The FDA’s Role In Marketing Hyperbaric Oxygen Therapy

  In response to a federal mandate, the FDA began to regulate hyperbaric chambers in 1976. The legislative source for this mandate is found in the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. The Act has been modified over time by subsequent amendments. In late 1979, the FDA classification rules for respiratory and anesthesiology devices were adopted. Hyperbaric chambers were classed as Class II medical devices at that time.

  With regard to hyperbaric chambers, as a Class II medical device, the chamber manufacturer must submit a Premarket Notification [510(K)] before the device can be legally offered for sale. In addition to submitting verification of the safety of the device (design, fabrication, performance standards, etc.) since 1996, the submitter must also inform the FDA of the indications for which the device is intended. The FDA considers these indications as a form of labeling for the device. The FDA has also defined hyperbaric chambers as a prescriptive device. This means that they cannot be sold or used without the prescription of a licensed physician.   When the FDA classification panel made their initial recommendation on hyperbaric chamber classification in 1978, the panel recommended that the list of indications from the Undersea & Hyperbaric Medical Society (UHMS) be adopted as indications of use for hyperbaric chambers.

  The current list from the 2003 edition of the Hyperbaric Oxygen Therapy Committee Report includes the following indications:
    1) Air or gas embolism
    2) Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
    3) Clostridial myositis and myonecrosis
    4) Crush injury, compartment syndrome, and other acute traumatic ischemias
    5) Decompression sickness
    6) Enhanced healing of selected problem wounds
    7) Exceptional blood loss anemia
    8) Necrotizing soft tissue infections
    9) Osteomyelitis (refractory)
    10) Delayed radiation injury (soft tissue and bony necrosis)
    11) Skin grafts and flaps (compromised)
    12) Thermal burns
    13) Intracranial abscess

  It is important to understand that the FDA does not regulate the practice of medicine. Their charter is to regulate the safety and effectiveness of drugs and devices. A key element of this regulation is how the drug or device is marketed. According to FDA requirements, the chamber manufacturer cannot legally market their device for any indication not listed and not cleared through the 510(K) clearance process. To market a hyperbaric chamber for any other indication is considered off-label and thus illegal. For example, it is perfectly acceptable to market a hyperbaric chamber for wound healing; it is not legal to market a hyperbaric chamber for autism. However, this is not to be confused with how the chamber is actually used. A physician may prescribe the use of a hyperbaric chamber for any indication for which in their medical judgment is deemed appropriate.

  What is not well understood is that the same marketing restrictions applied to the manufacturer of the chamber apply to the user of the device. As a user of a hyperbaric chamber, any wound care clinic can market their services for any of the listed indications. Using the same example as above, a clinic cannot market their services for the treatment of autism. The FDA has set precedence with warning letters issued to clinics advertising for off-label indications. While this has generally not been a problem with hospital-based or hospital-affiliated treatment centers, it is a growing problem when one moves to the freestanding, non-hospital based hyperbaric treatment centers. In the past 10 years, there has been an explosion of such centers that treat off-label indications almost exclusively. Since there are no mandatory staffing or training standards that apply to such facilities, the quality of care and patient safety in many of these centers is a very real concern. It is unfortunate that the FDA has not applied the necessary resources to be more vigilant with regard to regulating this troubling situation.

  In a companion article in Today’s Wound Clinic, this author discussed the value of participating in the UHMS’ Clinical Hyperbaric Facility Accreditation Program. Though not directly related to the FDA’s regulation of marketing, program surveyors have noted issues related to how programs locally market their services. It has been a common observation to find marketing brochures, etc., that list the indications for hyperbaric oxygen therapy. In many such instances, the list has been the complete list from the UHMS, including emergent indications such as air gas embolism, decompression illness, carbon monoxide poisoning, etc. Now this is perfectly fine if the center is staffed and equipped for emergencies and maintains a 24/7 treatment posture. However, if the center is outpatient only, and does not accept these types of cases, then the marketing material is misleading to the patient and to the community that the center serves. If a center is strictly outpatient and accepts no emergency patients, the center’s staff might want to review their brochures, etc., to ensure that only the indications treated at that center are marketed.

  In closing, it is important to return to the FDA. The FDA regulations are not intended to limit how hyperbaric chambers are used as long as a licensed physician directs their use. The FDA regulations are intended to limit how the devices are designed and how they are advertised. Therefore, in summary a physician can prescribe the use of a hyperbaric chamber for any indication based on his or her medical judgment. However, the physician can only advertise its use for the listed indications.

W.T. Workman, MS, CAsP, CHT, FasM, is the Director, Quality Assurance & Regulatory Affairs, Undersea & Hyperbaric Medical Society, at the UHMS Satellite office in San Antonio, Texas. For additional information on the role of the FDA plays in hyperbaric medicine, contact Tom Workman at (210) 404-1553 or uhmsqara@aol.com.