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Monthly Briefing May 2023

Most if not all readers will be aware of the upsurge in sales and promotion of hyperbaric chambers directed at non-hospital affiliated clinics, wellness centers and private home use. While several such clinics appear somewhat aligned with accepted clinical standards and FDA adherence, the vast majority are not. This latter category commonly employs the inflatable low pressure chamber. They are not built in compliance with prevailing design, construction, and installation standards, yet their manufacture and promotion continue unchecked, at least in the USA. North of the border the Canadian government recently banned their importation, marketing, sales, and use, making it a crime to do otherwise.

An increasing number of individuals and clinics have acquired small steel chambers capable of higher pressures. They are commonly manufactured overseas and likewise fall short of prevailing design and manufacturing codes and standards. To get these non-complaint chambers into the USA requires shipping agents to falsify their true nature to circumvent otherwise mandatory Customs inspections. I am presently looking at one such Bill of Lading that lists the commodity as “Stainless Steel Tank”. It was shipped from Shanghai, China to a certain hyperbaric clinic in California and slipped though the inspection process as intended.

Similar small steel single and dual person chambers are also produced in the USA. One manufacturer promotes them directly for lay person in-home use, noting that these are essentially “Do it Yourself” chambers with “controls located from inside only” on one version. The lay person selects size, occupant capacity, and what pressure relief valve to use, with ten to choose from! “Included is everything you will need to start your treatment protocol right from your own home except commercial oxygen ‘K’ size tanks that can be rented from your local supply house”. Earlier this week (today is May 25) one of this company’s chambers suffered an uncontrolled loss of pressure following an acrylic window failure. One occupant suffered pulmonary barotrauma with resulting pneumothorax, another suffered a ruptured tympanic membrane. It could have been much worse.

I’ll leave it to the FDA and others to hopefully address compliance and clinical futility, given many wholly unsupported claims of therapeutic effectiveness. Most concerning to me, beyond taking advantage of the gullible and the vain, is the issue of safety. Safety of unsuspecting (little in the way of meaningful informed consent) chamber occupants. Safety of those in proximity to these chambers. Operator (occasionally the patient themselves) training is clearly suspect. Issues related to the handling of HP oxygen cylinders, oxygen concentrators, managing oxygen system cleanliness and ability to monitor the chamber’s atmosphere are clearly concerning. So, too, issues related to maintaining and servicing these chambers.

Dick Clarke, President

National Board of Diving & Hyperbaric Medical Technology


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Updated April 20, 2023