About Hyperbaric Oxygen Therapy

FDA Clearance and UHMS Approval

Key Points

  • The US Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety and effectiveness of drugs, medical devices, and many other products.
  • Federal law authorizes the FDA to regulate the marketing of hyperbaric chambers as Class II medical devices.
  • The FDA regulations require valid scientific evidence that a Class II device is safe and effective for its intended use.
  • The intended use of a device includes the clinical indications (the specific diseases and conditions) it will be used to treat.
  • Applications to the FDA by manufacturers of hard-walled hyperbaric chambers reference the Report of the Hyperbaric Oxygen Therapy Committee (HOTC) of the Undersea and Hyperbaric Medical Society (UHMS) on approved indications. (Manufacturers of inflatable “mild hyperbaric chambers” reference the prior approval of a device known as the Gamow Bag.)
  • The Report of the Hyperbaric Oxygen Therapy Committee effectively determines the intended use of hyperbaric chambers legally marketed in the United States. (The intended use of mild hyperbaric chambers referencing the Gamow Bag as a predicate device is limited to treatment of Acute Mountain Sickness.)
  • The Hyperbaric Oxygen Therapy Committee evaluates valid scientific evidence regarding the safety and effectiveness of hyperbaric oxygen therapy for clinical indications to determine which merit approval.

FDA Clearance

Regulation of medical device manufacturers is the responsibility of the FDA’s Center for Devices and Radiological Health (CRDH). All manufacturers of medical devices must be registered with the CDRH. The CRDH databases can be used to find information about manufacturers and determine the clearance or approval status of their devices.

As makers of Class II medical devices, hyperbaric chamber manufacturers must obtain the FDA’s approval to market their products for the treatment of specific diseases and conditions, or clinical indications. This approval process is known as 510(k) clearance. Section 510(k) of the Food, Drug and Cosmetic Act requires each manufacturer to demonstrate that its device is substantially equivalent to a predicate device already on the market. Substantial equivalence means the new device is at least as safe and effective as the predicate.

Manufacturers of hard-walled hyperbaric chambers, citing earlier monoplace and multiplace chambers as predicates, generally receive 510(k) clearance to treat the full range of clinical indications approved by the UHMS. Manufacturers of soft-sided mild hyperbaric chambers, citing the earlier approval of the Gamow Bag as a predicate, receive 510(k) clearance for Acute Mountain Sickness (AMS) only.

Before clearance is granted the manufacturer must demonstrate that the device is labeled in accordance with FDA labeling regulations. Labeling is defined to include virtually all advertising by device manufacturers.

To maintain clearance, manufacturers must also comply with FDA requirements governing manufacturing processes and documentation.

Other federal regulations and standards apply to specific aspects of the design and operation of hyperbaric chambers.

The FDA recognizes two consensus standards that apply to the construction and operation of hyperbaric chambers. A hyperbaric chamber manufacturer must demonstrate to the FDA that its devices are in compliance with these standards:

  • American Society of Mechanical Engineers (ASME) Standard PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy
  • National Fire Prevention Association (NFPA) Code 99, Standard for Healthcare Facilities Chapter 20 – Hyperbaric Facilities

hyperbariclink commentary

Do not accept hyperbaric oxygen therapy in a medical device that is not cleared by the FDA and labeled by the American Society of Mechanical Engineers as a pressure vessel for human occupancy (ASME PVHO-1).

UHMS Approval

The Undersea and Hyperbaric Medical Society (UHMS) is a nonprofit association of physicians and scientists formed in 1967. Its mission includes providing information and support for hyperbaric medical research and patient treatment with hyperbaric oxygen, improving scientific knowledge of hyperbaric oxygen therapy, and improving standards of patient care and operational safety.

The UHMS certifies doctors in Undersea and Hyperbaric Medicine (UMS). It also accredits select treatment centers that have demonstrated the highest levels of facility safety and effectiveness.

The Hyperbaric Oxygen Therapy Committee of the UHMS is composed of doctors who evaluate the results of clinical trials and other scientific evidence according to a hierarchy adapted from the Oxford Centre for Evidence-Based Medicine.

The FDA relies on the Undersea and Hyperbaric Medical Society for guidance on the safety and effectiveness of hyperbaric oxygen therapy for specific diseases and conditions.

To date the UHMS Hyperbaric Oxygen Therapy Committee has recognized the following clinical indications:

  • Air or Gas Embolism
  • Carbon Monoxide Poisoning
  • Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
  • Clostridial Myositis and Myonecrosis (Gas Gangrene)
  • Crush Injury, Compartment Syndrome, and Other Acute Traumatic Ischemias
  • Decompression Sickness
  • Central Retinal Artery Occlusion
  • Sensorineural Hearing Loss
  • Enhancement of Healing In Selected Problem Wounds
  • Severe Anemia
  • Intracranial Abscess
  • Necrotizing Soft Tissue Infections
  • Osteomyelitis (Refractory)
  • Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
  • Compromised Grafts and Flaps
  • Acute Thermal Burn Injury

See our Diseases and Conditions section for links to additional resources and detailed information about each of these UHMS-approved clinical indications.

Read more about the UHMS approval process in Hyperbaric Oxygen Therapy Indications (12th Edition), available for purchase on the UHMS website.

Hyperbaric Oxygen Therapy Indications book cover

Implications for insurance reimbursement

The UHMS also provides guidance for the Centers for Medicare and Medicaid Services (CMS) and for private health insurance carriers in the financial reimbursement of hyperbaric oxygen therapy. CMS and private insurers generally reimburse the cost of hyperbaric oxygen therapy for patients who receive treatment for clinical indications approved by the UHMS in hyperbaric chambers cleared by the FDA.

Off-Label Treatment

Monoplace and multiplace hyperbaric chambers that receive FDA 510(k) clearance are “labeled” for the treatment of UHMS-approved clinical indications only.

Licensed physicians and healthcare institutions may legally use an FDA-cleared hyperbaric chamber to treat many unapproved or “off-label” diseases and conditions as well. It is illegal to promote or advertise such uses.

Patients and referring physicians should note that, for these off-label or investigational uses of hyperbaric oxygen therapy, the hyperbaric medical community has not yet established safe and effective treatment protocols and dosages (pressure, oxygen time).

One may reasonably question the safety and effectiveness of hyperbaric oxygen therapy for the treatment of diseases and conditions that have not been approved by the UHMS.

Our Diseases and Conditions section provides links to additional resources and detailed information about several of the most common off-label uses of hyperbaric oxygen therapy.

Each page in our Diseases and Conditions section includes our Evidence Index, an at-a-glance summary of the state of clinical evidence for the treatment of the disease or condition with hyperbaric oxygen therapy.

hyperbariclink commentary

Physicians providing off-label HBOT should clearly and cheerfully answer your questions about the medical devices employed and about the current state of the clinical evidence and insurance reimbursement for your disease or condition.

Never pay to participate in a clinical trial.

Always get a physician prescription for HBOT, no matter whether your disease or condition is UHMS-approved or your therapy is off-label.

Sources
US Food and Drug Administration, Center for Devices and Radiological Health. Retrieved 11 August 2011.
http://www.fda.gov/MedicalDevices/default.htm
Undersea and Hyperbaric Medical Society, Indications for Hyperbaric Oxygen Therapy. Retrieved 11 August 2011.
http://membership.uhms.org/?page=Indications
Page Data
Updated: 13 Aug 2011 12:00 AM
Created: 11 Aug 2011 12:00 AM
By: About the authors »