SAUHMA Position Statement
Low-Pressure Fabric Hyperbaric Chambers
Keywords: SAUHMA, UHMS, position, soft chamber, low-pressure chamber, Gamow bag, home chamber
Date created: 25 April 2017
Date revised:
Date of next revision: 24 April 2020
Authorship: SAUHMA Technical Advisor, SAUHMA Executive Committee, UHMS Safety Committee, UHMS Oxygen Therapy Committee.
Reviewed and approved by: SAUHMA Committee
Overview
The low-pressure, fabric hyperbaric chambers (operating at less than 1.4 ATA) marketed for sports and alternative medicine, have a U.S. Food & Drug Administration (FDA) 510(k) clearance for Acute Mountain Sickness only and are designed to be compressed only with air. The FDA prohibits the use of these devices with supplemental oxygen.[1]
In South Africa, there is no Medicines Control Council review or cautionary statements, nor concerns raised by the Department of Labour at this stage.
The internationally recognized NFPA 101 Life Safety Code and NFPA 99 Health Care Facilities Code describe the requirements for the construction, operation, and maintenance of hyperbaric facilities.[2] [3]
The Pressure Equipment Regulations (through SANS 347) classifies a typical Gamow bag (based on volume and maximum operating pressure at less than 1.5 ATA) as Category “Not regulated”. The low-pressure fabric hyperbaric chamber thus falls outside of any regulated requirements.[4]
The Diving Regulations specify that all persons exposed to pressures in excess of 100 millibar above ambient pressure (1.1 ATA) are required to conform to the requirements of these regulations, unless the treatment concerns medical conditions (non-diving) and in this case, the facility providing such treatments is required to be accredited by SAUHMA.
SANS 347 Annex A provides a schedule of health and safety standards approved by the Department of Labour. ASME PVHO-1 is listed as an approved safety standard.[5]
The ASME-PVHO-1 standard applies to any pressure vessel that encloses a human within the pressure boundary, with an external or internal pressure exceeding 2 psig above ambient pressure (1.14 atmospheres absolute).
SAUHMA’s approved indications require that treatment pressures given be at a minimum of 2 ATA. At this pressure, the pressure vessel is categorized as a Category III vessel, subject to all the design, construction, testing and certification requirements listed in SANS 347.
Accordingly, SAUHMA requires that all hyperbaric chamber construction is required to satisfy Category III requirements, as a minimum, and shall meet the relevant ASME-PVHO-1 requirements.
The SANS 347 vessel conformity categorization as Not Regulated is not appropriate where human occupancy adds a considerable safety responsibility to any pressure vessel product.
As considered by the UHMS, SAUHMA does not endorse the concept of “In Home” therapy at any time.[6]
Conclusions and Recommendations
[1] Food and Drug Administration, CFR _Code of Federal Regulations Title 21
[2] National Fire Protection Association, 101 Life Safety Code 2015 edition
[3] National Fire Protection Association, 99 Health Care Facilities Code, 2015 edition
[4] SANS 347: Categorization and conformity assessment criteria for all pressure equipment, 2nd Ed, 2012
[5] ASME PVHO-1, Safety standard for pressure vessels for human occupancy, 2015.
[6] Undersea and Hyperbaric Medical Society Position Statement on the Conduct of Hyperbaric Oxygen Therapy
Date created: 25 April 2017
Date revised:
Date of next revision: 24 April 2020
Authorship: SAUHMA Technical Advisor, SAUHMA Executive Committee, UHMS Safety Committee, UHMS Oxygen Therapy Committee.
Reviewed and approved by: SAUHMA Committee
Overview
The low-pressure, fabric hyperbaric chambers (operating at less than 1.4 ATA) marketed for sports and alternative medicine, have a U.S. Food & Drug Administration (FDA) 510(k) clearance for Acute Mountain Sickness only and are designed to be compressed only with air. The FDA prohibits the use of these devices with supplemental oxygen.[1]
In South Africa, there is no Medicines Control Council review or cautionary statements, nor concerns raised by the Department of Labour at this stage.
The internationally recognized NFPA 101 Life Safety Code and NFPA 99 Health Care Facilities Code describe the requirements for the construction, operation, and maintenance of hyperbaric facilities.[2] [3]
The Pressure Equipment Regulations (through SANS 347) classifies a typical Gamow bag (based on volume and maximum operating pressure at less than 1.5 ATA) as Category “Not regulated”. The low-pressure fabric hyperbaric chamber thus falls outside of any regulated requirements.[4]
The Diving Regulations specify that all persons exposed to pressures in excess of 100 millibar above ambient pressure (1.1 ATA) are required to conform to the requirements of these regulations, unless the treatment concerns medical conditions (non-diving) and in this case, the facility providing such treatments is required to be accredited by SAUHMA.
SANS 347 Annex A provides a schedule of health and safety standards approved by the Department of Labour. ASME PVHO-1 is listed as an approved safety standard.[5]
The ASME-PVHO-1 standard applies to any pressure vessel that encloses a human within the pressure boundary, with an external or internal pressure exceeding 2 psig above ambient pressure (1.14 atmospheres absolute).
SAUHMA’s approved indications require that treatment pressures given be at a minimum of 2 ATA. At this pressure, the pressure vessel is categorized as a Category III vessel, subject to all the design, construction, testing and certification requirements listed in SANS 347.
Accordingly, SAUHMA requires that all hyperbaric chamber construction is required to satisfy Category III requirements, as a minimum, and shall meet the relevant ASME-PVHO-1 requirements.
The SANS 347 vessel conformity categorization as Not Regulated is not appropriate where human occupancy adds a considerable safety responsibility to any pressure vessel product.
As considered by the UHMS, SAUHMA does not endorse the concept of “In Home” therapy at any time.[6]
Conclusions and Recommendations
- Hyperbaric oxygen therapy is defined as an intervention in which an individual breathes near 100% oxygen while [wholly enclosed] inside a hyperbaric chamber at a pressure equal to or greater than 1.4 ATA.
- SAUHMA approved indications commence at pressures greater or equal to 2 ATA.
- Low-pressure hyperbaric chambers, at pressures equal to or less than 1.4 ATA approved for acute mountain sickness only.
- Mild hyperbaric exposures with air, deliver no more oxygen to the body than breathing oxygen by mask at sea level pressure.
- Exposure to treatment pressures less than 2.0 ATA while breathing air does not meet the SAUHMA definition of therapeutic hyperbaric oxygen therapy and does not achieve the minimum pressure and oxygen levels required for any SAUHMA approved indication.
- All SAUHMA approved indications require that the patient breathe near 100% oxygen while enclosed in a chamber pressurized to a minimum of 2 ATA.
- SAUHMA does not recommend the use of mild hyperbaric therapy for any medical purpose other than acute mountain sickness.
[1] Food and Drug Administration, CFR _Code of Federal Regulations Title 21
[2] National Fire Protection Association, 101 Life Safety Code 2015 edition
[3] National Fire Protection Association, 99 Health Care Facilities Code, 2015 edition
[4] SANS 347: Categorization and conformity assessment criteria for all pressure equipment, 2nd Ed, 2012
[5] ASME PVHO-1, Safety standard for pressure vessels for human occupancy, 2015.
[6] Undersea and Hyperbaric Medical Society Position Statement on the Conduct of Hyperbaric Oxygen Therapy