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.

Date Event
November 8, 2024 The FDA provided an update that new neonatal incubators by additional manufacturers (Atom Medical, Bistos, and International Biomedical)  do not need to be run for a week before clinical use. The FDA continues to review testing data from LMT Medical Systems.
January 3, 2024 The FDA provided an update that new neonatal incubators by Drager (also known as Draeger) do not need to be run for a week before clinical use.
October 16, 2023 The FDA provided an update based on information from GE HealthCare and implementation of a process to reduce the levels of formaldehyde from new neonatal incubators before distribution. New GE HealthCare neonatal incubators received after September 5, 2023, do not need to be run for a week before clinical use.
June 13, 2023 The FDA provided an update based on GE HealthCare preliminary testing on their newly manufactured neonatal incubators that suggests the potential for higher levels of formaldehyde rapidly decreases over one week.
February 23, 2023 The FDA informed health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators.

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.

Manufacturer Brand Name Model/Version Unique Device Identifier (UDI)
LMT Medical Systems LMT nomag IC 1.5 0100015 04260486610568
LMT Medical Systems LMT nomag IC 3.0 0100025 04260486610575
Atom Medical Dual Incu i (Atom Infant Incubator 100 AC120V w/O2 Controller Unit) 61600 04942962616003
Atom Medical Dual Incu i (Atom Infant Incubator 100 AC120V w/o O2 Controller Unit ) 61602 04942962616027
Atom Medical Incu i (Atom Infant Incubator 101 AC120V  w/O2 Controller Unit ) 61605 04942962616058
Atom Medical Incu i (Atom Infant Incubator 101  AC120V  w/o O2 Controller Unit) 61607 04942962616072
Atom Medical V-808 Atom Transcapsule (Main Unit Only(120 V)) 61522 04942962615228
Atom Medical V-707 Atom Transcapsule (V-707 with Power Pack(100-120V) 61305 04942962613057
Bistos Co., Ltd. BT-500 BT-500 00887529000137
International Biomedical, Ltd. 185A+ Infant Incubator 185A+ 00868406000037
International Biomedical, Ltd. 185A+ Infant Incubator 185A+ 00868406000099
International Biomedical, Ltd. A750i Infant Incubator A750i 00868406000013
International Biomedical, Ltd. Aviator Transport Incubator Aviator 00865648000306
International Biomedical, Ltd. Aviator Transport Incubator Aviator 00868406000006
International Biomedical, Ltd. NxtGen Infant Transport Incubator NxtGen 00850018561020
International Biomedical, Ltd. Voyager Infant Transport Incubator Voyager 00865648000320
International Biomedical, Ltd. Voyager Infant Transport Incubator Voyager 00868406000020
Drager (also known as Draeger) Babyleo TN 500 Babyleo TN 500 04048675436607
Drager (also known as Draeger) Isolette 8000 plus Isolette 8000 plus 04049098090612
Drager (also known as Draeger) TI500 Transport Incubator TI500 Transport Incubator 04049098000208
GE HealthCare (and subsidiary Datex Ohmeda Inc). Giraffe OmniBed Carestation CS1 00840682116862
GE HealthCare (and subsidiary Datex Ohmeda Inc.) Giraffe Incubator Carestation CS1 00840682116855

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).