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Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers reminding providers and facilities about the safe use of Hyperbaric Oxygen Therapy (HBOT) devices and the importance of following the manufacturer’s instructions for use.
The FDA is aware of reports of serious injuries and deaths with use of HBOT devices and is providing recommendations for health care providers and facilities. Reviewing and following the manufacturer’s instructions for use for each HBOT device being used and ensuring proper fire prevention and safety measures are followed can help reduce potential risks associated with the use of these devices.
The Letter to Health Care Providers includes important information about these medical devices, including:
- Recommendations for health care providers and facilities.
- Instructions for reporting problems with a device.
Questions?
If you have questions about these medical devices, contact the Division of Industry and Consumer Education (DICE).
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