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.
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
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
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).