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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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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