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  • Writer's picturepaul watts

Hyperbaric Regulations Update: (NFPA) Technical Conference Outcome

Since the availability of mild Hyperbaric Oxygen chambers has become much more prevalent over the recent decade, many companies have entered the market to provide seekers of this amazing therapy with the tools to utilize its properties of Pressure and Oxygen to achieve their wellness goals. Very recently a large mild Hyperbaric Oxygen Therapy (mHBOT) organization has attempted to establish a separate section of the NFPA 99 Chapter 14 to address the regulation and oversight of mHBOT chambers. They attended the NFPA technical conference along with their law firm and political lobbying group.

What follows is an overview provided by the National Board of Diving & Hyperbaric Medical Technology concerning the outcome of the meeting:

Monthly NBDHMT Briefing July 2023

There has been increased discussion in the past couple of years regarding soft-sided/inflatable low pressure chambers, much of it directed at, and within, the NFPA Technical Committee on Hyperbaric and Hypobaric Facilities. This chamber type contrasts with the soft-sided higher pressure SOS Hyperlite chamber that is designed and manufactured in full compliance with ASME-PVHO standards. There are some who argue, incorrectly, that NFPA 99 does not address low-pressure chambers so new language is required to bring them into compliance. It’s important to emphasize here that NFPA standards exist for all monoplace chambers. NFPA 99 does not distinguish chamber design, fabrication materials, intended operating pressure, or compression gas. NPFA states quite simply that they are all “Class B-Human, single occupancy”. In terms of design and manufacture, ASME to its credit did not cave to threats to promptly approve these chambers or face legal action. ASME advised soft-sided low pressure chamber advocates that a code case process exists to apply for manufacturing approval. As noted above, ASME has already approved such a code case. There is another disturbing feature regarding low-pressure chambers worthy of note. Many who market and operate them incorporate an oxygen concentrator, in violation of the FDA. Approximately 95% oxygen is, therefore, introduced to a chamber occupant’s face mask or nasal cannula. Proponents argue their data indicates the chamber’s atmosphere never exceeded 23.5% during testing. Simple gas flow physics dictates, however, that somewhere near the oxygen delivery device values must be considerably higher, so by definition, therefore, an oxygen rich atmosphere. It’s all a matter of where one chooses to place the sample line’s internal take-off point. Two recent (2023) pressure vessel structural failures, causing serious injuries in Utah and five fatalities in the North Atlantic, should serve as an object lesson for why manufacturing codes and standards exist. In many cases these codes and standards are rooted in disasters past, so responsible individuals and organizations should be arguing for not against them. Dick Clarke, President National Board of Diving & Hyperbaric Medical Technology

In summary, every company that markets a mHBOT chamber system has to comply with established design and safety regulations in order to comply with Federal regulations. Currently, there is only one. That system is the Hyperlite, which is utilized by several militaries around the world and many commercial diving companies. The additional portion addressing the enriched oxygen environment is also a matter of great concern, due to the increased risks to those utilizing the mHBOT chambers. As stated in the position, NONE of the current commercial mHBOT systems besides the Hyperlite, are designed to utilize 100% oxygen under increased pressure. So, those commercial systems are out of compliance with the NFPA 99 Chapter 14. Hence, ILLEGAL for human utilization.


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