FDA Lifts Alert on Neonatal Incubators

An FDA update says all new neonatal incubators currently supplied in the U.S. do not show “concerning levels of airborne chemicals and therefore do not need to be run for a week before clinical use.” The agency raised concern about such devices 2/2023 and issued an alert stating that published literature had reported elevated levels of formaldehyde, cyclohexanone, and other volatile chemicals from neonatal incubators. An agency letter to healthcare providers said at the time that the potential sources of the airborne chemicals included materials used to make the incubators as well as natural and human-made sources external to them.

The update says that FDA is not currently aware of adverse events the incubators’ use and exposure to airborne chemicals from them. However, it says it will continue to monitor marketed devices’ postmarket performance and inform the public if significant concerns arise.