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Regulatory Focus™ > News Articles > 2020 > 9 > FDA warns of infection risk with CardioQuip heater-cooler

FDA warns of infection risk with CardioQuip heater-cooler

Posted 30 September 2020 | By Michael Mezher 

FDA warns of infection risk with CardioQuip heater-cooler

The US Food and Drug Administration (FDA) on Wednesday warned health care providers about the potential risk of Mycobacterium abscessus, a type of nontuberculosis mycobacteria (NTM), infection during cardiac surgery when using CardioQuip’s Modular Cooler-Heater.
 
The warning is the latest in a series of safety communications and other regulatory actions related to heater-cooler devices since 2015, when FDA first raised awareness of the risk of NTM infection posted by the devices.
 
Heater-cooler devices are used to control patient temperature during cardiothoracic surgery and cardiopulmonary bypass. While the devices do not come into physical contact with patients, it is possible for water circulating in the device to become colonized by bacteria and aerosolized. According to FDA, nontuberculosis mycobacteria are common — found everywhere from soil to tap water — and generally do not pose a threat to humans, but in rare cases can cause infections or death in seriously ill or immunocompromised patients.
 
Now, FDA says it recently became aware of three patients from a single US facility who were infected with Mycobacterium abscessus following cardiothoracic surgery. With the latest warning, FDA says it has received reports of NTM device contamination or patient infection for all manufacturers of heater-coolers in the US.
 
The agency says it will continue to review the CardioQuip Modular Cooler-Heater by following up with the facility that reported the infections and the manufacturer.
 
Health care providers are advised to follow FDA’s current recommendations for the use of heater-cooler devices to reduce the risk of NTM infections, which include strictly adhering to the most up-to-date manufacturer cleaning and disinfection instructions and not using tap water to rinse, refill or top-off the devices.
 
“Use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. When making ice needed for use in the heater-cooler, use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. Deionized water and reverse osmosis-treated water are not recommended because they may promote corrosion of the metal components of the system,” FDA says.
 
Other recommendations include aiming the devices’ exhaust vent away from surgical or sterile fields and toward operating room exhaust vents and removing heater-coolers from service if they show any signs of discoloration or cloudiness in the fluid lines or circuits.
 
FDA

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