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# 37% of Heater-Cooler Devices Reviewed are Contaminated: Research
- URL: https://www.fdaweb.com/37-of-heater-cooler-devices-reviewed-are-contaminated-research/
- Published: 2017-06-16T12:00:00.000Z
- Updated: 2026-09-14T22:29:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138955

New research finds that 37% (33 out of 89) heater-cooler units assessed between 7/2015 and 12/2016 tested positive for *Mycobacterium chimaera* associated with fatal infections in open-heart surgery patients. The research was recently presented at the 44th Annual Conference of the Association for Professionals in Infection Control and Epidemiology ([APIC](http://www.apic.org/?ref=fdaweb.com)). FDA and CDC have previously issued [safety warnings](https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492590.htm?ref=fdaweb.com) about such devices.

  
“These results highlight the importance of monitoring the decontamination and maintenance schedules of these devices to minimize the risk of patient harm,” [APIC says](https://www.eurekalert.org/pub%5Freleases/2017-06/afpi-mta060917.php?ref=fdaweb.com). “Hospitals must follow the cleaning and disinfection instructions provided in the manufacturer's device labeling, as well as updated communications from the FDA and CDC.”