Posts Tagged ‘FDA’
Wednesday, September 16th, 2009
I like to keep my finger on the pulse of MRI accidents and safety issues. One consequence of this is that I frequent the FDA’s MAUDE database (MAUDE is a tortured acronym for medical device user-reported mishaps). I have long criticized the FDA for their half-hearted efforts at collecting MRI accident data (which, in fairness, appears to be as much a product of congressional limitations on the FDA’s power as anything else), but MAUDE has been the only national database for these accidents that is publicly accessible.
Every so often there is an MRI accident description that is so stunning that it sends a jolt through me, reminding me why I do what I do. This is the entry that I came across just two weeks ago…
Click Here For The Jolting Description…
Tags: accident, database, death, FDA, imaging, injury, magnetic, MAUDE, Medwatch, missile, MRI, online, projectile, radiology, report, resonance, safety, scissors, Technologist
Posted in Other MRI Safety | 18 Comments »
Saturday, June 6th, 2009
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…
Tags: accident, accreditation, authority, death, event, FDA, injury, magnetic, MAUDE, MDR, MRI, near-event, near-miss, patient, Pennsylvania, photo, picture, pre-screen, projectile, regulation, regulatory, report, resonance, safety, screening
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | No Comments »
Wednesday, March 18th, 2009
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…
Tags: accident, burn, data, FDA, frequency, hyperbola, hyperbole, injury, magnetic, management, MAUDE, missile, MRI, projectile, radiology, rate, risk
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | No Comments »
Monday, March 16th, 2009
Last year, the United States Supreme Court decided that medical device manufacturers that had gone through the trial-by-fire of a FDA pre-market review are immune from civil action in the state courts for product liability (Riegel v. Medtronic). Just a few weeks ago, the Court threw what many considered to be a major curve-ball when they decided that comparable protections do NOT apply to pharmaceutical manufacturers (Levine v. Wyeth). What does this suggest to MRI providers (Technologists, Radiologists and Administrators)?
Click To Learn What This Supreme Court Decision Suggests…
Tags: accreditation, ACR, approval, civil, court, decision, detection, detector, device, FDA, ferromagnetic, legal, Levine, liability, magnetic, medical, Medtronic, MRI, NSF, pharmaceutical, regulatory, resonance, Riegel, safety, state, suit, supreme, Wyeth
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | No Comments »
Saturday, March 7th, 2009
‘NEWS FLASH: Large icebergs may present grave hazards to ocean liners.’
No, that’s not what the FDA just said, but the news in the FDA’s most recent alert is almost as dated as my hyperbolic example. What the FDA did in their March 5th alert on the MRI safety of transdermal medication patches was essentially … Click to find out what the FDA’s alert ‘essentially’ did…
Tags: ACR, alert, burn, drug-delivery, FDA, foil, hazard, heating, magnetic, medication, metal, MRI, patch, safety, transdermal
Posted in Other MRI Safety | No Comments »
Monday, March 2nd, 2009
The March issue of Anesthesiology, the journal of the American Society of Anesthesiologists (ASA), contains a new Practice Advisory on the safety of anesthesia care in the MRI environment. This new call from the ASA for a heightened level of attention is concurrent with startling growth in the rates of reported MRI accidents. The $43,172 question… Will JCAHO answer?
As I see it, the new ASA MRI Practice Advisory does three things… Click to learn about the effects of the new ASA Advisory…
Tags: accident, ACR, American College of Radiology, Anesthesia, Anesthesiologist, ASA, control, Environment of Care, FDA, infection, injury, JCAHO, Joint Commission, magnetic, MRI, resnonce, safety, Society
Posted in Other MRI Safety | No Comments »
Wednesday, February 11th, 2009
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!
Tags: accident, data, death, fatal, FDA, frequency, increase, injury, magnetic, MAUDE, MRI, numbers, rate, resonance, surge
Posted in Other MRI Safety | No Comments »
Sunday, December 21st, 2008
Yes, though we’ve got more than a full month’s worth of reports yet due, it turns out that 2008 is a record year for MRI safety!
No, I’m not talking about the year of record sales of ferromagnetic detection systems or the publication of no less than three MRI safety best practice guidance papers… What I’m talking about is the numbers of MRI accident reports to the FDA.
Click to read more about this record year…
Tags: accident, death, FDA, growth, increase, injury, magnetic, MRI, rates, record, report
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | No Comments »
Tuesday, November 25th, 2008
There are a number of startling statistics related to MRI safety that I’ve been wanting to weave into a posting or two. In bits and bites, these data points are interesting, but it’s when they’re taken all together that they tell the greatest story. So, at the risk of writing my driest entry to date, here’s the picture painted by a slew of statistics…
Click Here To Read The Statistics And View The Picture They Paint…
Tags: accident, FDA, imaging, injury, magnetic resonance, MRI, radiology, rates, report, statistics
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | No Comments »
Wednesday, November 19th, 2008
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…
Tags: accident, detection, detector, FDA, ferromagnetic, magnetic, MAUDE, metal, missile, MRI, policy, pre-screening, procedure, projectile, protocol, safety, screening
Posted in Ferromagnetic Detection for MRI Safety | 2 Comments »