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

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

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.

Click here for Tobias’ Twitter Profile

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.

Ferromagnetic detection doesn’t catch anything that existing screening protocols aren’t meant to catch.

That inflection makes a world of difference, as you’ll see in just a moment…

We’ve been screening for ferromagnetic materials as long as MRI has existed, but our historic technique of simply asking if someone has magnetic materials has not proven very effective. There are many accounts of magnet damage, injuries, and fatalities resulting from a failure to identify ferromagnetic materials before they were brought into the MRI room. And despite a universal familiarity with the risks of ferromagnetic materials, we as an industry seem unable to prevent them from recurring by using only these ‘old school’ screening protocols.

There was a policy in place to screen for ferromagnetic materials at this New York hospital in 2001:

And they had a policy to screen for ferromagnetic materials at this Seattle hospital in 2005:

They had a policy to screen for ferromagnetic materials at this hospital:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And here:

And lots, and lots of places that you can see here:

Honestly, I could drown you in pictures and accounts of ferromagnetic materials in the MRI suite. Suffice it to say that the accounts above are only the tip of the iceberg.

One of the most ironic (in light of what you’ve seen above) arguments against the need for ferromagnetic detection is that it isn’t foolproof.

Foolproof!?!? If that’s the standard, how can we reconcile the results of our conventional screening practices against this expectation of perfection? Clearly, we’re a very, very long way from that goal.

Instead of willfully disbelieving everything shown above… Instead of insisting on the infallibility of patient and visitor compliance with screening instructions, or the unblinking door-watching vigilance of the Technologists, or the guaranteed long-term effectiveness of MRI safety training for housekeeping, transport, engineering, security, anesthesia, ICU and respiratory staff, why can’t we accept that each of these protections, as valuable as they are, are imperfect, and that if maximum safety is our goal, we need to augment these long-standing – and incomplete – strategies with something new.

I freely state that ferromagnetic detection is not perfect. Under certain circumstances, it can miss things that we may want to find. It does, however, provide us with an entirely new feedback mechanism that helps us to more effectively monitor, train, screen, and protect people in the MRI environment. Imperfect though it is, it is remarkably effective at helping to improve the safety of everyone inside the MRI suite.

PS: I would like to thank the following people who have helped me by providing some of the images you’ve seen above, Moriel Ness Aiver, Raj Sangoi, and Keith Del Guercio.

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 Department of Veterans Affairs has an amazing resource, the National Center for Patient Safety, which has access to detailed accident evaluations that, by law, are kept confidential within the VA. What NCPS has done over the years, however, is to evaluate and distil the data, providing useful pictures of complex risk profiles.

Late last year, the NCPS updated their previously published ‘MR Hazard Summary‘ in which they quantified, for the first time, the average cost of one MRI missile accident at $43,172.

What isn’t included in the VA’s cost average, because they don’t operate on a per procedure reimbursement rate, is the lost revenue from MRI downtime. This 5-figure cost average does include magnet system damage, cost of care for injury accidents, costs associated with farming-out MRI patients to other providers, but not the overhead expenses and lost revenue that would be critical components of commercial providers’ costs.

Even though revenue for an efficient MRI provider should be on the order of $1,000 per hour and overhead costs are several thousand dollars per business day, let’s assume, for the sake of argument, that the VA’s number is equally true for the per-procedure payees.

• If a box of donuts will entice staff to a lunch-hour meeting, you could provide over 19 years of daily MRI safety updates to your staff for the cost of a single accident.
• Or, if MRI safety conferences cost $2,000 to attend, $43,172 would provide for 21 conferences (plus a little extra for the bar tabs) for a site’s Technologists.
• Or, for less than half of the cost of a single accident you could buy, have installed, and provide regular training for a pass-through Mednovus MRI Sentinel® ferromagnetic detector.
• Or you could provide the hand-held Mednovus SAFESCAN Target Scanner™ and have more than $40,000 left over!

When people assert that ferromagnetic screening tools are simply ‘too expensive,’ it must be because nobody has shown them the real business costs of just a single MRI missile accident. It’s not ferromagnetic detection that’s expensive, it’s the accidents that they help prevent!

Yes, every business must balance their books and money doesn’t materialize in the bank account simply because there is a need. But when substantial help with MRI safety for patients and staff is so cost-effective as compared to projectile accidents, and the ROI requires only grade school math, why wouldn’t every MRI provider provide ferromagnetic detection screening for patients, staff and equipment?

So here’s your call to action… if you haven’t already done so, finagle ferromagnetic detection into this year’s budgetary priorities. Avoid the unplanned $40,000+ ‘hit’ with a fiscally-wise, planned deployment of a ferromagnetic screening system.

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.