First, a little background. I am neither beholden to, or have an axe to grind against, any of the prominent (potential) players in MRI safety. They’ve each provided me opportunities to advance the cause, and rebuffed me. In the interest of transparency, here are my relationships with both the American College of Radiology (ACR) and the Joint Commission (TJC).

Dr. Emanuel Kanal, MRI safety guru extraordinaire, has been the ACR’s MRI Safety Committee chairperson since the group was formed in 2001. He invited me to serve on that committee in 2006, and an ACR executive group, which holds veto power over committee appointments, approved me. I participated on that committee and am one of the authors of what became the 2007 ACR Guidance Document for Safe MR Practices. When Dr. Kanal successfully lobbied the ACR to support an update to the Guidance Document last year, the prior committee was disbanded and each individual was subject to re-appointment. I was renominated by Dr. Kanal, but my reappointment was blocked by the ACR executive group. I do not serve on the current incarnation of that committee (which is working on an update to the ACR Guidance Document due out later this year).

Through the ACR, I got one superb opportunity to influence MRI safety. I thought I would get more than one… but it was just one. I have no engrained personal interest in lifting up the ACR, so when I recommend the Guidance Document, it’s because I believe that this product is worth my support. Similarly, when I criticize the ACR with respect to MRI safety (as I did, pretty unabashedly, here), it is because I believe that they can do better, and not some petty personal resentment. I did, after all, get that superb opportunity through them.

Switching gears, my relationship with the Joint Commission is strikingly similar to my relationship with the ACR. Over the years, Joint Commission Resources (their educational arm) has asked me to write several pieces for them on MRI safety for various publications. They’ve also interviewed me for another publication (a piece that almost didn’t see print because of a disagreement between me and TJC’s Standards and Survey Methods division about what SEA #38 meant to an accredited provider’s internal risk assessment). I also had the opportunity to provide an introduction to MRI safety as surveyor training to TJC’s ambulatory accreditation surveyor corps after TJC was selected as an approved radiology accrediting body under the MIPPA law. That’s the good (or, at least ‘mostly good’).

TJC is a large organization, and while I’ve gotten along successfully with their education group, spoken at one of their conferences, and provided services to their ambulatory group, the ‘mother ship’ of TJC is their hospital accreditation organization. I’ve butted heads, usually privately… though sometimes not, with the hospital side of the organization. Most recently I’ve been informed that TJC can not accept any of my services, paid or volunteered, because of a potential appearance of a conflict of interest. Effectively, I’ve been ‘blackballed’ from the Joint Commission. While there is much more that I would like to accomplish with and through TJC, I’ve already managed to do a fair amount with them. As with the ACR, I think I’m on even terms with TJC… no debt… no malice.

I lay this groundwork to get around to the main gist of this post. A few weeks ago I posted, and then, within a week, took down the TJC companion piece to the ACR critique.

“Why would you give preferential treatment to the Joint Commission… or did you go off the deep-end and say something you regretted?”

I think that the TJC piece was equivalent to the ACR piece. They’re both accurate and critical of certain actions within each organization. I don’t think that anything in either piece is inflammatory, or hurtful. I didn’t write anything that I regret having put down in bits. I know that several regular readers of this blog did see the TJC piece, and I invite any who did read it to post with any thoughts they had that it was / wasn’t appropriate and fair.

“So, why’d you take it down then?”

Those of you who know me know that I’m something of an MRI safety evangelist. I have said and done (foolishly and unrepentantly) things that were not in my own personal best interest when I felt that they advanced MRI safety. I have zero interest in having an “I told you so” moment, either in elevating myself or in denigrating healthcare / radiology institutions. I want improvement. I want results. And that’s why I took down the Joint Commission critique.

“Ummm, OK… But how did taking it down advance those improvements or results?”

For a long time, years in fact, TJC has been toying with the idea of substantive MRI safety programs, but there are both internal and external hurdles to overcome to allow this to happen. Every historical effort towards implementing MRI safety on the hospital side of the organization has atrophied and died.

Very shortly after I posted the Joint Commission MRI safety critique, I learned that my friend and colleague, Dr. Kanal, was arranging a meeting with TJC to re-spark the conversation about advancing MRI safety within TJC’s hospital accreditation program. While I have no direct involvement with TJC and Dr. Kanal in these conversations, Dr. Kanal and I did collaborate for the non-hospital MRI safety introduction for the Joint Commission, and I didn’t want the critique I wrote, coupled with any legacy of prior collaboration, to poison Dr. Kanal’s current efforts. So I took the post down.

If I felt that there were any parallel efforts underway at the ACR, and that taking down that post would advance those efforts, I’d pull it down in a heartbeat, too. To my knowledge, however, there aren’t, so until I see an advantage to taking it down, it stays and I invite everyone interested in this topic to read it, here.

And if the situation with the Joint Commission changes, and the current effort on MRI safety slips into the comfortable, well-worn precedent of failure, know that the post isn’t gone, it’s only disappeared, and will reappear if / when it’s absence isn’t more constructive.

Ultimately, it’s all about affecting change. We expect that we have thousands, perhaps tens-of-thousands, of MRI adverse events occurring every year in the US, and the vast, VAST majority of these are readily preventable, or would be if we had enforced standards. That’s what I’m after.

And this is me, being as transparent about the whole situation as I can be.

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So, here is the justification my new nPSG, using the Joint Commission’s own words…

PPS (a Joint Commission publication) Feb, 2007 – “Safety in the MRI suite is both vitally important and unusually challenging to implement because of the invisibility of of the threats coupled with the increasingly common presence of objects that MRI can act upon with disastrous results.”

SEA #38, Preventing Accidents and Injuries in the MRI Suite, Feb, 2008 – “The Joint Commission offers the following recommendations and strategies to health care organizations for reducing  MRI accidents and injuries:” [Ten explicit objectives follow]

EoC News (a Joint Commission publication) May, 2009 – “In January 2009, the Joint Commission issued Standard EC.02.02.01, Element of Performance (EP) 1, which lists Sentinel Event Alert among the sources of information to assist in proactively identifying safety and security risks associated with the environment of care.”

EC.02.01.01 – “The organization identifies safety and security risks associated with the environment of care. Note: Risks are identified from internal sources… …and from credible external sources such as Sentinel Event Alerts.”

EoC News (a Joint Commission publication) May, 2009 – “…[W]e do ask each organization to look at the literature — any credible external sources, such as Sentinel Event Alerts — and put into place those things that can help prevent a safety incident involving their patients.” — John Fishbeck, R. A., Associate Director, Department of Standards, The Joint Commission.

SEA #38, Preventing Accidents and Injuries in the MRI Suite, Feb, 2008 – “Implement systems to support safe MRI practice such as written protocols and checklists and periodically review, and assess compliance with your organization’s MRI policies, procedures and protocols.” — paraphrasing Dr. Emanuel Kanal, FACR, FISMRM

Admittedly, a good editor could take my own words and re-purpose them to say something that I would find antithetical, but that’s not what I’ve done here. While I suspect that voices within the Joint Commission might be quick to come up with qualifications / rationalizations as to the un-enforceability of MRI safety, I can’t imagine that they would actually disagree with words that they themselves have spoken, written or published on the subject.

What follows are the 2011 nPSG’s which follow, fairly directly, from the hazard description above:

• nPSG.11.01.01 – Accredited Health Care Organizations that provide MR services must perform a risk / hazard analysis for those services in accordance with EC.02.01.01.
• nPSG.11.01.02 – Provide access restrictions, and both clinical and physical screening, for all persons prior to being granted access to the controlled access areas of the MRI suite, in accordance with the ACR Guidance Document for Safe MR Practices: 2007 and the ACR 4-Zone model described therein.
• nPSG.11.01.03 – Appoint a dedicated MR safety officer with responsibility and authority for implementing and enforcing MR safety procedures.
• nPSG.11.01.04 – Provide and document MR safety training for all MR staff at least annually.
• nPSG.11.01.05 – Use only portable equipment tested and approved as ‘MR Safe’ or ‘MR Conditional’ as appropriate to the MR environment.
• nPSG.11.01.06 – Provide ferromagnetic (only) detection screening for persons and objects prior to admission to controlled access areas within the MRI suite as stipulated in nPSG.11.01.02.
• nPSG.11.01.o7 – Provide padding in accordance with MR equipment manufacturer recommendations to isolate patients from RF coil elements or from conductive materials in proximity to the patient (including the skin-to-skin contact of the patient’s own tissues) during the MR exam.
• nPSG.11.01.08 – Provide hearing protection for all persons in the MR examination room during the MR exam, verifying proper fit before initiation of the exam.

These 8 nPSG’s, if enforced, could actually slash the number of MR accidents dramatically! A retrospective analysis of MRI accident reports to the FDA indicated that more than 92% of MRI clinical adverse events are burns, projectiles and hearing damage. Adherence to these 8 steps could nearly eliminate MRI accidents and injuries!

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“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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This past weekend I had the privilege of participating in OSU MRI conference. I was able to sit-in on a number of the presenters, plus I presented, and was asked to sit-in on a panel discussion on safety with Bill Faulkner and Candi Roth. The conference provided me the opportunity to hear from a number techs regarding their most recent Joint Commission surveys, and I was encouraged by what they had to say.

My (longstanding) prior criticism of the Joint Commission and their MRI patient safety survey efforts have centered around one simple fact… they didn’t do anything with respect to MRI safety. JCAHO hasn’t ever had MRI-specific standards or survey criteria, but I was certain that the 2008 release of Sentinel Event Alert #38 on MRI accidents and injuries would change that, instantaneously (a SEA being the Joint Commission’s ultimate patient safety warning). It didn’t.

I was certain that the change to the Joint Commission’s 2009 changes to their Environment of Care (EC) standard which specifically invoked Sentinel Event Alerts would immediately change their survey methods. Reports I received from JCAHO accredited providers who were surveyed in the first half of 2009 indicated that I was to be disappointed again. But at the OSU conference, the clouds parted and glorious beams of hope shot down from the sky and landed on me.

Yes, I did hear several of the expected ‘their shadow never crossed our doorway’ stories of JCAHO surveyors ignoring MRI. There were also the accounts of ‘checked fire extinguisher and walked out.’ As little as one year ago, I would have expected that to be the end of the list, but several people came up to me and recounted recent surveys in which Joint Commission surveyors asked about…

• Screening forms
• ACR four-zone separations
• MR Conditional equipment
• Infection control procedures
• Emergent / code procedures, and,
• Ferromagnetic screening

One person told me of how the surveyor spent more than 30 minutes in their department, tracing the entire sequence of the screening and care of an MRI patient.

These heartening stories of surveyor attention to MRI were the minority, but given that JCAHO surveys occur on a 3-year interval, that there was any change in the status quo in the past year is likely an indicator of a significant prioritization of MRI safety at the Joint Commission.

The hazards of MRI come from the fact that – as soon as you step into that room – the fundamental laws of physics change, without any outward indication. Non-ferromagnetic objects still fall down, but ‘gravity’ works in a different direction for magnetic materials. This simple, invisible truth requires a host of MRI-specific safety protocols. Application of generalized hospital-wide patient safety standards to MRI hasn’t worked terribly well (as in, not at all) in the past, so I can’t tell you how encouraged I am by this recent news.

If one is truly interested in patient safety, and has been critical of others for a lack of attention to these issues, there is no sweeter sound than to hear that you are wrong. When weighed against the benefits to be realized by MRI patients, staff and providers from enhanced safety (fewer accidents), any swelling of my personal ego is of zero importance. I hope that the degree of my wrongitude only grows from here going forward.

‘On the Joint Commission,’ I should add. I do have my weekly PowerBall lottery ticket, and I would very much love to be right on that.

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The other two have had modality-specific accreditation programs for years, so what was the TJC going to do? Well, they’ve released their accreditation criteria, and one of the most wonderful surprises is that MRI safety is more prominent than it is in either of the other two ‘imaging’ accrediting bodies!

That’s right, the ACR, despite having been the name behind three publications of the ‘White Paper on MR Safety’  (now the ‘Guidance Document for Safe MRI Practices’), has no physical safety standards for their MRI accreditation program. And at last check, ICAMRL didn’t even have the contemporary terminology for MRI safety-tested medical devices in their standards. So, in an amazing ‘come from behind’ showing, TJC has now bested the veteran agencies in patient safety protections.

From the perspective of MRI patient safety, one of the most wonderful things is the addition to the Joint Commission’s Environment of Care (EC) standard. In this updated version (effective immediately), TJC explicitly mandates MRI safety protections:

Excerpted from EC 02.01.01, EP 14

At a minimum, the organization manages safety risks in the magnetic resonance imaging (MRI) environment associated with the following:
- Patients who may experience claustrophobia, anxiety, or emotional distress
- Patients who may require urgent or emergent medical care
- Metallic implants and devices
- Ferrous objects entering the MRI environment

OK, I might have chosen a slightly different list, but these four items nail some of the greatest environmental threats to the safety of patients and staff in the MRI suite. And given that it’s the first requirement from an accrediting body (the recent MRI safety changes to the healthcare building code, Guidelines, are regulatory / licensure requirements), I’m more than happy to give JCAHO a little slack.

If you would like to download your own PDF copy of the changes to the ambulatory accreditation program’s Environment of Care standards, which includes the explicit MRI safety requirements, identified above, please click here.

In a nutshell, these new standards echo many, many prior recommendations, including JCAHO’s own, for MRI safety. Namely, these are to plan for emergent situations, screen patients more effectively for contraindications, and screen for ferromagnetic materials.

With the new EC standards it is no longer acceptable to simply say, ‘yeah, we have a policy and procedure manual that outlines how to handle each of these.’ Now, as a part of regular accreditation, providers will have to provide risk assessments and explain how their actions are proportionate responses to those risks.

Earlier in that same EC standard, it makes specific mention to seeking external sources of information to establish risks and responses. For MRI, that list would likely include the ACR Guidance Document, the VA’s MRI Design Guide, the ASHE monograph ‘Designing and Engineering MRI Safety’, the ECRI Institute’s Top-10 Medical Technology Hazards, and perhaps even the MHRA MRI risk assessment.

What recommendation is common to all of these industry-standard-setting publications (that explicitly addresses one of the 4 new EC requirements)? The use of ferromagnetic detection systems.

As you conduct your risk assessments, and determine a path to MRI safety and regulatory conformance, I hope that you’ll contact the people at Mednovus regarding their ferromagnetic MRI screening systems. When your next state or accreditation surveyor comes around, you’ll be so very glad you did.

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The National Council on Aging just released a study which details these alarming numbers. The matter-of-fact language of their release did nothing to diminish my welling fear as the study went on to detail chronic failures in our healthcare system to educate, alert, and prevent the dangers inherent in MR imaging of medical implant patients. Here are a few of the particulars:

• Medical implant patients over age 65 have between a 50% and 75% chance of requiring imaging during the useful life of their implant.
• While 90% of physicians knew of MRI risks for some pacemakers, over half of doctors say that they aren’t informed about imaging limitations when a patient is implanted.
• Nearly a third of patients who receive medical implants are not informed of MRI restrictions.
• After exposed to the MRI risks to their implant, nearly 20% of these device patients experience some sort of problem or malfunction with their implant.

Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams

The near universal opinion (98%) of healthcare providers is that they require additional information and training on these MRI safety risks.

Let’s hope that regulatory (FDA and States) and accreditation (JCAHO, ACR, and IC) bodies for MR imaging look at ways that they can take a more active role in promoting education and protecting these patients.

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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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For those of you who aren’t familiar with the Guidelines, they are the design requirements that are cited by the Joint Commission and, at last count, 42 of the 50 U.S. State Departments of Health. Technically, they aren’t a building code, but the function in almost the exact same way. For the first time, the Guidelines are going to have specific MRI suite design requirements for patient safety.

2010 Guidelines

The 2010 edition of the Guidelines are purported to codify the single most often cited MRI suite safety design criteria, the 5-gauss line (or three-dimensional bubble, more accurately). The design must necessarily control access to locations where the static magnetic field is present at strengths of 5-gauss or more.

the 2010 Guidelines will also define situational-awareness requirements for suite layouts. These will include a requirement that the patient can be seen inside the scanner from the operators’ console location, and that the operator has direct visual control of the entrance to the MR scanner room.

The unique challenges of infection control and handwashing in the MRI environment are also explicitly addressed, for the first time, in the new Guidelines.

And one of my favorite provisions is the new requirement that MRI suites be designed to follow the ACR 4-Zone model for screening and access controls, including ferromagnetic detection systems!

The Guidelines publication is undergoing a significant organizational overhaul along with the regular content update, so I don’t have specific section citations to where the new MRI safety design requirements will be (though MRI probably won’t have the same section numbers as the current, 2006, edition has). My understanding, however, is that the publication will be released on schedule in January, so it is only a very short time until we can verify the specific contents and section numbers.

It is particularly encouraging that these new requirements validate what the some of the best MRI providers have been doing for years. Clearly MRI site-safety, including ferromagnetic detection, can no longer be regarded as simply “a good idea.” With the 2010 edition of Guidelines, we will have one more codified example of how these elements are truly part of the contemporary standard of care.

If you would like more information about the Guidelines, including information on how to order a copy of the document, please click here.

Link

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.