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Why do so many US clinics having soft-sided HBOT chambers keep getting shut down?

Why do so many US clinics having soft-sided HBOT chambers keep getting shut down?

2023-03-31 10:57

Here in North Carolina we’ve heard it a few too many times over the past year, “Another clinic using soft HBOT chambers has been shut down by the fire department”.  But, why?! Perhaps they are in violation of their local fire codes, we don’t know. But what we do know is that in North Carolina there is a PVHO mandate.  PVHO is Pressure Vessels for Human Occupancy and under the state of NC (and 10 others — Arkansas, California, Delaware, Georgia, Hawaii, Minnesota, Oregon, Tennessee, Washington, and Wisconsin) there are mandates in place that  state all clinical HBOT chambers operated within their state must comply with ASME PVHO-1.  Soft-sided chambers used for mild-HBOT (or mHBOT) do not meet this mandate (learn more).

In today’s Idaho Stateman, they highlight soft-sided chambers and call out a few clinics that have recently been sent cease and desist letters to immediately stop using their soft HBOT chambers.

The cease-and-desist orders were issued to Meridian businesses using the soft-sided hyperbaric chambers, which don’t comply with regulations because of their fire hazards and risks of suffocation. Many of the centers that use them do so without accreditation.

The businesses were also provided with copies of a bulletin issued by Idaho State Fire Marshal Knute C. Sandahl in January. The bulletin said that hyperbaric chambers must satisfy the requirements outlined by regulatory agencies, including those related to fire suppression, fire alarms and emergency planning. Sandahl noted the bulletin does not apply to the use of the devices in private dwelling units, but is recommended.

It’s our understanding that there are 11 states that adopted statutes that mandate ASME PVHO-1, and Idaho is not one of them. However, HBOT chambers need to be compliant with NFPA 99 (National Fire Protection Association Standard 99), which defines a “hyperbaric facility” to minimize fire and explosion risk. Idaho has adopted that fire code, so it appears this is where things get sticky to be a compliant facility to administer HBOT in the state of Idaho.

Hyperbaric chambers are regulated by the 2018 edition of the International Fire Code as adopted by the state of Idaho, according to the bulletin Sandahl issued. Section 609 of the IFC requires hyperbaric facilities to be inspected, tested and maintained in accordance with the National Fire Protection Association Standard 99, which defines a “hyperbaric facility” as a building, structure or space that houses hyperbaric chambers.

Sandahl wrote that hyperbaric chambers should comply with the NFPA Standard 99, a code established to minimize the hazards of fire, explosion and electricity in health care facilities. The cease-and-desist letters delivered by Bongiorno said that “soft-sided hyperbaric chambers do not meet NFPA 99 and the 2018 IFC.”

The article continues to discuss safety concern with soft-side chambers and explains why it’s important to understand the difference.

Soft-sided chambers, which are inflatable and sealed with a zipper, are at risk of explosions because of their high concentration of oxygen. A power disruption could also cause the chambers to deflate, suffocating the person inside. Hard-shell chambers, on the other hand, have much higher concentrations of oxygen but are manufactured to meet U.S. regulations. The soft-sided versions are also not approved by the U.S. Food and Drug Administration for use in hyperbaric oxygen therapy except when treating people with altitude sickness. The portable chambers were originally designed for divers and mountain climbers to use temporarily until they could be taken to a hard-shell hyperbaric chamber for treatment, according to the National Hyperbaric Treatment Center. Wellness centers claiming to use them for other ailments are providing off-label treatments.

In 2009, a soft-sided hyperbaric chamber in Florida caught fire and killed a 4-year-old with cerebral palsy and his grandmother, resulting in a $2 million settlement and leading the Florida Board of Medicine to revoke the medical licenses of five physicians. And in 2011, a 19-year-old autistic man in North Carolina suffocated after falling asleep inside a soft-sided hyperbaric chamber used at home. The chamber was shipped to his home from a nearby clinic for temporary use.

Fire marshals across the country have halted the use of such chambers, including in Utah, Georgia and South Carolina, said Tom Workman, recently retired director of quality assurance and regulatory affairs for the Undersea and Hyperbaric Medical Society. The nonprofit supports hyperbaric medical research and has a hyperbaric facility accreditation program.

Dr. Jason Quinn, an emergency medicine physician at the Saint Alphonsus Health System, previously told the Statesman that the biggest difference between medical and mild hyperbaric therapy is the pressure. Hard-shell hyperbaric chambers, which are capable of reaching pressures much higher than their soft-shell counterparts, are typically used by physicians in hospitals and other medical clinics to treat conditions like decompression sickness, carbon monoxide poisoning and diabetic foot ulcers.

Soft-sided hyperbaric chambers deliver 24% oxygen to the person inside, while hard-shell hyperbaric chambers deliver 100% oxygen, according to the National Hyperbaric Treatment Center.

Read more at Idaho Stateman

Pressure alone, and any amount of pressure at that, has shown great benefit in helping with the healing process.  If you are interested in using Hyperbaric Oxygen Therapy for medical or therapeutic health & wellness reasons, try to find a facility that uses hard-HBOT chambers to achieve the maximum benefit of oxygen and pressure. Extivita- RTP also has good information on this if you’d like to learn more about the difference between hard and soft HBOT chambers.

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Why do so many US clinics having soft-sided HBOT chambers keep getting shut down? - HBOT News - Hyperbaric Oxygen Therapy News


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