What are the main differences between the hard-sided Hyperbaric chambers, that are used in hospitals and free-standing clinics around the country, and the soft-sided chambers that patients can now buy for their homes?
Benefits of Hard Hyperbaric Chambers, from Bay Area Hyperbarics
1) “Soft-sided” or “Inflatable” Chambers DO NOT Provide the Same Benefit as Hard Chambers.
2) HBOT provided in a hard chamber can regrow bone and tissue in severely damaged areas of the body; soft-sided chambers cannot achieve these objectives.
3) Treatment provided in a hard chamber is supported by thousands of clinical studies which validate successful healing when using a hard chamber. No such correlation has been made with soft-sided chambers and healing.
4) Most treatment in hard chamber is recognized for reimbursement by insurance companies and the federal government. This is not true for soft-sided chambers.
5) Hard chambers are made to go to pressures that heal; soft-sided chambers are designed to temporarily treat divers and mountain climbers in route to a hard chamber.
6) Soft-sided chambers promote the undesirable growth of aerobic bacteria whereas hard chambers kill harmful bacteria. Scientific literature shows that oxygen becomes bacteriostatic (biological or chemical agent that prevents bacteria from reproducing) at 1.5 ATA. Since inflatable bags can only produce 1.3ATA they not only can’t prevent bacteria from growing, they can actually enhance the growth of some molds, fungus, and aerobic bacteria.
7) Soft-sided chambers cannot go past 1.3 absolute atmospheres and thus cannot heal like a hard chamber can.
The above information can be found by visiting BAY AREA HYPERBARICS
Also on this topic, from Healing Chambers International
We asked one of our Science and Advisory Board members for his opinion on the zippered urethane inflatable chambers, now becoming popular in the United States and elsewhere. The essence of his comments . . . .”These so-called ‘mild-hyperbaric’ (mHBOT) chambers do not give any of the therapeutic results of regular ‘hard’ chambers and thus waste the patients’ most precious resource — their time.”
“When you see these chambers used in hospitals, only then can you believe that this is serious medicine . . .”
“Any physician that advocates having patients spend hours zipped into an inflatable air chamber demonstrates a profound ignorance of physics, physiology and the many years of research into the effects of high density oxygen on the human body. If these physicians do understand the science and still use these ‘bags’ then their interest has to be based on profit rather than patient wellbeing and standards of care.”
Robert L. Sands is uniquely qualified to comment on the science relating to the inflatable chambers. For three years Sands administered research and development for the Commonwealth of Australia and his first hyperbaric chamber patent application was lodged in 1983 for an inflatable chamber. Sands abandoned the inflatable concept after expending considerable resources and went on to design and build chambers in the “conventional” manner meeting American Society of Mechanical Engineers, Pressure Vessels for Human Occupancy (“ASME PVHO-1″) standards. Sands eventually designed and developed the revolutionary transportable recompression chamber system that is now in fleet-wide use with the U.S. Navy, Marine Corps and Coast Guard. Sands holds the patent for that transportable chamber system.
Sands commented “There were many valid scientific and technical reasons to abandon the development of an inflatable chamber in 1985 and those reasons are still valid twenty years later in the year 2008. It is appropriate that I sum up the comments that I am about to justify:
“One problem is the lack of pressure in these inflatable chambers. In actual fact, oxygen pressures lower than 1.3 ata (4.4 psig) promotes the growth of aerobic bacteria in injured tissue within the body. Pressures have to be increased to to sufficient levels for oxygen to become bacteriostatic.” See footnote #1 (on the website, link below)
“Any chamber that will not hold more than 4 pounds per square inch (psig) pressure, and where the patient is breathing air rather than oxygen, fails most patients. It consumes their time and wastes their money.”
and this was also shared on their website (link is below) …
Important questions must be asked since the inflatable air-bag is proliferating throughout the United States.
– Is the inflatable air-bag treatment pressure adequate or even beneficial for most patients needing HBOT as life or limb salvage? Or to help eliminate chronic disease? The answer is a resounding “NO.”
Identical partial pressures of oxygen occur if you spend an hour at the bottom of a 9 foot deep swimming pool, breathing from a SCUBA tank and the physiological changes to the human body are virtually the same!
Code compliance – the FDA:
These inflatable air-bag chambers do have FDA “510(k)” clearance numbers. These use the “Gamow” bag as their predicate device. They are cleared by the FDA for marketing ONLY for the treatment of acute mountain sickness (where at higher elevations there is less oxygen in the air and climbers become ill)) known as AMS.
Mild hyperbaric chambers can only be legally marketed for AMS and it has a low world-wide incidence rate!
However, these inflatable chambers are becoming popular with health spas, chiropractors, sporting teams and caregivers. There has been an “underground” effort to promote the use of 100% oxygen (H cylinders) and oxygen concentrators in pressurizing these inflatable chambers. As well, some owners have modified the valves to increase the pressure past maximum allowable operating pressure of the inflatable chamber. There is one U.S. confirmed catastrophic failure of an inflatable chamber which burst when taken to 14 PSIG.
As an FDA Class II medical device, whether the bag is full of air or oxygen, a licensed physician or dental surgeons’ prescription is mandatory for any use. While many chiropractors and other health practitioners have great skills, the law is the law. Despite their skills, they cannot write that prescription. You must have a prescription from a physician (M.D. or D.O.) or a dental surgeon (D.D.S.) to purchase an inflatable air-bag. Referring to the air-bag as “mild” hyperbaric oxygen therapy (mHBOT) does not erase FDA rulings. Chiropractors (D.C.) naturopathic doctors (N.D.) or any other practitioners are breaking the law if they prescribe mild hyperbarics and face arrest by their local district attorney. Sadly, so too are any well-meaning caregivers that allow others to use their personal inflatable chambers.
Code compliance – the local fire department:
In addition to the FDA rules, the local fire marshal will insist that any clinic that uses hyperbaric chambers comply National Fire Protection Agency (NFPA) 99-11 codes with fire walls and certified fire doors, sprinklers and other code compliance.
Now the important part. The NFPA-99 mandates that all chambers that can increase pressure over 2 psig are designed to the fabrication codes of American Society of Mechanical Engineers (ASME) Pressure Vessel for Human Occupancy — level 1 (PVHO-1) and embossed with the PVHO-1 stamp. Mild hyperbaric inflatable chambers have not been able to demonstrate that they comply with any recognized hyperbaric chamber design or fabrication standard. These enforceable statutes prohibit these non-PVHO-1 inflatable chambers from being used anywhere except in a home.
Inflatable chambers are not code compliant with PVHO-1. If the State where they are being used is a PVHO-1 State (e.g., CALIFORNIA) it is illegal to sell or use these “soft” bag chambers.
Eleven States and three U.S. cities are now enforcing the PVHO-1 codes and scrutinizing health care practitioners who advertise for patients.
Ethical questions for clinicians recommending or using the inflatable air-bag:
These air-bags cost little money (in comparison to ASME PVHO-1 chambers) and are selling well, probably because of the growing demand for affordable HBOT. However, many of the operators of these air-bags are charging prices that are only marginally less than the cost of a treatment in a “hard” 100% oxygen chamber and where their patients could be treated at a pressure that was medically proven to be appropriate for their illness. The ethical problem facing the practitioner who is presented with a patient who is in crisis is “Am I wasting the patient’s most precious resource – their time?”
1 footnote — See Textbook of Hyperbaric Medicine, page 143,4th Revised Edition, K.K. Jain, et al.
There is a great deal more information on this, and other topics, on this website. They also have some great illustrations showing the differences between the types of units.
Healing Chambers International
To see a video regarding the differences between Hard and Soft-sided chambers, click here!
For more information on the difference between hard and soft-sided chambers, CLICK HERE.
