Description

Murray RA. A Critical Look at Soft-Sided and Hard-Sided “Mild” Hyperbaric Chambers – Risks,

Regulations, and Ethical Oversights. Undersea Hyperb Med. 2026 Third Quarter; 53(3):523-534.

Soft-sided hyperbaric chambers, as well as some hard-sided (mild) hyperbaric chambers, which are

low-pressure, hyperbaric chambers that are typically designed for operational pressures of 3-5psi, have

gained popularity in recent years. They are marketed as safe and effective for various conditions but lack

compliance with critical regulatory and safety standards and codes. This raises concerns regarding patient

safety, the validity of manufacturers’ claims, and the ethical obligations of medical professionals and

regulators.

This manuscript examines the risks, regulatory gaps, and ethical implications of using soft-sided fabric

chambers, as well as hard-sided (mild) hyperbaric chambers, focusing on their failure to meet FDA

clearance, NFPA 99 & NFPA 101 codes, and ASME-PVHO standards.

A comprehensive review of regulatory guidelines, safety reports, and marketing practices was

conducted, supplemented by illustrations of adverse events linked to the use of these devices. Ethical

principles, including beneficence, non-maleficence, and informed consent, were applied to analyze the

responsibilities of manufacturers, healthcare providers, patients, and regulators.

These chambers are often marketed with misleading claims about their efficacy and safety. Their non-

compliance with FDA clearance, as well as not following industry standards and safety codes increases

the risk of patient harm, including otic and pulmonary barotrauma, suffocation, fire hazards, structural

failure, and, in extreme cases, death. Regulatory oversight remains inconsistent, allowing manufacturers

to exploit loopholes. Furthermore, ethical concerns arise when patients are not fully informed of the

limitations and risks of these devices.

The widespread use of these hyperbaric chambers poses significant safety and ethical challenges.

Stricter enforcement of regulatory standards and codes, transparent marketing practices, and ethical

accountability from healthcare providers and manufacturers are essential to protect patients and uphold

public trust in medical technologies.

Keywords: fire or explosion; mild hyperbaric treatment; hyperbaric oxygen; hyperbaric oxygen treatment;

soft-sided, hard-sided