Tag Archives: state

“The Magnetic Elephant In The Room (Or Congressional Hearing Chamber)”

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…

MRI Design Requirements – Guidelines Dominoes

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…

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…