The FDA issued a letter to health care providers urging them to follow manufacture’s instructions when using hyperbaric chambers.
The FDA said it is “aware of reports of serious injuries and deaths with use of HBOT devices and is providing recommendations for health care providers and facilities to help reduce potential risks.”
Two people in the United States have died in hyperbaric chamber fires this year. A man in Arizona died in July, and 5-year-old Thomas Cooper was killed in an explosion at the Oxford Center in Troy.
The FDA is urging health care providers to follow the manufacturer’s instructions. Prosecutors have argued that proper safety protocols weren’t followed when Cooper was killed and his mother was injured in an explosion.
Oxford Center CEO Tamela Peterson and three other workers were charged in Cooper’s death. Peterson, along with Jeffrey Mosteller, the safety manager, and Gary Marken, the primary management assistant, was charged with second-degree murder. They were also given the alternative charge of involuntary manslaughter, which means that a jury will decide which charge accurately fits their conduct.
Aleta Moffitt, who was allegedly operating the hyperbaric chamber at the time of the explosion, was charged with involuntary manslaughter and falsifying medical records.
---> Full coverage on the Oxford Center hyperbaric chamber explosion.
Here’s what the FDA’s letter recommends
The FDA made the following recommendations for health care providers and facilities:
- Review and follow the manufacturer’s instructions for use for each hyperbaric oxygen therapy (HBOT) device being used.
- Ensure fire prevention and safety measures are followed for HBOT devices.
- Be aware that there is a heightened risk of fire with use of oxygen at a high concentration.
- Ensure proper grounding equipment is used.
- Ensure proper training is provided and maintained for staff with use of HBOT devices.
- Ensure the patient is properly monitored and supervised for the duration of the treatment with use of HBOT devices.
- Ensure that manufacturer recommended cleaning procedures, maintenance intervals, and safety checks are followed for each HBOT device being used.
- Follow the manufacturer’s instructions to avoid potentially prohibited items during use of the HBOT device, including electrical or static devices. Be aware that some items may require additional grounding measures.
- Ensure patients wear clothing that is made of hyperbaric compatible materials according to the manufacturer’s instructions, such as cotton.
- Be aware that some patient clothing and some fabrics may produce more static electricity than others (such as wool and synthetic materials).
The Undersea and Hyperbaric Medical Society, the organization that accredits hyperbaric chamber facilities, said on it’s website that it “strong supports the FDA’s safety communication.”
The Investigators at Local 4 have reached out to the Undersea and Hyperbaric Medical Society asking for a more in-depth statement.
---> Hyperbaric chambers: What they are, what they treat, risks, and accreditation
What is hyperbaric oxygen therapy?
Hyperbaric oxygen therapy involves breathing 100% pure oxygen.
During a hyperbaric oxygen therapy (HBOT) session, a patient is placed in a hyperbaric chamber and the air pressure inside is raised to a level that is higher than normal air pressure, according to the FDA.
The increased air pressure helps the lungs collect more oxygen, getting more oxygen to the tissues that need it. The treatment can help the body heal and fight certain infections.
The FDA notes that too much oxygen can cause damage to the body. Because of this, the FDA regulates both the oxygen used in HBOT and the hyperbaric chambers.
Risks of hyperbaric oxygen therapy
HBOT is considered generally safe. The FDA said that serious complications are rare when chambers are used for treatment cleared by the FDA.
Here is the FDA’s list of potential risks:
- Ear and sinus pain
- Middle ear injuries, including tympanic membrane rupture
- Temporary vision changes
- Lung collapse (rare)
The FDA noted that because of the high concentrations of oxygen, there is a risk of fire. The risk of fire is “one reason why the FDA recommends treatment at an accredited facility.”
Accredited hyperbaric chambers in Michigan
The FDA recommends those who need treatment get it at an accredited facility saying, “Explosions and fires have occurred in HBOT chambers that have not been reviewed by the FDA and are located at unaccredited facilities.”
The FDA said the facility should be accredited by the Undersea and Hyperbaric Medical Society, though accreditation is not a requirement. According to the UHMS map, only two locations in Michigan have been accredited, and they are in Grand Rapids and Niles.
In a statement to Local 4, the Michigan Department of Licensing and Regulatory Affairs (LARA) said that state law does not require hyperbaric oxygen facilities to be licensed or regulated by LARA.
According to the Undersea and Hyperbaric Medical Society, accreditation is only required by insurance companies in upstate New York and Utah. It is not an insurance requirement in Michigan.
How does the accreditation process work?
The Undersea and Hyperbaric Medical Society sends a manual to the location to make sure they’re up to the codes. Then they sent out a team, which consists of a physician, nurse, and technician who specializes in the field. The inspection takes two days.
The inspection focuses on safety, patient care, and quality of care. The Undersea and Hyperbaric Medical Society said there haven’t been any fire or explosive incidents at any accredited facilities since 2001, which is when the accreditation process started.
The Undersea and Hyperbaric Medical Society is pushing for accreditation to be a requirement for insurance.
Read the letter from the FDA
Read the letter from the FDA in the embedded PDF below or click here to view the letter on the FDA’s website.