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CardioGen-82 Caused Airport Lockout

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Sarasota, FLHow much radiation is too much? No doubt three patients who were treated at a Sarasota Clinic earlier this year using a nuclear drug delivery device called the CardioGen-82 are asking that question after they set off airport security scanners. The first two travelers set off scanners at the US border and then it happened to a third international traveler after a potential CardioGen-82 radiation overdose investigation was underway.

The World Nuclear Association (which represents the "global nuclear profession") has a radiation guide but CardioGen-82 isn't mentioned. It's not something you can figure out yourself. Of course we are exposed to radiation all the time, including when we receive medical treatment. And we know that exposure to large doses of radiation (think Chernobyl) can have catastrophic effects, but experts say these three patients likely did not absorb enough radiation from CardioGen to harm them. However, it was in their bodies longer than it should have been, said Enrique Urrutia, a professor of radiology and nuclear medicine at the University of South Florida.

After the first two patients were tested at Oak Ridge National Laboratory for strontium levels—a radionuclide that can harm bone marrow—the FDA found "no objectionable conditions" in its visit to Heart Specialists of Sarasota and that "the risk of harm from this exposure is minimal, although any unnecessary exposure to radiation is undesirable." Still, the agency did ask Bracco Diagnostics, the manufacturer, to recall its device.

The third patient—the international traveler—was scanned in late February, as were 30 other patients who are all waiting for final results of their screenings. All of the patients underwent a PET (positron emission topography) scan, which detects heart malfunctions by measuring blood flow through the organs. The highly accurate scanner tracks the movement of a radioactive chemical which uses a device such as the CardioGen-82—the nuclear drug delivery device that produces the chemical. Because the chemicals strontium-82 and -85 have such a short half-life, it has to be generated at the time of each PET test. (These chemicals are not to be confused with the much more dangerous strontium-90, the chemical found at weapons tests and nuclear meltdowns.)

According to a report by the Florida Bureau of Radiation Control, the FDA is investigating a possible manufacturing problem that led to a shortage of the CardioGen-82, beginning in January. So far the FDA has not commented on its investigation.


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