“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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Ready? OK…

Let’s start at the very beginning (“what a very good place to start”). Back in the 80′s, when GE was seeking FDA approval for their new-fangled ‘nuclear magnetic resonance’ scanner, they were keenly aware of the risks of things going flying into the giant magnet. It turns out to be extremely difficult to have a giant, super-powerful electromagnet (one that doesn’t have an on/off switch) that doesn’t draw in every conventional ferromagnetic wheelchair, oxygen tank, gurney, mop bucket, rolling cart, etc… that comes near.

New Ferromagnetic Detector Requirement to Mitigate Magnetic Projectiles Risks In MRI Suites

In an effort to help identify these threats before they were brought into the room, the GE application to the FDA called for mandatory metal detectors for screening patients and equipment as a part of each and every MRI installation.

Well, it turns out that this well-intentioned gesture was not very practical. As sites that have foolheartedly ventured down this path can tell you, darn near everything that is brought to the MRI suite has metal in it. This means that darn near everything, including objects that are at no risk of flying into the MRI, will set off the conventional metal detector. If the objective is to find only those things that would like to go flying into the MRI scanner, your conventional ‘airport style’ metal detector is of no use.

In the 1980′s there weren’t alternative means of detecting only ferromagnetic materials (those that become magnetized and get drawn to the MRI scanner), so the GE requirement for metal detection atrophied to nothing, becoming a forgotten (well-intended) bad idea.

Fast-forward about 20 years. At this point MRI technology is ubiquitous at hospitals (those with at least a couple hundred beds) across the country. Estimates were that there were somewhere around 8,000 MRI scanners in the US, and that most of them were GE products.

Concurrent with the growth in numbers of MRI scanners were increases in the magnetic strength and improvements to the ‘active shielding’ systems. Each of these enhancements had the coincidental effect of increasing the forces that draw magnetic materials into the scanner. When coupled, these factors actually multiplied the attractive force applied to magnetic objects, meaning that the risks associated with magnetic-projectiles flying into MRI scanners increased dramatically as the imaging technology advanced.

There have been magnetic-projectile accidents that jeopardize patients and staff in the MRI suite as long as there have been MRI scanners. The overwhelming majority of these remain ‘under the radar’ of safety, regulatory and accreditation bodies. One event occurred in the summer of 2001, however, that exploded through the veil of embarrassment that typically keeps these types of accidents secret.

In 2001, a young boy was anesthetized for an MRI scan and required oxygen during the exam. When the wall-outlet O2 didn’t work, the anesthesiologist called for oxygen. The technologists administering the exam left the control room to try and fix the oxygen supply problem and, while they were out, a nurse entered and told the anesthesiologist that there were oxygen tanks right there in the control room. Immediately upon bringing one of the portable tanks into the MRI scanner room, the magnetic field of the MRI ‘grabbed’ the tank and pulled it into the center of the doughnut-shaped scanner, where it struck the boy.

That six-year-old boy, Michael Colombini, died from the injuries a couple days later.

Splashed across the media and throughout radiology journals & trade publications, this event reignited the interest in metal detectors, many of the lessons learned from the prior experiments with ‘airport style’ detectors having been forgotten.

“If only there was a metal detector that only alarmed on magnetic materials,” was a common refrain. In 2001, there wasn’t (at least not an effective commercial product for pre-MRI screening). Ever the ‘mother of invention,’ the necessity for a magnetic-projectile screening tool prompted several companies, including Mednovus, to develop ferromagnetic only detection systems.

These products started becoming commercially available just a few years after the 2001 Colombini tragedy, and initially struggled to differentiate themselves from the failed legacy of’ ‘airport style’ detectors. In the years since, however, ferromagnetic detectors have become viewed as a valuable tool for safety in the MRI suite.

Would GE have mandated ferromagnetic detection (instead of the ‘airport style’ metal detectors) with their FDA application if the products had been available 20 years ago? Since the stated intention was to prevent projectile accidents, it would seem logical that they would have. They’re not the only MRI manufacturer to have indicated that choice, either.

In a 2008 interview with the Israeli business publication, Globes, Walter Marzendorfer, CEO of Siemens Medical Systems’ MRI Business Unit, was quoted as saying, “[t]he main safety issue where MRI is involved is the fact that it is a magnet. Accidents happen when a doctor enters the MRI room with a scalpel in his pocket and bends over the patient. People forget. There must be metal detectors at the entrance to every room with a MRI device.”

It would seem that Siemens has exactly the same take on the necessity for projectile safety in the MRI environment that GE had, namely that there should be some form of automated screening. I’ll chalk-up the use of the term “metal detector,” instead of the projectile-specific screening provided by a ferromagnetic detector, to the multiple languages likely involved in ultimately arriving at an English text. Both GE and Siemens have stated the necessity for some form of automated projectile screening, but it doesn’t end with the equipment manufacturers.

GE and Siemens aren’t alone in the calls for some form of  requisite screening for projectile risks…

• In 2007, the ACR Guidance Document for Safe MR Practices amended language from prior publications which recommended against ‘airport style’ detectors to include the explicit recommendation for using ferromagnetic detection systems.
• In 2008, the US Department of Veterans Affairs (VA) MRI Design Guide echoed this recommendation.
• In 2008, the Joint Commission’s Sentinel Event Alert #38 offered ferromagnetic detection systems as an example of a conformance tool for their objective of verified patient screening.
• In 2009, the American Society of Healthcare Engineering (ASHE) published a monograph entitled Designing and Engineering MRI Safety which explicitly called for ferromagnetic screening.
• In 2009, ECRI Institute published their Top-10 Medical Technology Hazards watch-list for 2010. On that list is MRI projectiles and among the ECRI Institute’s recommendations are ferromagnetic detection systems.

There are others, but you get the gist. The technology of the ferromagnetic detector answers the need for MRI projectile protection which was identified nearly 30 years ago. It fits precisely with the intention of GE’s original FDA application for approval of MRI as a clinical device, and with the much more recent statement by Siemens’ top MRI guy. It has been recommended by major institutional standards and both professional and accrediting bodies, so it must be a ‘done deal,’ right?

Unfortunately, there has been one missing element… a requirement for MRI projectile safety protections.

It turns out that ‘perfect fits’ with manufacturers’ intentions and a ‘who’s who’ list of recommending bodies wasn’t enough. Yes, there have been many adopters of ferromagnetic screening tools, but estimates are that most of the MRI providers in the US still don’t use ferromagnetic screening for people entering the MRI suite. If they’ve been waiting for a requirement, that wait is just about over.

42 of the 50 US states, the Joint Commission, and many, many other health regulatory bodies around the world, use the Guidelines for Design and Construction of Health Care Facilities, originally jointly produced by the American Institute of Architects (AIA) and the US department of Health and Human Services (HHS). With updates to the standard published every 3 to 4 years, Guidelines is, in effect, the building code that governs most licensed and accredited MRI providers in the US. The 2010 edition of Guidelines just came out last month.

In the 2010 edition, for the very first time, Guidelines includes MRI safety protection requirements in the design criteria. Here’s one excerpt from the new code:

2.2-3.4.4.2 Design configuration of the MRI suite

(1) Suites for MRI equipment shall be planned to conform to the four-zone screening and access control protocols identified in the American College of Radiology’s “Guidance Document for Safe MR Practices.”

(2) The layout shall include provisions for the following functions:

(a) Patient interviews and clinical screening
(b) Physical screening and changing areas (as indicated)
(c) Siting of ferromagnetic detection systems
(d) Access control
(e) Accommodation of site-specific clinical and operational requirements

That’s right, the inclusion of ferromagnetic detection systems is a requisite element of MRI suite design in the 2010 Guidelines!

Since the 2010 edition of Guidelines has only just been published, it hasn’t (as of this writing) yet been adopted by the various authorities that use Guidelines, but that’s only a question of time.

And while the Guidelines, as a building code, might only apply to new MRI facilities and newly-sited MRI equipment, it appears that this may be just the first requirement-domino to fall.

In 2006 (yes, four years ago), the ACR’s MR Safety Committee issued a formal request to the ACR’s MR Accreditation Committee, include the Safety Committee’s Guidance Document principles as requirements for MR site accreditation. The MR Accreditation Committee has agreed that it will do something relative to MR safety in the accreditation process, but has yet to specify what this will be. It makes sense to me that the ACR MR Accreditation Committee would (minimally) appropriate existing physical safety requirements put forward by other entities (preserving the ability to deflect criticism with, ‘it’s not our standard, it’s just one that many of our accredited providers will be held to by other agencies and we felt it prudent to include it in our accreditation standards to make sure that they weren’t otherwise caught unaware.”).

Similarly, the Joint Commission (TJC), having just received ‘deemed status’ and the ability to accredit advanced imaging providers (CT, MRI, PET) for the 2012 Medicare requirements, is purportedly working on imaging-specific patient safety standards. While TJC will adopt the 2010 Guidelines as their physical facility standard, that may also provide them with the ability to develop their own MR safety specific accreditation standards. I would expect to see a flurry of imaging-specific guidance and standards coming from TJC starting this summer / fall.

What does this all mean if you’re an MRI provider? One of the things it means is that if you don’t already have a ferromagnetic detection system, you should get one, and get it soon. Setting aside the ‘best practice’ standards, loss-reduction, safety improvement, and throughput benefits, ferromagnetic detectors will be requirements of accreditation and licensure.

If I can be of any assistance to you, navigating the new requirements or addressing questions about ferromagnetic detection, please do contact me.

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Throughout 2009, we saw tantalizing glimpses of potential MRI safety improvements, which repeatedly escaped becoming real. Here are my ‘Top 3′ near-miss opportunities of 2009 to substantially reshape MR safety…

• After failing to do anything with their Sentinel Event Alert #38 in 2008, JCAHO implemented an ‘Environment of Care’ standard which invoked SEA’s as a part of the required risk assessment, but failed to follow through on this rare 2nd opportunity.
• Formally requested (by their own MR Safety Committee) back in 2006, at the AHRA annual meeting the ACR announced that it would implement safety requirements as a part of MR Accreditation. To date there’s no evidence that any real progress has been made in developing this standard.
• The oft-delayed Colombini lawsuit, which held the promise of defining civil responsibility toward MR patient safety (since regulatory and accreditation standards appear lackluster, at best), fizzled in an ‘out-of-court’ settlement in October after some egregiously poor pre-trial decisions by the judge that largely absolved any individual responsibility for MR patient safety.

And yet, despite the barrage of setbacks, I am more confident about the year ahead than I have been before. ‘Why,’ you ask?

Starting January 12th, copies of the 2010 update for the Guidelines for Design and Construction of Healthcare Facilities (Guidelines, for short) will begin shipping. Guidelines is, in effect, the building code for hospitals throughout the US. The advanced draft I saw included MR safety design requirements, including the ACR 4-zone, line-of-sight situational awareness, and ferromagnetic detection. It will take many months for the various authorities having jurisdiction (AHJ’s) to adopt the 2010 edition of Guidelines, but the path to greater MR suite safety is clearly laid out in front of us.

Though getting MR safety into JCAHO surveyor training materials has been a non-starter for years, it looks as thought that’s about to end. SEA #38 on MRI accidents and injuries actually encapsulates some of the very best safety guidance available, and it appears as thought this year will be the first that JCAHO provides its surveyors with explicit training on the risks addressed in SEA #38.

In 2010 the ACR’s MR Safety Committee will be issuing an update to the Guidance Document for Safe MR Practices (the document originally known as the ‘White Paper on MR Safety’). Since the prior version, released in 2007, the American Society of Anesthesiology came out with their MR acuity levels which will hopefully be included as a part of the updated ACR document. This (and many other refinements) will help to tailor safety responses that are appropriate to the type and level of care provided.

The confluence of the other events should, in theory, make it much easier for the ACR’s MR Accreditation Committee to act on the now-four-year-old request to implement safety standards in the accreditation program.

Have you ever done one of those trust exercises where a number of people stand front-to-back in a tight ring, and everyone slowly sits down, putting their weight on the knees of the person behind them? 2010 now promises to be the year when Guidelines, JCAHO and the ACR (and, if we luck out, MR system manufacturers and the FDA) will form that ring.

Most bureaucratic regulatory / accreditation bodies dread being first, but long to be a quick second, in developing new standards.With the Guidelines document taking the first step, it will hopefully be much easier for JCAHO, ACR, and even the MR manufacturers and the FDA, to take ‘me too’ positions on MRI safety.

2010 holds tremendous promise for MR safety regulatory and accreditation improvements. A number of us will be working, diligently, to steer this herd of cats towards the goal of closing out 2010 with substantially more effective guidance / governance than 2009.

Here’s wishing each of you readers a healthy, happy, prosperous, and MR-accident free 2010!

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You can view the Aunt Minnie article by clicking here.

The first special event is a presentation that AHRA invited me to give entitled ‘MRI Safety, Liability, and Best Practice.’ If you received the conference program mailers a few weeks ago that indicated that I am giving this presentation on that first Sunday of the conference, don’t believe it! I am not giving this presentation on Sunday, but I am giving it on Monday, August 10th, from 2:30 – 4:00. (They’ve done a little juggling that changed a few scheduled presentations.)

The program will touch on a number of the MR safety developments of the last several years, though even more from a management perspective than any of my prior presentations to AHRA.

This is the first special invitation and I would very much love for you to join me on Monday afternoon. There are lots of other great sessions, however, and I understand if you have your eyes on another program scheduled for the same slot. I’ll miss you though, and will stare wistfully at your empty chair in the presentation.

Which brings me to my ½-event invitation. It’s actually a full event. It’s 90-minutes long, just like my Monday presentation. In fact, it’s almost exactly like the 90-minute Monday presentation because AHRA has asked me to offer this program twice! If you can’t make Monday afternoon, please come by Tuesday morning, from 8:00 – 9:30, to see ‘MRI Safety, Liability, and Best Practice’. I’ll actually feel much better on Monday if you’re not there, since we have this opportunity to meet up on Tuesday. And if you’re a glutton for punishment, or if you just want to see what I do to mix it up from one day to the next, you’re welcome to attend both sessions.

The last special event to which this post invites you is actually a revolving, ongoing set of conversations that I would love to share with you. When I’m not on the podium in front of large audiences, I will be in the Mednovus booth on the exhibit hall floor (booth #828 / 830), having one-on-one and small group conversations. I invite you to come by and join in a personal conversation with me and my colleagues about how best to prepare your MRI facility for the rapid-fire changes that are in process.

Though it’s only 4 weeks until AHRA, the great people at Mednovus are diligently working on special announcements that will be released in the lead-up to the annual meeting. Please stay tuned to be among the first to learn of what’s going on.

I hope to have the chance to see you at the annual meeting. Please do join me in one (or both) of my presentations, and do visit with me and my colleagues in our booth. I’m really looking forward to it.