December 13, 2011 – During RSNA 2011, Bracco explained it is working with the U.S. Food and Drug Administration (FDA) to re-introduce CardioGen-82 (Rubidium Rb 82 Generator) since its recall this past summer.
In July 2011, the U.S. Department of Homeland Security (DHS) notified the FDA about two individuals, who had previously undergone positron emissions tomography (PET) myocardial perfusion imaging (MPI) scans with CardioGen-82, crossing U.S. borders who triggered very sensitive gamma ray emission sensors. Full body scans of those two patients at Oak Ridge National Laboratory determined the estimated amount of unexpected radiation to be minimal and similar to what other patients may receive with cumulative exposure to certain other types of cardiac imaging procedures. Bracco’s investigation regarding a third patient detected at the border remains underway.
Maintaining its commitment to patient safety, Bracco has implemented several initiatives to ensure that its products meet the highest standards, including a voluntary recall of Rubidium (Rb) 82 Generators, a clinical assessment program and an Rb-82 Generator quality review program.
In support of a market return, Bracco is in the process of revalidating its manufacturing process and reviewing labeling and user training to ensure proper generator use. Bracco has been in constant communication with the FDA to investigate the root cause of the unexpected radiation detected in the border individuals and to address the FDA’s concerns.
Bracco has proposed an orderly, phased reintroduction of CardioGen-82 generators to user facilities, with data collection and evaluation of the actual field use of each generator. Based on the outcome of its reintroduction discussions with the FDA, Bracco anticipates a limited and progressive reintroduction of the product to commence in the first or second quarter of 2012.
For more information: www.cardiogen.com