Excess Radiation With CardioGen-82

Shelley Wood

Disclosures

July 15, 2011

July 15, 2011 (Rockville, Maryland) — The FDA is alerting the public and medical imaging community about a risk for increased radiation exposure from a specific positron emission tomography (PET) scanner used for cardiac imaging because of an isotope "breakthrough" problem.

The device in question is the CardioGen-82 PET scan. So far, the FDA has received 2 reports of patients who received more than the expected radiation dose from the strontium-based isotope used in the test, Rb-82. According to the Safety Communication issued Friday, the excess radiation exposure occurred as a result of a "strontium breakthrough" problem with the CardioGen-82, although the FDA is still investigation just how this is occurring.

"At this time, FDA believes that the risk of harm from this exposure is minimal, although any unnecessary exposure to radiation is undesirable," the Safety Announcement reads. "The estimated amount of excess radiation the two patients received is similar to that other patients may receive with cumulative exposure to certain other types of heart scans; it would take much more radiation to cause any severe adverse health effects in patients."

The agency is advising physicians who use this scanner to consider using alternative imaging tests until the investigation is completed. If the CardioGen-82 is used, physicians should follow the specific steps detailed on the FDA's Web site to minimize the risk for strontium breakthrough.

Patients should contact their physicians if they've recently undergone a PET scan and have questions, or if they are scheduled to undergo an imaging test that they think might be with the CardioGen-82.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....