Understanding Hyperbaric Oxygen Therapy: Safety, Regulations, and Common Misconceptions

Hyperbaric oxygen therapy (HBOT) is a medical treatment that involves breathing pure oxygen in a pressurized environment. This therapy is used to treat a variety of medical conditions, from carbon monoxide poisoning and diabetic foot ulcers to more serious conditions such as decompression sickness and severe burns. However, with many false claims surrounding its benefits, it is crucial to understand the truth about HBOT and its safety standards.

What is Hyperbaric Oxygen Therapy (HBOT)?

During HBOT, a patient breathes 100% pure oxygen while inside a pressurized chamber. The chambers can be designed to hold one person or multiple people, depending on the treatment requirements. The increased air pressure in the chamber allows the lungs to absorb a higher concentration of oxygen, which in turn increases the amount of oxygen that can reach the body’s tissues.

The FDA's Role in Regulating HBOT

The U.S. Food and Drug Administration (FDA) plays a significant role in ensuring the safety and efficacy of HBOT. The FDA regulates the oxygen used in these treatments and the hyperbaric chambers themselves, which must meet strict safety and quality standards.

Regulations for Oxygen and Chambers

Both the oxygen used in HBOT and the hyperbaric chambers themselves must meet specific regulatory requirements. The FDA ensures that the chambers are safe and effective by conducting inspections and accreditations of facilities. These inspections include multiple safety checks to prevent issues such as fires and explosions, which can occur in improperly regulated or unaccredited facilities.

Conditions Approved by the FDA for HBOT

The FDA has approved hyperbaric chambers for treating a specific set of medical conditions, including:

It is important to note that the FDA has not approved HBOT for curing diseases such as cancer, Lyme disease, autism, or Alzheimer's disease. While HBOT is being studied for additional conditions, such as COVID-19, it has not yet been officially approved for these uses.

Risks and Safety Considerations of HBOT

While HBOT is generally safe when performed under FDA-regulated conditions, potential risks include:

The FDA strongly recommends that HBOT treatments be conducted in accredited facilities to minimize these risks. Using unregulated or improperly built devices can significantly increase the chances of accidents and severe injuries.

Other Hyperbaric Devices

The FDA has also approved a special type of bag, commonly referred to as a zippered bag, for treating altitude sickness. These bags provide pressure without needing to be attached to an oxygen tank. However, they are not cleared for use with oxygen tanks or oxygen concentrators, and their use as homemade HBOT devices can pose serious risks.

Conclusion

Hyperbaric oxygen therapy is a powerful tool in medical treatment, but it is essential to approach it with caution. Always consult with your healthcare provider and ensure that any facilities you choose are accredited and comply with FDA regulations. By doing so, you can safely benefit from the therapeutic effects of HBOT while avoiding potential risks.