Agency is reminding health care providers to carefully follow the manufacturer’s instructions
By Stephanie Brown HealthDay Reporter
WEDNESDAY, Aug. 27, 2025 (HealthDay News) — The U.S. Food and Drug Administration has sent letters to health care providers alerting them to the importance of following manufacturer instructions for the safe use of hyperbaric oxygen therapy (HBOT) devices.
HBOT uses a pressurized chamber to deliver 100 percent oxygen, helping the lungs absorb more oxygen to support healing and fight infections, according to the FDA.
The agency has recently received reports of fires with HBOT devices causing serious injuries and deaths. Though rare, these events highlight the importance of following manufacturer instructions to reduce risks, the FDA notes. The agency advises health care providers to follow strict fire prevention and safety measures with HBOT devices, including proper grounding.
Staff working with HBOT devices should receive ongoing training and always keep in mind that high concentrations of oxygen increase the risk for fire.
Patients need to be continuously monitored during treatment and should wear manufacturer-recommended hyperbaric-compatible clothing (e.g., cotton), as fabrics like wool and synthetics can generate more static electricity. In addition, staff and patients should follow manufacturer instructions regarding prohibited items such as electrical or static devices.
Facilities should follow manufacturer-recommended cleaning, maintenance, and safety check procedures for each HBOT device.
The FDA will collaborate with manufacturers and professional societies to promote training and safe HBOT device use. The agency urges health care providers to report any adverse or suspected adverse events related to these devices.
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