What is an FDA ‘accepted’ use of an hyperbaric oxygen therapy chamber?*
Currently, 14 clinical indications have been accepted for premarket review and clearance of hyperbaric chambers:
• Air or Gas Embolism
• Carbon Monoxide Poisoning Complicated By Cyanide Poisoning
• Clostridial Myositis and Myonecrosis (Gas Gangrene)
• Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
• Decompression Sickness
• Enhancement of Healing In Selected Problem Wounds
• Severe Anemia
• Intracranial Abscess
• Necrotizing Soft Tissue Infections
• Osteomyelitis (Refractory)
• Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
• Compromised Grafts and Flaps
• Acute Thermal Burn Injury
• Ideopathic Sudden Sensorineural Hearing Loss
However, not all hyperbaric chambers qualify for all indications because the actual performance of each hyperbaric chamber may not be acceptable for every indication. Marketing of the use of a hyperbaric chamber is expected to conform to the product label based upon information that the FDA has determined as safe and effective use of the device.
* Source: Food and Drug Administration
The FDA “acceptance” is for the premarket 510-K “Clearance to market the chambers.” Consequently, the chambers with this 510-K cannot be promoted as a “cure” for any other malady or injury. However, “off-label” prescriptive use of such a 510-K chamber is lawful.
Note: the FDA uses the word “accepted” in the appropriate context, and the substitution of the word “approved” is highly misleading to patients and physicians.
The FDA chooses to defer to the recommendations of the Undersea and Hyperbaric Medicine Society, (“UHMS”), an advisory body only of health scientists. The UHMS is not an enforcement arm of the FDA.
Insurance companies and Medicare/Medical/Medicaid follow the UHMS list and limit their payments to these UHMS “approved” maladies, and traumas. Hospital based chambers have a much higher fixed-cost operational environment and cannot treat off-label maladies, even for private pay patients.
A licensed physician can use best-care medical judgment and is lawfully allowed to prescribe HBOT for illnesses other than the “approved” UHMS indications.
Because the FDA views oxygen-under-pressure as a drug, a prescription from a registered Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or Doctor of Dental Surgery (D.D.S.) is mandatory for all patients.
Note: This information is for informational purposes only and applies to the United States. It is not intended to substitute for the advice of a physician.