Posts Tagged ‘FDA’
Wednesday, January 6th, 2010
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…
Tags: accident, accreditation, ACR, American College of Radiology, best practice, FDA, imaging, JCAHO, Joint Commission, magnetic resonance, MRI, radiology, regulation, safety, TJC
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | 2 Comments »
Monday, December 7th, 2009
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…
Tags: accident, accreditation, FDA, imaging, injury, magnetic, MAUDE, MRI, never event, patient, radiology, regulation, resonance, risk, safety
Posted in Ferromagnetic Detection for MRI Safety | 7 Comments »
Wednesday, November 18th, 2009
For a couple of months, at least, the FDA’s MAUDE database wasn’t displaying all of the accident narratives online… This appears to have been fixed!
A number of the MRI accident reports, when the narratives weren’t appearing, were little more than the name and mailing address of the MRI manufacturer. Today, if you want to read about the MR Technologist who had a pair of scissors magnetically-impelled into his forehead, you can do so. So Click Here If You’re Curious…
Tags: accident, database, device, FDA, hazard, imaging, injury, magnetic, MAUDE, MDR, medical, missile, MRI, projectile, resonance, risk, safety, scissors
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | 3 Comments »
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 | 14 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 »