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BCMS – TOGETHER
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Copyright Undersea and Hyperbaric Medical Society (UHMS) Photography.
sures, high oxygen content and the attendant risk
for both fire and explosive decompression. It is
vital that the equipment involved in treatment,
especially the pressure vessel itself, be designed,
manufactured, installed and maintained to the
highest standards. This requires adherence to es-
tablished hyperbaric design and operational stan-
dards provided by the NFPA (National Fire
Protection Association) and the American Soci-
ety of Mechanical Engineers Safety Standards for
Pressure Vessels for Human Occupancy (ASME
PVHO-1). Perhaps, most importantly the cham-
bers should be cleared in accordance with the
Pre-Market Notification Process (FDA 510k) by Class B Monoplace FDA-approved Chamber
the FDA.
Over the past decade or so, “mild hyperbaric”
facilities have proliferated in the U.S. and inter-
nationally. These “mild hyperbaric” centers are
mostly located in Spas, Wellness Centers, and
even shopping center store fronts. They are not
being operated as medical facilities or even doc-
tors’ offices. They frequently operate with mini-
mal or no physician involvement. Staff are often
inadequately trained. Many, if not most, employ
pressure vessels to deliver mild hyperbaric “treat-
ment” that fail to meet the safety standards of the
NFPA or ASME and frequently they are not
FDA cleared. Many use zip-up chambers made of
non-rigid material very much akin to a canvas
Class A Multiplace FDA-approved Chamber. The door is sealed for treatment.
bag. Some of the soft-sided chambers have FDA
clearance for the treatment of acute mountain
sickness but are not cleared for the range of dis-
orders scientifically supported by the UHMS
(Undersea and Hyperbaric Medical Society) and
are not cleared when combined with oxygen.
Even more recently we have seen rigid chambers
manufactured in other countries and exported to
the U.S. in parts and pieces to be assembled. In
this piecemeal fashion, these uncleared chambers
are often not detected by inspectors and pass into
the country to be used without FDA awareness.
Standard, main stream hyperbaric medicine re-
quires treatment most often at ambient pressures
of 2.0 to 3.0 ATA (atmospheres absolute) with This photo shows a soft-sided chamber typical of chamber used for “mild hyperbarics.” This
oxygen delivery at those pressures exceeding 95% type of chamber can only be approved by the FDA for the treatment of mountain sickness.
of the breathing gas mix. The “mild” hyperbaric The photo also shows an oxygen concentrator which is not approved for usage with hyperbaric
treatments.
facilities typically treat their patients - more prop-
continued on page 20
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