Princeton, NJA year after the CardioGen-82 recall was announced, Bracco Diagnostics announced that the CardioGen-82 received clearance to be reintroduced. When the CardioGen-82 PET recall was announced, the US Food and Drug Administration (FDA) indicated that there were some deficiencies with the generator, however more recent reports suggest the problem was with how the generator was used. Either way, it is vital that with the CardioGen-82 being reintroduced that steps are taken to ensure patients are safe.
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).
Furthermore, the FDA wrote, of patients surveyed at 43 clinical sites, there were only two sites at which patients were identified as having abnormal screening test results. Both of those sites reportedly had insufficient documentation of compliance with the label recommendations.
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.
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