“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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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.

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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.