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FDA To Host Conference Call on Heater-Cooler Contamination

An upcoming Food and Drug Administration (FDA) conference call will allow health care providers to discuss recent alerts about the potential contamination of heater-cooler devices used during cardiopulmonary bypass procedures.

The FDA call will take place from 2:303:30 pm ET on Nov. 1. To join the call, dial 800.475.0478 and use passcode HCD.

FDA and the Centers for Disease Control and Prevention (CDC) earlier this month alerted health care providers that Stӧckert 3T heater-cooler devices might have been contaminated with Mycobacterium chimaera (M. Chimaera) during the manufacturing process.

CDC advised hospitals to alert patients who have had open-heart surgery involving a Sorin Stӧckert 3T heater-cooler device that they might be at risk for developing an M. Chimaera infection. To assist hospitals in their outreach, CDC has developed a toolkit that includes a sample notification letter to patients, as well as a letter for patients to take to their health care providers; a letter for clinicians; and a questions-and-answers document. Also, members of America’s Essential Hospitals can access a recording of an Oct. 11 CDC informational conference call and sample talking points about the potential heater-cooler contamination.

Contact Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Michelle Rosenfeld is senior writer/editor at America's Essential Hospitals.

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