Tag Archives: regulation

Gurney Crashes MRI, Patient Injured, Hospital Fined $50K

It is the stuff of fabled oral-histories, often dismissed as MRI urban-legend. The patient is wheeled into the MRI room on a gurney that goes flying toward the scanner. “How on Earth could these accidents happen when we know about these risks,” the skeptics question? Almost never does more than a single fragment of information surface about these sorts of accidents and, without verification, nearly all accounts can be erroneously written-off as fiction. Or, that was until enough pieces fell into place to conclusively document a recent episode… Click Here To Read More About MRI Gurney Accidents…

2009 – The MRI Safety Year That Wasn’t

But 2010 holds the promise of reversing course.

Throughout 2009, we saw tantalizing glimpses of potential MRI safety improvements, which repeatedly escaped becoming real. Here are my ‘Top 3’ near-miss opportunities of 2009 to substantially reshape MR safety…

Can We Still Call Them ‘Never Events’ When Accidents Happen So Frequently In MRI?

This post attempts to draw-together two recent threads from here on the MRI Metal Detector blog. First, there was a long-running question about the FDA and their online-accessible database of medical device accidents which, for months, appeared to be malfunctioning, and recently was repaired. Second, there was my post in which I identified 5 MRI ‘Never Events’ which, if industry standard procedures are followed, should never occur.

Click For Several Recent Examples Of MRI Never Events…

2010 ‘Guidelines’ Healthcare Building Code To Have MRI Safety Requirements

“Tweet, tweet” is usually all I hear from little birdies… but one little bird that flew past my office recently had a surprisingly large vocabulary and told me of new requirements that will be introduced in the forthcoming 2010 update to the ‘Guidelines for Design and Construction of Health Care Facilities’ (commonly referred to as ‘Guidelines’).

For those of you who aren’t familiar with the Guidelines, they are the design requirements that are cited by the Joint Commission and, at last count, 42 of the 50 U.S. State Departments of Health. Technically, they aren’t a building code, but the function in almost the exact same way. For the first time, the Guidelines are going to have specific MRI suite design requirements for patient safety.

2010 Guidelines

2010 Guidelines

Click Here To Read About The Specific MRI Safety Design Requirements…

Colombini Lawsuit For Most Infamous MRI Death – Settled

That’s right. Yesterday, October 26th, the Colombini family formally accepted a settlement offer for the MRI vs. oxygen tank accident which killed their 6-year-old son in 2001. The settlement puts to rest 8 years of litigation resulting from the single largest MRI safety incident in the industry’s consciousness. And though precedent-setting verdicts won’t result, the dollar-value of the settlement will likely cause many MRI providers to sit up and take notice.

Just how much is the settlement? Click Here To Learn More About The Settlement…

AHRA 09 – You’re Cordially Invited To 2½ Special Events

As if you needed a personal invitation from me, here it is nonetheless. Please join me (and a several thousand of your colleagues) at the American Hot Rod Association [ahem] American Healthcare Radiology Administrators annual meeting in August. And though it may not really be my place to invite you to the conference, I do want to extend to you a personal invitation to 2½ special events that will happen during that week.

Click Here To Learn About Your Special 2½ Invitations…

“Aaawwwwww. I’m Tellin’!”

When I was eight, these words struck fear in my heart. It didn’t matter how small the infraction I committed was (or if there even was an infraction to begin with), I would beg the other kid to not ‘tell’ whoever it was that they were planning to tell. It may have been their kindly grandmother that they planned on telling, but in my mind it was always some 7-foot troll who would have undoubtedly come outside and chewed me to bits.

It took a while, but slowly I realized that tellin‘ and getting in trouble were two, very different things. This is a lesson that we in the MRI community would do well to learn regarding accidents.

Click Here To Learn More About Tellin’ And MRI Accidents…

JCAHO, MRI Safety, and EC Standard Update Teleconference

Break out the can of alphabet soup, because here we go, off  into the far reaches of acronym land…

That’s right, the Joint Commission is offering a teleconference / webinar on the 2009 changes to the Environment of Care (EC) standard and what they mean to accredited MRI providers. Never heard of the EC standards before? Well, you’re not alone, but that doesn’t mean that they don’t apply to you. In just a couple weeks, however, you can get the low-down on the new requirements.

Click to get the specifics on JCAHO’s new stand on MRI safety…

MRI Safety at AHRA Fall Meeting

Last month, I was honored to have been given the opportunity to present to one of the national American Healthcare Radiology Administrators (AHRA) meetings. In October I gave a presentation on the current state of MRI Safety, including regulatory, legal and accreditation changes that are all in the works.

The full presentation was 90 minutes, including an extensive audience Q&A, but I’ve pulled out one particular section that is particularly relevant to our topic at hand, ferromagnetic detection for MRI pre-screening.

The video excerpt below addresses forthcoming changes to the ‘Guidelines for Design and Construction of Health Care Facilities’, a poly-cyllabic mouthful that roughly translated means the healthcare building code, and changes regarding MRI suite design…

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As mentioned in the video above, the proposed changes to the healthcare building code are currently open for public review and comment. The proposed language includes references to the ACR 4-zone principles as well as planning for ferromagnetic detection.

If you would like to see, review or even comment upon the proposed changes to the hospital and healthcare provider building code, public comment for the ‘Guidelines’ is open until December 15th, 2008.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com

New Joint Commission Environment of Care (EC) Requirements

Starting in January of 2009, the drought of MRI safety regulation will begin to end.

It surprises many that the Joint Commission has no specific MRI safety accreditation standards. Surveys of accredited MRI providers have, over the past many years, focused largely on general safety standards, adapted for the MRI environment. Historically, a surveyor’s check for a non-magnetic portable fire extinguisher was the only MRI-specific safety check provided by the Joint Commission.

Despite the fact that many MRI-specific safety articles, recommendations, and, most recently, Sentinel Event #38 have been offered by the Joint Commission and its allied Joint Commission Resources educational arm, there have not previously been specific MRI safety standards for accreditation, and it is only through the new Environment of Care requirements that MRI safety will become an implicit standard for Joint Commission accredited facilities.

Starting this coming January 2009, inpatient and outpatient accredited facilities will need to abide by the new Risk Management provisions of the Joint Commission Environment of Care standard. The Standards Improvement Initiative will require facilities to prospectively define the physical hazards within the facility and develop specific responses to manage and mitigate those hazards.

The new standard specifically cites Sentinel Event Alerts as one external reference that must be considered in defining risks. For MRI, this automatically means Sentinel Event Alert #38. And since SEA #38 draws so heavily from the ACR Guidance Document for Safe MR Practices: 2007, it only follows that the ACR Guidance Document is the underlying industry standard document for defining MRI safety. Another external reference that specifically addresses MRI physical hazards which should be used as a basis for risk analysis is the VA MRI Design Guide.

What do Sentinel Event Alert #38, the ACR Guidance Document, and the VA MRI Design Guide all recommend? Well, lots of common elements, actually, but one of the key recommendations is for the use of ferromagnetic screening (click here to download a PDF document that outlines many of the recent recommendations for ferromagnetic detection).

While it is starting with the Joint Commission Environment of Care, my expectation is that MRI-specific patient safety requirements will spread to other accreditation requirements, building codes, and standards of practice. This will include not just recommendations, but requirements for the use of ferromagnetic detection for MRI pre-screening.

Over the next few months, all Joint Commission accredited MRI providers will need to review the standards of practice in the ACR Guidance Document for MR Safe Practices. Specific actions must be taken to identify, document, and respond to the unique hazards in the MR environment. One of those immediate actions should be planning for ferromagnetic detection at your MRI facility.

If you have any questions about the new MRI safety standards, the best-practice recommendations for ferromagnetic equipment siting, and incorporating these vital safety instruments in your MRI screening practices, I recommend that you heed the advice of the ACR Guidance Document, the VA MRI Design Guide, and other safety practice documents. If you still have questions about these standards, I invite you to contact me.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com