“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 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.