Low-pressure fabric hyperbaric chambers

Abstract

Low-pressure fabric hyperbaric chambers To the Editor: The Southern African Underwater and Hyperbaric Medical Association (SAUHMA) has released a position statement on low-pressure fabric hyperbaric chambers. [1] The purpose of this statement is to raise awareness about the inappropriate use of lowpressure hyperbaric chambers and potential financial exploitation of members of the public, and it forms part of SAUHMA's strategy to advocate for evidence-based hyperbaric oxygen therapy. The low-pressure fabric hyperbaric chambers (operating at <1.4 atmosphere absolute (ATA)) marketed for sports and alternative medicine have US Food and 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. [2] In South Africa there have been no Medicines Control Council review or cautionary statements, or concerns raised by the Department of Labour, at this stage. SAUHMA has approached the National Department of Health in an attempt to formally regulate hyperbaric oxygen therapy, and in the meantime has taken on the task of self-regulating. A strict hyperbaric facility accreditation system has been set in place to ensure patient safety. The internationally recognised National Fire Protection Association (NFPA) 101 Life Safety Code and NFPA 99 Health Care Facilities Code describe the requirements for the construction, operation and maintenance of hyperbaric facilities. [3,4] The Pressure Equipment Regulations (through South African National Standard (SANS) 347) classify a typical Gamow bag (based on volume and maximum operating pressure at <1.5 ATA) as category 'not regulated'. [5] The low-pressure fabric hyperbaric chamber therefore falls outside of any regulated requirements. The Occupational Health and Safety Act No. 85 of 1993: Diving Regulations 2009, [6] promulgated in January 2010, specifies 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), in which 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 (American Society of Mechanical Engineers) PVHO-1 is listed as an approved safety standard. [7] 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 ATA). SAUHMA's approved indications require that treatment pressures given be at a minimum of 2 ATA. At this pressure, the pressure vessel is categorised 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 ...

Hyperbaric Oxygen therapy and anti-aging Practice and Protocols

“…Hyperbaric oxygen therapy (HBOT) involves exposing the body to an environment with pressures greater than one absolute atmosphere (ATA) while breathing 100% oxygen [14,15]. It has evolved into a firmly established therapeutic approach for numerous medical conditions.…”