![]() ![]() Report any issues with neonatal incubators to the FDA.Follow the neonatal incubator manufacturer’s instructions for use, including disinfection and cleaning, prior to first use with patients.While the FDA further evaluates this issue, as an interim precautionary measure, consider running new neonatal incubators prior to use with patients for a week in a well-ventilated space using clinically relevant conditions for temperature and humidity, as the release of these airborne chemicals may decline over time.Review your current plan for proper air ventilation in neonatal settings.Remain alert for further updates and recommendations from the FDA and neonatal incubator manufacturers. ![]() Be aware that the FDA is working with manufacturers to understand the potential for exposure to airborne chemicals (formaldehyde, cyclohexanone, and other volatile chemicals) that may be released from neonatal incubators, potential health risks, and mitigation strategies, if needed.The FDA recognizes that incubators are critical for neonates (infants less than four weeks old) that cannot maintain their body temperature. RecommendationsĪt this time, the FDA has the following recommendations for health care providers and facilities: ![]() Currently, the FDA is not aware of any reported adverse events related to the use of neonatal incubators and exposure to these airborne chemicals. The FDA is working with manufacturers of neonatal incubators to collect and evaluate data from their products to determine whether these airborne chemicals are released, and if so, the amount of exposure and the potential risks to health from such exposure, if any, for newborns and others (such as health care providers). Potential sources of these airborne chemicals include materials used to make neonatal incubators as well as natural and human-made sources external to the incubator. The FDA is evaluating published literature that reports elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals (such as human-made chemicals used and produced in manufacturing) from neonatal incubators. Food and Drug Administration (FDA) is informing health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators. ![]()
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