FDA: Heater–Cooler Devices Linked to Infection

FDA: Heater–Cooler Devices Linked to Infection
The FDA issued a warning about possible infections associated with heater–cooler devices and issued steps that health care providers and facilities could take to mitigate risks to patients.

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. These 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 be aerosolized through the device’s exhaust vent into the environment and to the patient, according to the FDA.

The FDA reviewed adverse event reports, medical literature, and information from national and international public health agencies, and found that the use of heater–cooler devices has been associated with nontuberculous mycobacterial (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.
Nontuberculous mycobacteria are common in the environment and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections among immunocompromised individuals.
Between January 2010 and August 2015, the FDA received 32 medical device reports (MDRs) of patient infections associated with heater–cooler devices or bacterial heater–cooler device contamination. Twenty-five of these MDRs were reported to the FDA in 2015.
Some reports described NTM infections related to cardiothoracic surgeries, but other reports do not specify the procedures the patients underwent. Eight reports were related to three events describing patient infections occurring in U.S. health care facilities. The remaining 24 reports involved health care facilities outside the United States, most of these in Western Europe. In some cases, patients presented with infections several months to years after their surgical procedures. Of note, half of the 32 reports submitted to the FDA described bacterial contamination of the heater–cooler device without known patient involvement or infection. The FDA is not aware of NTM infections acquired by hospital staff.
The FDA said there was a possibility that there were more infections, but they went unreported. Not everyone recognizes that infections, particularly NTM infections, may be associated with the use of or exposure to a particular medical device, the agency said. The FDA continues to evaluate reports through follow-up with health care facilities and manufacturers to determine which factors may have contributed to the reported events.
In addition to following standard precautions, 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 disinfecting instructions provided in the manufacturer’s device labeling. Ensure you have the most current version of the manufacturer’s instructions for use readily available to promote adherence.
  • Do not use tap water to rinse, fill, refill or top off water tanks, as 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 μm.
  • 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 μm. Deionized water and sterile water created through reverse osmosis are not recommended because it may corrode 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.
  • Develop and follow a comprehensive quality control program for maintenance, cleaning and disinfection of heater–cooler devices.
  • Immediately remove from service heater–cooler devices that show discoloration or cloudiness in the fluid lines/circuits, which may indicate bacterial growth. Consult the 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.
Health care facilities should follow their internal procedures for notifying and culturing patients if they suspect infection associated with heater–cooler devices.
The FDA also asked that any suspected infections be reported to FDA MedWatch.

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