The Joint Commission (TJC or, to those of us schooled in their acronym more than 3 years ago, JCAHO): TJC has just referenced the 2010 edition of the Guidelines for Design and Construction of Health Care Facilities as the new design and construction standard (effective today). The 2010 Guidelines codifies a number of the MR safety recommendations that have passed from the Joint Commission’s own lips and makes them standards for new construction. In 2011 I will apply whatever cajoling, leveraging, sweet-talking, or shaming that will help the Joint Commission to apply it’s own standards to the thousands of existing MRIs at TJC accredited providers. This began last year with training provided to TJC’s ambulatory care surveyors, forestalled and rebuffed offers of the same for their hospital surveyors.

Centers for Medicare / Medicaid (CMS): At least somewhat in response to the public attention that was focused on the issues of radiology / nuclear medicine safety through the ongoing series of articles by Walt Bogdanich of the New York Times, in 2010 CMS began development of a set of radiology / nuclear medicine patient safety standards that they intend to roll-out as a condition of reimbursement. It is anticipated that these will be unveiled in the spring for public comment before being enacted some time later. I know that, last year, MR safety proposals were presented to CMS, and at the anticipated public meeting I will seek to make sure that the single largest healthcare benefits provider in the US includes substantive MR safety standards.

Food and Drug Administration (FDA): Quick as they were to arrange public hearings on radiology safety (after the first couple Bogdanich articles saw print), the FDA has been ‘in the planning and coordination’ stages of a similar meeting on MRI safety for well over six months. Originally proposed for last year September, the prospective date has been nudged enough times that, as of my last inquiry, they’ve stopped even suggesting months, or even seasons, and I was last left with the promise of ‘sometime in 2011… hopefully the first half…’ I will endeavor to see that this meeting takes place (perhaps in concert with the CMS meeting), because I know that smart, capable people within the FDA have done analyses of MRI accidents and have developed an MR safety ‘short list’ of preventions which the FDA has yet to release, to say nothing of promulgate or endorse. Sitting on effective safety solutions when the accident rate is quadrupling is… well… inconceivable.

American College of Radiology (ACR): At the ACR’s presentation at the 2009 annual meeting of the American Healthcare Radiology Administrators (AHRA), the ACR representatives announced that the organization was going to incorporate MR safety standards from it’s own ACR Guidance Document for Safe MR Practices: 2007 in the ACR’s MR accreditation program. In 2010 I was privately told by a very well-placed person within the ACR that the new CMS oversight of the MIPPA accreditation process made it ‘logistically onerous’ to change the existing MR accreditation program (this despite the fact that the ACR was pleased to submit to CMS — and receive prompt approval for — an entirely new breast MR accreditation program). In 2011 we expect to see a new edition of the Guidance Document, which will make the fourth publication appearing under the ACR’s name that speaks to effective solutions for the reduction of MR accidents… and the fourth one that the ACR will have not included as an element of their own MR accreditation program. Whether it’s through meaningful standards passed down from CMS, or by reversing the apparent hypocrisy of the ACR, itself, I will spend 2011 working to see that substantive MR safety standards are incorporated as a part of the ACR’s MR accreditation program.

So what is the monster-list of standards that would be necessary to mitigate the vast majority of MRI accidents and injuries? Well, it turns out that it isn’t long at all, and all of these are already promulgated as best practice recommendations…

1. Provide annual MR safety training for all MR personnel (and MR irregulars)
2. Restrict access to controlled areas of the MR suite for unscreened / unsupervised persons and untested equipment per the ACR 4-zone model
3. Provide uniform and documented screening for all persons entering controlled areas of the MR suite
4. Screen persons and objects with a ferromagnetic-only detector before allowing access to controlled areas of MR suite
5. Provide hearing protection (and ensure proper usage) for all persons remaining in the magnet room during the MR exam
6. Use positioning aids and insulating pads as recommended to separate the MR patient from RF elements and conductive materials (including their own tissues)

These six items would likely cut the rates of MR accidents by more than 90%! These items have also been recommended (or very similar elements) by the Joint Commission, ACR, and others. If they were enforced, however, we could very nearly eliminate MR accidents in governed facilities!

Getting us to enforcement, that is my 2011 New Year’s Resolution, but I won’t make it there alone. Can I count on you to work on this with me?

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It starts with the evidence that nearly all FDA reported MRI accidents fall into the ‘never event’ categories of projectiles, burns and hearing damage. These accidents aren’t complicated. They don’t typically require a five-year root-cause analysis to figure out why they happened. They happen either because something that should be there (padding or earplugs) isn’t, or because something that shouldn’t be there (ferromagnetic objects) is.

Human beings are fallible, myself at least as much so as anyone else. This applies to MR patients, visitors, transport, housekeeping, Technologists, Nurses, and even MD’s. To reduce MRI errors and accidents we need to supplement the skills of observation of MR staffers with affirmative checks, such as a pilot’s pre-flight run-down.

1. Did Mrs. Jones pass the clinical-contraindication screening?
2. Are there contraindications for contrast?
3. Did she effectively change / gown / remove metal?
4. Did she the clear the ferromagnetic detector without it alarming?
5. Was the intercom explained to her?
6. Was the squeeze ball explained to her?
7. Was she given the squeeze ball?
8. Was she positioned / padded so that she doesn’t contact the bore wall?
9. Was she positioned / padded so that her body doesn’t form any large-caliber loops?
10. Was she instructed about maintaining body position throughout the exam?
11. Was she provided ear plugs / muffs?
12. Was she instructed on the proper placement of hearing protection?
13. Was she assisted in the proper placement of hearing protection?

If we did these 13 tasks, as appropriate, for anyone and everyone approaching the MRI magnet, we could eliminate the vast majority of MRI accidents.

This is at the crux of our ‘No More’ in ’09 commitment. By following this checklist of known and established best practices, we have the ability to stem the growing tide of MRI accidents. And while I would love to have 2009 be a wholly accident free year for MRI, we need to start first with reversing the trend of the last several years.

MRI accident reports have nearly tripled in the last several years. Before we can really begin to drive the number of accidents down, we first need to stop this growing hemhorrage of MRI injuries. ‘No More’ in ’09 means exactly what it says… we must work to see to it that the tally of MRI accidents for the coming year does not exceed the 2008 tally (which we should have in a month or so).

Of course, the easy way to reach this metric is to simply stop reporting those accidents that do happen, but not only is that in violation of the spirit of the commitment, it’s counter to the intention of the goal of reducing accidents. One reason that MRI accidents persist (and persist in great numbers) is that the lessons learned from one site’s accident are rarely shared with the larger MRI community.

So the goal is really two-fold. First, follow the best practices to eliminate MRI accidents at your site(s). Second, when there is a breakdown and an injury or near-event occurs, report it with as much detail as you can for the benefit of your colleagues around the world.

If we follow these steps, next year at this time we can reflect upon whether we have been able to improve the safety for MRI patients and staff. It’s not a question of whether we can. It’s only a question of whether we will.