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A preterm newborn baby laying inside an incubator in the NICU.

FDA finds newly manufactured incubators safe for use amid concerns of airborne chemicals

January 16, 2025

The Food and Drug Administration (FDA) announced on Thursday that all new neonatal incubators in the United States are safe to use following concerns of airborne chemicals within the devices.

The FDA has determined that new neonatal incubators do not need to be run for a week before clinical use because testing does not demonstrate concerning levels of airborne chemicals.

In February 2023, the FDA informed health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators.

Thursday’s announcement comes after the agency reviewed all available information to determine the safety of the incubators. The FDA worked with device manufacturers to evaluate the data from tests of newly manufactured neonatal incubators.

The evaluation was conducted to understand the potential for exposure to formaldehyde, cyclohexanone and other volatile chemicals that may be released from neonatal incubators, potential health risks and mitigation strategies if needed. Exposure to elevated levels of these chemicals may lead to neurological impairment or respiratory problems, which is concerning for neonates who may have immature pulmonary functions and other comorbidities.

In addition, the FDA worked with GE HealthCare to implement a process to reduce the levels of formaldehyde from its new neonatal incubators before distribution.

The FDA is not aware of adverse events related to the use of neonatal incubators and exposure to airborne chemicals. However, the FDA will continue to monitor the postmarket performance of neonatal incubators.

FDA officials recommend that clinicians follow the neonatal incubator manufacturer’s instructions for use, including disinfection and cleaning, prior to first use with patients. Any issues should be reported to the FDA.

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