Dive Brief:
- GE HealthCare has cut the levels of formaldehyde released from newly manufactured neonatal incubators after the Food and Drug Administration flagged potential exposure to the chemical.
- In February, the FDA alerted healthcare providers and facilities to the potential for neonatal incubators to emit airborne chemicals. Follow-up work by GE HealthCare found levels of formaldehyde rapidly decrease over the week after the incubator is assembled.
- GE HealthCare responded to the problem by implementing a new process to reduce the levels of formaldehyde before distribution. Hospitals can use devices received after Sept. 5 immediately.
Dive Insight:
The FDA began assessing the potential for incubators to expose babies to airborne chemicals in response to reports of elevated levels of formaldehyde, cyclohexanone and other volatile chemicals. Officials identified materials used to make neonatal incubators as potential sources of the chemicals.
By June, GE HealthCare had determined that there was potential for higher levels of formaldehyde in the environment around newly manufactured incubators, but that levels rapidly decreased within one week.
The preliminary testing informed the recommendation that healthcare facilities assemble GE HealthCare Giraffe OmniBed Carestation and Giraffe Incubator Carestation devices and leave them running for one week in a well-ventilated space. After one week, the devices would be ready for clinical use.
That recommendation still applies to devices received by healthcare facilities before Sept. 5. However, the advice no longer applies to devices received from that date onward. Changes made by GE HealthCare mean the devices are safe to use without the previously recommended one-week wait period.
GE HealthCare has not received reports of patient injury or adverse effects related to potential exposure to formaldehyde in incubators. The FDA has no evidence that the levels of formaldehyde seen in the company’s incubators have caused adverse health effects, but it is continuing to collect and analyze data on exposure to airborne chemicals that may be released by such devices.
