Last month, the judge in the Michael Colombini lawsuit (the case resulting from the infamous death by oxygen tank / cylinder brought into the MRI room while the boy was in the scanner) decided on three of the last outstanding pre-trial motions. The Judge’s decisions appear to have excused one defendant, entirely, and tempered the degree of potential liability for others.
RT-Image brought a stack of their August 3rd issue to the AHRA and handed them out at the MRI safety presentation. Why (apart from general publicity)? Because the primary thrust of the issue was on many aspects of MRI safety. This issue has feature articles on the new MR Conditional pacemaker, infection control in the MRI suite, and even one that I wrote for them…
Once again, we’re approaching the anniversary date of the most infamous MRI fatality and the corresponding MRI Safety Week. This year, through the in-kind support of my employer, Mednovus, I’m able to make available a MRI safety quiz (actually, it’s two quizzes, one for radiology / MR staff and one for the MRI layperson).
One of the most oft-cited rationalizations for not complying with contemporary best practices that call for using ferromagnetic detection (FMD) for MRI pre-screening is that ‘FMD doesn’t catch anything that existing screening protocols aren’t meant to catch.’ What you may find surprising about this statement is that I agree with it wholeheartedly… I would just change the inflection a bit. I would say it more like…
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…
A few weeks ago I posted my layperson’s summary of why there’s even an issue with metal and MRI (click here to read that post on MRI and Metal). In this posting, I hope to explain why it’s so critical to find metals, particularly ferromagnetic metals, being carried by people or inside objects.
The ECRI Institute has again published their annual Top-10 Health Technology Hazards document for 2008, which is available as a free download from their website. Number 9 on the ECRI list is one of the well known MRI hazards. But before I tell you which MRI hazard made their list, let me give you a little background on what the ECRI Institute is and what they do…
I have a serial weakness for medical dramas. I get sucked-in and watch for a couple of seasons before the absurdity catches up with me. With respect to MRI, it seems that 99% of the time the shows are so wildly off-base that it seems that each must outdo its own crazy scenarios (and those of the other medical dramas) to come up with a new MRI-related plot gimmick.
But then, typically after I’ve lost all hope of seeing anything that approaches reality, something plausible and even downright real is shown on one of these programs…
There are a number of startling statistics related to MRI safety that I’ve been wanting to weave into a posting or two. In bits and bites, these data points are interesting, but it’s when they’re taken all together that they tell the greatest story. So, at the risk of writing my driest entry to date, here’s the picture painted by a slew of statistics…
I was tremendously honored to have been asked to give a presentation to the ISMRM / SMRT MR Safety Workshop which was held a couple weeks ago in Lisbon, Portugal. Mine was actually the second-to-last of two days of back-to-back-to-back presentations and I was worried that all of my content would have been covered by prior presenters. I mean MR safety is a pretty broad area, but still, having about 30+ notable MR authorities from around the world go before me, would my material be so well-worn before it was even my turn that my presentation would push the entire audience into a boredom-induced coma?
Turns out that I needn’t have worried…
ISMRM is a fabulous organization, but the long form of the organization’s name (the International Society for Magnetic Resonance in Medicine) gives a bit of indication about their perspective. The conference wasn’t broadly about MR safety (at least before they got to my presentation), it was about implants, dynamic field affects and heating… essentially safety at or inside the bore of the MRI.
- There was no discussion about staffing numbers or qualifications.
- There was no discussion of screening techniques or their effectiveness.
- There was no mention of access restrictions or 4-zone implementation.
- There wasn’t anything about whether or not MRI exams are actually getting any safer for patients… nothing provided as a metric as to whether the workshop’s efforts were providing any positive feedback to the MR industry.
- And certainly there was nothing about ferromagnetic detection.
Despite the fact that I was invited to speak on my perspective on MR safety issues before I joined Mednovus, a company which manufactures ferromagnetic detection (FMD) systems, and had planned on speaking about the technology, I thought that anything I said on the subject might be viewed as being motivated by personal financial interests. So I actually said nothing to the group about FMD. Instead I presented information on the official record of MRI accident rates in the US from the FDA MAUDE database over the last several years…
And I talked about how the physical design of the MRI suite can mitigate a number of risks that are inherent (and growing) in the MRI environment.
As MRI scanners are made more and more powerful, the projectile / missile effect increases. As we use MRI for older and more acutely ill patients, the risks associated with medical device contraindications grows. As we grow the interventional applications for MRI, we bring more people and more stuff into the MRI suite, increasing all sorts of risks. As the financial pressures increase the demand for greater throughput, the time allotted for preparation and pre-screening of patients may suffer, if not protected.
In short, the clinical, financial and technical forces on MRI are all combining to ratchet-up the risks in the MRI environment. MRI has a well-earned reputation as the safest and most informative diagnostic tool available, but that reputation is eroding and is at risk of being catapulted backward when another high-profile fatality is splashed across CNN.
I am deeply honored to have been asked to present at the ISMRM MR Safety Workshop and I hope to have many more opportunities to share my thoughts and experience with the group. My opinion, however, is that we’ve got a long way to go to get the professional, regulatory and accrediting bodies to address MRI safety in the holistic way that is necessary to bring about the substantial change needed to protect both MRI patients and providers.Tobias Gilk, President & MRI Safety Director Mednovus, Inc. Tobias.Gilk@Mednovus.com www.MEDNOVUS.com
Change is often difficult, especially when we’re asked to change the ways in which we do things and the change doesn’t appear to have any direct, personal benefit.
‘Employees will be required to park in “Lot K” beginning on September 1st.’
‘The company has switched health insurance providers and you will receive your new card in the mail in 4 – 6 weeks.’
‘All persons entering the MRI scanner room must successfully clear a ferromagnetic screening.’
Except that sometimes, things that don’t appear to be in our best interests in fact are to our personal benefit, and ferromagnetic detection is one of them.
First, let’s dispel the myth that ferromagnetic detection is somehow there to ‘grade’ the screening effectiveness of the Technologist. The fact is that most of the time when ferromagnetic material makes it through the screening process it is because the person bringing it failed to comply with instructions that they’d been given!
Yes, there are differences among Technologists and some are more thorough than others, going beyond the standard screening forms. But time and time again we find that projectile accidents are compliance lapses on the part of patients, visitors, contractors, transport, housekeeping, anesthesiology and the myriad of others who come to the MRI suite.
If you had a tool to verify that patients complied with your critical safety instructions, wouldn’t you want to use it?
So, ferromagnetic detection is – first and foremost – present to make sure that patients, staff and visitors comply with the MR Technologist’s instruction. An alarm on your ferromagnetic detector should be viewed as a patient compliance issue.
Second, ferromagnetic detectors help to protect Technologists (and medical directors, and radiology administrators) from liability. The civil lawsuit resulting from the death of the young boy in a 2001 MRI accident personally names the two Technologists and the medical director for the MRI provider. Even if they aren’t found to have any individual civil liability in the trial, they’ve already had a multi-million dollar lawsuit hanging over their heads for the last 6 years or so.
While the presence of a ferromagnetic detector won’t transform an MRI provider into a guaranteed accident-free site, when used effectively these instruments can dramatically improve compliance with the Technologist’s instructions and help reduce the likelihood of future ferromagnetic projectile / missile accidents.
Maybe there’s a silver lining to having to walk the extra two blocks from the newly designated employee parking lot or switching healthcare insurance companies (then again, maybe there isn’t), but there should be no question that ferromagnetic detectors are definitely in the best interests of Technologists, radiology administrators, and MRI medical directors.Tobias Gilk, President & MRI Safety Director Mednovus, Inc. Tobias.Gilk@Mednovus.com www.MEDNOVUS.com