Source: US Food & Drug Safety Administration (FDA) and The Wall Street Journal
The FDA just announced a potential patient safety issue with perfusion CT imaging of the head. The issue? overexposure to dangerous levels of radiation. Where is this test most prominent? For imaging to diagnose stroke and to determine treatment for stroke.
Over an 18 month period, 206 patients at an unidentified hospital received radiation doses 8x the level expected. The maximum recommended dosage for the head is 0.5 Gy. Patients in the investigation received 3-4 Gy. So what’s a little hair loss and erythema (redness of the skin), right?
Well the Wall Street Journal was kind enough to “out” the facility under investigation as Cedars-Sinai Medical Center in LA. According to a spokesperson for Cedars-Sinai, there was a “misunderstanding about an embedded default setting.” No sh*t, Sherlock.
The reason any of this matters to you? One, it proves that even we trial lawyers are correct about medical errors every once in a while. Two, the FDA has suggested that the incident, “May reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure.” Government speak for, “OMG! WTF?!”
According to their official statement, the FDA is, “Working with the parties involved to gather more data about the situation and to understand its potential public health impact.”
Oh good. I feel safer already.
Posted by David Marc Schwadron, Esquire
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[...] You will recall that in October of 2009, we reported on the FDA’s investigation of Cedars-Sinai Hospital in LA and documented overdosing of radiation during CT scans. http://www.medicalmalpracticelawyerblogphiladelphia.com/?p=394 [...]