Blog: FDA Urges Strict Adherence to Safe Use of Hyperbaric Oxygen Therapy Devices

1. Context & Safety Warning

On August 25, 2025, the FDA issued a Letter to Health Care Providers, reminding clinicians and facilities of the critical importance of following manufacturer instructions when using hyperbaric oxygen therapy (HBOT) devices—given rising reports of serious injuries and fatalities U.S. Food and Drug Administration.

Key recommendations include:

• Strict adherence to manufacturers’ instructions for use.
• Fire safety precautions due to the heightened fire risk in high-oxygen environments.
  • Proper grounding and fire prevention protocols are essential.
• Comprehensive staff training and ongoing competency checks.
• Continuous patient monitoring throughout each treatment session.
• Routine maintenance, device cleaning, and safety checks.
• Avoidance of prohibited items inside chambers (especially electrically active or static-generating devices).
• Use of hyperbaric-compatible clothing, typically cotton, to minimize static risks U.S. Food and Drug Administration.

The FDA emphasized that while serious adverse events are rare, they do occur—and compliance is paramount U.S. Food and Drug Administration.

2. HBOT: Indications, Popularity & Off-label Risks

HBOT involves delivering 100% oxygen inside a pressurized chamber. The FDA has cleared HBOT (via 510(k) process, Product Code CBF) for several conditions, such as:

• Air or gas embolism
• Severe anemia (when transfusion isn’t an option)
• Decompression sickness
• Carbon monoxide poisoning
• Severe burns
• Gas gangrene
• Sudden hearing or vision loss
• Radiation and crush injuries
• Non-healing diabetic foot ulcers and skin grafts at risk of failure U.S. Food and Drug AdministrationUndersea & Hyperbaric Medical Society

However, HBOT’s use has expanded beyond FDA-cleared indications—often into experimental or alternative treatments with insufficient evidence and increased risk Undersea & Hyperbaric Medical SocietyU.S. Food and Drug Administration.

Though serious complications are generally rare under appropriate use, potential risks include:

• Ear and sinus pain or injury
• Vision changes, temporary or more sustained
• Lung injury or collapse
• Oxygen toxicity and fire hazards (especially outside accredited facilities) U.S. Food and Drug AdministrationMayo Clinic

3. Clinical Trials & Evidence

Although the FDA’s letter doesn’t cite specific trials, here’s what research highlights:

• Clear evidence supports HBOT effectiveness in thermal injuries, non-healing wounds, decompression sickness, and radiation-induced tissue damage U.S. Food and Drug AdministrationUndersea & Hyperbaric Medical Society.
• Other indications—like traumatic brain injury, autism, or COVID-19—have not been FDA-approved and trials remain inconclusive U.S. Food and Drug AdministrationWikipediaUndersea & Hyperbaric Medical Society.
• Mechanistic research underscores risks of HBOT, such as reactive oxygen species (ROS)-mediated tissue damage, including lung, retinal, and neurological toxicity. This may even induce convulsions via oxidative stress and neurotransmitter imbalance arXiv.
• A systematic review found minor barotrauma in ~24% of HBOT patients, but without serious consequences in most cases Wikipedia.

4. Tragic Incident Highlights Stakes

A harrowing example underscores the letter’s urgency: In January 2025, a 5-year-old boy tragically died when a hyperbaric chamber erupted in flames at a non-accredited center in Michigan. The facility was using HBOT for unapproved conditions (sleep apnea, ADHD), ignoring safety standards. This led to criminal charges—including second-degree murder—for staff involved People.comAP News.

This fatal outcome powerfully illustrates the severe consequences of deviating from FDA-cleared use and safety protocols.

5. Summary Table

Focus Area	Key Points
FDA Reminder	Issued August 25, 2025—urges following instructions to minimize rare but serious risks
Use & Risks	FDA-cleared for specific indications; off-label use and poor safety practices raise risks
Clinical Evidence	Strong for approved uses; limited or negative for others
Toxicity Research	Highlights ROS effects and rare neurological risk
Real-world Hazard	Fatal fire in non-accredited facility using HBOT unsafely

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