Tag Archives: MAUDE

“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…

MRI Accidents, Hyperbola And Not Hyperbole

Def.  Hyperbolic:  Mathematical curve functions which have relations to the hyperbola.

Def.  Hyperbolic:  Rhetorical exaggeration or diminishing beyond the fact; exceeding the truth; as, an hyperbolical expression.

I have this sense that some feel that virtually all talk of MRI accidents is hyperbolic, or exaggeration. To those who believe this, I say there is a truth buried in this thought, but it’s not what they may think…

Click To Learn The Truth Within The Hyperbole…

MRI Accidents Jump 30% in 2008!

Well, hopefully accidents didn’t jump a full 30%, but the number of reports to the FDA of MRI accidents did! This makes four consecutive years in which the numbers of MRI accident reports have climbed, increasing a whopping 270% above the 2004 rates!

Click to learn how many MRI accidents are likely happening!

27.5 Million People DON’T Want Their 175% Raise!

27.5 million people… That’s how many people the healthcare market research company IMV estimates received MR exams in the US in 2007. Other estimates put the number over 30 million, but regardless of whichever number you use, we’re talking about a lot of people (27.5 million is roughly equivalent to those living inside all of the 13 most populous cities in the US)!

And when I say that these millions of people don’t want the 175% raise they’ve received, I’m not referring to their salary. No, the raise that these millions of people got — and most definitely don’t want — is … Click To Learn What 175% Raise They Got…

News From Lisbon – ISMRM / SMRT MR Safety Workshop

I was tremendously honored to have been asked to give a presentation to the ISMRM / SMRT MR Safety Workshop which was held a couple weeks ago in Lisbon, Portugal. Mine was actually the second-to-last of two days of back-to-back-to-back presentations and I was worried that all of my content would have been covered by prior presenters. I mean MR safety is a pretty broad area, but still, having about 30+ notable MR authorities from around the world go before me, would my material be so well-worn before it was even my turn that my presentation would push the entire audience into a boredom-induced coma?

Turns out that I needn’t have worried…

ISMRM is a fabulous organization, but the long form of the organization’s name (the International Society for Magnetic Resonance in Medicine) gives a bit of indication about their perspective. The conference wasn’t broadly about MR safety (at least before they got to my presentation), it was about implants, dynamic field affects and heating… essentially safety at or inside the bore of the MRI.

  • There was no discussion about staffing numbers or qualifications.
  • There was no discussion of screening techniques or their effectiveness.
  • There was no mention of access restrictions or 4-zone implementation.
  • There wasn’t anything about whether or not MRI exams are actually getting any safer for patients… nothing provided as a metric as to whether the workshop’s efforts were providing any positive feedback to the MR industry.
  • And certainly there was nothing about ferromagnetic detection.

Despite the fact that I was invited to speak on my perspective on MR safety issues before I joined Mednovus, a company which manufactures ferromagnetic detection (FMD) systems, and had planned on speaking about the technology, I thought that anything I said on the subject might be viewed as being motivated by personal financial interests. So I actually said nothing to the group about FMD. Instead I presented information on the official record of MRI accident rates in the US from the FDA MAUDE database over the last several years…

Table showing MRI accident rate increases

And I talked about how the physical design of the MRI suite can mitigate a number of risks that are inherent (and growing) in the MRI environment.

As MRI scanners are made more and more powerful, the projectile / missile effect increases. As we use MRI for older and more acutely ill patients, the risks associated with medical device contraindications grows. As we grow the interventional applications for MRI, we bring more people and more stuff into the MRI suite, increasing all sorts of risks. As the financial pressures increase the demand for greater throughput, the time allotted for preparation and pre-screening of patients may suffer, if not protected.

In short, the clinical, financial and technical forces on MRI are all combining to ratchet-up the risks in the MRI environment. MRI has a well-earned reputation as the safest and most informative diagnostic tool available, but that reputation is eroding and is at risk of being catapulted backward when another high-profile fatality is splashed across CNN.

I am deeply honored to have been asked to present at the ISMRM MR Safety Workshop and I hope to have many more opportunities to share my thoughts and experience with the group. My opinion, however, is that we’ve got a long way to go to get the professional, regulatory and accrediting bodies to address MRI safety in the holistic way that is necessary to bring about the substantial change needed to protect both MRI patients and providers.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.