FDA Investigating Neonatal Incubators for Potential Chemical Exposure Risk

The Food and Drug Administration (FDA) is investing the possibility of exposure to airborne chemicals released from newborn incubators.

According to published literature, reports have shown elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals released from neonatal incubators. Though the Agency is not aware of any reported adverse events related to this issue, exposure to elevated levels of formaldehyde or cyclohexanone have been associated with neurological and respiratory impairment.

To assess the potential risk, the FDA is working with manufacturers of neonatal incubators, evaluating data from their products. Following an initial review, the Agency has concluded that currently available information is inadequate to assess the potential exposure and risk to newborns and others. Additional testing and analysis will be required to evaluate the factors that may contribute to the release of these chemicals.

At this time, health care providers and facilities are being advised to continue using neonatal incubators as they are critical for neonates who are unable to maintain their body temperature. Health care providers and facilities should also review their current plan for proper air ventilation in neonatal settings and consider running new neonatal incubators prior to use with patients in a well-ventilated space using clinically relevant conditions for temperature and humidity.

Adverse events or suspected adverse events experienced with any medical device should be reported to the FDA’s MedWatch Voluntary Reporting program.

Reference

Evaluation of airborne chemicals from neonatal incubators – letter to health care providers. US Food and Drug Administration. Accessed February 27, 2023. https://www.fda.gov/medical-devices/letters-health-care-providers/evaluation-airborne-chemicals-neonatal-incubators-letter-health-care-providers.