Hyperbaric Oxygen Chamber Fires, Injuries Lead to New FDA Safety Recommendations

Federal regulators admit that the root cause of the deadly hyperbaric oxygen chamber fires remains unknown.

Recent reports of fires occurring in hyperbaric oxygen chambers have led federal regulators to reiterate guidance regarding the devices.

The U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers on August 25, reminding them to follow manufacturer use instructions for hyperbaric oxygen therapy (HBOT) chambers.

These hyperbaric chambers are pressurized devices patients can enter to receive an increased amount of 100% oxygen that will saturate their blood and tissues. It is often assumed that these high-pressure, oxygen-rich environments stimulate new blood vessel growth and combat certain infections. 

The devices are available as individual or multi-person units, and have been approved by the FDA for certain treatments, such as carbon monoxide poisoning, decompression sickness, diabetic foot ulcers and some non-healing wounds.

However, the high oxygen levels of hyperbaric chambers can also greatly increase the risk of fires, often leading to serious injuries or deaths as individuals are fully enclosed within the devices when a hyperbaric oxygen chamber fire ignites.

As a result, multiple hyperbaric oxygen chamber fire lawsuits have been filed in recent years. One such complaint resulted from an explosion and flash fire in a multi-person device, which led to the death of a 4-year-old cerebral palsy patient and his 62-year-old grandmother.

More recently, a 5-year-old boy receiving treatment for sleep apnea and attention deficit hyperactivity disorder (ADHD) died in a hyperbaric oxygen chamber fire, despite the devices not being approved for treatment of those conditions.

Following a series of these events, the FDA is reminding providers and facilities to be sure they adhere to hyperbaric chamber manufacturers’ instructions for use, as well as ensuring other proper protocols are followed, which include:

• Following proper fire prevention and safety measures for all hyperbaric oxygen chambers
• Providing proper training for staff
• Making sure patients are properly monitored for the duration of their stay in any oxygen therapy device
• Staying up to date with all recommended cleaning procedures, maintenance intervals and safety checks
• Avoiding any prohibited items from entering the chamber, including electrical devices
• Ensuring all patient clothing is made of hyperbaric compatible materials, such as cotton (as opposed to fabrics like wool, which can create a static charge)

The FDA is reminding patients and providers that a list of all approved hyperbaric oxygen therapy (HBOT) chambers can be found by searching the device serial number in the federal 510(k) registration database.

“While the FDA believes that serious adverse events associated with HBOT devices are rare, health care providers and users should be aware that these events can and do occur and should follow the manufacturer’s instructions to help reduce potential risks.”

— FDA, Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices – Letter to Health Care Providers

Any adverse events can be reported to the FDA’s safety information and adverse event reporting program, Medwatch.

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