Tag Archives: device

CMS Asked To Review MRI For Pacemaker Patient Exclusion

The Centers for Medicare & Medicaid Services (CMS) has opened a brief public comment period on a request to lift reimbursement restrictions on imaging pacemaker patients with pacemakers.

Example of a Pacemaker Pulse-Generator Which Could Present Dangerous Contraindications For MRI Exams

Click To Read More And Link To The CMS Info…

30% Of Contraindicated Implant Patients Get MRIs Anyway!

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…

RSNA / AAPM Identify Halo Ferromagnetic Risks

In the Tuesday, December 1st, issue of the RSNA Daily Bulletin, the ‘Tip of the Day’ was provided by the American Association of Physics in Medicine. The tip identifies specific risks of ferromagnetic tools and hardware associated with orthopedic devices, such as ‘halo’ vests…

AAPM Warns of MRI Ferromagnetic Risks of Halo Devices

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FDA’s MAUDE Database Appears To Be Restored

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…

5 MRI ‘Never Events’

For those unfamiliar with the term, a ‘never event’ is a label used to describe an adverse event that is wholly avoidable by simply following established best practices. For example, if you have an accurate count of the surgical instruments before and after surgery, there should never be an event where the patient leaves the OR with a sponge or clamp sewn up inside of them. A retained surgical instrument, or wrong-site surgery, or bed-sores, or patient mis-identification, or medication errors are all examples of ‘never events’.

Some insurance payers are beginning to refuse reimbursement for care that is necessitated by certain ‘never events’, and that list is likely to grow. And while they may not always result in patient injury, I’d like to propose my own list of 5 MRI ‘never events’ which should at least trigger an investigation…

Click To Read The 5 MRI Never Events…

The Supreme Court, MRI Accidents, And You…

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…