FDA Finds New Drager Neonatal Incubators Do Not Release Harmful Chemicals

Other neonatal incubators should still be run for a full week before use to rid the devices of potentially harmful chemicals, FDA regulators said.

Following warnings issued last year about high levels of airborne chemicals released by certain neonatal incubators, federal medical regulators have determined that new devices manufactured by Drager (also known as Draeger) do not appear to pose a threat.

In February 2023, the U.S. Food and Drug Administration (FDA) warned healthcare providers about the risk of elevated levels of formaldehyde, cyclohexanone, and other volatile compounds emitted from neonatal incubators, which could pose serious health risks for newborns.

Several months later, the FDA issued a warning about GE Healthcare Carestation neonatal incubators, indicating that the devices should be run for a full week prior to use on pediatric patients, to avoid releasing high levels of toxic chemicals.

A similar process was recommended for Drager neonatal incubators at that time. However, following tests of new devices manufactured by Drager, the FDA issued a revised update on January 3, indicating the Drager incubators do not need to be run for a week prior to clinical use with newborns, since testing suggests the devices do not release concerning levels of airborne chemicals.

The full-week run process was originally intended to help reduce levels of formaldehyde before use and prevent harm to infants. But the new update indicates running new Drager incubators for a week is unnecessary and that the newly manufactured devices do not pose a health risk.

The FDA recommends other incubators that do not fall under the recent updates should continue to be run for a week prior to use with patients. Healthcare providers should also review their plans for proper air ventilation in neonatal intensive care (NICU) settings.

Incubator Chemical Exposure Risks

Neonatal incubators are critical in caring for infants less than four weeks old. They are used in NICUs to create a suitable environment for newborns who cannot regulate their body temperature. They provide heat and humidified air with an enclosed bed compartment.

Because incubators are an environment for increased heat and humidity, they can trap chemicals inside which can become a hazard to infants.

Formaldehyde is a toxic chemical used in many consumer products. Research indicates exposure to formaldehyde can cause cognitive impairment in young people and increase a person’s risk of developing rare forms of cancer, including leukemia and neck tumors.

Formaldehyde is widely used in personal care products, cosmetics, building materials, and paper products. Most health concerns stem from workplace exposure to formaldehyde, which can cause a person to develop amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s disease.

So far, no patient injuries or adverse effects related to chemical emissions from neonatal incubators have been reported.

The FDA continues to evaluate the release of airborne chemicals from neonatal incubators and will update healthcare providers and consumers as necessary.

Side effects or adverse events should be reported to the FDA’s MedWatch Adverse Event Reporting program.