The
FDA's primary interest in oxygen as a drug, as that interest affects hyperbaric
facilities, is in the claims that are made for its effectiveness. At this time, the FDA recognizes the 13
indications for HBO that are defined in the UHMS document: "Hyperbaric Oxygen Therapy: A Committee
Report" (UHMS HBO Report). Claims, especially in advertising, that a
hyperbaric service can treat other conditions can leave it open to a visit by
FDA investigators. This isn't a
"black & white" issue, and the FDA doesn't normally get involved
unless someone files a complaint, there is an accident or an apparently
non-compliant situation somehow comes to his or her attention. The FDA typically does not try to regulate
standard medical practice. However, if
a facility is claiming it can treat conditions not listed in the UHMS HBO
Report as accepted indications, it should be prepared to explain its reasons
for doing so, if challenged.
Hyperbaric
chambers are used to administer hyperbaric oxygen, therefore, hyperbaric
chambers and certain related accessories are considered by the FDA to be
medical devices. Consequently, they are
subject to FDA controls that apply to all medical devices entered into
commercial distribution after May 28, 1976.
Hyperbaric chambers and other medical devices built prior to that date
or in continuous production since before that date are not subject to FDA
controls.
The
medical device rules apply to manufacturers and organizations that refurbish/recondition
medical equipment. They do not apply to
the users of medical equipment so long as those users are not modifying the
equipment. The rules address the
design, manufacturing, labeling and marketing of the products. Manufacturers are also required to have
established procedures for tracking and responding to complaints from
users.
Medical
devices are divided by the FDA into three classes with differing levels of FDA
involvement:
Class
I: General Controls: These are simple devices where performance is not much of a concern,
such as tongue depressors. The FDA's
oversight controls are generally limited to labeling, manufacturing QA,
records, inspections, etc. Pre-market
Notification (notification of intention to market the device) to the FDA is
required under Section 510(k) of the Safe Medical Device Amendments enacted in
1976. FDA clearance of the Pre-Market
Notification (hence the term 510(K) clearance) is required prior to marketing
the device or placing it in commercial distribution.
Class
II: Special Controls: These are complex devices where performance is a concern, but at a
somewhat general level. Class II
devices must comply with general controls and the requirements of some
applicable standard. A 510(k)
Pre-market Notification to the FDA is required. FDA clearance of the Pre-Market Notification is required prior to
marketing the device or placing it in commercial distribution.
Class
III: Pre-market Approval: These are generally devices that are directly related to patient life
support with a substantial risk of injury in the event of malfunction. An example is a cardiac pacemaker. Pre-market approval by the FDA is required. The related design and manufacturing
controls are very strict.
Hyperbaric
chambers are generally treated as Class II devices. The "applicable standard" requirement is taken to be
the applicable industry consensus standards, primarily NFPA 99, Chapter 19
"Hyperbaric Facilities" and ASME PVHO-1, "Safety Standard for
Pressure Vessels for Human Occupancy".
All
Classes of medical devices are subject to the FDA's Good Manufacturing
Practice (GMP) regulations. The FDA GMP rules are very similar to
international quality assurance regulations (ISO 9000, ISO 9001, etc.) that have come into widespread use in recent
years. The main requirements are: