Assessment of Airborne Substances Emitted by Neonatal Incubators – A Message to Healthcare Professionals
UPDATE: November 8, 2024
The U.S. Food and Drug Administration (FDA) is updating the public regarding the ongoing assessment and collaboration with manufacturers about the possible release of airborne chemicals from neonatal incubators.
The FDA previously reported that new neonatal incubators from GE HealthCare received post-September 5, 2023, and Drager do not require a week of operation before being used in clinical settings.
Furthermore, the following manufacturers have been confirmed to have new neonatal incubators that also do not necessitate a pre-use running period, as testing has shown no significant airborne chemicals:
The FDA continues to partner with this specific manufacturer to thoroughly evaluate testing results, and the existing advice regarding running their neonatal incubators for a week prior to clinical applications remains valid:
The FDA will maintain communication with healthcare providers as new information emerges.
February 23, 2023
The FDA is informing healthcare providers and medical facilities regarding potential exposure to airborne chemicals that may emanate from neonatal incubators. The agency is analyzing literature indicating elevated concentrations of formaldehyde, cyclohexanone, and other volatile substances possibly produced during manufacturing from neonatal incubators. These airborne chemicals could arise from materials in the incubators or external natural and synthetic sources.
The FDA is collaborating with neonatal incubator manufacturers to gather and assess their product data to understand if these airborne pollutants are emitted, the levels of exposure, and any associated health risks for newborns and healthcare professionals. Currently, there have been no reports of adverse health incidents linked to neonatal incubators and such airborne chemicals.
Recommendations
The FDA advises healthcare providers and facilities using LMT Medical Systems neonatal incubators to:
- Continue utilizing these incubators, as they are essential for neonates (infants less than four weeks old) who cannot self-regulate their body temperature.
- Stay informed, as the FDA is assessing potential airborne chemical exposure risks from these incubators and any required mitigation strategies.
- Evaluate air ventilation plans in neonatal environments.
- As a precaution, consider running new LMT Medical Systems incubators for a week in a well-ventilated area under clinically relevant conditions for temperature and humidity before clinical use, given that potential chemical emissions might reduce over time.
Here is the Unique Device Identifier (UDI) information for LMT Medical Systems neonatal transport incubators:
| Brand Name | Model/Version | Unique Device Identifier (UDI) |
|---|---|---|
| LMT nomag IC 1.5 | 0100015 | 04260486610568 |
| LMT nomag IC 3.0 | 0100025 | 04260486610575 |
New data from the manufacturer indicate that Atom Medical’s neonatal incubators do not require a week’s operation before clinical deployment. Testing demonstrated no alarming airborne chemical levels.
UDI information provided by Atom Medical:
| Brand Name | Model/Version | Unique Device Identifier (UDI) |
|---|---|---|
| Dual Incu i (Atom Infant Incubator 100 AC120V w/O2 Controller Unit) | 61600 | 04942962616003 |
| Dual Incu i (Atom Infant Incubator 100 AC120V w/o O2 Controller Unit ) | 61602 | 04942962616027 |
| Incu i (Atom Infant Incubator 101 AC120V w/O2 Controller Unit) | 61605 | 04942962616058 |
| Incu i (Atom Infant Incubator 101 AC120V w/o O2 Controller Unit) | 61607 | 04942962616072 |
| V-808 Atom Transcapsule (Main Unit Only(120 V)) 61522 | 61522 | 4942962615228 |
| V-707 Atom Transcapsule (V-707 with Power Pack(100-120V) | 61305 | 04942962613057 |
The latest information confirms that Bistos neonatal incubators do not require a week of operation before clinical application, as their recent testing did not reveal any significant airborne chemical levels.
UDI details for Bistos include:
| Model Name | Unique Device Identifier (UDI) |
|---|---|
| BT-500 | 00887529000137 |
Based on new findings, International Biomedical’s neonatal incubators no longer require a week of operation prior to clinical use, as testing has not shown any concerning airborne chemical emissions.
UDI information provided by International Biomedical:
| Brand Name | Model/Version | Unique Device Identifier (UDI) |
|---|---|---|
| 185A+ Infant Incubator | 185A+ | 00868406000037 |
| 185A+ Infant Incubator | 185A+ | 00868406000099 |
| A750i Infant Incubator | A750i | 00868406000013 |
| Aviator Transport Incubator | Aviator | 00865648000306 |
| Aviator Transport Incubator | Aviator | 00868406000006 |
| NxtGen Infant Transport Incubator | NxtGen | 00850018561020 |
| Voyager Infant Transport Incubator | Voyager | 00865648000320 |
| Voyager Infant Transport Incubator | Voyager | 00868406000020 |
Drager’s newly manufactured neonatal incubators also do not require running for a week prior to their clinical use. Recent assessments revealed no harmful airborne chemicals.
UDI information from Drager includes:
| Model Name | UDI |
|---|---|
| Babyleo TN 500 | 04048675000051 |
| Isolette 8000 plus | 04049098090612 |
| TI500 Transport Incubator | 04049098000208 |
GE HealthCare has initiated processes to minimize formaldehyde emissions from new neonatal incubators before they are provided for use.
- New GE HealthCare Giraffe OmniBed Carestations or Giraffe Incubator Carestations:
- Incubators received after September 5, 2023, do not require a week of pre-operation prior to clinical application.
- Those received before September 5, 2023, that have yet to be utilized clinically should be assembled and run for a week in a well-ventilated area under high temperature and humidity, with panels securely closed.
- For inquiries about your new neonatal incubator, please reach out to your GE Healthcare representative.
- Incubators received after September 5, 2023, do not require a week of pre-operation prior to clinical application.
- For incubators currently in use, please continue their operation. These incubators are essential for the care of neonates unable to maintain body temperature.
Unique Device Identifier (UDI) details provided by GE HealthCare:
- Giraffe OmniBed Carestation: 00840682116862
- Giraffe Incubator Carestation: 00840682116855
No injuries or adverse effects associated with formaldehyde exposure in GE HealthCare incubators have been reported. Thus far, no evidence suggests adverse health consequences linked to formaldehyde levels detected in GE HealthCare incubators.
- Always adhere to the instructions from manufacturing companies regarding usage, as well as disinfection and cleaning protocols, before first patient interaction.
- Report any concerns regarding neonatal incubators to the FDA.
Background
Neonatal incubators are pivotal for newborns in hospital settings like neonatal intensive care units (NICU), offering a regulated environment necessary for those needing assistance in maintaining stable body temperatures through heated and humidified air within an enclosed compartment.
The FDA’s initial literature review has deemed the current data insufficient to evaluate the potential exposure levels and health risks associated with airborne chemicals (formaldehyde, cyclohexanone, among other volatile compounds) from neonatal incubators. Factors influencing these emissions could include heightened temperature and humidity. Additionally, airborne chemical concentrations may decrease as time progresses. More thorough testing is required to clarify which incubators emit airborne chemicals, the specific substances involved, factors affecting emissions, exposure durations, and associated health risks.
Exposure to airborne chemicals can occur from both natural sources, such as radon, and anthropogenic results from manufacturing byproducts, cleaning agents, tobacco smoke, and various plastics. The health effects linked to these chemicals depend on variables including the type of chemical, exposure levels, encounter frequency, duration, and the individual’s sensitivity to those substances.
Elevated exposure to formaldehyde or cyclohexanone might result in issues such as neurological impairments or respiratory difficulties (e.g., asthma, reduced lung functionality, inflammation), particularly alarming for neonates with underdeveloped pulmonary systems and other conditions. Currently, the FDA is not aware of adverse events tied to neonatal incubator usage and airborne chemical exposures.
FDA Action (Updated November 8, 2024)
The FDA continues collaborating with LMT Medical Systems to assess their findings and conclusions. Upon completion, the FDA will ascertain whether any mitigation steps are necessary.
On October 31, 2024, the FDA designated the prior guidance for GE HealthCare, advising that neonatal incubators received prior to September 5, 2023, undergo a week of operation as a Class I recall, the most serious recall classification. This action is corrective, not a withdrawal of the product.
The FDA will keep the public informed about essential updates or new recommendations as they arise.
| Date | Event |
|---|---|
| January 3, 2024 | The FDA offered an update that neonatal incubators from Drager do not necessitate pre-use operation. |
| October 16, 2023 | The FDA provided an update from GE HealthCare regarding the process implemented to minimize formaldehyde levels from new neonatal incubators before distribution. |
| June 13, 2023 | The FDA reported an update based on preliminary testing by GE HealthCare indicating the quick reduction of potential formaldehyde levels over a week. |
| February 23, 2023 | The FDA informed healthcare facilities about airborne chemical exposure risks from neonatal incubators. |
Reporting Problems to the FDA
The FDA encourages healthcare practitioners to report any adverse reactions or suspected problems encountered with medical devices. Timely reporting helps the FDA identify risks linked with medical devices and improve patient safety.
Contact Information
If you have inquiries regarding this notice, please reach out to the Division of Industry and Consumer Education (DICE).