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FDA evaluating potential release of airborne chemicals from incubators

February 23, 2023

The Food and Drug Administration (FDA) is evaluating whether airborne chemicals are being released from neonatal incubators and if potential health risks are involved.

In a letter to health care providers, the FDA said published literature reported elevated levels of formaldehyde, cyclohexanone and other volatile chemicals from neonatal incubators. It is working with manufacturers of incubators to collect and evaluate additional data to determine whether chemicals are released, and if so, the amount of exposure and potential risks to newborns and others.

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. The FDA is not aware of any adverse events related to the use of incubators and exposure to airborne chemicals.

While exposure to airborne chemicals can result from natural and human-made sources, the health effects depend on various factors, including the chemical; the amount, length of time and frequency of exposure; and the susceptibility of the person exposed. Other contributing factors may include increased temperature and humidity, and the concentration of these airborne chemicals may decrease over time.

While further testing and analysis are conducted, health care providers and facilities are advised to:

  • Continue using neonatal incubators.
  • Review their facility’s plan for proper air ventilation in neonatal settings.
  • Consider running new neonatal incubators for a week in a well-ventilated space using clinically relevant conditions for temperature and humidity prior to use with patients.
  • Follow manufacturer instructions for use, including disinfection and cleaning.
  • Report any issues with neonatal incubators to the FDA.
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