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Hard vs. Soft Chambers

What is the difference between hard sided hyperbaric oxygen chambers and inflatable hyperbaric chambers?

The question about the difference between hard sided medical grade hyperbaric oxygen chambers and inflatable hyperbaric chambers (also called mild/soft hyperbaric chambers) is a commonly asked question.  At Oxygen Oasis Hyperbaric Wellness Center we use only hard sided ETC and REIMERS chambers (also referred to as monoplace or multiplace chambers; we offer both).  Inflatable bags are a far less expensive and simpler alternative to hard chambers and do not require an extensive build-out to meet the extensive NFPA-99 guidelines.  However, many have reported they have not been an effective treatment modality.  The UHMS Safety Committee published the following Special Report: 

Pressure Online

Special Report from the Safety Committee

RISK MANAGEMENT AND THE USE OF HYPERBARIC OXYGEN CHAMBERS

TOM WORKMAN and JIM BELL, UHMS Safety Committee

Over the past four decades we have seen a geometric growth in the number of clinical hyperbaric medicine facilities. The numbers have grown, from approximately 27 facilities in the early 1970s to now more than 1,350 hospital-based programs. There is no reliable estimate of the number of non-hospital based facilities in operation. For the most part, facilities that are a part of a healthcare system are well regulated; those in non-healthcare rated occupancies, such as health spas, commercial office buildings and homes, much less so.

Areas of concern

A segment of the community that presents the highest level of concern is based on the use of portable, fabric, low-pressure hyperbaric chambers that do not meet existing safety codes such as the National Fire Protection Association (NFPA) 99, Health Care Facilities Code. These types of chambers, while cleared by the FDA as a Class II medical device,
do not comply with American Society of Mechanical Engineers, Pressure Vessels for Human Occupancy -1 (ASME PVHO-1) hyperbaric chamber design and fabrication code (as required by NFPA 99) nor with the installation and operational requirements mandated in NFPA 99.

A confounding problem is that local authorities having jurisdiction (AHJs) are not aware that these devices are being used in their jurisdiction. When a traditional hyperbaric chamber is installed, installation permits, and other paperwork are required, and accordingly, AHJs are appropriately notified. There is no comparable notification process for these low-pressure chambers, as they are delivered by a commercial carrier (such as FedEx) and require no traditional installation. Plus, they can be operational within 15-30 minutes of receipt. Because of this, there is no mechanism to notify the AHJ of their presence, and thus they routinely operate “under the radar” of the established regulatory community. There are estimated to be more than 10,000 such hyperbaric chambers in use throughout the country.

Additional examples of non-compliance . . .

Other examples of non-compliance to NFPA 99 are numerous. For example, NFPA 99 requires that the exhaust from a hyperbaric chamber be piped to the exterior of the building housing the chamber. These low-pressure chambers, however, vent to the ambient space in the room in which they are located. 

Perhaps the most concerning risk is that these chambers are frequently used with oxygen concentrators to increase the concentration of oxygen that the patient breathes while in the chamber. When used in this configuration, the concentration of oxygen inside the chamber often exceeds the NFPA 99 limit of 23.5%. Operation of hyperbaric chambers with atmospheres containing more than 23.5% oxygen requires the patient to be grounded. Patients treated in these portable chambers are rarely, if ever, electrically grounded. This is exacerbated by facility operators who encourage or allow patients to take into the chamber with them their tablet, cell phone, laptop, and similar devices. The use of these types of electrical devices in a hyperbaric chamber is strictly prohibited by NAPA 99.

. . . and a recent example

The death of a young autistic boy from North Carolina (June 9, 2011) might have been avoided had these low-pressure chambers been regulated as required. As noted above, they do not comply with the well-established design and fabrication code, ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy. North Carolina mandates compliance to this code. NFPA 99 mandates compliance to this code. The Life Safety Code (NFPA 101) invokes compliance to the hyperbaric requirements noted in NFPA 99, which also mandates compliance through reference. Therefore, if properly regulated, hyperbaric chambers of this type would not have been allowed to operate in North Carolina.

The National Fire Protection Association recently highlighted the importance of this issue in the January/February issue of its magazine, NFPA Journal. The story, entitled “The Air In There,” provides a general overview of the hazards and challenges associated with hyperbaric chambers and informs local authorities having jurisdiction about the magnitude of the problem while offering suggestions on how to deal with it.

“This is an area of health care that a lot of AHJs may not know that much about,” said Scott Sutherland, executive editor of NFPA Journal. “With these types of facilities proliferating, though, it’s important for AHJs to understand the potential hazards. I think our story does a good job of describing those hazards and of explaining why this is an area of concern right now.”

Read the complete NFPA Journal story at http://www.nfpa.org/news-and-research/publications/nfpa-journal/2017/january-february-2017/features/hyperbaric-chambers

The Food and Drug Administration (FDA) has posted a consumer update – “Hyperbaric Oxygen Therapy: Don’t Be Misled” –  for the use hyperbaric oxygen on its website http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm364687.htm

It’s a growing concern

A casual search of the internet demonstrates the prolific use of low- pressure fabric chambers for indications that have not been proven. At the time of the posting the FDA had received 27 complaints from consumers over three years about treatment centers promoting hyperbaric chambers for uses not cleared by the agency.

Low-pressure fabric chambers are designed and have an FDA 510(K) premarket notification to be pressurized with air to treat acute mountain sickness. They are not built to ASME PVHO or NFPA 99 codes. However, they are routinely being operated outside of the FDA approval and NFPA codes and standards. The use of these chambers is sometimes referred to as mild hyperbaric oxygen therapy (mHBOT).    

From a position of risk management we do not support the use of low-pressure portable fabric chambers for anything other than acute mountain sickness. Clinical hyperbaric oxygen therapy as defined by the Undersea and Hyperbaric Medical Society, Hyperbaric Oxygen Therapy Indications, 13th edition, requires that the patient breathe near 100% oxygen while inside a chamber pressurized to at least 1.5 atmospheres absolute. The low-pressure fabric chambers are not designed to provide this clinical dose of oxygen and pressure. Clinical hyperbaric oxygen chambers need to be designed, manufactured, housed and operated according to the FDA, NFPA and ASME-PVHO codes.

Jim Bell CHT/EMT/CFPS is Chair of the UHMS HBO2 Safety Committee; Tom Workman MS, CAsp, CHT, FAsM is UHMS Director of Quality Assurance and Regulatory Affairs and a dedicated committee member.

Let’s examine the reasons why we do NOT use inflatable bags and why they are called “hyperbaric chambers” (in contrast to hyperbaric oxygen chambers).

  1. Our chambers can deliver up to 9 times more oxygen (medicine) than an inflatable bag and a simple oxygen mask hooked up to an oxygen tank can deliver more oxygen(418mmHg) than an inflatable bag(237mmHg).

If you are good at math and dimensional analysis, below is the explanation. If you are not technical, feel free to skip to number 2.

Inflatable bags can not generate pressure above 1.3 atmospheres. If our goal is to try to deliver large amounts of oxygen, let’s examine how much oxygen can be delivered.

-As you read this, the amount of oxygen being delivered to you is 1 atmosphere of pressure x 760mmHg(pressure at sea level) x 21(% of oxygen in the air we breath). So, you are breathing (1 x 760 x0.21= 157mmHg).

– If you are in an inflatable bag and the pressure is 1.3 atmospheres and they are able to concentrate the oxygen to 24%, they are delivering (1.3ATA x 760mmHg x 0.24=237mmHg.

-Consider this: If you have a non-rebreather oxygen mask hooked up to an oxygen tank (the oxygen mask you see paramedics use when transporting a patient), the mask can deliver about 55% oxygen. By using the same equation (1ATA x 760mmHg x0.55=418mmHg).  The moral of the story is that an oxygen mask can deliver a higher amount of oxygen than an inflatable bag so why would you expose yourself to the time and expense for such little benefit.

– Our chambers are able to generate 3 ATA of pressure and typical treatment protocols are between 2.0ATA and 2.4ATA. So, at 3.0ATA (3.0ATA x 760mmHg x 100%=2,280mmHg) we can deliver almost ten times the amount of oxygen (medicine) to you. At our typical treatment depths we generate 1,520 mmHg of pressure at 2 ATA (almost 7 times as much oxygen) and 1,824mmHg at 2.4ATA (almost 8 times as much oxygen as an inflatable bag.

  1. All valid scientific studies demonstrating the benefit of hyperbaric therapy were performed at pressures higher than those able to be achieved in an inflatable bag.  You can’t extrapolate those benefits at the much lower pressures generated from inflatable bags.
  2. The FDA does not recognize inflatable bags as a medical device for hyperbaric oxygen treatment and you will not find them in any reputable hospital or medical office. The FDA only recognizes inflatable bags as a device used to treat altitude sickness during transport to a definitive medical facility.
  3. 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.
  4. Risk Management as described in The UHMS Safety Committee published Special Report: 

When looking for a provider of hyperbaric oxygen therapy, inquire about the chambers they use, age of their chambers, service records, oxygen provider, and are there certified hyperbaric technicians on staff including an on site Safety Director who has gone through the Safety Director course.

Questions?

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