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October 13, 2021 – The FDA today has sent a letter to health care providers that it continues to monitor the risk of Nontuberculous mycobacteria (NTM) infections in patients that have had cardiothoracic surgery and used heater-cooler devices, and create strategies to help prevent the risk of infections during cardiothoracic surgery.

CardioQuip and Gentherm Medical LLC are heater-cooler manufactures that are now announcing voluntary recalls in order to update labeling and plans to reduce the risk of NTM infections.

The recalled models are as follows:

CardioQuipMCH-1000(i) Cooler Heater
MCH-1000(m) Cooler Heater
Gentherm Medical LLCHemotherm CE Dual Reservoir
Cooler/Heater, Model 400CE

Two other makers, Terumo and Maquet are not recalling their devices because they are NOT pursuing a cleaning and disinfection plans that address the risk of NTM infection.

FDA statement to health care providers is:  

“The FDA wants to ensure that health care providers and users are aware to discontinue use of the Maquet and Terumo heater-cooler devices, and of the interim mitigations from CardioQuip and Gentherm Medical LLC. The FDA is continuing to work with CardioQuip and Gentherm Medical LLC to ensure they provide test results on cleaning and disinfection validation as well as aerosolization. The FDA will continue to work with manufacturers on strategies to minimize the risk of NTM patient infection.”

What are Heater-Cooler Devices?

These common devices are used to help control body temperatures during surgeries to help improve the medical care and surgery outcomes.  Most of these devices have water tanks that use temperature controlled water that is pushed through blankets in closed circuits.

What are the dangers of Heater-Cooler devices?

Even though the water doesn’t come into direct contact with the patient, some contaminated water can enter into the device’s exhaust vent or other pathway and then into the room, and then to the patients.  The possibility of bacteria becoming airborne is the main concern.

The FDA has noted that cases where people have become infected with NTM are rare, and use of heater-cooler blankets outweighs the risk of NTM.

What is Nontuberculous mycobacteria 

Nontuberculous mycobacterial (NTM) lung disease is a type of infection caused by bacteria that are common in the environment and may lead to lung damage. Primary transmission is via aerosolized particles in the air. Sources of NTM can be in both soil and water. Most people will come into contact with this bacteria but not everyone will become sick. Those that have other health issues such as COPD, asthma or bronchiectasis have a greater risk of becoming ill.

FDA Recommendations for Providers:

  • Strictly adhere to the cleaning and disinfection instructions provided in the manufacturer’s heater-cooler device labeling. Ensure you have the most current version of the manufacturer’s instructions for use readily available for staff who interact with these devices.
  • DO NOT use tap water to rinse, fill, refill, or top-off heater-cooler water tanks since this may introduce NTM organisms. 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.

For the complete details of the FDA recommendations for Heater-Cooler Devices, please visit this link: https://www.fda.gov/medical-devices/what-heater-cooler-device/recommendations-use-any-heater-cooler-device

The lawyers at Asllani & Associates are monitoring this new FDA warning, and want to assure anyone who may have contracted an NTM infection during cardiothoracic surgery to contact us today for a free review of your situation. Use the secure form on this page or call us direct at 1-800-811-1577