Unintended Strontium-82 (Sr-82) and Strontium-85 (Sr-85) Radiation Exposure

High Level Radiation Exposure with Use of Incorrect Eluent and Failur to Follow the Eluate Testing Protocol

High Level Radiation Exposure with Use of Incoorect Eluent

Patients are exposed to high radiation levels when the CardioGen-82 generator is eluted with the incorrect eluent due to high Sr 82 and Sr 85 breakthrough levels

• Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator.
• Immediately stop the patient infusion and permanently discontinue the use of the affected CardioGen-82 generator if the incorrect solutionis used to elute the generator.

• Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow.

• Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol
• Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the rubidium Rb 82 chloride injection exceed specified limits.
• Record each generator eluate volume, including waste and test volumes, and keep a record of the cumulative eluate volume.
• Strictly adhere to the generator eluate testing protocol, to minimize the risk of excess radiation exposure, including daily testing and additional testing at Alert Limits.
• Stop using the generator if it reaches any of its Expiration Limits:

                               17 L for the generator’s cumulative eluate volume, or
                               42 days post generator calibration date, or
                               An eluate Sr 82 level of 0.01 ?Ci /mCi Rb 82, or
                               An eluate Sr 85 level of 0.1 ?Ci /mCi Rb 82

• CardioGen-82 is contraindicated if a solution other than additive free 0.9% Sodium Chloride Injection USP has been used to elute the generator at any time. Immediately stop the patient infusion and permanently discontinue the use of the affected CardioGen-82 generator whenever the incorrect eluent is used.
• Use only additive free 0.9% Sodium Chloride Injection USP to elute the generator. Apply the provided saline tag to the additive free 0.9% Sodium Chloride Injection USP container before use. Additives present in other solutions (particularly calcium ions) expose patients to high levels of radiation by causing the release of large amounts of Sr 82 and Sr 85 into the eluate regardless of the generator’s age or prior use.
• Immediately stop the patient infusion and discontinue use of the affected CardioGen-82 generator if the incorrect eluent is used and evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow. When solutions containing calcium ions are used to elute the generator, high levels of radioactivity are present in any subsequent eluate, even with the use of additive free 0.9% Sodium Chloride Injection USP.
• Excess radiation exposure occurs when the Sr 82 and Sr 85 levels in rubidium Rb 82 chloride injections exceed the specified generator eluate limits.
• Strictly adhere to the eluate testing protocol to minimize radiation exposure to the patient. Stop using the rubidium generator when the expiration limits are reached.