The Food and Drug Administration (FDA) has updated its advice on use of neonatal incubators due to potential health risks from airborne chemicals that may be released from the incubators.
Published literature has described elevated levels of formaldehyde, cyclohexanone and other volatile chemicals, but the FDA is not aware of any reported adverse events related to the use of neonatal incubators and exposure to these airborne chemicals.
In a letter to health care providers Wednesday, the FDA said testing has determined that new neonatal incubators by Drager (also known as Draeger) and certain GE Healthcare neonatal incubators do not need to be run before clinical use as advised in October 2023.
However, FDA recommendations have not changed for new neonatal incubators made by other manufacturers. The FDA is advising that health care providers and facilities:
- Continue to use neonatal incubators, which are critical for neonates who cannot maintain their body temperature.
- Be aware that the FDA is working with manufacturers to understand potential for exposure to airborne chemicals that may be released, potential health risks and mitigation strategies, if needed. Remain alert for further updates and recommendations.
- Review your facility’s current plan for proper air ventilation in neonatal settings.
- As an interim precautionary measure, consider running new neonatal incubators for a week in a well-ventilated space prior to use with patients. Use clinically relevant conditions for temperature and humidity, as release of airborne chemicals may decline over time.
- Report any issues with neonatal incubators to the FDA.
For more details, consult the Jan. 3 FDA letter to health care providers.
