The United States Food and Drug Administration (FDA) has issued an alert concerning heater-cooler devices. Through analysis of adverse event reports, the medical literature, and information from national and international public health agencies, FDA is aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.
Heater-cooler devices are used during cardiothoracic surgeries, as well as other medical and surgical procedures to warm or cool a patient to optimize medical care and improve patient outcomes. Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device's exhaust vent into the environment and to the patient.
The FDA recommends that facilities and staff using heater-cooler devices consider implementing the following measures to reduce risk to patients:
- Strictly adhere to the cleaning and disinfection instructions provided in the manufacturer's device labeling. Ensure you have the most current version of the manufacturers' instructions for use readily available to promote adherence.
- Do not use tap water to rinse, fill, refill or top-off 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 patient cooling during surgical procedures 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 sterile water created through reverse osmosis is not recommended because it may promote corrosion of the metal components of the system.
- Direct the heater-cooler's vent exhaust away from the surgical field to mitigate the risk of aerosolizing heater-cooler tank water into the sterile field and exposing the patient.
- Establish regular cleaning, disinfection and maintenance schedules for heater-cooler devices according to the manufacturers' instructions to minimize the risk of bacterial growth and subsequent patient infection.
- Develop and follow a comprehensive quality control program for maintenance, cleaning, and disinfection of heater-cooler devices. Your program may include written procedures for monitoring adherence to the program and documenting set up, cleaning, and disinfection processes before and after use.
- Immediately remove from service heater-cooler devices that show discoloration or cloudiness in the fluid lines/circuits, which may indicate bacterial growth. Consult your hospital infection control officials to perform the appropriate follow up measures and report events of device contamination to the manufacturer.
- Consider performing environmental, air, and water sampling and monitoring if heater-cooler contamination is suspected. Environmental monitoring requires specialized expertise and equipment to collect and process samples, which may not be feasible in all facilities.
- Health care facilities should follow their internal procedures for notifying and culturing patients if they suspect infection associated with heater-cooler devices.
For details, please refer to the FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm467151.htm
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm
Posted on 16 October 2015