Ethical Issues, Standards, and Quality Control in the Practice of Hyperbaric Medicine

Abstract

We will discuss the safety and ethics of hyperbaric oxygen therapy (HBOT) amidst a boom in public demand and usage. Although there are 14 indications recognized by the Undersea and Hyperbaric Medical Society (UHMS) in the United States, there are dozens of off-label indications (most unsupported by scientific evidence) for which HBOT is utilized in clinics, medical spas, and the home. In many cases, “hyperbaric oxygen therapy” is being provided with compressed air in inflatable chambers at 1.3 ATA. These “mild hyperbaric” treatments do not meet the definition of HBOT according to the UHMS. Furthermore, clinical trials have been published that evaluate the efficacy of these “mild hyperbaric” treatments, using oxygen partial pressures so low that they could have been achieved breathing oxygen with a simple face mask at sea level atmospheric conditions. Thus, some studies purporting to demonstrate the effectiveness of HBOT did not even employ HBOT. Despite the excellent safety record of HBOT in general, when pure oxygen is provided to patients under hyperbaric conditions, there is a risk of side effects and adverse events including deaths from hyperbaric chamber fires, gas mishandling, and poor decompression practices, all of which might have been prevented by adherence to safety regulations and proper training. The risk of HBOT must be weighed against the potential benefit, and this is difficult to do when the benefit is unknown. The economic implications of the rise in HBOT use are significant. Fraudulent use of HBOT can occur with approved as well as off-label indications. Consumers may pay out of pocket for unproven treatments without a clear understanding of the scientific evidence for its use, or third party payers may pay for the improper use of HBOT in patients who do not meet coverage criteria and maybe unlikely to benefit. A more clear definition of what constitutes “hyperbaric oxygen therapy” would improve publication standards for clinical trials involving HBOT. The creation of a national registry to make outcome data available and more federal resources directed at the enforcement of safety standards would reduce patient risk.

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