Hyperbaric Chamber Usage And Legal Requirements Explained

Hyperbaric chambers are used for hyperbaric oxygen therapy (HBOT), which involves breathing pure oxygen in a pressurised environment. HBOT is used to treat a variety of health problems, including carbon monoxide poisoning, diabetic foot ulcers, and decompression sickness in scuba and deep-sea divers. The therapy is generally safe, but there are some risks, including ear injuries, temporary vision changes, and lung collapse. The U.S. Food and Drug Administration (FDA) regulates the use of hyperbaric chambers and has cleared them for the treatment of specific disorders.

FDA regulations

Hyperbaric chambers are regulated by the US Food and Drug Administration (FDA) as Class II medical devices. This classification is given to devices that pose a moderate to high risk to the patient and/or user. The FDA has specific requirements and guidelines for the use and manufacture of hyperbaric chambers.

• The FDA “clears” hyperbaric chambers for use in specific conditions. When a device is used for a cleared condition, it is considered “on-label” use. On the other hand, “off-label” use refers to when a device is used for a condition not on the FDA clearance list. While off-label use is common and does not limit appropriate clinical use, payers often use the FDA clearance list as a reason to deny payment for off-label treatments.
• As of July 2021, the FDA has cleared hyperbaric chambers for the following disorders: air and gas bubbles in blood vessels, severe anemia, severe burns, carbon monoxide poisoning, decompression sickness, sudden hearing loss, severe infection of the skin and bone, skin graft flap at risk of tissue death, sudden vision loss, and diabetic foot ulcers.
• The FDA is currently studying the use of hyperbaric chambers for other conditions, including COVID-19. However, it has not yet cleared or authorized the use of hyperbaric chambers for these conditions.
• The FDA regulates both the oxygen used in hyperbaric oxygen therapy (HBOT) and the hyperbaric chambers themselves. HBOT involves breathing 100% pure oxygen in a hyperbaric chamber, which increases the air pressure and helps the lungs collect more oxygen.
• All hyperbaric chambers used in the US for hyperbaric medicine fall under the jurisdiction of the FDA. The FDA requires these chambers to comply with the American Society of Mechanical Engineers PVHO (Pressure Vessel for Human Occupancy) Codes and the National Fire Protection Association Standard 99, Health Care Facilities Code. Similar conditions apply in most other countries.
• The FDA has specific standards for hyperbaric chamber equipment to mitigate the inherent hazards of hyperbaric medicine. The FDA requires hyperbaric chambers to meet ASME PVHO and NFPA 99 standards or the local equivalent. All chambers that meet FDA standards must have an ASME data plate, and patients seeking hyperbaric treatment should ensure that the equipment and facilities meet these standards.
• The FDA recommends that HBOT be administered in accredited facilities to reduce the risk of fire and explosions caused by high oxygen concentrations.
• The FDA has cleared large, zippered bags for treating altitude sickness. However, these bags are not cleared for use with oxygen tanks or oxygen concentrators. The FDA warns against using these bags to create homemade HBOT devices, as they pose a risk of fire and suffocation.
• The FDA advises individuals considering HBOT to consult with their healthcare provider to ensure they are pursuing the most appropriate care. If HBOT is recommended, the FDA suggests seeking treatment at a hospital or facility accredited by the Undersea and Hyperbaric Medical Society.
• The FDA encourages individuals to report any serious health or safety problems related to HBOT through MedWatch, their safety information and adverse event reporting program.

Safety and side effects

Hyperbaric chambers are generally safe, and serious complications are rare. However, there are some side effects and potential risks associated with their use.

Side Effects

During hyperbaric oxygen therapy (HBOT), patients may experience discomfort due to the high pressure inside the chamber. Ear pain and a popping feeling in the ears are common. Some people may also experience fatigue, lightheadedness, and sinus congestion. These side effects are generally mild and can be mitigated by taking short breaks during the therapy to breathe normal air.

Potential Risks

More severe problems can occur, including lung damage (including lung collapse), fluid buildup or rupture of the middle ear, changes in vision (usually temporary nearsightedness), and oxygen poisoning. Oxygen poisoning can lead to lung failure, fluid in the lungs, seizures, and even death in severe cases. Middle ear injuries, such as tympanic membrane rupture, are also a potential risk.

Safety Precautions

To ensure safety and minimize risks, it is important to be treated by certified and trained medical staff. The healthcare provider directing the therapy should have special training in hyperbaric medicine, and the technicians operating the chamber should be certified hyperbaric technicians. It is also important to use HBOT only as intended and for approved indications.

Legal Considerations

The use of hyperbaric chambers for medical and therapeutic procedures is generally regulated. In the United States, the Federal Food and Drug Administration (FDA) regulates both the oxygen used in HBOT and the hyperbaric chambers themselves. The FDA has cleared hyperbaric chambers for specific disorders, including air and gas bubbles in blood vessels, severe anemia, severe burns, carbon monoxide poisoning, decompression sickness, and severe infection of the skin and bone.

Hyperbaric chamber types

Hyperbaric chambers are used to perform hyperbaric oxygen therapy (HBOT), which involves breathing pure oxygen in a pressurised environment. This therapy is used to speed up the healing of wounds that won't heal, carbon monoxide poisoning, gangrene, decompression sickness, and infections where tissues are starved of oxygen.

There are two types of hyperbaric chamber:

Monoplace Chamber

This is a chamber built for one person. It's a long, plastic tube that looks like an MRI machine. The patient slips into the chamber, which is slowly pressurised with 100% oxygen.

Multiplace Chamber

This chamber or room can fit two or more people at once. The treatment is largely the same, but the difference is that people breathe pure oxygen through masks or hoods. A technician may also be in the chamber with the patient to monitor them and assist with equipment.

Hyperbaric oxygen therapy (HBOT) uses

Hyperbaric oxygen therapy (HBOT) is a type of treatment used to speed up the healing of carbon monoxide poisoning, gangrene, and wounds that won't heal. It is also used for infections in which tissues are starved of oxygen. HBOT is well-known for treating scuba and deep-sea divers affected by the rapid change in pressure around them. However, it has also been approved for more than a dozen conditions, including:

• Air or gas bubbles in blood vessels (air or gas embolism)
• Decompression sickness (the bends)
• Gangrene caused by bacteria Clostridium (gas gangrene)
• Severe bone and skin infections
• Crush injuries
• Burns
• Acute or traumatic reduced blood flow in the arteries
• Compromised skin grafts and flaps
• Infection in a bone (osteomyelitis) that doesn't respond to other treatments
• Delayed radiation injury
• Flesh-eating disease (necrotizing soft tissue infection)
• Chronic infection called actinomycosis
• Diabetic wounds that are not healing correctly
• Hearing loss (idiopathic sudden sensorineural hearing loss)
• Vision loss (central retinal artery occlusion)
• Anaemia (severe anaemia when blood transfusions cannot be used)

HBOT involves breathing 100% pure oxygen while inside a hyperbaric chamber. The air pressure inside the chamber is raised to a level that is 1.5 to 3 times higher than normal air pressure. This helps the lungs gather and absorb more oxygen, which is then carried by the blood throughout the body to infuse injured tissues. The higher pressure in the chamber increases the amount of oxygen in the blood, helping to repair tissues and restore normal body function.

HBOT has been shown to be effective in treating conditions such as decompression sickness, gas gangrene, and carbon monoxide poisoning. Research is also being conducted to examine the potential benefits of HBOT for other conditions such as cerebral palsy, multiple sclerosis, and COVID-19. However, it is important to note that HBOT is not considered safe and effective for all conditions. For example, there is no reliable evidence to support its use in autism, cancer, diabetes, HIV/AIDS, Alzheimer's disease, asthma, depression, heart disease, or stroke.

HBOT treatment process

Hyperbaric chambers are subject to the laws and regulations of the country in which they are used. For example, in the United States, hyperbaric chambers fall under the jurisdiction of the Federal Food and Drug Agency (FDA). The FDA requires hyperbaric chambers to comply with the American Society of Mechanical Engineers PVHO Codes and the National Fire Protection Association Standard 99, Health Care Facilities Code. Similar conditions apply in most other countries.

Now, here is a detailed description of the HBOT treatment process:

The HBOT Treatment Process

Hyperbaric oxygen therapy (HBOT) is a medical treatment that involves breathing pure oxygen while inside a pressurised hyperbaric chamber. This therapy is used to speed up the healing process for various conditions, including carbon monoxide poisoning, gangrene, and wounds that are not healing properly. The treatment works by increasing the amount of oxygen in the blood, which can help repair tissues, fight infections, and restore normal body functions.

During HBOT, patients enter the hyperbaric chamber, which can be a long plastic tube (monoplace chamber) or a room that accommodates multiple people (multiplace chamber). The air pressure inside the chamber is then raised to 1.5 to 3 times the normal air pressure. This increased pressure helps the lungs collect more oxygen, which is then carried by the blood to the injured tissues in the body.

It is important to note that HBOT should only be prescribed by a healthcare provider, and it is not suitable for everyone. Those who have recently had ear surgery, injuries, a cold, fever, or certain lung diseases may not be able to undergo HBOT. The most common complication of HBOT is middle ear trauma, but other possible complications include eye damage, lung collapse, low blood sugar, and sinus problems. In rare cases, oxygen poisoning can occur, leading to seizures, fluid in the lungs, and lung failure.

A typical HBOT session can last anywhere from 45 minutes to 300 minutes, depending on the condition being treated. Patients may experience a plugged sensation in their ears as the pressure is raised, similar to the feeling during air travel. Swallowing or chewing gum can help relieve this pressure. After the session, patients may feel lightheaded, and mild side effects such as claustrophobia, fatigue, and headaches may occur. It is recommended to have someone drive the patient home after the treatment.

Multiple sessions of HBOT are often required, and it is important to check with your insurance company beforehand to see if the cost of the treatment is covered. Overall, HBOT is a safe and effective treatment for a variety of conditions, but it should be carefully administered by trained personnel to mitigate potential risks and ensure patient safety.

Frequently asked questions