UHMS, AMA & FDA Agree – Mild Hyperbaric Oxygen Therapy Unsafe
In recent weeks we have seen three of the leading medical institutions, The American Medical Association (AMA), the Undersea and Hyperbaric Medical Society (UHMS) and the U.S. Food and Drug Administration (FDA) issued statements formally acknowledging the use of mild hyperbaric oxygen therapy as unsafe in certain settings due to the dangers of fire and suffocation that are presented in settings that operate outside of FDA guidelines.
The Risks Of Using Oxygen With Zippered Chambers
In addition to the CMS-approved indications for HBOT that we report regularly on, the FDA has approved a large, zippered bag-type chamber, intended solely for the treatment of altitude sickness. In order to treat altitude sickness, these zippered chambers provide pressure, but they do not connect to oxygen tanks. For use with oxygen tanks or oxygen concentrators, the FDA has not approved these bags. People have used these bags to make their own HBOT devices, which pose a risk of fire and suffocation.
At Hyperbaric Aware we are on a mission to not only raise awareness of the lifesaving benefits that HBOT can provide but to do so safely. If your healthcare provider has recommended you as a candidate for HBOT, you can find hard-sided medical grade chambers, capable of sustaining pressure of 1.5-5.0 ATA, by using our "Find Treatments" locater. All treatment centers that we promote are staffed and supervised by trained physicians and patients are monitored by a hyperbaric technician during each treatment. Patient safety is our priority, all centers are equipped with monoplace or multiplace hard-sided chambers at each of our facilities.
Oppose Unsafe Use of “Mild Hyperbaric Therapy” D-270.986
American Medical Association
Of the many treatments proposed for COVID-19, few directly address the severe hypoxia among COVID-19 patients. Interim results from our single-center, non-randomized clinical trial (NCT04332081) suggest that hyperbaric oxygen therapy may reduce inpatient mortality or the need for mechanical ventilation among COVID-19 patients by more than half. Hyperbaric oxygen therapy is delivered by increasing the atmospheric pressure surrounding a patient, which results in increased oxygen delivery to a patient's blood at a rate higher than any other available modality. It is already FDA-approved for several indications, including conditions with impaired gas exchange and severe infectious processes. Furthermore, several studies have found that hyperbaric oxygen therapy inhibits the production of proinflammatory cytokines, which may play a role in the pathophysiology of COVID-19. The goal of this proposal is to perform a multi-center, randomized controlled trial to evaluate the short-term and long-term efficacy of hyperbaric oxygen therapy for COVID-19 patients. This proposal will rigorously test whether hyperbaric oxygen therapy can reduce the substantial mortality and morbidity of this challenging disease.....
Hyperbaric Oxygen Therapy: Get the Facts
By U.S. Food & Drug Administration
Hyperbaric oxygen therapy (HBOT) is well known for treating scuba and deep-sea divers affected by the rapid change in pressure around them. But did you know that HBOT is also used to treat a variety of other health problems, including carbon monoxide poisoning and diabetic foot ulcers?
If you are considering the use of a HBOT device for yourself or a loved one, be aware that some claims of what it can do are unproven. For example, HBOT devices are not proven to cure cancer, Lyme disease, autism or Alzheimer’s disease. The U.S. Food and Drug Administration recommends you check with your health care provider before using a HBOT device to make sure you are pursuing the most appropriate care...
UHMS Position Statement: Low-Pressure Fabric Hyperbaric Chambers
By Nick Bird, MD, UHMS Safety Committee & UHMS Oxygen Therapy Committee
It is the position of the Undersea and Hyperbaric Medical Society (UHMS) that hyperbaric chambers be constructed, operated, and maintained according to current Codes and Standards. The FDA lists hyperbaric chambers as Class II medical devices. Hyperbaric therapy requires physician prescription for procurement and use. The UHMS recommends that physicians or, as permitted by local regulations, supervised non-physician providers who are appropriately trained in Undersea and Hyperbaric Medicine, be available immediately throughout the administration of hyperbaric oxygen therapy.
The marketing and operation of portable low-pressure fabric hyperbaric chambers for indications other than Acute Mountain Sickness is considered off-label. Low-pressure fabric chambers are not designed to be used in conjunction with supplemental oxygen therapy and are not designed to be pressurized to greater than 1.4 atmospheres pressure. All UHMS-approved indications for hyperbaric oxygen therapy currently require a minimum of 2.0 ATA while breathing near 100% oxygen....