Andrew Melnyczenko, BSHCA, CHT
CONSUMER WARNING: The Dangers of Soft-Sided Bag Chambers
The growing presence of soft-sided bag chambers in the marketplace has led to several questions and concerns for many in the hyperbaric community. This article aims to reveal some of the facts and misconceptions surrounding these chambers and identify the hazards associated with their use. It is important to know that soft-sided bag chambers and the facilities in which they operate are subject to the exact safety requirements of any hard-sided chambers. These safety requirements can be found in the following Fire Protection Codes and Engineering Standards:
NFPA 101: Life Safety Code (This code applies to all public and private buildings, including 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 the U.S. and enter the country piecemeal 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). Notably, the Canadian equivalent of the US Food and Drug Administration (Health Canada) has banned 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 results. The delay in appropriate treatment could have resulted in permanent disability or even death. In India, in 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. The fire risks associated with using concentrated oxygen under pressure are also very real. Many examples of soft-sided bag chamber facilities allow cell phones, tablets, and other electronic devices inside the chambers. In almost all of these devices, there appear to be no static grounding mechanisms present, as required by NFPA 99. While these non-certified devices are very poorly regulated, the training requirements for operators are even less so. This presents another significant risk to the occupant and anyone near the chamber while it is in operation. Please stay away from these devices; if you encounter them, alert your local Fire Marshal.
Andrew Melnyczenko is a Certified Hyperbaric Technologist with 26 years of experience in the Hyperbaric Industry in civilian and Military settings. He has been Chairman of the UHMS Hyperbaric Oxygen Safety Committee since 2018. You may contact Andrew by emailing him at melnyczenko.andrew@mayo.edu.
POSITION STATEMENTS FROM HYPERBARIC ASSOCIATIONS:
Link to the UHMS Position Statement on Low-Pressure Fabric Hyperbaric Chambers:
https://www.uhms.org/images/Position-Statements/UHMS_Position_Statement_LP_chambers_revised.pdf
SAMJ publication related to soft-sided chambers and the SAHUMA Position Statement:
https://journals.co.za/doi/abs/10.7196/SAMJ.2019.v109i4.13524
https://sauhma.org/blog/2020/04/25/low-pressure-fabric-hyperbaric-chambers
ECHM-EUBS Position Statement on the use of ‘mild hyperbaric therapies’ in humans
https://www.eubs.org/wp-content/uploads/2022/12/ECHM-EUBS-Position-Statement-Mild-Hyperbaric-Therapies-20.12.22.pdf
NBDHMT Monthly Briefings, July 2023, May 2023, August 2022.
REFERENCES:
- American Medical Association. “Oppose Unsafe Use of “Mild Hyperbaric Therapy” D-270.986. 2022.
- American Society of Mechanical Engineers. Safety Standard for Pressure Vessels for Human Occupancy, ANSI/ASME PVHO-1-1912. New York: ASME, 2023.
- Burman, F. (2019). Low-pressure fabric hyperbaric chambers. South African Medical Journal, 109(4): 12574. doi: 10.7196/SAMJ.2019.v109i4.13524. PMID: 31084683.
- National Fire Protection Association. NFPA 101: Life Safety Code. 2024 edition. Quincy, Mass. NFPA, 2024.
- National Fire Protection Association. NFPA 99: Health Care Facilities Code. Quincy, Mass. NFPA, 2024.
- National Board of Diving and Hyperbaric Medical Technology. “Monthly Briefing July 2023”. Accessed October 22, 2024.
- National Board of Diving and Hyperbaric Medical Technology. “Monthly Briefing May 2023”. Accessed October 22, 2024.
- National Board of Diving and Hyperbaric Medical Technology. “Monthly Briefing August 2022”. Accessed October 22, 2024.
- Southern African Undersea and Hyperbaric Medical Association. SAUHMA Position Statement: Low-Pressure Fabric Hyperbaric Chambers. Accessed 10/18/2024.
- Undersea and Hyperbaric Medical Society. UHMS Position Statement: Low-Pressure Fabric Hyperbaric Chambers. Accessed 10/18/2024.
- S. Food and Drug Administration. Hyperbaric oxygen therapy: Get the facts. Published July 26, 2021.
- Health Canada. Unauthorized soft-shelled hyperbaric chambers may pose serious health risks. Published October 25th, 2019.