According to a letter from Bracco Diagnostics (dated 3/26/12; found online at www.asnc.org), steps have been taken to ensure the generators are used properly, including all sites completing training and knowledge assessments, all sites having a Bracco technical expert onsite for the first two days of use, all sites submitting daily QC reporting and Bracco monitoring the QC daily.
On July 26, 2011, the FDA announced that it identified deficiencies with the CardioGen-82 manufacturing procedures. In a follow-up, however, the FDA stated that those deficiencies were not linked to situations in which some patients were exposed to excessive radiation. "The recalled CardioGen-82 generators that were functional following shipping were tested by the manufacturer to identify potential structural or functional causes of strontium breakthrough. None of the tested generators showed signs of breakthrough," (1/12/12).
READ MORE CARDIOGEN-82 LEGAL NEWS
CardioGen-82 is a generator used at clinical sites to produce a rubidium-82 chloride injection, which is used in positron emission tomography to evaluate a patient's heart. The CardioGen-82 recall was announced after some patients were exposed to high levels of strontium. After an investigation, the FDA indicated that the problem was with how the generators were used, rather than with the generators themselves.
"FDA believes it is unlikely that this excessive exposure posed significant risks to patients, though exposure to any excessive radiation is undesirable," the agency noted.