由 Olga Deshchenko
, DOTmed News Reporter | July 26, 2011
Health care professionals should stop using CardioGen-82 for cardiac positron emission tomography scans, the U.S. Food and Drug Administration said Tuesday.
The device manufacturer Bracco Diagnostics, Inc. is voluntarily recalling CardioGen-82, the agency said.
CardioGen-82 is a generator that's used to produce rubidium (Rb)-82 chloride injection, a medical isotope with a short half-life used for heart scans in nuclear medicine.
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The announcement comes on the heels of a warning issued by the agency on July 15. After receiving reports of two patients who were exposed to increased levels of radiation from CardioGen-82, the FDA issued a safety announcement, alerting the medical imaging community of the potential of increased radiation exposure.
The additional radiation was due to an undetected strontium breakthrough with CardioGen-82, the FDA said in the safety announcement.
In today's alert to doctors, the FDA said further investigation has "determined that the current CardioGen-82 manufacturing procedures are not sufficient to ensure reliable performance of the generator used to produce the Rb-82 chloride injection."
The agency is currently investigating efficacy of testing procedures that are used to detect strontium breakthrough at clinical sites that use CardioGen-82.
The FDA recommends that medical imaging professionals use alternatives to the CardioGen-82 generator when scheduling nuclear medicine cardiac scans for patients.
"The extent to which any additional patients may have received inadvertent radiation exposure is also under investigation," the agency said. "FDA plans to notify the public with updates."