Health Canada Clarifies requirements
Applying to Hyperbaric Oxygen Chambers and Notes No Evidence
Supporting Usefulness in MS
Medical Update Memo
JULY 13, 2001
Summary
Health Canada has issued a bulletin clarifying the legal requirements
governing the importation, sale and use of hyperbaric oxygen
(HBO) treatment facilities. The bulletin also states that Health
Canada has not received any conclusive information to support
the use of HBO chambers to treat any neurological conditions
such as multiple sclerosis, cerebral palsy or migraine. There
have been claims for a number of years that breathing oxygen
under increased pressure in an HBO chamber improves the signs
and symptoms of MS. However, according to the new publication
Multiple Sclerosis: The Guide to Treatment and Management, six
separate controlled double-blind studies found no positive effect
on any objective outcome measure of the disease process.
Details
Health Canada has issued a bulletin clarifying the legal
requirements governing the importation, sale and use of hyperbaric
oxygen (HBO) treatment facilities. The bulletin notes that HBO
chambers are Class 3 medical devices and to legally sell an
HBO chamber in Canada, the manufacturer must obtain a medical
device licence from Health Canada.
The bulletin also states that Health Canada
has not received any conclusive information to support the use
of HBO chambers to treat any neurological conditions such as
multiple sclerosis, cerebral palsy or migraine. Because of the
lack of scientific information, HBO chambers are not licensed
for treatment of these conditions.
The use of HBO chambers and other medical
devices for investigative purposes is permitted as long as research
is carried out in an ethical and controlled manner by qualified
investigators. Health Canada investigational use provisions
require submission by the manufacturer of a risk analysis, an
acceptable study protocol, informed patient consent forms and
evidence of ethics committee approval.
Health Canada recognized uses
HBO therapy is allowed to be used for medical conditions where
there is reliable scientific evidence of effectiveness. Such
conditions include:
- Decompression sickness
- Air or gas embolism
- Carbon monoxide poisoning
- Smoke inhalation
- Gas gangrene
- Crush injury
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- Acute traumatic ischemia (reduction
in blood supply to a part of the body)
- Burns
- Radiation damage
- Severe anemia
- Some kinds of serious or
chronic infection
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MS and HBO treatments
There have been claims for a number of years that breathing
oxygen under increased pressure in an HBO chamber improves the
signs and symptoms of MS. However, according to the new publication
Multiple Sclerosis: The Guide to Treatment and Management, six
separate controlled double-blind studies found no positive effect
on any objective outcome measure of the disease process. The
single exception was minimal bladder improvement in some participants.
The studies took place in the United States, Canada, Great Britain
and the Netherlands and used a variety of assessments including
magnetic resonance imaging, laboratory procedures and clinical
examination. There are risks to HBO therapy including blindness,
seizures and lung problems.
Disclaimer
The Multiple Sclerosis Society of Canada is an independent,
voluntary health agency and does not approve, endorse or recommend
any specific product or therapy but provides information to
assist individuals in making their own decisions.
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