CardioGen-82 Problems Result of User Error

The voluntary CardioGen-82 recall by Bracco Diagnostics Inc. last July and the subsequent FDA alert to health care professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans prompted one Tennessee hospital to test more than 100 cardiac patients for radiation exposure. However, in January 2012, the FDA said the CardioGen-82 problems appear to be the result of user error.

CardioGen-82 Problems Result of User Error

"Bracco is waiting for FDA to approve final labeling changes, but the CardioGen-82 should be back up and running by the end of the first quarter," says Beth Hodge, director of communications, American Society of Nuclear Cardiology. "There are still some final steps in the process which require FDA approval, so I can't provide a specific return-to-market date."

That is good news for Bracco, but where does that leave the patients from the Sarasota clinic? They set off airport radiation detectors and initiated the recall. According to an FDA official in September to the Nuclear Regulatory Commission's Advisory Committee on Medical Use of Isotopes, radioactive strontium was still present in their systems two and four months after undergoing PET scans. At that time, the FDA had no idea how many people had been exposed to radiation leakage from the generator and they didn't know what was causing the leakage.

Federal and state officials began scanning the Tennessee patients—randomly chosen from cardiac patients who had undergone a PET scan with CardioGen-82—last October 2011. According to Meg Lockhart, a spokeswoman for the Division of Radiological Health, the checks found no exposure to people that exceeded regulatory requirements. In the meantime, Tennessee's Baptist Hospital closed its hospital-based PET scan department, resulting in employees losing their jobs.

The CardioGen-82 is a generator manufactured by Bracco Diagnostics Inc. It produces rubidium-82, the radioactive isotope used in the scans by causing a longer-lived strontium compound to decay. Bracco's generator is the only FDA-approved device for producing rubidium-82.

Dr. Manuel Cerqueira, chairman of nuclear medicine and a staff cardiologist at Cleveland Clinic, said that cardiac PET scans are a very accurate means for diagnosing blockages in the blood vessels to the heart, particularly in obese patients. A CardioGen-82 PET scan is one of a variety of nuclear medicine scans that uses radioactive drugs to evaluate the heart.

CardioGen-82 Problems Result of User Error

CardioGen-82 Legal Help

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