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The U.S. Food and Drug Administration (FDA) is informing health care providers and facilities that the FDA is evaluating the potential for exposure to airborne chemicals that may be released from neonatal incubators. The FDA is working with manufacturers of neonatal incubators to collect and evaluate data from their products to determine whether airborne chemicals such as formaldehyde, cyclohexanone, and other volatile chemicals are released, and if so, the amount of exposure and the potential risks to health from such exposure, if any. Currently, the FDA is not aware of any reported adverse events related to the use of neonatal incubators and exposure to these airborne chemicals.
The FDA recognizes that neonatal incubators are critical to patient care, and providers should continue to use these devices. The Letter to Health Care Providers includes:
- Recommendations for health care providers and facilities.
- Background information about the issue.
- The FDA’s actions to address the issue.
- Instructions to report problems with medical devices.
Questions?
If you have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE).
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