Meridian businesses receive cease-and-desist letters for hyperbaric chambers. What to know
The Meridian Fire Department has issued cease-and-desist orders to four businesses and a chiropractor for using oxygen devices that fail to comply with state and federal regulations.
The oxygen devices, called hyperbaric chambers, are pressurized chambers in which users breathe a higher concentration of oxygen. Soft-sided hyperbaric chambers have been advertised by some wellness centers as a way to treat autism, Lyme disease and cerebral palsy, though there’s no scientific proof they work for those conditions.
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.
Which businesses received the notices?
Joe Bongiorno, deputy chief of fire prevention at the Meridian Fire Department, delivered the bulletin and cease-and-desist letters to Restore Hyper Wellness, Karlfeldt Center, Idaho Brain and Body Institute and Scott Gibbons of BridgeTower Chiropractic, according to information obtained by the Idaho Statesman through a public records request.
“If you have (soft-sided hyperbaric chambers) in your facilities in Meridian, please have them removed,” Bongiorno said in the letters.
Restore Hyper Wellness, Karlfeldt Center and Idaho Brain and Body Institute did not respond to requests for comment from the Statesman. Gibbons, a doctor of chiropractic care, told the Statesman by email that his business sold the soft-sided hyperbaric chamber it was using upon receiving the cease-and-desist letter.
The Statesman reported in August that a complaint to local fire authorities over safety concerns named Restore Hyper Wellness, a rapidly expanding company with locations in Meridian and Boise, and the Karlfeldt Center in Meridian.
What regulations do the chambers violate?
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.”
Martin Gresho, a fire protection engineer consultant for Restore Hyper Wellness, previously said in a public comment on fire safety standards that the company’s services are therapeutic, not medical, and so the code should not apply.
What are the safety concerns?
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.
What are the chambers approved for?
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.
Only four hospital-affiliated wound care and hyperbaric centers are accredited by the Undersea and Hyperbaric Medical Society in Idaho: the Saint Alphonsus Wound Healing & Hyperbaric Medicine program in Boise, St. Luke’s Health System in Meridian, Portneuf Medical Center in Pocatello and Saint Alphonsus Medical Center in Nampa.
Wellness centers, on the other hand, often tout mild hyperbaric therapy as treatment for a wide range of ailments, according to the FDA.
What are they not approved to treat?
“If you are considering the use of a (hyperbaric oxygen therapy) device for yourself or a loved one, be aware that some claims of what it can do are unproven,” the FDA says.
The FDA notes on its website that the devices are not proven to cure cancer, Lyme disease, autism, Alzheimer’s disease or COVID-19. However, some wellness centers claim the opposite.
The Statesman reported in August that the Karlfeldt Center in Meridian received a warning letter from the Federal Trade Commission in 2021 for “unsubstantiated claims for coronavirus prevention and treatment.” The letter cited advertisements and social media posts made or reposted by the center that said mild hyperbaric oxygen therapy could treat COVID-19.
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.
“The idea behind hyperbaric oxygen therapy and its success as a treatment option depend on flooding the body with higher levels of oxygen,” to the National Hyperbaric Treatment Center said on its website. “Unfortunately, you see that soft-sided chambers don’t really offer much more than the air you naturally breathe.”
Soft-sided hyperbaric chambers are significantly cheaper than hard-shell hyperbaric chambers, making the soft-shell chambers a more affordable option for wellness centers to buy.
“They’re claiming to treat all kinds of things under the sun that there’s really no data for,” Quinn previously told the Statesman. “I would encourage patients to get the facts.”
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