Make no mistake, Nephrogenic Systemic Fibrosis (NSF), a horrible (and thankfully very rare) disease which can afflict persons with significantly impaired kidney function who receive certain gadolinium based MRI contrast agents. Over the past few years, tremendous resources have been poured into the identification of patients, research on the specific mechanisms of disease, and effective means of prevention. NSF has run into a problem, however, which has dramatically curtailed further research… we’ve darn-near eliminated this disease!
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…
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)?