FDA Patient Safety News Report

  • August 11, 2011

By Bob Roth

Inadvertent radiation exposure: once again called out as an 800 pound gorilla in the room. Whereas acute radiation poisoning is generally a most obvious problem, lower-grade radiation exposures are the perfect gorilla. Well-known low-grade radiation sources such as ground radon and cosmic exposure during air travel are recognized to increase cancer risk long-term, but because these effects take many decades to manifest the risks are widely minimized. X-irradiation risks of a much greater magnitude similarly tend to be deemed acceptable by much of the public and the medical community, and only rarely does your doctor decide not to evaluate your stomach discomfort with a CT scan, or your dental health with a full-scan oral X-ray, because of concern over long-term risks from the radiation exposure.

As publicized earlier this year in FDA’s Patient Safety News (Jan. 2011), long-term radiation risks from CT scans do not always go undetected and unreported. Ongoing FDA investigations of radiation overdose exposures from CT brain perfusion scans now number several hundred such events. FDA reports that these over-exposures are most likely related to operator error rather than equipment problems. Clues such as hair loss and skin burns will occasionally make the gorilla turn visible and lead to these investigations, but of course the bigger and more important question is how often the risks remains invisible. We’re all advised to keep the radiation gorilla in mind.

Bob Roth is Vice President and Worldwide Medical Director at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.