In wake of child's death, industry leaders call for regulation of hyperbaric chambers

• It took the death of 5-year-old Thomas Cooper to highlight the need for regulation of hyperbaric oxygen chambers, said the executive director of the Undersea & Hyperbaric Medical Society.
• Calls are rising for regulation to rein in the medical spas and wellness centers that offer hyperbaric oxygen therapy for treatments that are not authorized by the FDA.

The death of a 5-year-old boy inside a hyperbaric oxygen chamber in Troy 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, said John Peters, executive director of the Undersea & Hyperbaric Medical Society.

And the result, Peters said, is that people die.

People like Thomas Cooper, who wore his Super Mario Bros. pajamas as he underwent his 36th treatment inside a hyperbaric oxygen chamber at the Oxford Center on Jan. 31 in Troy, when what appeared to be static electricity sparked a "fireball," killing the Royal Oak child in a span of 3 seconds, Troy police said in court documents obtained by the Free Press.

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.

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."

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 Michigan. 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 laid out the criminal charges against Oxford Center CEO Tamela Peterson, 58, of Brighton, and three other employees in the child's death. All have pleaded not guilty.

Nessel said her office doesn't have authority to inspect all of the facilities that provide hyperbaric oxygen therapy in Michigan to ensure they are operating safely. The only time she could do inspections would be when there is "probable cause to believe 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 said.

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:

• Decompression sickness
• Severe anemia when blood transfusions can't be used
• Severe and large burns
• Carbon monoxide poisoning
• Crush injuries
• Air and gas bubbles in blood vessels
• Gas gangrene
• Hearing loss that occurs suddenly and without a known cause
• Radiation injuries
• Severe infections of the skin and bone
• Radiation injury
• 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.

"You could buy one right now online," he said. His organization has evidence people are doing just that.

"We can trace them from the manufacturer in China, to the U.S. port, to the buyer, to the distributor, to the end user. And we've given all that information to the FDA, and they're doing nothing about it," he said. "Nothing. And so whenever there's somebody who dies in these chambers, I feel like they are responsible."

In an emailed response to questions from the Detroit 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."

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.

They are:

• Corewell Health’s Lakeland Center for Wound Care & Hyperbaric Medicine in Niles.
• Corewell Health Grand Rapids Hospitals Wound Healing & Hyperbaric Medicine – Barclay.

The other 40 Michigan hospitals that got Medicare payments for hyperbaric oxygen treatments that are not accredited include others within Corewell Health, and some affiliated with Ascension Michigan, Bronson Healthcare, Covenant HealthCare, the Detroit Medical Center, Henry Ford Health, the University of Michigan Health, McClaren Health Care, Munson Healthcare, Trinity Health Michigan, MyMichigan Health and the UP Health System, Gelly said.

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

"When somebody says, 'I can't afford it,' ... what I hear is 'I don't care enough about my patients' safety to invest in an external review.' That's what I hear.

"I know that approximately 37% of hospitals today are operating in the red. I understand that ... but you need to prioritize. ... If you're delivering patient care, you need to make sure that the patient care that you're delivering is the safest possible care that you can deliver."

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

"If you're going inside of a pressure vessel, wouldn't you want it to meet code?" Peters asked. "Well, then why don't the other 39 states have the same mandate?"

Calls grow for hyperbaric oxygen therapy regulation

Thomas Crites, 73, of Jonesville, spent about 40 years working in the commercial diving industry on drilling operations in the Gulf of Mexico, off the coast 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 said, 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."

Rather, 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 to see more regulation, training, certifications and other safety protocols.

Peters would like to see that, too.

"Let's do the right thing," Peters said, suggesting 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.

Harrington, the Cooper family's attorney, said he's hopeful that the Michigan Legislature and governor will act to protect the safety of Michiganders.

"We need swift action from the lawmakers of the state of Michigan and a bipartisan effort to propose and introduce and sign law ... that provides oversight, regulation, training, adherence to safety standards, and criminal penalties for violations.

"This needs to be done immediately, in light of the fact that there are ... thousands of Michigan citizens that are receiving treatment on literally a weekly basis. ... This is just a recipe for disaster for something like this to happen again."

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.

"By the grace of God, little Thomas' mother is still alive and nobody else was hurt. I just ask everybody to pray and send prayers to the family."

Contact Kristen Shamus: kshamus@freepress.com. Subscribe to the Detroit Free Press.