The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration are alerting health care providers that certain heater-cooler devices used during cardiopulmonary bypass procedures might have been contaminated with Mycobacterium chimaera (M. Chimaera) during the manufacturing process.
In CDC’s Morbidity and Mortality Weekly Report, the agency said patients for whom Stӧckert 3T heater-cooler devices — manufactured by LinaNova PLC (formerly Sorin Group Deutschland GmbH) — were used during cardiac surgery might be at risk of developing infections. More than 250,000 of these cardiac procedures take place in the United States annually, and the Stӧckert 3T represents about 60 percent of the national market for such devices.
CDC is advising 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 firstname.lastname@example.org or 202.585.0127 with questions.