The growing presence of soft-sided bag chambers in the marketplace has led to several questions and concerns for many of us in the hyperbaric community. It is important to know that soft sided bag chambers and the facilities in which they are operating are subject to the same safety requirements as any hard-sided chambers, as identified in the following code and standard references:
NFPA 101: Life Safety Code (This code applies to all public and private buildings, to include assembly occupancies, business occupancies, daycare facilities, educational occupancies, health care occupancies, residential occupancies, and high-rise buildings).
“8.7.5 Hyperbaric Facilities. All occupancies containing hyperbaric facilities shall comply with NFPA 99 unless otherwise modified by other provisions of this code.”
Annex Note on 8.7.5:
“A.8.7.5 while the scope of NFPA 99 is limited to healthcare occupancies, it is the intent that this requirement to be applied to hyperbaric facilities used in all occupancies.”
NFPA 101 Handbook Note on 8.7.5:
“Hyperbaric facilities can be found in a variety of occupancies in addition to healthcare occupancies. For example, hyperbaric chambers have been installed in amusement centers and physical fitness centers and have been promoted as health-enhancing aids. Paragraph 8.7.5 extends the use of the provisions of NFPA 99, Healthcare Facilities Code, to hyperbaric facilities, regardless of occupancy classification.”
Per NFPA 99 (2024) Section 1.1 Scope:
“1.1.12 Hyperbaric Facilities. Chapter 14 establishes criteria for design and operation of hyperbaric chambers and facilities. Chapter 14 covers electrical, fire, pressure, and gas hazards associated with hyperbaric facilities that are used, or intended to be used, for medical and experimental procedures at gauge pressures from 0 kPa to 690 kPa (0 psi to 100 psi).”
Annex Note on 1.1.12:
“A.1.1.12 Hyperbaric chambers are found in a variety of settings, including but not limited to hospitals, doctor’s offices, private clinics, and business occupancies. Not all hyperbaric facilities are designed or equipped the same. Hyperbaric treatment and facilities are used for a variety of emergent and non emergent conditions, and the acuity of patients ranges from stable to critical. These variations lead to differences in hyperbaric equipment, ancillary support equipment, and facility location. This chapter is intended to provide minimum safeguards for hyperbaric patients and personnel regardless of the location of the facility.”
NFPA 99 (2024) Chapter 14, section 14.2.2.1 requires that:
“Chambers for human occupancy and their supporting systems shall be designed and fabricated to meet the requirements of ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy, by personnel qualified to fabricate vessels under such codes.”
Per ASME PVHO-1 (2024), Section 1 General Requirements, 1-2 Scope:
1-2.1 Application
“This standard applies to all pressure vessels that enclose a human within their pressure boundary while under internal or external pressure exceeding a differential pressure of 2 psi (15 kPa). PVHOs Include, but are not limited to, submersibles, diving bells, and personnel transfer capsules, as well as decompression, recompression, hypobaric, and hyperbaric PVHOs.”
Many soft-sided chambers on the market are not registered with the FDA, and even those that are, do not comply with NFPA 99 (Chapter 14), and are not designed, fabricated and certified to the ASME PVHO -1 safety standard. In many cases, non-certified devices are being constructed outside of the U.S. and enter the country in piecemeal fashion to avoid recognition by inspecting governmental entities at the border. They are then assembled after entry. In some cases, purveyors of these bag chambers claim that their product is substantially equivalent to the FDA-cleared Gamow bag. The Gamow bag was designed to deliver only compressed air to the occupant and was never designed to provide hyperbaric oxygen therapy. The Gamow Bag is ONLY intended to treat ACUTE MOUNTAIN SICKNESS at altitude and is not certified for use with any level of supplemental oxygen (Link: FDA Consumer Alert). It is notable that the Canadian equivalent of the US Food and Drug Administration (Health Canada) has banned the use of soft-sided bag chambers in their country. (Link: Health Canada Alert)
Do not be fooled. The use of these chambers is not without risk. We know that at least one person, a young man in North Carolina, has died from asphyxia at home when undergoing treatment in a “Mild Hyperbaric Chamber” which was unattended. Also in Great Britain, a diver with decompression illness was treated in a “Mild Hyperbaric Chamber” without resolution. Eventually, this diver was treated at a mainstream certified chamber at adequate doses with good result. The delay in appropriate treatment could have resulted in permanent disability or even death. In India, September 2024, a soft sided bag chamber ruptured with the occupant inside. The chamber was not attended. The man sought medical attention but to our knowledge did not receive an evaluation by a hyperbaric specialist. The status of his condition is not known.
There are many other reasons to dissuade people from entering or operating these chambers. Among them is the fact that they are not compressed with certified CGA Grade N Medical Air or even modified Grade E (breathing air for use at pressure), as required by NFPA 99, and many are sold with oxygen concentrators, a device not authorized to be used in conjunction with fabric, soft-sided chambers. The quality and purity of the gases breathed is a major concern. Additionally, the fire risks associated with the use of concentrated oxygen under pressure are very real. There are many examples of soft-sided bag chamber facilities allowing cell phones, tablets, and other electronic devices inside the chambers. In almost all of these devices, there appears to be no static grounding mechanisms present, as required by NFPA 99. While the use of these non-certified devices is very poorly regulated, the training requirements for operators even less so. This presents another great risk to the occupant and anyone near the chamber while it is in operation. The UHMS urges you to please stay away from these devices, and if you encounter them, alert your local Fire Marshal.
