The U.S. Food and Drug Administration (FDA) is urging health care providers to strictly follow manufacturer guidelines for the safe operation of hyperbaric oxygen therapy (HBOT) devices, citing recent reports of fires that have resulted in serious injuries and fatalities.
HBOT involves placing patients in a pressurized chamber that delivers 100 percent oxygen, allowing the lungs to absorb higher levels of oxygen to aid healing and fight infection. While generally safe when used correctly, the FDA emphasized that the oxygen-rich environment increases the risk of fire.
The agency has documented rare but severe incidents involving HBOT devices and is calling for heightened precautions. Providers are advised to adopt strict fire prevention practices, including proper equipment grounding, ongoing staff training, and continuous patient monitoring during treatment.
Patients should wear only manufacturer-approved, hyperbaric-compatible clothing—such as cotton garments—since fabrics like wool and synthetics can generate static electricity. In addition, both patients and staff must comply with restrictions on prohibited items, including electrical and static-producing devices.
The FDA also stressed the importance of routine cleaning, maintenance, and safety checks in accordance with manufacturer recommendations.
To further reduce risks, the agency plans to work with manufacturers and professional societies to strengthen training initiatives. The FDA is encouraging health care providers to report any adverse events or suspected safety issues linked to HBOT devices.
