requirement” for safety in the MRI suite.

As described in my exhaustive summary of a couple weeks ago, conventional “airport” style metal detectors are actually horribly counterproductive to pre-MRI screening for most patients, particularly when screening for ferromagnetic materials. Operationally, this is a truth that simply couldn’t be known to GE at the time that they were preparing their recommendations for MRI safety, a concern that never really existed before they brought this product to market.

This metal detector “minimum requirement” soon became an unwelcome nuisance, and GE’s promotion of it as a safety tool withered to near-nothingness.

That’s not to say that the hazard that the metal detector was to help mitigate withered, too. In fact, as GE (and Siemens, and Philips, and Toshiba, and Hitachi…) made stronger and better MRI systems, the risks of ferromagnetic projectiles kept ratcheting upward, too.

Today we’re faced with sticky situation… The entire FDA approval of MRI can be traced back to this GE application, which recognized – and required – projectile protection. The only available tool (at the time) turned out to be far less effective than hoped, so its use was discontinued. After a tragic, headline-grabbing MRI projectile fatality in 2001, real ferromagnetic (only) MRI pre-screening instruments were developed, and have been available for a number of years. However, these new tools, which respond specifically to the needs identified by GE almost 30 years ago, haven’t been appointed by manufacturers and regulators to the safety role that they’re meant to play.

Perhaps it’s all a product of the ongoing effort on the part of the government to keep the secret of time-travel… well… secret, but nobody seems interested in revisiting patient protections called for in 1983.

And what became of those GE physicists who originally stumbled upon the secret of MRI time-travel? Well, after collecting data on the forthcoming 20 years worth of Superbowls, World Series’, and PowerBall jackpots, they each decided that working for a living was, simply, too much work.

But you can bet, whatever private island-paradise they own today, when their doctor proscribes them an MRI, they find one with ferromagnetic pre-screening.

; )

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Ready? OK…

Let’s start at the very beginning (“what a very good place to start”). Back in the 80′s, when GE was seeking FDA approval for their new-fangled ‘nuclear magnetic resonance’ scanner, they were keenly aware of the risks of things going flying into the giant magnet. It turns out to be extremely difficult to have a giant, super-powerful electromagnet (one that doesn’t have an on/off switch) that doesn’t draw in every conventional ferromagnetic wheelchair, oxygen tank, gurney, mop bucket, rolling cart, etc… that comes near.

New Ferromagnetic Detector Requirement to Mitigate Magnetic Projectiles Risks In MRI Suites

In an effort to help identify these threats before they were brought into the room, the GE application to the FDA called for mandatory metal detectors for screening patients and equipment as a part of each and every MRI installation.

Well, it turns out that this well-intentioned gesture was not very practical. As sites that have foolheartedly ventured down this path can tell you, darn near everything that is brought to the MRI suite has metal in it. This means that darn near everything, including objects that are at no risk of flying into the MRI, will set off the conventional metal detector. If the objective is to find only those things that would like to go flying into the MRI scanner, your conventional ‘airport style’ metal detector is of no use.

In the 1980′s there weren’t alternative means of detecting only ferromagnetic materials (those that become magnetized and get drawn to the MRI scanner), so the GE requirement for metal detection atrophied to nothing, becoming a forgotten (well-intended) bad idea.

Fast-forward about 20 years. At this point MRI technology is ubiquitous at hospitals (those with at least a couple hundred beds) across the country. Estimates were that there were somewhere around 8,000 MRI scanners in the US, and that most of them were GE products.

Concurrent with the growth in numbers of MRI scanners were increases in the magnetic strength and improvements to the ‘active shielding’ systems. Each of these enhancements had the coincidental effect of increasing the forces that draw magnetic materials into the scanner. When coupled, these factors actually multiplied the attractive force applied to magnetic objects, meaning that the risks associated with magnetic-projectiles flying into MRI scanners increased dramatically as the imaging technology advanced.

There have been magnetic-projectile accidents that jeopardize patients and staff in the MRI suite as long as there have been MRI scanners. The overwhelming majority of these remain ‘under the radar’ of safety, regulatory and accreditation bodies. One event occurred in the summer of 2001, however, that exploded through the veil of embarrassment that typically keeps these types of accidents secret.

In 2001, a young boy was anesthetized for an MRI scan and required oxygen during the exam. When the wall-outlet O2 didn’t work, the anesthesiologist called for oxygen. The technologists administering the exam left the control room to try and fix the oxygen supply problem and, while they were out, a nurse entered and told the anesthesiologist that there were oxygen tanks right there in the control room. Immediately upon bringing one of the portable tanks into the MRI scanner room, the magnetic field of the MRI ‘grabbed’ the tank and pulled it into the center of the doughnut-shaped scanner, where it struck the boy.

That six-year-old boy, Michael Colombini, died from the injuries a couple days later.

Splashed across the media and throughout radiology journals & trade publications, this event reignited the interest in metal detectors, many of the lessons learned from the prior experiments with ‘airport style’ detectors having been forgotten.

“If only there was a metal detector that only alarmed on magnetic materials,” was a common refrain. In 2001, there wasn’t (at least not an effective commercial product for pre-MRI screening). Ever the ‘mother of invention,’ the necessity for a magnetic-projectile screening tool prompted several companies, including Mednovus, to develop ferromagnetic only detection systems.

These products started becoming commercially available just a few years after the 2001 Colombini tragedy, and initially struggled to differentiate themselves from the failed legacy of’ ‘airport style’ detectors. In the years since, however, ferromagnetic detectors have become viewed as a valuable tool for safety in the MRI suite.

Would GE have mandated ferromagnetic detection (instead of the ‘airport style’ metal detectors) with their FDA application if the products had been available 20 years ago? Since the stated intention was to prevent projectile accidents, it would seem logical that they would have. They’re not the only MRI manufacturer to have indicated that choice, either.

In a 2008 interview with the Israeli business publication, Globes, Walter Marzendorfer, CEO of Siemens Medical Systems’ MRI Business Unit, was quoted as saying, “[t]he main safety issue where MRI is involved is the fact that it is a magnet. Accidents happen when a doctor enters the MRI room with a scalpel in his pocket and bends over the patient. People forget. There must be metal detectors at the entrance to every room with a MRI device.”

It would seem that Siemens has exactly the same take on the necessity for projectile safety in the MRI environment that GE had, namely that there should be some form of automated screening. I’ll chalk-up the use of the term “metal detector,” instead of the projectile-specific screening provided by a ferromagnetic detector, to the multiple languages likely involved in ultimately arriving at an English text. Both GE and Siemens have stated the necessity for some form of automated projectile screening, but it doesn’t end with the equipment manufacturers.

GE and Siemens aren’t alone in the calls for some form of  requisite screening for projectile risks…

• In 2007, the ACR Guidance Document for Safe MR Practices amended language from prior publications which recommended against ‘airport style’ detectors to include the explicit recommendation for using ferromagnetic detection systems.
• In 2008, the US Department of Veterans Affairs (VA) MRI Design Guide echoed this recommendation.
• In 2008, the Joint Commission’s Sentinel Event Alert #38 offered ferromagnetic detection systems as an example of a conformance tool for their objective of verified patient screening.
• In 2009, the American Society of Healthcare Engineering (ASHE) published a monograph entitled Designing and Engineering MRI Safety which explicitly called for ferromagnetic screening.
• In 2009, ECRI Institute published their Top-10 Medical Technology Hazards watch-list for 2010. On that list is MRI projectiles and among the ECRI Institute’s recommendations are ferromagnetic detection systems.

There are others, but you get the gist. The technology of the ferromagnetic detector answers the need for MRI projectile protection which was identified nearly 30 years ago. It fits precisely with the intention of GE’s original FDA application for approval of MRI as a clinical device, and with the much more recent statement by Siemens’ top MRI guy. It has been recommended by major institutional standards and both professional and accrediting bodies, so it must be a ‘done deal,’ right?

Unfortunately, there has been one missing element… a requirement for MRI projectile safety protections.

It turns out that ‘perfect fits’ with manufacturers’ intentions and a ‘who’s who’ list of recommending bodies wasn’t enough. Yes, there have been many adopters of ferromagnetic screening tools, but estimates are that most of the MRI providers in the US still don’t use ferromagnetic screening for people entering the MRI suite. If they’ve been waiting for a requirement, that wait is just about over.

42 of the 50 US states, the Joint Commission, and many, many other health regulatory bodies around the world, use the Guidelines for Design and Construction of Health Care Facilities, originally jointly produced by the American Institute of Architects (AIA) and the US department of Health and Human Services (HHS). With updates to the standard published every 3 to 4 years, Guidelines is, in effect, the building code that governs most licensed and accredited MRI providers in the US. The 2010 edition of Guidelines just came out last month.

In the 2010 edition, for the very first time, Guidelines includes MRI safety protection requirements in the design criteria. Here’s one excerpt from the new code:

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

That’s right, the inclusion of ferromagnetic detection systems is a requisite element of MRI suite design in the 2010 Guidelines!

Since the 2010 edition of Guidelines has only just been published, it hasn’t (as of this writing) yet been adopted by the various authorities that use Guidelines, but that’s only a question of time.

And while the Guidelines, as a building code, might only apply to new MRI facilities and newly-sited MRI equipment, it appears that this may be just the first requirement-domino to fall.

In 2006 (yes, four years ago), the ACR’s MR Safety Committee issued a formal request to the ACR’s MR Accreditation Committee, include the Safety Committee’s Guidance Document principles as requirements for MR site accreditation. The MR Accreditation Committee has agreed that it will do something relative to MR safety in the accreditation process, but has yet to specify what this will be. It makes sense to me that the ACR MR Accreditation Committee would (minimally) appropriate existing physical safety requirements put forward by other entities (preserving the ability to deflect criticism with, ‘it’s not our standard, it’s just one that many of our accredited providers will be held to by other agencies and we felt it prudent to include it in our accreditation standards to make sure that they weren’t otherwise caught unaware.”).

Similarly, the Joint Commission (TJC), having just received ‘deemed status’ and the ability to accredit advanced imaging providers (CT, MRI, PET) for the 2012 Medicare requirements, is purportedly working on imaging-specific patient safety standards. While TJC will adopt the 2010 Guidelines as their physical facility standard, that may also provide them with the ability to develop their own MR safety specific accreditation standards. I would expect to see a flurry of imaging-specific guidance and standards coming from TJC starting this summer / fall.

What does this all mean if you’re an MRI provider? One of the things it means is that if you don’t already have a ferromagnetic detection system, you should get one, and get it soon. Setting aside the ‘best practice’ standards, loss-reduction, safety improvement, and throughput benefits, ferromagnetic detectors will be requirements of accreditation and licensure.

If I can be of any assistance to you, navigating the new requirements or addressing questions about ferromagnetic detection, please do contact me.

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Nearly nine years after the accident, the lawsuit was settled for $2.9 million, a settlement that was likely both diminished by, and made possible by, a pre-trial motion which excused GE Healthcare as a defendant to the suit.

The county-owned hospital, which almost immediately asserted its responsibility for the accident, ultimately settled the case on behalf of all of the remaining defendants, which included the head of radiology and the technologist who administered the boy’s scan.

Perhaps now, with the lawsuit resolved, we can actually learn something about the events that precipitated this tragedy, beyond the fragmentary slivers of information gleaned from court documents and news accounts.

That’s right, despite the fact that this one event has become the touchstone for MRI safety, there has not been a single root-cause analysis to inform MRI suite design, departmental operations, regulatory and accreditation frameworks… at least not one that has been shared with the public.

Hopefully, with the lawsuit resolved and jeopardy attached for all defendants, we can have an open conversation about what contributed to the accident and what can be done, at the thousands of MRI suites across the country, to help see that this sort of accident never recurs. Based on recent news accounts and last year’s shocking collection of ferromagnetic projectile accidents, the lessons from the Colombini tragedy are still profoundly needed.

If we are willing to explore this darkest chapter in the brief history of MRI, we may learn lessons that will help protect the 30 million Americans who will receive MRI’s this year, and next year, and the year after that.

If we fail, next year we’ll be able to look back at this moment, wistfully, and imagine young Michael getting his drivers’ license, or attending his junior prom, on the verge of adulthood. But he is forever trapped in 2001… a victim of circumstances he had no control over.

Let’s see what we can do, together, to help make sure that this never happens again.

My heartfelt thoughts and prayers are extended to the Colombini family.

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