ASNC/SNMMI Alert: Important Drug Safety Information
Recently, there has been a report of high-level radiation exposure with use of incorrect eluent in Rubidium 82 Rb82 generators after a failure to follow the eluate testing protocol.ASNC and SNMMI members are reminded to use only additive-free, 0.9 % Sodium Chloride Injection, USP (normal saline) to elute the Rubidium 82 Rb82 generator. Immediately stop the patient infusion and permanently discontinue the use of the affected generator if any solution other than the additive-free Sodium Chloride Injection USP was used for elution.
In the reported incident, the incorrect eluent contained calcium (Ca+2), which caused high levels of strontium 82 (Sr 82) and strontium 85 (Sr 85) breakthrough in the rubidium chloride injection. Patients were exposed to high levels of radiation.
Members are reminded to strictly adhere to the mandatory eluate testing protocol. Details of the testing protocol are found in the package insert provided by the manufacturer. Contact the manufacturer of the Rubidium 82 Rb82 generator for additional details.
Details of the testing protocol from the Food and Drug Administration (FDA) website
More details of the testing protocol from the Food and Drug Administration (FDA) website