The AMA advises against unsafe ‘mild hyperbaric oxygen therapy’ and the FDA has endorsed UHMS accreditation
The American Medical Association has adopted a resolution opposing the unsafe use of so-called “mild hyperbaric oxygen therapy” in “mild hyperbaric facilities.” The policy D-270.986, adopted 26 July 2022, was initiated by the Undersea and Hyperbaric Medical Society and represented by UHMS Past President Dr. Laurie Gesell, an active practitioner of hyperbaric medicine and a member of the House of Delegates (HOD), the legislative and policy-making body of the American Medical Association.
The resolution, which can be found at this website, reads:
- opposes the operation of “mild hyperbaric facilities” unless and until effective treatments can be delivered safely in facilities with appropriately trained staff including physician supervision and prescription and only when the intervention has scientific support or rationale; and
- will work with the U.S. Food and Drug Administration and other regulatory bodies to close facilities offering “mild hyperbaric therapy” until and unless they adopt and adhere to all established safety regulations, adhere to the established principles of the practice of hyperbaric oxygen under the prescription and oversight of a licensed and trained physician, and ensure that staff are appropriately trained and adherent to applicable safety regulations.
As noted by the AMA, testimony on this issue was unanimously supportive of the resolution. Numerous safety concerns were noted regarding these facilities offering “mild hyperbaric therapy,” such as inappropriate targeting of vulnerable populations, inappropriate dosing and delaying patients seeking proper treatment.
In a July 26 release entitled “Hyperbaric Oxygen Therapy: Get the Facts” the U.S. Food and Drug Administration cleared the use of hyperbaric oxygen therapy (HBOT/HBO2) for the treatment of several conditions. The release further states: “If your health care provider recommends HBOT, the FDA advises you get the treatment at a hospital or facility that has been inspected and is accredited by the Undersea and Hyperbaric Medical Society.”
The agency advises that individuals seeking hyperbaric oxygen therapy check with their health care provider to make sure they are pursuing the most appropriate care, noting that some facilities operate outside recognized FDA guidelines. “The FDA is aware there are some hyperbaric oxygen treatment centers promoting hyperbaric oxygen chambers for uses that have not been cleared or approved by the FDA, such as treatment of cancer, Lyme disease, autism, or Alzheimer’s disease.”
The UHMS has expressed concern over the use of unsafe and misleading practices in hyperbarics. In January 2017, the Society issued a warning against the use of low-pressure fabric hyperbaric chambers. Revised in 2018, the statement can be found at this website
FDA-cleared conditions to be treated with hyperbaric oxygen
Taken from MedWatch, The FDA Safety Information and Adverse Event Reporting Program, the FDA has cleared hyperbaric oxygen therapy for treatment in these disorders:
- air and gas bubbles in blood vessels
- anemia (severe anemia when blood transfusions cannot be used)
- burns (severe and large burns treated at a specialized burn center)
- carbon monoxide poisoning
- crush injury
- decompression sickness (diving risk)
- gas gangrene
- hearing loss (complete hearing loss that occurs suddenly and without any known cause)
- infection of the skin and bone (severe)
- radiation injury
- skin graft flap at risk of tissue death
- vision loss (when sudden and painless in one eye due to blockage of blood flow)
- wounds (non-healing, diabetic foot ulcers)
HBO2 treatment is being studied for other conditions, including COVID-19, but has not cleared or authorized the use of any hyperbaric device to treat COVID-19 or any conditions beyond those listed above. The websites clinicaltrials.gov and the UHMS home pages at https://www.uhms.org/images/Position-Statements/HBO2_and_COVID_8-10-2020_clinicaltrials_8-12-2020.pdf have more information on hyperbaric clinical trials for COVID-19 and other conditions.
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