The Hyperbaric Community to Campaign for HBOT Approval from the FDA

The Hyperbaric Community to Campaign for HBOT Approval from the FDA

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The global hyperbaric community is working hard to make this alternative treatment option widely and easily accessible for all the patients who need it. Hyperbaric oxygen therapy, also known as HBOT, is a well-known treatment modality used for a variety of ailments, including decompression sickness among divers, diabetic foot ulcers, gas embolism, and carbon monoxide poisoning.

However, not all uses of hyperbaric therapy are considered to be ‘on-label’. In other words, the US Food and Drug Administration (FDA), has only officially approved the use of HBOT as treatment for a handful of medical conditions. All other applications, that are yet to receive FDA approval, are considered to be ‘off-label’.

Some health conditions for which the use of hyperbaric medicine is popular, but still remains off-label, are autism spectrum disorders, COVID-19 infections, and cerebral palsy. For off-label conditions, hyperbaric treatment is not covered by health insurance. Therefore, the cost of the treatment can be very high, sometimes so much as to be prohibitive for most patients.

Getting quality hyperbaric treatment for off-label conditions can also be difficult for another reason. Most hospitals and large medical institutions do not offer HBOT for off-label health conditions. Hence, to get this treatment, patients have to rely on dedicated hyperbaric clinics or small, private practices.

Finding a reliable physician who can provide hyperbaric therapy for off-label conditions can, therefore, be difficult and time-consuming. Besides, it may not be possible for critically ill patients to travel all the way to a hyperbaric clinic, when they could have availed this treatment at their local hospital if the condition was on-label.

Role of the Hyperbaric Community in Gaining FDA Approval

Due to these reasons, the hyperbaric community around the country has been campaigning to remedy the situation by gaining FDA approval for this effective and non-invasive treatment option. The hyperbaric community comprises physicians, healthcare workers, and researchers in the field of medicine. They aim to make HBOT available to all patients who might benefit from it, regardless of their financial standing or other factors. This goal can be achieved if many different applications of hyperbaric therapy are approved and deemed ‘on label’ by the FDA.

For this purpose, reputed hyperbaric associations in the US regularly organize informative CME conferences and events, so as to spread awareness about HBOT among medical professionals and the public at large. Furthermore, the hyperbaric community also attempts to provide timely and accurate information about this treatment option to the patients and their caregivers who might need it the most. Such critical information is disseminated freely by the hyperbaric community, through various digital and print publications.

The CME events organized by the hyperbaric community also facilitate networking and collaborations among physicians and researchers interested in the field of hyperbaric medicine. This allows for innovation and growth in the hyperbaric sector. New research and studies about HBOT are currently underway and many clinical trials have been conducted over the years to determine the efficacy of the procedure for different health issues. Hence, the hyperbaric community helps doctors and medical professionals improve patient outcomes through constant technological advancements and knowledge expansion.

It is hoped that these factors will come together to further popularize and legitimize the use of hyperbaric therapy for live-saving and limb-saving applications. HBOT is also frequently used to treat non-healing wounds, crush injuries, concussions, and head trauma. Sportspersons and military veterans suffering from traumatic brain injuries (TBI) have benefitted greatly from the use of hyperbaric therapy for treatment. The hyperbaric community in the US is working to ensure that more such people will be able to regain their health and independence through HBOT treatment in the future.

While the hyperbaric community comprises medical professionals from around the world, it is not just physicians and nurses who understand the benefits of HBOT for quick recovery and sustained wellbeing. Professional athletes, such as Terrell Owens of the National Football League, are also part of the hyperbaric community and are very vocal about the positive effects of HBOT on sports-related injuries. Renowned musician Justin Bieber has shared his hyperbaric journey with his followers on social media.

The Process of Hyperbaric Oxygen Therapy

The word ‘hyperbaric’ simply means ‘high pressure’. Therefore, hyperbaric oxygen therapy just involves administering oxygen to patients at higher than normal levels of atmospheric pressure. A dedicated hyperbaric chamber, typically made from plastic or metal, is used for this purpose.

For a hyperbaric session to begin, the patient needs to step inside the sealed vessel known as a hyperbaric chamber, which usually contains a mattress, a sealed glass window, and a small medicine cabinet. For the duration of the session, the patient can take a nap or read a book inside the sealed chamber.

Within this pressurized chamber, the patient breathes in pure, unadulterated oxygen for a period of sixty to ninety minutes. The oxygen dissolves quickly into the bodily fluids, thanks to the enhanced air pressure inside the chamber. Then, the plasma and the cerebrospinal fluid can carry the oxygen to various parts of the body and the brain, enabling all organs to receive an enhanced supply of oxygen.

According to studies conducted by the hyperbaric community, HBOT promotes stem cell generation and the growth of new blood vessels. Oxygen enhances the natural recovery process through angiogenesis, while also preventing common issues such as hypoxia, which are caused by oxygen deprivation.

For the best results, patients should only avail hyperbaric therapy under the supervision of an experienced physician who has previously administered hyperbaric treatment. The quality of the hyperbaric chamber used for the sessions might also impact the outcome of the treatment.

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