Post-market review of neonatal incubators

The TGA has completed a post-market review of all neonatal incubators included in the Australian Register of Therapeutic Goods (ARTG). 

What are neonatal incubators?

Neonatal incubators are devices that help to maintain the body temperature in premature or sick newborns. These devices play a vital role in the care of newborns, especially in neonatal intensive care units (NICU).

The incubators provide a controlled environment by circulating heated and humidified air within an enclosed bed compartment.

Background

In February 2023, the US Food and Drug Administration (FDA) issued a letter to health care providers about the potential for exposure to airborne chemicals that may be released from neonatal incubators. The FDA continues to provide updates about the ongoing evaluation and work with manufacturers as additional information becomes available.

It was reported that higher levels of substances such as formaldehyde and cyclohexanone could be released from these devices. Exposure to elevated levels of these substances may be unsafe for neonates. 

The purpose of the review was to determine whether these devices supplied in Australia continue to be safe to use.

We required all sponsors of neonatal incubators included in the ARTG to provide information to us about their device, including:

• evidence of the testing undertaken by the manufacturer
• the manufacturer’s risk assessment and risk mitigation strategies
• whether the devices pose any unnecessary risk to the health of the baby during normal use.

Post-market review: outcomes and actions

We have reviewed the evidence provided by the sponsors and manufacturers of all neonatal incubators included in the ARTG. The neonatal incubators currently being supplied in Australia complied with state-of-the-art standards and did not demonstrate concerning levels of airborne chemicals. 

In addition, the evidence showed that any emissions that occur at the time of manufacture decrease quickly over time. This means that neonatal incubators that have been previously supplied, but were not part of the post-market review, are unlikely to have any residual safety issues.

During the post-market review, some sponsors decided to cease supply of their products in the Australian market. Sponsors may make this decision at any time, and they are not required to provide us with a reason for their withdrawal from the market.

Where a neonatal incubator has been cancelled from the ARTG, they are not being recalled from the market. The cancelled devices will no longer be available for purchase.

Information for consumers and healthcare professionals

Currently, the TGA is not aware of any adverse effects associated with the exposure of airborne chemicals in neonatal incubators supplied in Australia.

Healthcare facilities can continue to use neonatal incubators.

Consumers should follow the manufacturer’s instructions for use, including recommendations for cleaning and disinfection of these devices, prior to patient use.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see TGA Incident reporting and Investigation Scheme (IRIS).

We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

Devices included in the review

The neonatal incubators that were included in the post-market review and any associated outcomes are listed below.