Posts Tagged ‘regulation’
Sunday, February 28th, 2010
Here we sit, on the cusp of mandatory accreditation for ‘Advanced Imaging’ modalities at outpatient providers (these are CT, MRI and PET), and a series of articles on medical radiation exposure splashes across the New York Times.
In nearly concurrent moves, the Joint Commission (JC) unveils their just-developed Advanced Imaging (AI) accreditation program, the FDA is clamoring for new authority to regulate medical device safety (or gearing-up to use authority that it’s been hiding for safe-keeping, that isn’t exactly clear to me), the US Congress whips together a set of hearings on the issue, and, at those hearings, the American College of Radiology (ACR) recommends that the Feds expand the scope of the AI accreditation requirement to include radiation therapy and to apply the expanded accreditation requirements to hospitals, too.
Whew, that’s a lot of ground covered for radiology in just the last few weeks! Wait a minute… who is that sitting in the backseat? Who has been drug through all of the hullabaloo about radiation exposure and patient safety without once having been considered, individually? MRI, that’s who.
Click To Read About How MRI Should Be Considered…
Tags: accident, accreditation, ACR, advanced imaging, American College of Radiology, CMS, congress, CT, diagnostic, exposure, FDA, hearing, IAC, ICAMRL, imaging, injury, Intersocietal Commission, ioinizing, JC, Joint Commission, magnetic resonance, MRI, PET, radiation, radiology, regulation, reimbursement, requirement, safety, standard, state
Posted in Other MRI Safety | No Comments »
Thursday, February 25th, 2010
In stark contrast to the speed with which we expect to see medical technology advance, the more bureaucratic process of regulatory or accreditation tends to be more deliberative and… oh heck, I’ll just say it… glacial in its pace to keep up. Every once in a while, however, these efforts ’sling-shot’ forward.
Much to my surprise (and delight), this is happening with the new Guidelines for Design and Construction of Health Care Facilities (or Guidelines, for short). Though the 2010 edition of Guidelines has only been published for about a month (and the publisher has been struggling to catch up on back-ordered copies), two states have already adopted the 2010 edition as their requirements for licensure.
Click To Learn If Your State Is Among The First…
Tags: architect, code, design, engineer, equipment, facility, Georgia, guideline, Guidelines for Design and Construction of Health Care Facilities, hospital, imaging, license, magnetic resonance, MRI, New Jersey, planner, radiology, regulation, requirement, safety, standard, state, vendor
Posted in Ferromagnetic Detection for MRI Safety | No Comments »
Tuesday, February 23rd, 2010
And what’s even more alarming is that 20% of those implant patients that get MRIs experience some sort of device malfunction afterward! And yet, the dangers of imaging these patients are not well known by the doctors who prescribe these imaging studies.
Click To Learn Just How Many Doctors and Patients Are Ill-Informed Of These Risks…
Tags: accreditation, ACR, Aging, American College of Radiology, contraindicated, Council, device, doctor, FDA, imaging, implant, Intersocietal Commission, JCAHO, Joint Commission, magnetic resonance, MRI, National, pacemaker, patient, regulation, scan, study, TJC
Posted in Other MRI Safety | No Comments »
Thursday, February 18th, 2010
OK, I’ve been reading too many headlines in supermarket check-out aisles, but what else is a guy with an overactive imagination supposed to come up with?
You see, back in 1983 when GE was going through their pre-market approvals with the FDA for their first commercial clinical MRI system, they indicated that MRI suite safety minimally required ferromagnetic detection pre-screening. The only problem was, it hadn’t been invented yet!
Click Here For The Rest Of The Time-Traveling Story…
Tags: airport, death, detection, detector, FDA, ferromagnetic, GE, General Electric, hazard, healthcare, Hitachi, injury, metal, missile, MRI, Philips, physicist, projectile, regulation, safety, Siemens, Toshiba
Posted in Ferromagnetic Detection for MRI Safety | No Comments »
Wednesday, February 10th, 2010
Go grab yourself a cup of coffee before you continue… this is going to be a long (for me, anyway) rant.
Ready? OK…
Let’s start at the very beginning (“what a very good place to start”). Click To Read The Whole Story…
Tags: accident, accreditation, ACR, American College of Radiology, ASHE, best practice, colombini, death, detector, ECRI, FDA, ferromagnetic, GE, guidelines, Guidelines for Design and Construction of Health Care Facilities, healthcare, imaging, injury, JCAHO, Joint Commission, law, lawsuit, legal, license, magnetic, magnetic resonance, Marzendorfer, Mednovus, metal, Michael, MRI, MRI Design Guide, radiology, regulation, require, safety, Siemens, standard, TJC, VA
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | 4 Comments »
Thursday, February 4th, 2010
This week the settlement documents were released — closing the chapter on the lawsuit that arose from the seminal event in MRI safety, the 2001 oxygen tank fatality of then-six-year-old Michael Colombini.
Click To Learn More About The Accident And Settlement…
Tags: accident, civil, colombini, death, fatality, ferromagnetic, hazard, imaging, injury, lawsuit, liability, magnet, magnetic, magnetic resonance, medical, metal, missile, MR, MRI, patient, projectile, radiology, regulation, resonance, safety, screening, suit, trial
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | 2 Comments »
Sunday, January 24th, 2010
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…
Woman On Hospital Gurney 'Sandwiched' Against MRI :
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Tags: accident, accreditation, death, detection, detector, FDA, ferromagnetic, hazard, imaging, injury, magnetic, magnetic resonance, MAUDE, medical, metal, missile, MR, MRI, patient, projectile, radiology, regulation, resonance, risk, safety, screening, suit
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | 3 Comments »
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 | 1 Comment »
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 »
Tuesday, November 17th, 2009
“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
Click Here To Read About The Specific MRI Safety Design Requirements…
Tags: accreditation, ACR, architecture, building code, design, detection, detector, Environment of Care, ferromagnetic, guidelines, hazard, imaging, JCAHO, Joint Commission, metal, MR, MRI, radiology, regulation, resonance, risk, safety, standard, standard of care, suite
Posted in Ferromagnetic Detection for MRI Safety, Other MRI Safety | No Comments »