PUBLICATION COPY
"TECH TALK" Column
for Spring 1997 issue of TRIAGE
Quarterly Journal of the
National Board of Diving and Hyperbaric Medical
Technology
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Editor: S. D. Reimers, PE
TechTalk
is a regular column providing original information and responses to questions
from readers in the areas of hyperbaric equipment and technology.
Of
all of the organizations that have something to say about hyperbaric equipment
and the operations there are two that have very real teeth - the local Fire
Marshall's office and the Food and Drug Administration (FDA). The relevance of the NFPA 99 "Standard
for Health Care Facilities" to hyperbaric facilities and the role of the
local Fire Marshall's office in enforcing its
requirements
are generally well appreciated, although
not always well understood. The FDA's role is even less well
understood.
The
Food and Drug Administration (FDA) has what could be called a
"background" role in modern clinical hyperbarics. It is generally out of sight, but ALWAYS
there. With the accelerating expansion
of clinical hyperbarics into mainstream medicine, the FDA's role is becoming
more important. It is also becoming
more visible with encouragement from both the NFPA Committee on Hyperbaric and
Hyperbaric Facilities and the ASME Safety Code Committee on Pressure Vessels
for Human Occupancy (PVHO). Both
Committees have invited the FDA to send a representative to participate in the
Committee's work.
So
what is the role of the FDA?
With
respect to hyperbarics, the FDA's scope of authority breaks down into two
areas:
Drugs:
Safety, Effectiveness, Labeling
Medical Devices: Safety, Effectiveness,
Labeling
The
FDA classifies oxygen as drug.
Therefore, both its application and the devices used to administer it
fall under the FDA's jurisdiction.
As
a drug, oxygen can be administered only on the order of a physician. The classification of oxygen as a drug
creates some situations that could be used to make a good political
cartoon. Clearly, oxygen used under
hyperbaric conditions for wound healing purposes is a "drug" in the
true sense of the word. However, the
same oxygen partial pressure occurring in compressed air
or
enriched air diving, or in oxygen breathing during decompression is not of
interest to the FDA. The many
facets, and there are many, of regulating the use of oxygen as a drug may be
the subject of a future column.