Statement From The American College Of Hyperbaric Medicine

Position Statement on Hyperbaric Oxygen Chambers for Legislative Use

Issued by:
Tyler Sexton, MD
President, American College of Hyperbaric Medicine

Overview

The American College of Hyperbaric Medicine (ACHM) supports the safe, medically appropriate, and evidence-based practice of hyperbaric oxygen therapy (HBOT). As legislators consider standards for the State of Michigan Hyperbaric Bill, the ACHM submits this position statement to clarify which devices meet accepted clinical, regulatory, and engineering criteria for medical hyperbaric therapy.

The ACHM does not endorse low-pressure, fabric, inflatable, or consumer-grade chambers as medical hyperbaric chambers, nor do we support their inclusion in statutory definitions of HBOT.

Regulatory and Safety Framework

Medical hyperbaric chambers are regulated medical devices and must comply with established engineering and safety standards, including:

FDA device regulations applicable to Class A and B hyperbaric chambers.

NFPA 99 – Health Care Facilities Code and NFPA 101 – Life Safety Code, which govern facility safety, operations, and fire protection requirements.

ASME-PVHO-1 standards, which apply to any human-occupied pressure vessel operating 1.4 ATA (2 psig over ambient) or above and establish minimum engineering, construction, and safety criteria for hyperbaric chambers.

These standards form the foundation for safe medical practice and are essential for patient protection, facility accreditation, and regulatory oversight.

Position of the ACHM on Low-Pressure Soft Chambers

Low-pressure, fabric, inflatable chambers operating below 1.4 ATA are often marketed for sports recovery, wellness, or alternative medicine. ACHM’s position is as follows:

1. Limited FDA Clearance

These soft shell devices hold FDA 510(k) clearance only for Acute Mountain Sickness and are explicitly designed to be compressed with air only.

They are prohibited by the FDA from use with supplemental oxygen.

2. Do Not Meet Medical HBOT Criteria

Medical HBOT requires:

A therapeutic pressure ≥ 1.4 ATA
The patient to breathe near 100% oxygen
A chamber built to medical engineering standards (ASME-PVHO-1)
Medical supervision by qualified personnel.

Soft chambers fail to meet these requirements and cannot deliver the oxygenation levels necessary for any recognized medical indication.

3. Not Designed or Constructed to Medical Standards

Low-pressure inflatable devices:

Are not built to ASME-PVHO-1 standards.
Are not compatible with NFPA 99/101 facility requirements.
Cannot be incorporated into a medically regulated hyperbaric program.

4. No Evidence for Medical Indications

There is no credible clinical evidence that exposure to pressures below 1.4 ATA breathing air provides therapeutic benefit beyond that of simple surface oxygen administration.

5. Impossible to Track or Regulate

Because soft chambers:

Are sold outside clinical environments
Lack standardized manufacturing oversight
Are used off-label for a wide variety of unregulated indications

They are not suitable for inclusion within a state-regulated medical hyperbaric framework.

Definition of Medical Hyperbaric Oxygen Therapy (HBOT)

The ACHM defines medical HBOT as:

A medical intervention in which a patient breathes near 100% oxygen while fully enclosed in a hyperbaric chamber pressurized to ≥ 1.4 ATA, constructed to ASMEPVHO-1 standards, within a facility compliant with NFPA 99/101, and supervised by appropriately trained medical personnel.

ACHM Recommendations:

1. Medical HBOT should be strictly defined as treatment performed in ASME-PVHO-1, FDA 510K compliant hyperbaric chambers CLASS A OR B , that deliver ≥ 1.4 ATA with near 100% oxygen.

2. Low-pressure, fabric, inflatable, or consumer-grade chambers should be explicitly excluded from the definition of HBOT and should not be authorized for clinical use.

3. Only FDA-cleared, medically engineered hyperbaric systems should be recognized for use in licensed hyperbaric facilities.

4. HBOT should be administered only under physician supervision or by trained nonphysician providers operating under appropriate medical direction.

5. Facilities offering hyperbaric services should follow recognized hyperbaric safety codes and pursue national accreditation when applicable.

Conclusion

The ACHM strongly supports legislation that promotes patient safety and ensures that hyperbaric oxygen therapy is delivered only in environments that meet established medical, engineering, and regulatory standards. Low-pressure soft chambers do not meet these criteria, cannot be effectively regulated.

Respectfully submitted,

Tyler Sexton, MD, MAPWCA
President, American College of Hyperbaric Medicine

Since 1983

Physician-Led

Evidence-Based

Statement From The American College Of Hyperbaric Medicine