Potential Patient Infection Risks for Cardiac Surgery
Heater-coolers are devices used by hospitals across the nation during certain open heart surgery procedures. In rare cases, these devices have been associated with infections due to nontuberculous mycobacteria, sometimes called NTM. The CDC estimates the risk of infection associated with these devices to be less than 1%.
In late 2015, an international outbreak due to one type of NTM was reported. While BIDMC did not have cases detected, patients were notified of potential risk as recommended by federal agencies. In 2020, BIDMC detected a few cases of another type of NTM associated with heater-coolers and took appropriate actions. Although it is unlikely that patients undergoing cardiac surgery procedures were impacted, details on both events are below with information and recommended actions for patients.
CardioQuip Modular Cooler-Heater Device and Mycobacterium abscessus Infections
BIDMC identified a small number of infections due to a type of NTM called Mycobacterium abscessus following cardiac surgery procedures that occurred in February and March 2020. Through a thorough investigation, these infections were found to be associated with the CardioQuip Modular Cooler-Heater Device.
Patients who underwent open cardiac procedures during the time period of risk received a letter from BIDMC in December 2020 with more information.
Stöckert 3T Heater-Cooler System and Mycobacterium chimaera Infections
In December 2015, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) reported that the Stöckert 3T Heater-Cooler System was linked to a rare bacterial infection caused by Mycobacterium chimaera, a type of NTM. BIDMC acted quickly after receiving reports of this international issue to eliminate the use of the Stöckert 3T Heater-Cooler System.
Patients who underwent open cardiac procedures during the time period of risk received a letter from BIDMC with more information. Although infections at this point would be extremely unlikely, infections could occur up to 10 years following.