On August 25, 2025, the U.S. Food and Drug Administration (FDA) issued an important Letter to Health Care Providers reminding clinicians and facilities of the critical importance of following manufacturer instructions for safe use of hyperbaric oxygen chamber (HBO₂) devices. This action follows recent reports of fires, injuries, and fatalities associated with HBO₂ device use.

Key FDA Recommendations

• Follow the manufacturer's Instructions for Use for each hyperbaric chamber device.
• Implement strict fire prevention protocols, including proper grounding of hyperbaric equipment.
• Ensure all staff are fully trained and maintain competency in HBO₂ operation.
• Maintain continuous patient supervision and monitoring throughout treatment.
• Adhere to cleaning, maintenance, and safety-check schedules set by the manufacturer.
• Avoid prohibited or static-generating items in the chamber environment.
• Require patients to wear hyperbaric oxygen-compatible attire to minimize static risk.

Why This Matters

The FDA emphasizes that although adverse events remain rare, the hyperbaric chamber environment is inherently associated with oxygen-rich, high-pressure fire risk. Proper adherence to safety protocols is essential to prevent harm.

UHMS Perspective

UHMS strongly supports the FDA's safety communication. These recommendations align with standards required under UHMS Hyperbaric Facility Accreditation and related codes such as NFPA 99 Chapter 14 and ASME PVHO-1.

• Report suspected adverse events to the FDA MedWatch program.
• Comply with Medical Device Reporting (MDR) requirements.
• Follow facility reporting protocols promptly to ensure risks are identified and addressed.

Additional Resources

• FDA Safety Communication – August 25, 2025
• Hyperbaric Oxygen Therapy: Get the Facts | FDA
• NFPA 99: Health Care Facilities Code, Chapter 14 – Hyperbaric Facilities
• ASME PVHO-1: Safety Standard for Pressure Vessels for Human Occupancy (2023 Edition)
• UHMS Hyperbaric Facility Accreditation Program - Undersea & Hyperbaric Medical Society

UHMS encourages all members to review this FDA communication in full, reinforce adherence to safety protocols within your facilities, and continue promoting the highest standards of patient and staff safety in hyperbaric medicine.