In nearly concurrent moves, the Joint Commission (JC) unveils their just-developed Advanced Imaging (AI) accreditation program, the FDA is clamoring for new authority to regulate medical device safety (or gearing-up to use authority that it’s been hiding for safe-keeping, that isn’t exactly clear to me), the US Congress whips together a set of hearings on the issue, and, at those hearings,  the American College of Radiology (ACR) recommends that the Feds expand the scope of the AI accreditation requirement to include radiation therapy and to apply the expanded accreditation requirements to hospitals, too.

Whew, that’s a lot of ground covered for radiology in just the last few weeks! Wait a minute… who is that sitting in the backseat? Who has been drug through all of the hullabaloo about radiation exposure and patient safety without once having been considered, individually? MRI, that’s who.

So congress is alarmed at the lack of regulatory oversight on ionizing modalities, such as CT or beam therapies, hmm? The ACR couldn’t get to the hearings fast enough to recommend that the Congress mandate both deeper and broader accreditation requirements (which the ACR would be pleased to provide, by the way). The argument in favor of these enhanced accreditation requirements is that the patchwork body of existing state requirements are simply inadequate to protect patient safety.

What was the reaction to the fact that there are zero (and I’m not being dramatic here… I mean zero) requirements at state or federal levels for physical safety around MRI systems? Or what was the reaction to the fact that the FDA’s own data shows a near-four-fold increase in the number of MRI accidents in recent years? What about the fact that in states like Missouri, where I was born, don’t even require any credentialling of technologists who administer MRI exams? (Seriously, in Missouri you have to have vastly more proof-of-competence to give someone colored highlights in their hair than administer their MRI exam.)

MRI Accidents As Reported To The FDA

What was the reaction? None. Nada. Zilch.

Why? Because MRI has just been ‘along for the ride,’ apparently.

Regulation:

It’s important to realize that the bulk of radiology’s regulatory oversight grew out of federal standards for ionizing radiation protection of workers on the Manhattan project. Those standards became the template to be adopted and adapted by the individual states. The FDA, which regulates the approval of radiology equipment as diagnostic or therapeutic device, has left the oversight of the safety of the administration of that exam / procedure to the states.

What resulted was a patchwork of mix-matched state regulations governing ionizing radiation devices that use X-rays (such as CT and mammography), and radioisotopes (such as in nuclear medicine and many therapies).

In the 80′s, MRI came along. Since MRI didn’t use ionizing radiation, it was almost as if the absence of regulation was seen as ‘proof’ that MRI was safe. Neither hospitals nor the equipment manufacturers were interested in promoting regulation for this new modality, and quite honestly most state authorities and elected officials didn’t really understand what MRI was (and their inaction probably saved us from some very bad legislation at the time… look no further than the contemporary European Physical Agents Directive to see what ill-informed regulation can do to MRI).

Accreditation:

Let there be no mistake about it, MRI accreditation efforts have been driven primarily by payors. Apart from the last few weeks, the overall accreditation program balance between image quality and patient safety has leaned heavily towards the side of image quality. Let’s use the ACR’s MRI accreditation program as the example…

To be accredited by the ACR for MRI, there is a long list of quality controls that have to be implemented regularly. And since image interpretation is largely a qualitative skill, the ACR went so far as to develop a specialized imaging phantom to distill otherwise-subjective quality differences into objective tests (can you see the proper number of spokes on the phantom image?). There are logs, tests, data-collection, reports, all necessary to help assure that the machine is capable of producing pictures of a minimum requisite quality.

ACR Phantom Showing Radiating 'Spokes' Of Contrast Dots

At the same time that the ACR has made such remarkable efforts at standardizing measures of quality, they have largely ignored even their own MR Safety Committee’s request to include physical safety criteria in the MR accreditation program.

In 2006, during the MR Safety Committee’s working session to develop what became the ACR Guidance Document for Safe MR Practices: 2007, the Safety Committee, unanimously, issued a formal request to the College to include the standards developed by the Safety Committee as a part of the MR accreditation program. Four years later, there is no objective evidence that this formal request has been taken seriously.

Both the ACR and the other primary imaging accrediting body, the Intersocietal Accreditation Commission (IAC), assert that their standards for MRI accreditation are serious and robust, yet neither have identified how their MRI safety standards have successfully responded to the nearly 300% increase in MRI accidents in the last several years. If these accrediting bodies are serious about MRI safety, how can the reconcile the alarming MRI accident growth with their wet-noodle protections?

I have left the Joint Commission out of this evaluation of accreditation standards because – prior to this year – the JC has not offered a single modality-specific accreditation standard for MRI, or any other imaging device. From an MRI patient safety perspective, they’ve been virtually a non-factor, even though their accreditation services cover thousands of providers across the US that offer MRI services.

So today, MRI is lumped-in with CT and PET as a part of the AI accreditation program. And AI accreditation is largely seen as the way to address the headline-grabbing concerns about ionizing radiation exposure.

To be perfectly clear, I support greater attention to standards and safeguards for ionizing modalities, but I find the omission of any mention of MRI safety in the current conversation surrounding the Advanced Imaging accreditation program as an indictment of the earnestness of this as a patient safety campaign.

I think that accreditation should follow the path that the ACR has laid out, and I don’t begrudge them their efforts at positioning themselves as the preferred accrediting body for this expanded role. However, I think that a little ‘truth in advertising’ is called for (one could even call it a quid pro quo).

The ACR (and IAC, who I imagine is equally interested in expanded mandatory accreditation) should balance their own indisputable self-interest in new accreditation requirements with some substantive action on objective MRI physical safety requirements. Standards for MRI safety have literally been ‘laid at their doorstep,’ now all they have to do is adopt them.

If we fail to look at the escalating rates of accidents and injuries in MRI and address them as a part of the broader ‘radiology safety’ conversation; if we focus solely on ionizing radiation to the exclusion of all else, then we will again ignore the giant magnetic elephant in the room… the one that represents the alarming rate at which we’re increasingly injuring MRI patients.

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Much to my surprise (and delight), this is happening with the new Guidelines for Design and Construction of Health Care Facilities (or Guidelines, for short). Though the 2010 edition of Guidelines has only been published for about a month (and the publisher has been struggling to catch up on back-ordered copies), two states have already adopted the 2010 edition as their requirements for licensure.

That’s right, in less than a month, the states of New Jersey and Georgia have already moved to the new 2010 edition of Guidelines, complete with its wholly rewritten section on MRI suite design and safety. What does this lightning-fast adoption of the new edition of Guidelines foretell for the other states and authorities (like the Joint Commission) that use Guidelines for their standard?

"As go Georgia and New Jersey, so goes the rest of the nation..."

“If the Guidelines code is updated every 3 – 4 years, why is this update so significant for MRI suite safety and design?”

Excellent question. The answer lies in what hasn’t been in the past 25-years worth of Guidelines, and that is any sort of design standard pertaining to safety for the MRI suite. Clinical MRI has been around that long, and yet the last edition of the standard (released in 2006) had nothing about MRI safety. If you just compared the number of words in that prior edition, there was nearly 5 times as much guidance for laundry facilities as there was for MRI.

And though it may not be significant from an MRI safety standpoint, a number of authorities – the Joint Commission among them – still reference the 2003 edition of Guidelines! Given the pace of healthcare developments, it’s hard to imagine anything remaining unchanged over a 7-year period. Georgia and New Jersey are just the first in what appears to be a multi-jurisdiction sprint to the new standards (some just staying current, others playing ‘catch-up’).

“What does this mean for MRI suites and the hospitals and imaging centers that build them?”

Among other things, it means that the verbatim cut-and-paste templates from the MRI equipment vendors are now insufficient for state licensure approval (I contend that they, alone, have been insufficient on many levels, but until now state licensure hasn’t been one of them). MRI suites will now have to be designed to respond to the new line-of-sight, access-controls, and ferromagnetic screening requirements in the 2010 edition of Guidelines.

Architects, engineers, equipment planners and facility managers are all having the performance bar raised relative to MRI safety design provisions. Here’s just one section of the new requirements for MRI suite design in the 2010 edition of Guidelines:

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

While I was expecting the roll-call of states adopting the contemporary 2010 edition of Guidelines to begin late this spring, or even this summer, I’m very pleased that this has bested my expectations. This means that as of right now, the new MRI safety standards are already required at the state level in Georgia and New Jersey… months ahead of schedule. We may actually see a very sizable number of authorities moved to the current version by this summer, the time I had expected the first adopters to announce.

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It suggests that, legally, you’re out on your own.

Let’s contrast this with two situations, starting with an adverse Gadolinium contrast reaction.

If a site were to inject a patient with impaired renal function with Gadolinium contrast and that patient developed NSF (God forbid), and the damages were determined to be $10 million, that patient could conceivably sue the pharmaceutical manufacturer for failing to make the NSF warning sufficiently bold on the packaging (by the way, watch for news reports of lawsuits mimicking this hypothetical model following this decision). Yes, the provider would likely have a piece of the $10 million pie, but the liability would move up and down the ‘food chain’.

If, on the other hand, a catastrophic SAR accident in MRI facility were to critically injure a patient, and the damages for that accident were similarly determined to be $10 million, the Supreme Court decision suggests that the device manufacturer can not be held liable in a state suit. This reasoning concludes that the sum-total of any liability, malfunction, or negligence is laid at the feet of the MRI provider.

Personally, I think that these two decisions bracket the area where the law should be on this issue, but they are both so far from the rational middle-ground that it will require at least one more case before we can begin to make sense of this.

In the meantime, what this suggests to me is that MRI providers are out in the legal forest with no ‘Hansel and Gretel’ breadcrumb trail back to others who share their responsibility to patient safety.

What does this mean, in terms of how these facts should influence our behavior?

For a multitude of reasons (including the specter of legal liability), MRI providers should proactively look at their MRI safety protocols and provisions. All sites should follow the ACR and JCAHO recommendations and use ferromagnetic-only screening instruments. If you are Joint Commission accredited, take a look at the new EC Standards and Sentinel Event Alert #38. All MRI providers should also scrutinize the ACR Guidance Document as the basis for their own safety manuals.

A combination of these new 21st century MRI safety technologies, updated accreditation standards, and the industry-standard practices documents, should guide providers to help deploy the greatest protection for patients and staff (and liability protection for themselves).

Until this legal-liability disparity is resolved between pharmaceutical and device manufacturers, it seems to me that the most prudent course of action is to take the additional steps needed to provide the recommended safety solutions as indicated by the ACR and JCAHO. These would include careful adherence to established screening protocols and the use of recommended ferromagnetic detection systems.

PS: you might be interested in a similar article I wrote for The Health Care Blog