“Hey, you, MR technologist! Make sure you know what you’re supposed to know to keep people safe around MRI.“

Make no mistake, as someone who spent a decade in college (which included a Masters degree and about half of a 2nd Bachelors), I’m a huge fan of education. What I’m adamantly opposed to – when it comes to MRI safety – is education without any standards or benchmarks, which is precisely where we find ourselves today.

The title of this post really isn’t far off the mark of what the current expectations of safety are. Regulatory, licensing and accreditation bodies seem to be unanimous in their concern that explicit MRI safety standards (even for education) would be ‘burdensome’ to the provider. As a result, many MRI providers find themselves in a position where they aren’t provided support tools to enhance safety, with the rationale that a ‘good tech is all you need.’ But at the same time, nobody has defined what MRI safety knowledge makes the ‘good tech’, well… good.

In a few weeks I’m going to be at the ACR ‘Maximizing Value in Radiology through Quality and Safety Improvements‘ meeting. At that meeting, I’ll be presenting information from a paper written by Dr. Emanuel Kanal and me; a retrospective analysis of FDA adverse event reports on MRI. The data is pretty grim.

Since 2004, reported MRI adverse event reports are up to a number more than 4-times what they were. Of the MR-specific reports, just over 92% of them fall into 3 categories, each of which could be significantly attenuated if existing ‘best practice’ guidance was simply adopted as required standards. Our analysis found that 80% of these adverse events had an explicit, measurable best practices that would have stopped them, and that doesn’t even include benefits to be gained from ill-defined standards for ‘provide MR safety training.’ Presumably enhanced training would both reinforce the explicit performance measures (enhancing the effectiveness of mitigating those 80% of events), and would likely diminish the 20% remainder that weren’t directly combated by the explicit measures.

So while the trend data is very disconcerting, the good news is that we already have the tools to reverse the alarming growth in MRI accidents. This patient safety initiative is so extremely ‘shovel ready’ that it could be deployed with little more than a few words amending existing accreditation and license standards.

In the meantime, imaging providers are slashing staffing ratios, cutting out travel allowances for conferences and training, seeking out less-experienced MR personnel (who will work for a lower salary). So while we admonish MR techs to ‘learn what you don’t know that you don’t know,’ we’re simultaneously taking away the tools that they might actually need to accomplish this near-impossible task.

In the weeks ahead I’ll be able to share more of Dr. Kanal’s and my research, but the take-away is already apparent…

We will continue to injure our MR patients, visitors and techs at increasing rates unless the accrediting bodies (ACR, TJC, and IAC), the regulatory authorities (FDA and individual State departments of health) and 800-pound gorilla payors (CMS) pick up and codify the practice standards that have been laid at their feet.

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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.

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

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

Between 2004 and 2008, MRI Accident Rates Increased 310%

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

What would happen in your town if:

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

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

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

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

NOTHING!

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

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

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This is just one example of a laundry-list of serious projectile accidents that occurred in 2009.

I should note that the above isn’t a real X-ray of this injury, but hopefully it was ‘real enough’ to at least get you to swallow hard at the thought.

In this incident occurred when a technologist was positioning the patient on the table for the MRI exam. At that moment, the person who brought the patient to the MRI department entered the room with a pair of ferromagnetic scissors. The rest, as they say, is history.

But what about this one event makes it worth holding out as an example?

It, like the many other serious projectile injuries of last year, was completely avoidable. And the same is true for the burn injuries, and those that occurred as a result of incomplete clinical screening. These three causes are responsible for over 90% of the serious injuries in MRI.

Often these occur because the only accident protection in place is the vigilance of the technologist on duty (which, increasingly often, is only a single individual). When everything depends on that one, fallible, individual, the process will break down.

Effective clinical screening depends, in part, on the appropriate prescription of MR studies by primary care clinicians (more than half of which, according to a recent study, were unaware that medical implants were a contraindication for MRI exams). A review of the patient’s accurate medical records, effective pre-screening by scheduling staff, careful review of the patient’s screening form, all of which should be done to reduce the burden on the Technologist.

For burns, patients should be transported to MR without any extraneous monitors, equipment or devices. Upon arriving, they should be switched to MR Conditional monitoring equipment, as needed. The site should provide ample insulating and positioning pads to properly situate the patient for the exam. As with the preliminary screening steps, these will also reduce the burden on the Tech’s unblinking vigilance to prevent these types of accidents.

For projectiles, it isn’t realistic to keep a metal-free MRI suite. This means that the objects which can hurt patients or staff, and damage million-dollar scanners, are littered, like time-bombs, throughout our day. Changing patients, educating key support staff, implementing rigorous access controls, and using ferromagnetic detection can dramatically cut the risks associated with projectile accidents.

These preventative steps, above, have two things in common. First, their almost universally accepted as industry best practice. Second, they are universally omitted from any patient safety requirements! That’s right, no regulatory or accreditation body has objective standard requirements for screening, positioning, or projectile protection!

As long as these instances of head-piercing scissors, or leg-crushing gurney rides, or brain-damaging flying carts, or face-whalloping monitor panels, or any of the others, are viewed as just text descriptions of statistical aberrations, instead of easily-preventable human tragedies, we’ll stay stuck with ineffectual recommendations and scores of stupid, stupid injuries.

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Yes, that’s right, a recent news story from the NBC television affiliate station in Jacksonville, Florida, provides an account of how an off-duty police officer’s pistol wound up stuck to their MRI scanner, and cost the provider something in the neighborhood of $150,000 to remove!

You pretty much have to ignore the completely unintelligible explanation as to how MRI’s work or what would have caused the gun to be attracted to the MRI, but the underlying story of a police officer’s pistol getting stuck to the magnet (and pinning her hand to the scanner) again demonstrates the seriousness and frequency of MRI accidents.

And it’s not as though this is the first time. There are other, similar accounts, including this one in which the magnet caused the pistol to fire, despite the fact that the safety was engaged.

Perhaps, since the industry hasn’t taken any formal steps to improve patient screening with standard procedures or tools, we may have needed a reminder about the pervasiveness of screening accidents on the local newscast.

Screening lapses are nothing new. Time and time again we demonstrate that an exclusive dependence upon the vigilance of MR Technologists is not the most effective way to prevent these accidents. Patient safety, and the protection of millions of dollars of MRI equipment should come from layers of protection.

Additional layers of protection, such as ferromagnetic detection, aren’t an indictment of our Technologists, they’re necessary supports to help ease the burden on Techs and provide the greatest protection possible to patients, visitors, and millions of dollars of MRI equipment.

PS: Though this isn’t a picture of the account in this story, the image below is of a gun, or more precisely a pistol, drawn into an MRI scanner. Between the photo, below, the newscast from Jacksonville, and the journal article linked above, clearly these pistol-versus-MRI accidents aren’t unheard of.

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.

Every so often there is an MRI accident description that is so stunning that it sends a jolt through me, reminding me why I do what I do. This is the entry that I came across just two weeks ago…

“Event Type Injury   Patient Outcome Life Threatening; Hospitalization Required Intervention”

‘Wait a minute… that may border on interesting (and I’m being very generous there), but that’s hardly a ‘jolt.’ What gives?’

Well, two weeks ago that exact same incident report described an accident in which an MR technologist had to be rushed to surgery to extract the pair of scissors from their forehead! Turns out that the tech was between the magnet and another staff person who had brought a pair of ferromagnetic scissors into the magnet room. The magnet ‘grabbed’ the scissors and started drawing them into the bore, but for the fact that the technologist’s head was in the way!

My longstanding complaint with the FDA and their MAUDE data has been that they seem completely disinterested in actually collecting it with regard to MRI accidents. The overwhelming majority of MRI accidents are a product of the inherent risks, and not a result of equipment malfunction and it seems to me as if the very existence of the MAUDE database is NOT as a patient safety tool, but as a CYA tool to validate that the approval of a medical device was warranted.

Now the hobbled MAUDE data (built on the FDA’s Medwatch program) has gone mute and the actual substance of an accident report is no longer there. Today there’s more information about the postal address of the company that manufactured the MRI than there is about the accident that is being reported, at least that’s the contemporary reality via the online database.

So I implore the FDA to please restore the narratives associated with MRI accidents. Removing this information does a grave disservice to patients and those who advocate for MRI patient safety.

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.

Eight years ago this month (July 27th, 2001, to be exact), young Michael Colombini was fatally injured in an MRI accident involving a portable oxygen cylinder. The week surrounding the date of that accident is set aside each year as MRI Safety Week. This year, 2009, it falls July 27th through August 2nd.

During MRI Safety Week, MRI providers are encouraged to provide additional emphasis on safety provisions, training, inspection and equipment. This could serve as the anniversary date for annual inspections (cryogen safety systems, infection control, etc…). It is sometimes the additional motivator for special projects like labeling all portable equipment with the contemporary MR Safe, MR Conditional, MR Unsafe labels and designations. And sometimes it can be an opportunity to reinforce safety training for our MR staff and share a little bit of our daily safety mission with those outside MRI.

To make this easier, I’m posting two free Jeopardy-styled MRI safety quizzes (in Power Point format) for you to use for your staff, or for those who may not be quite so familiar with MRI safety. These resources are available at my new MRI Safety Week webpage.

But beyond sharing these resources with you, I am also offering for this to serve as a clearinghouse of MRI safety resources that you want to share with your colleagues. Drop me an email (my contact information is always at the foot of each post, or in the ‘about Tobias Gilk, editor’ in the box above and to the right) and we’ll see if we can share your posters, table-tents, questionnaires, articles, quizzes, or other downloadable resource with the broader MRI community.

This year, MRI Safety Week is more important than ever. The number of MRI exams continues to slowly climb, year-over-year, but rates of reported accidents are skyrocketing! We’ve seen nearly a 3-fold increase in the number of MRI accident reports to the FDA in just the last 4 years. Collectively, we have the opportunity to make a substantial impact in MRI safety.

Thanks to Mednovus for allowing me the time and resources to prepare these materials for you. But mostly, thank you for joining with me in again celebrating and promoting excellence in MRI safety through this special week.

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.