“Why — now — ten years later would you post these documents?”

Excellent question! Here’s why I didn’t publish these long ago…

I didn’t have them.

Yes, the civil suit had been underway for years. Yes, individual documents had been filed and made public during the course of the civil litigation, but the civil suit was only resolved a year ago and it took several months for the last of the documents to be made public through the Westchester County Clerk’s Office (who, by the way, were profoundly helpful in accessing these public records).

Here’s why I am publishing them now… Despite the fact that this is the watershed event in MR safety, the degree to which the industry has really dissected this event and identified the causative factors has been wanting. Desperately wanting.

I’m currently working with a colleague on a root-cause-analysis of this event, drilling down through the simple (don’t have ferrous oxygen tanks in the MR suite) to get at more meaningful elements of this accident that we can work to prevent similar accidents. It promises to be unlike anything you’ve learned about why this accident happened.

Given the trajectory of MR accidents and adverse events, this sort of analysis appears to be desperately needed.

So, what are the documents? They are transcripts of the depositions of many of the key people involved in the accident and couple of ‘official’ reviews. These are the source materials. The news accounts you’ve previously read are all synthesized from these (or from others’  interpretations of these). If you’re so inclined, you can download and read these for yourself.

The essential elements of the sequence of events for the accident are these:

• Michael Colombini, a young boy, was injured from a playground accident
• The ER had a head CT run, which revealed an unknown / asymptomatic brain tumor
• The boy had surgery very shortly thereafter to remove the tumor
• Prior to discharge, the boy was sent for a baseline MRI as a reference for future monitoring
• The boy was sedated prior to the exam and placed in the MR with a cannula to deliver oxygen
• Before the exam began, the anesthesiologist observed a decline in O2 saturation, and realized that the oxygen from the wall outlet was not flowing, despite his attempts to turn it up
• The anesthesiologist called the technologist who was to administer the exam to the door of the MR room, instructing her to find and fix the source of the problem with the oxygen flow
• This technologist was not familiar with the oxygen supply system, which — in apparent violation of codes — was fed to only the MR exam room from a bulk cylinder without any pressure or flow alarms
• The technologist sought her colleague who she believed knew the oxygen system and together they entered the MR equipment room to try and fix the supply problem
• The anesthesiologist cried out for help, though the technologists in the MR equipment room could not hear this
• A nurse (who had accompanied an earlier patient to the MR suite was returning to retrieve an item she had left) heard the anesthesiologist’s cries for help and handed him a portable cylinder near the door to the MR exam room
• The anesthesiologist turned to approach the boy with the oxygen tank when the magnetic attractive force of the MRI pulled the cylinder from the doctor’s grasp
• The tank flew into the MRI where it struck the boy in the face and head, inflicting fatal wounds

The following PDF documents vary in size from 1 MB to 25 MB, and will take a few minutes to download, depending on your connection speed.

Deposition of Patricia Lauria, technologist who was to have administered the Colombini scan
Deposition of Paul Daniels, other technologist on duty who assisted in the repair of the oxygen supply
Deposition of Jian Hou, MD, anesthesiologist who sedated / monitored Colombini for the MR exam
Deposition of Terrence Matalon, MD, Radiologist who was simultaneously the hospital’s Director of Radiology and president of the private company subcontracted by the hospital to provide operations for the MRI service
New York State Department of Health incident report
Westchester Medical Center incident review

As you might suspect, these documents are but the tip of the iceberg of the body of the court filings in this civil suit. However, for those interested in what happened and why (as opposed to the legal maneuvering), these documents are the most illuminating.

In the months ahead, the 10th anniversary of the 2001 Colombini fatality will include a deeper look into this accident and the changes that have taken place (and those that are still needed if we wish to avoid repeating this accident). This has begun, slowly, with the new building code requirements that are being adopted by various US states and the Joint Commission, but may pick up steam with federal government intervention.

Please check back periodically for the latest information on MRI safety… both as it relates to specific preventions, such as ferromagnetic detection systems, and broader awareness such as knowledge of the factors in the Colombini fatality.

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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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Just how much is the settlement? Well that’s (temporarily) subject to a little ‘good news – bad news’ dichotomy.

The good news is that the settlement is not confidential and will be part of the public record. The bad news is that we will have to wait a month or so until all of the formal paperwork is filed with the court to become part of the public record. The parties to the suit (and now the settlement) have agreed to keep everything on the down-low and not seek any publicity associated with the resolution. In short, they’re not talking.

My understanding is that Westchester Medical Center’s parent organization settled on behalf of itself, and the director of radiology / owner of the MRI management company, and the technologists who had been named. This settlement may, ironically, have been both enabled and motivated by the fact that GE had been dismissed as a defendant to the suit in a pre-trial motion.

I can’t begin to fathom the difficulty for the family, reliving their greatest loss through nearly a decade of incessant litigation. In that context, I can fully appreciate the desire to resolve the suit and avoid a trial. I have made no secret, however, of the fact that I wanted a public trial, replete with special reports from Sanjay Gupta televised on CNN.

Why would I want to shine such a glaringly bright light on our industry? Not out of any lack of sympathy for the family. Not to feed an irrational panic about what is one of the safest medical services available. But to focus attention on how we can eliminate at least 90% of all the MRI accidents through changes to operations and protocols. I even had a ‘dream team’ list of non-monetary concessions I wanted to see from the various parties.

From Westchester Medical Center: I wanted the hospital to honor the original promise of transparency made by then-hospital President and CEO, Edward Stolzenberger. I wanted articles, presentations, papers, that explained what went wrong, and what interventions they’ve developed (or that others have developed that they support). I’d like to see a real failure mode effects analysis (FMEA) for this accident.

From GE Healthcare: I wanted to see a new corporate policy that every MRI projectile accident for magnets under GE’s care of which they’re notified (as in “please come and pull out this wheelchair,” or, “we got the wheelchair out, but we need to have this busted coil replaced,” or, “did we ever tell you about what happened here last week?”) to be recorded. Three things should happen. The event should be recorded in the magnet’s service history. A letter should be sent to the client site, notifying them that the record of this accident (and the grave safety risk that it presented) has been entered in the service history. And an incident report should be filed with the FDA for their Medwatch database.

The Colombini family: I do know that one of the principal motivations for the family was to try and make sure that similar accidents don’t happen to other families. I would like to see them lend their name to the development of a fund dedicated to the promotion of MRI safety. In fact, it could be something like an endowed faculty position, but with an ad hoc expert paid to provide presentations or develop materials free from institutional bias. I can even think of someone I’d nominate for the ‘Colombini MR Safety Chair’… the name (absurdly) rhymes with “banal.”

Do I think that these things can still happen without their having been a trial and jury verdict? Yes, they can. My fear, however, is that each of the parties involved would like nothing more than for this entire event to ‘slip quietly into the night’ and fade from everyone’s memory. And while I understand that motivation, I’m afraid that this will rob us of the ability to leverage meaningful change from the MRI industry that would make the next fatality less likely.

UPDATE: Details of the lawsuit settlement are available here.

Now, this time line actually fits nicely within the trial judge’s own disposition deadline of January 4th, 2010. At the moment, however, there still is one unresolved pre-trial motion, and there’s nothing to say that the parties to the trial won’t want to go and file more motions (which may wind up pushing the entire time line back, yet again).

Just over a month ago, I wrote about the resolution of three of the pre-trial motions in this case. I was startled by what appears to me to be a disconnect between the judge’s decisions on some of the questions put to the court in the pre-trial motions, and the real world practice of MRI.

It remains to be seen if, as has been done with an earlier pre-trial decision rendered by this same judge, the attorneys for the Colombini family seek to challenge the judge’s rulings on responsibility and authority of the defendants. If that happens, I imagine that it could easily result in another postponement of the actual start of the trial.

If you are interested in following developments on the trial (and other issues of MRI safety) more closely, you are invited to follow me on Twitter for periodic updates, as they become available.

This case (and the event that precipitated it) are likely to be the most important influences on MR safety (hopefully) for a long time. I invite and encourage you to follow these events as they unfold.

UPDATE: Details of the finalized lawsuit settlement are available here.

The first of the three motions decided was from GE Healthcare, seeking to be excused, altogether, as a defendant in the case. The trial judge granted GE’s motion, citing (primarily) Riegel v. Medtronic which gives manufacturers of medical devices very broad protections in state courts because the devices have been vetted for safety at the federal level.

The second outstanding motion, which was one filed by the Colombini family’s attorney, sought the ability to reinstate punative damages claims against GE Healthcare for their involvement in the accident. This motion was rendered moot when the judge granted GE’s motion to be excused from the case, entirely.

The last of the decided motions was a smorgasbord of requests of the remaining (non-GE) defendants to dismiss claims against assorted defendants, to disallow punitive damages against some defendants, and to disallow claims of ‘emotional distress’ by the father of the boy.

• The judge dismissed all causes of action against the senior MR technologist in the suite at the time of the accident because (1) it was not demonstrated that he bore any responsibility for a safe suite environment (in fact the judge’s decision defines the limits of his responsibility to the scanner room, itself), and (2) he was not the tech administering the scan for the boy and therefore had no direct responsibility for his care. The judge’s notes also diminish the technologists’ role in safety by stating that they are not MD’s and had minimal safety training.
• The judged refused to dismiss claims agains New York Medical College (affiliated with the hospital) based on the College’s contention that NYMC had no direct role in training of persons involved in the accident, allowing this issue to be tried in court.
• The judge dismissed claims associated with the father’s contention that he suffered emotional distress based on the legal definition which requires that the person filing the claim feel “unreasonbly threatened by bodily harm” directly to them. That the father felt that his son was unreasonably threatened falls outside the legal definition for the basis of a claim of emotional distress.
• The judge refused to dismiss claims for punitive damages against UIMA, the company that ran the MRI unit for the hospital, allowing that the failure to provide complete and effective safety training may ammount to “utter indifference or conscious disregard for the safety of others.”
• The judge stated that she thought that the technologist administering the scan exaggerated her job duties when she had previously stated that technologists were the MRI suite “gatekeepers” with responsibility to keep a “watchful eye” to prevent ferromagnetic material from being brought in. Since, per the judge, overall suite safety was NOT deemed a reasonable responsibility of a technologist, the judge disallowed the possibility of punitive damages against the tech that administered the scan.
• Finally, the judge dismissed any action for punitive damages against the radiologist who served both as the hospital’s Director of Radiology and president of UIMA, the contractor providing MRI services to the hospital, because he “had no experience supervising MRI facilities . . . and did not view himself as having taken on any supervisory responsibilities with respect to the MRI facility. . .”

If we accept that some level of MRI safety should be a basic right of everyone inside the MRI suite (including staff), then we need to identify who has a role in making sure that MRI safety is actually implemented.

My view is that all parties involved in providing and administering MRI exams have an obligation to the safety of the patient. This includes the organizations who own and operate the scanners for establishing standards and providing applicable training and verifying competencies, directors / administrators / safety officers who have broad duties on behalf of the organization for the protection of patient safety, any person — whether MD, RN or technologist — who works in the MR environment, sites where accidents occur to report incidents in which there was a reasonable potential for harm, and MR equipment manufacturers to actively collect, report, and distribute details of accidents that might help others to better protect against these risks. These responsibilities are both institutional and individual.

If the judge’s decisions on these motions are not challenged (as has happened previously in this case), we should be inching closer towards a real trial date. As of the date of this post, the case is still scheduled to be fully resolved by early January of 2010. It remains to be seen whether that deadline will hold, or be pushed back.

If you would like to read this most recent decision by the judge on the three pre-trial motions she decided, it is available for download. Just click here to download the judge’s decision in Word format (.doc) from the blog site New York Injury Cases. To see the blog site, just click here.

Of course, if you come back here to the ‘MRI Metal Detector’ blog, or subscribe to the RSS updates (click here for more information on the free RSS subscription), I’ll provide you with any and all updates as I get them.

UPDATE: Details of the finalized lawsuit settlement are available here.

The Technologist, Laura Price, claims that her former employer, Horizon Diagnostic Center in Orange Park, FL, ignored repeated requests from Ms. Price and other Technologists to repair the coils on the MRI, and that the image quality was so poor as to compromise the clinical value of the scans. She was purportedly fired for insisting that the coils be repaired. She is suing for wrongful termination and has taken her efforts public in an interview with a local television news station.

What is particularly interesting (to me at least) is that there is not currently any claim of injury or misdiagnosis based on the claimed failure to keep the MRI equipment in operational condition. Therefore, this is strictly a claim against the practices of the provider and their adherence to standards of care and best practices.

Though the MRI fatality case has yet to go to trial (having been postponed ad nasuem for years, now), the Technologists are named defendants in that suit, suggesting at least that Techs have a legal obligation for safety and the standard of care.

This Florida suit is intriguing because it puts operations squarely in the legal crosshairs. When legal liability is tied only to injury, it fosters an ‘ends justify the means’ culture of safety. Something akin to, “if we haven’t hurt anybody, it proves that we’re doing things right.”

Many patient safety experts decry this sort of ‘negative proof’ of safety. Getting all the way across the freeway unscathed, on foot, blindfolded, is not proof that walking blindfolded across the freeway is a safe practice, yet this is the logic that prevades MR safety at many locations.

Whatever you may think of this one case, or the Technologist who is bringing it, I am very interested simply because it does put safety practices in the spotlight. I’m also very interested in what you may think of this, so please share your comments, below.

The multi-million dollar lawsuit has been grinding through the legal system as a myriad of claims and counter-claims have been ricocheting around among the parties. Those who’ve been watching the pre-trial activities may attest to it sometimes resembling a soap-opera with shifting alliances, but it appears that the parties’ day in court will come in less than 100 days.

While skillful lawyering often has as much to do with the outcome of civil actions as do the merits of the case, the merits fall clearly in favor of the family, and are squarely against the combined defense which includes the Medical Director, hospital, Technologists, and the MRI manufacturer.

The young boy was not the first patient to die in an MR and, given the current MRI accident trajectory, won’t be the last (and already isn’t according to some anecdotal accounts). What makes this incident such a touchstone, however, are the incidental facts surrounding the boy’s death.

First, could there be a more sympathetic victim than a young boy who had just survived the removal of an otherwise fatal brain tumor? Second, this fatality was splashed across CNN and newspapers and was not immediately gagged with non-disclosure agreements and out-of-court settlements which is common of many MRI injuries. Lastly, as the spark that ignited the MRI safety movement, many industry watchers will follow this case if only to observe the epilogue. But odds are that the civil trial will be as central to MRI safety as the original accident was.

Nearly 8 years after-the-fact and there is not a single MRI safety requirement that has been imposed that would short-circuit the sequence of events that caused the accident in the first place. There is an impressive list of recommendations and best-practice calls from a heretofore unrelated collection of professional and accrediting bodies, but no requirements.

Would a multi-million dollar judgment change that? I think that it would. I think that the fear of a high-profile lawsuit and a huge judgment would spur action in ways that the accident which precipitated it hasn’t.

We may all learn, in about 100 days, whether I’m right or not… whether the echo of this incident is as loud as the event itself.

UPDATE: Details of the finalized lawsuit settlement are available here.

In order for that accident to occur, a few standard procedures had to go awry, and not in ways that you might think. The anesthesiologist’s primary goal was to get his patient oxygen. The Technologists’ primary goal was to figure out why the oxygen (which the anesthesiologist was yelling for) wasn’t working. The nurse passing the MRI unit’s primary goal was to help out when she heard someone calling for help. This accident, like so many others, was the product of well-intended efforts in an environment where the rules are all imperceptibly changed.

There were a number of interventions that could have potentially broken the chain of events that resulted in this fatality. Better access controls, more effective training for the Technologists and anesthesiologist, storage to keep hazardous ferromagnetic materials out of sight, suitable portable cylinders, better QA/QC on the medical gas system… each of these might have been enough to avert this accident.

Add to this list the effective use of ferromagnetic detection, which might have provided the automatic feedback needed to sequester the fatal oxygen cylinder before the MRI exam even began, or remind the anesthesiologist of which materials were dangerous near the magnet, or provide warning feedback to the nurse who let herself into the suite.

As the Colombini accident illustrates, projectile accidents in the MRI suite are most often the result of multiple factors. Effectively interdicting these sorts of accidents requires vigilance on many fronts. While there are no ‘silver bullet’ solutions to MRI risks, no one product or training session that can eliminate the risks, there are products and solutions that help to minimize the risks. Most of the solutions have been around nearly as long as MRI, but only recently has ferromagnetic detection been added to the MR safety armamentarium.

This new ferromagnetic-only detection technology substantially increases the opportunity for Technologists and MR-staff to find and quarantine ferromagnetic threats worn by, or carried by, persons approaching the MRI magnet. In a forthcoming post I’ll describe the flurry of recent ‘best practice’ standards that all now call for the use of ferromagnetic detection to improve MRI safety.

UPDATE: Details of the finalized lawsuit settlement are available here.