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  5. Update: Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers
  1. Letters to Health Care Providers

Update: Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers

January 16, 2025

The U.S. Food and Drug Administration (FDA) is providing an update on its evaluation of the potential for exposure to airborne chemicals that may be released from neonatal incubators.

Based on the FDA's review of the totality of the available information including testing data, we have determined that all new neonatal incubators currently supplied in the United States do not demonstrate concerning levels of airborne chemicals and therefore do not need to be run for a week before clinical use.

Recommendations

  • New neonatal incubators do not need to be run for a week before clinical use.
  • Follow the neonatal incubator manufacturer's instructions for use, including disinfection and cleaning, prior to first use with patients.
  • Report any issues with neonatal incubators to the FDA.

Background

Neonatal incubators are critical to care for newborns in hospital settings such as neonatal intensive care units (NICU). The incubators help create an optimal environment for newborns that need support in regulating their body temperature, by providing heated and humidified air within an enclosed bed compartment.

The FDA worked with device manufacturers to evaluate data from testing of newly manufactured neonatal incubators. This evaluation was conducted 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 if any, and mitigation strategies if needed. In addition, the FDA worked with GE HealthCare to implement a process to reduce the levels of formaldehyde from their new neonatal incubators before distribution. The FDA has determined that all new neonatal incubators currently supplied in the United States do not need to be run for a week before clinical use because testing does not demonstrate concerning levels of airborne chemicals.

Currently, the FDA is not aware of adverse events related to the use of neonatal incubators and exposure to airborne chemicals.

FDA Actions

The FDA will continue to monitor the postmarket performance of neonatal incubators.  

The FDA will inform the public if significant new information or recommendations become available.

Unique Device Identifier

The FDA established the unique device identification (UDI) system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.

You can find the UDI provided by the manufacturers for neonatal incubator devices by checking the table below.

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with any medical device. Prompt reporting can help the FDA identify and better understand the risks associated with medical devices and improve patient safety.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).

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