Uncategorized

OP-ED: The MRI Safety Gap

• 9

By Tobias Gilk

In health care, particularly in patient safety, there is a cultural predisposition towards excellence. There’s a fundamental desire to create better, safer environments in support of care. That applies to staff qualifications, policies & procedures, medical technology, and—usually—standards for accreditation.

I say ‘usually’ because there is a glaring hole, more than two decades old, in patient safety accreditation standards: MRI (magnetic resonance imaging).

Approximately 1 in 10 Americans—or roughly 30,000,000 people—had an MRI last year. Most if not all of them went through some type of screening and passed signs with cryptic warnings as they entered locked doors to the MRI suite. The screening and warnings are intended to prevent serious accidents and injuries. Ferromagnetic materials (such as oxygen tanks, wheelchairs, cleaning equipment) must be kept outside the MRI suite lest they become magnet-homing missiles, which have killed patients in the past. Patients with contraindicated implants may experience potentially fatal adverse interactions with the MRI’s magnetic field or RF energies, and facilities must prevent MRI devices, which can cost in excess of $2 million, from accidental damage.

MRI accidents

The chart shows the numbers of MRI accidents (product code ‘LNH’)
reported to the FDA’s MAUDE database over the last several years have
seen a 185% increase from 2004 to 2007. MAUDE data for 2008 is not
complete, but already shows an almost 20% increase over 2007 with only
11 months of data available.

The FDA’s account of MRI accident rates has nearly tripled in the past four years, but there is not one explicit site-specific MRI safety requirement
in any accreditation standard. As of January 1st, however, changes to
the Joint Commission Environment of Care (EC) standard present an
opportunity for the first substantive move towards MRI safety
standardization.One of the new requirements under the EC
standard is for accredited facilities to use, as a minimum, all
previously published Sentinel Event Alerts—the Joint Commission’s
highest patient safety warning—to assess risk. Should a particular
Alert apply to the facilities or practices of the provider, the risk
assessment must detail whether the facility complies with current best
practices for each identified hazard or patient safety objective
enumerated in the Alert.Last February, the Joint Commission released Sentinel Event Alert #38, MRI Accidents and Injuries,
which details 10 explicit safety objectives (plus another three in the
body of the Alert) for improving safety in the MRI suite. Because the
objectives identified in the Alert pertain to the general MRI
environment (as opposed to specific MRI devices or particular clinical
settings), the Alert applies universally to all Joint Commission
accredited providers of MRI services.

So—perhaps unknowingly—the Joint Commission, through their EC
standard update, has established a requirement that accredited MRI
providers conduct a risk assessment. What does this mean in practice?
Absolutely nothing, unless the Joint Commission chooses to enforce the
new standard.

The Joint Commission can become a victim of it’s own institutional
inertia, simply ignore the fact that the new EC standard applies to MRI
safety, and continue the legacy of inaction, or it can honor the new
standard and verify that accredited providers have conducted their own
evaluations of risk factors.

I encourage the Joint Commission to hold itself to at least a ‘B-’
standard with regard to the new EC provisions for MRI safety, namely
that they verify the presence of an MRI risk assessment in at least 80%
of surveyed accredited MRI providers.

Stunning growth in MRI accident reports, Sentinel Event Alert #38,
the new EC standards, and a desire to catch-up after 20 years of
accrediting hospitals without applying MRI-specific safety standards
should be all the motivation needed to spur serious improvements for
the benefit of MRI patients, their families, as well as their
caregivers.

Additional information on MRI risks and safety is available from the following resources:ACR Guidance Document for Safe MR Practices: 2007VA National Center for Patient Safety: MR Hazard Summary“New Tools for MRI Safety: Ferromagnetically Naked”, PSQHTobias
Gilk is a member of the American College of Radiology’s (ACR) MR Safety
Committee and President and MRI Safety Director for Mednovus, Inc. He
has written hundreds of articles on MRI safety (including a few for the
Joint Commission) and is a popular speaker on the subject. This
editorial is jointly published by The Health Care Blog and Patient
Safety & Quality Healthcare (PSQH.com).

Categories: Uncategorized

Tagged as: , ,

9 replies »

  3. I have been asked to perform some minor inspection/construciton work in a MRI room while the MRI machien is remamped up-ON position. On the MRI qustionnaie I checked box “yes” for metal in the eye. The hospital will pay for the cost for eye-Xray at a different medical company, but will not assume the responsibty for performing the eye x-ray at the hospital in question..
    The hospital facility department is almost demanding this inspection/construction work be performed, yet they cannot produce a safety manual or procedure for this application. Can anyone asssist???

  4. As an instructor to MRI students, the fact that the technologist is the last line of defense for a patient is of utmost importance, morally and legally. While I find many sites push to get technologists up to speed on equipment for cross-training in order to have higher throughput and subsequent profits, the facility has no realistic idea of the amount of liability they are incurring by putting some of these casually trained techs in charge of each patient’s safety!

  6. Stephen Motew – to your question about the real rates of accidents… FDA data, which I cite in the piece, shows a 185% increase in the 2007 numbers of MRI accidents over the 2004 (baseline) data. In the three elapsed years, MRI volumes have grown at about 3% per year, so a net volume growth of 10% over that 3 year period.
    The problem (or one of them, at least) is that the FDA MRI accident data is so – profoundly – under-representative of what actually happens. If you compare the MRI-classified accident data from the State of Pennsylvania’s mandatory reporting system (and it’s not mandatory for all providers within the state, either), and extrapolate the numbers out over a period of time, it turns out that Pennsylvania, alone, has more MRI incidents than does the whole of the USA as represented by the FDA’s data! The reporting criteria aren’t identical, but to have such wildly different numbers defies rational explanation.
    Sources familiar with accident reporting and MRI safety have theorized, based on exemplars from other systems, that the FDA data captures something less than 10% of occurring accidents. In fact, system comparisons between the FDA’s data and that collected internally within the VA led a former co-director of the VA’s National Center for Patient Safety to theorize that the FDA’s numbers may be two orders of magnitude disparate from reality.
    With such abysmal reporting, one can’t rule-out the possibility that a jump in numbers is representative of better disclosure, except that while risk factors in MRI have all been climbing in recent years (implants, magnetic field strength, sedation / anesthesia, patient acuity, interventional applications, financial pressures, etc…), there has been no corresponding effort to promote reporting, either from professional bodies (JCAHO or ACR) or government (FDA).
    Follow my name-link for a collection of contemporary MRI utilization / accident data.

  7. Are the event rates listed true ‘rates’ or ‘incidents’…ie what is the denominator? If indeed the incidence/population base is increased 185% this is a serious problem, or does this relate to a concomitant increase in the total number of MRIs? Certainly more alarming to me is the tremendous total number of ‘costly’ imaging studies as a frequent substitute for basic clinical evaluation.

  8. Don’t forget, improving safety in the MRI suite includes infections like MRSA. It’s not that hard to kill MRSA on inanimate objects. But as usual, it’s about ENFORCEMENT!!!