The U.S. Food and Drug Administration (FDA) issued guidelines this week on the safe use of hyperbaric oxygen therapy (HBOT) and the importance of following the manufacturer’s instructions for use.
The therapy is used to treat conditions such as decompression sickness in divers, wounds, trapped air bubbles in blood vessels, carbon monoxide poisoning, and tissue damage from radiation therapy.
“The FDA is aware of recent reports of fires that occurred with HBOT devices that resulted in serious injuries and deaths,” the FDA stated. “Currently, the root cause of these events is not known.”
The FDA’s recommendations include being aware that there is a heightened risk of fire with use of oxygen at a high concentration, ensuring proper grounding equipment is used, and ensuring the patient is properly monitored and supervised for the duration of the treatment and is wearing clothing that is made of hyperbaric-compatible materials, such as cotton.
The time it’s taken for the FDA to issue the guidelines is what surprises medical professionals like HBOT USA medical director Jason Sonners, who teaches hyperbaric medicine and safety and is the author of “Oxygen Under Pressure.”
“Unfortunately, like with many other position statements or regulation changes, it takes accidents to become urgent enough to take the time to make important recommendations like these,” Sonners told NTD.
Last month, a Lake Havasu City, Arizona physical therapist named Walter Foxcroft, 43, died after a flash fire occurred inside a hyperbaric oxygen chamber at his Havasu Health and Hyperbaric medical clinic.
The Lake Havasu City Fire Department stated in a press release that emergency workers responded to a call at 10:50 p.m. on July 9 involving a patient with burns inside a hyperbaric chamber.
“As the industry has grown there have been manufacturers of equipment that have skipped the approval process and clinics operating without proper training,” Sonners added. “This is an issue that can really hurt the industry as well as end poorly for the offices and patients hurt by skipping these critical steps.”
