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‘The Bump’ Disrupts Cardiac PET Schedules

June 22, 2012
Written by: , Filed in: Cardiac Imaging, Diagnostic Imaging, Nuclear Medicine
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Beware “the bump.” It’s causing delays in PET imaging of cardiac patients, according to HealthImaging.com.

The problem involves the CardioGen-82 machine, which produces the rubidium-82 radiotracer used in PET myocardial perfusion imaging. The CardioGen was pulled from the market last year when three patients were found to have elevated levels of radiation several months after PET stress tests. Bracco Diagnostics resumed shipping the CardioGen in February with a beefed-up warning. (See our earlier report here.)

Howard C. Lewin, MD, of Cardiac Imaging Associates in Los Angeles, told HealthImaging that Bracco sent a letter at the end of May to the 106 sites that had reintroduced CardioGen generators. The letter warned of a “bump” in levels of strontium-82, which is used to produce the rubidium. The bump occurred early in the machine’s life cycle. If strontium “breaks through” in sufficient amounts, it can harm patients.

The bumped-up strontium remains well within safe limits. But Bracco was using strontium from a single supplier, and the Food and Drug Administration suggested a change, Dr. Lewin said:

Since Bracco could not explain why the bump was occurring, the FDA recommended that the company stop using that supplier. Unfortunately, that supplier was Bracco’s largest source of strontium—leading to an effective strontium shortage.

The company has said the problem should be resolved by late August, when another strontium supplier ie expected to catch up with demand. “At that time, we should at least be on a schedule that does not mandate downtime,” Dr. Lewin said. “Through these shortages, busy labs are struggling to manage patients and referring physicians.”

One point deserves emphasis, he said: “No patients are at risk, nor will they be exposed to excess radiation due to the new concern.”

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Radiologist steals patient data to market himself. Check our Facebook page to see how he was penalized.

Related seminar: Cardiac Imaging

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