Experts call for hyperbaric chamber regulations after child’s death

DETROIT – The death of a 5-year-old boy in Michigan has prompted industry leaders to call for regulation of medical spas and wellness centers that offer hyperbaric oxygen therapy for treatments not authorized by the FDA.

Thomas Cooper was in the midst of his 36th hyperbaric oxygen therapy treatment when the pressurized chamber burst into flames on Jan. 31 at the Oxford Center, an alternative medicine facility in the Detroit suburb of Troy. The child died within seconds after what appeared to be static electricity sparked a “fireball,” Troy police said in court documents obtained by the Detroit Free Press, part of the USA TODAY Network.

Thomas was being treated for ADHD and sleep apnea, said his family’s attorney, James Harrington, managing partner at Fieger Law. Neither of those conditions is among those the U.S. Food and Drug Administration says are authorized for treatment using hyperbaric oxygen therapy.

John Peters, executive director of the Undersea & Hyperbaric Medical Society (UHMS), said the incident highlights failure at nearly every level of government to regulate an industry that too often preys on vulnerable people desperate to find alternative treatments for conditions they haven’t been able to relieve with conventional medicine.

Peters, who leads the international nonprofit association that provides accreditation for hyperbaric oxygen therapy programs, said the lack of oversight and regulations to ensure that hospitals, health centers, and medical spas adhere to safety standards is “atrocious.”

“This is a watershed moment,” he said. “This is an inflection point for everybody: that’s government, that’s payers, that’s regulators, that’s the physicians, patients, nurses. Are we going to continue to repeat history and not accept accountability and not do what’s right and not be transparent? If we do, then the next time somebody dies in an event like this, we’re saying ‘It’s OK.'”

‘Where’s the oversight?’: After fire kills 5-year-old boy, lawyer questions oversight of hyperbaric oxygen chambers

No laws in Michigan require oversight of hyperbaric chambers

Michigan Attorney General Dana Nessel, in her public comments on the tragedy, laid out a loosely knit web of licensing requirements and accreditation recommendations for the use of hyperbaric oxygen chambers in the state. Peters described them as being rife with holes, “like Swiss cheese,” that creates a dangerous situation for consumers.

“Michigan law doesn’t require any oversight over the use of hyperbaric chambers,” Nessel said Tuesday, when she also announced the criminal charges against Oxford Center CEO Tamela Peterson, 58, and three other employees in the child’s death. All have pleaded not guilty.

Nessel said her office doesn’t have the authority to inspect all the facilities that provide hyperbaric oxygen therapy in the state to ensure they are safely in operation. Nessel can only inspect when there is enough probable cause “that there are crimes being committed involving hyperbaric chambers.”

The Michigan Department of Licensing and Regulatory Affairs “does not have the capability to do that, either, because (hyperbaric oxygen chambers) are not licensed within the state,” Nessel added.

She urged all Michiganders to “exercise caution before engaging in any unapproved therapies. … Hyperbaric chambers are not an approved therapy for ADHD, but the Oxford Center boasted over 100 diagnoses that (hyperbaric therapy) could help with,” she said.

The FDA regulates the oxygen used in hyperbaric oxygen therapy. It also authorizes the use of hyperbaric oxygen chambers as medical devices to treat the following specific conditions:

• Severe anemia when blood transfusions can’t be used

• Carbon monoxide poisoning

• Air and gas bubbles in blood vessels

• Hearing loss that occurs suddenly and without a known cause

• Severe infections of the skin and bone

• Skin graft flap at risk of tissue death

• Vision loss when it is sudden and painless in one eye due to the blockage of blood flow

• Nonhealing wounds such as diabetic foot ulcers.

Peters said the FDA should stop alternative healing centers, medical spas, and wellness facilities from using these devices to treat conditions not on that list, as the Oxford Center did.

“It’s going to take the FDA doing their job with regard to the wellness centers,” he said, which are treating conditions that haven’t been proven to help the myriad problems some purport to treat, and “serves no purpose other than to suck the money out of people’s pockets, vulnerable people. … I think it’s health care fraud.”

Peters said anybody can buy a hyperbaric chamber and start using it, even people without any medical training. He also noted that his organization has evidence of people buying hyperbaric chambers online.

In an emailed response to questions from the Free Press, the FDA said hyperbaric oxygen chambers “are cleared as prescription-only devices … (that) should only be operated by an appropriately licensed medical practitioner.”

“The FDA recommends patients check with their health care provider before using a (hyperbaric oxygen therapy device) to make sure they are pursuing the most appropriate care. If a health care provider recommends HBOT, the FDA advises patients go to a hospital or facility that has been inspected and is properly accredited by the Undersea & Hyperbaric Medical Society,” the statement said.

“As a general matter, if the FDA becomes aware of an incident involving a device failure or malfunction, the FDA follows appropriate processes to review and gather information on the incident to determine appropriate next steps, including but not limited to a device recall or a safety communication.”

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42 Michigan hospitals got paid; just 2 were accredited

While the FDA and Nessel encouraged patients to seek treatment only at sites with UHMS accreditation, there aren’t many options in Michigan – including at hospitals – that meet the criteria.

That’s because accreditation is not required for medical facilities to provide hyperbaric oxygen treatments in Michigan. It’s entirely optional.

Of the 42 medical facilities in Michigan that billed the U.S. Centers for Medicare and Medicaid Services for hyperbaric oxygen therapy in 2023, only two had UHMS accreditation, said Dr. Helen Gelly, who serves on the UHMS Board of Directors and works as a regenerative and hyperbaric medicine specialist in Georgia.

The UHMS accreditation process is rigorous, includes on-site inspections, and isn’t free. The process costs $10,000, which accredits the organization for three to four years, depending on the level, Peters said.

The Oxford Center wasn’t accredited by the UHMS, Nessel said, adding that its leaders also didn’t have current certifications. No licensed physician was on-site to administer the treatments on the day Thomas died, either, she said.

Peters said that in addition to having only two accredited sites in Michigan, the state doesn’t require hyperbaric oxygen chambers to meet safety standards set by the American Society of Mechanical Engineers. Eleven other states do.

Calls grow for hyperbaric oxygen therapy regulation

Thomas Crites, 73, spent about 40 years working in the commercial diving industry on drilling operations in the Gulf of Mexico, renamed the Gulf of America by the U.S. government; off the coasts of Alaska, California, Brazil; and in the North Sea. Some of his training was at Duke University Medical Center’s F.G. Hall Laboratory and with the U.S. Navy.

He said he has seen hyperbaric oxygen therapy work wonders for people who need treatment of wounds that won’t heal and for decompression sickness and other conditions that have FDA authorization. But, he added, those who operate wellness centers that promote it as a therapy for dozens of conditions that are not FDA-approved are “charlatans.”

“They’re only in it for the bucks,” he said. “There’s a right way to do it, a safe way to do it, and there’s a wrong way.”

Crites would like to see a U.S. ban on all monoplace hyperbaric oxygen chambers that are compressed with pure oxygen, like the kind Thomas used. He called the chambers, which have room for just one person, “potential death traps” because of the fire risk they pose “because there’s no way to get out of there.”

Instead, he supports multiplace air chambers that allow medical facilities to treat several people at once in a larger room with special hoods or masks. He’d also like more regulation, training, certifications and other safety protocols.

Peters echoed similar sentiments and suggested that state and federal governments:

• Create a registry of businesses that operate hyperbaric chambers along with a registry of equipment so chambers can’t be bought, sold and reused unsafely.

• Mandate accreditation through the UHMS to ensure the proper training and safety measures are in place.

• Require all programs to have a physician certified in hyperbaric treatment on-site when a chamber is in operation.

• Require the FDA to enforce restrictions on wellness centers, alternative medical spas, and other health centers from promoting the use of hyperbaric oxygen therapy for conditions that are not FDA-approved and providing those treatments.

Peters acknowledged hyperbaric chamber fires are rare – there is roughly one incident every two or three years worldwide. But when they occur, they are almost always fatal, he said.

Annie Cooper, who watched her son die in the fire at the Oxford Center, suffered severe burns when she tried to save Thomas from the fiery chamber, Harrington said.

“The scarring is going to be permanent, and it will be a reminder of what happened on that day. … If the emotional wounds aren’t enough, every time she looks at her arms, that’s what she’s going to remember,” Harrington said.

Contact Kristen Shamus: [email protected]. Subscribe to the Detroit Free Press.

This article originally appeared on Detroit Free Press: Thomas Cooper case: Experts call for hyperbaric chamber regulations