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.
| 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.
- Health care personnel employed by facilities that are subject to the FDA's User Facility Reporting Requirements should follow the reporting procedures established by their facilities.
- Voluntary reports can be submitted through MedWatch: The FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
Contact Information
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).