American College of Hyperbaric Medicine Applauds Canadian Regulatory Action Regarding Unauthorized Soft-Shelled Hyperbaric Chambers

The American College of Hyperbaric Medicine (ACHM) applauds Health Canada for its recent public safety communication concerning unauthorized soft-shelled hyperbaric chambers and the potential health risks associated with devices that do not meet established medical, engineering, and safety standards. ( Unlicensed soft-shelled hyperbaric chambers may pose serious health risks - Canada.ca) 

The ACHM believes this action highlights an increasingly important issue facing patients, healthcare providers, and regulators worldwide: the distinction between medically supervised hyperbaric oxygen therapy delivered in regulated environments and the growing number of devices marketed directly to consumers without sufficient evidence, oversight, or adherence to recognized hyperbaric safety standards.

Hyperbaric oxygen therapy is a medical treatment that requires appropriate patient selection, physician oversight, trained chamber operators, emergency preparedness protocols, and equipment manufactured to rigorous engineering specifications. Accredited hyperbaric facilities utilize chambers that are subject to recognized regulatory and safety requirements, including applicable FDA 510(k) clearances, compliance with Pressure Vessels for Human Occupancy (PVHO) standards, and manufacturing requirements established through ASME and related engineering codes designed to ensure structural integrity and patient safety.

These standards exist for a reason. Hyperbaric chambers are pressure vessels intended for human occupancy and must be designed, tested, maintained, and operated according to strict specifications. Properly regulated systems incorporate extensive safety measures, including fire protection systems, pressure control systems, emergency procedures, maintenance requirements, and operator training that may not be present in unauthorized or unregulated environments.

The ACHM remains concerned that many soft-shelled devices are marketed in a manner that may lead consumers to believe they are receiving the same treatment as that delivered within accredited medical hyperbaric programs. In reality, there are substantial differences in engineering standards, operational oversight, oxygen delivery systems, emergency capabilities, physician supervision, and clinical evidence supporting use.

The College echoes concerns raised internationally regarding:

• Use of chambers lacking appropriate regulatory clearance or authorization.
• Devices not manufactured to recognized PVHO and applicable engineering standards.
• Unsubstantiated medical claims and unsupported therapeutic marketing.
• Potential fire and oxygen-enriched environment hazards.
• Lack of trained hyperbaric personnel and physician oversight.
• Delayed diagnosis and treatment of serious medical conditions.
• Inadequate emergency response capabilities in non-medical settings.
• Patient confusion regarding evidence-based hyperbaric oxygen therapy versus wellness-oriented products.

The ACHM strongly supports the principle that patients deserve accurate information regarding the capabilities, limitations, and safety requirements associated with hyperbaric technologies. Hyperbaric oxygen therapy has demonstrated clinical benefit for specific evidence-based indications when delivered appropriately; however, patient safety must always remain paramount.

The College encourages patients to seek consultation with qualified hyperbaric medicine providers and to receive treatment in facilities that adhere to recognized regulatory, engineering, and clinical standards.

The ACHM also recognizes the efforts of organizations such as the Wound Healing Alliance (WHA) in raising awareness regarding unauthorized hyperbaric devices and promoting evidence-based hyperbaric medicine practices.

As hyperbaric medicine continues to advance, the ACHM supports collaboration among regulatory agencies, manufacturers, clinicians, researchers, and patient advocates to ensure that innovation occurs within a framework that prioritizes safety, scientific evidence, transparency, and patient protection.

Patient safety is not optional. Engineering standards, physician oversight, and evidence-based practice remain the foundation of responsible hyperbaric medicine.

Tyler Sexton, MD, MAPWCA
President
American College of Hyperbaric Medicine (ACHM)

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About the American College of Hyperbaric Medicine

The American College of Hyperbaric Medicine is committed to advancing the science, safety, education, and clinical practice of hyperbaric medicine through physician leadership, evidence-based care, professional collaboration, and patient advocacy.