http://www.mssociety.ca/en/research/CAT010713.htm
Medical Update Memo
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
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.
Multiple Sclerosis Society of Canada
Toll free to reach nearest division
office: 1 800 268-7582
© 2001 Multiple Sclerosis Society
of Canada
JULY 13, 2001
Air or gas embolism
Carbon monoxide poisoning
Smoke inhalation
Gas gangrene
Crush injury 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
250 Bloor Street East, Suite 1000
Toronto, Ontario M4W 3P9
Telephone: (416) 922-6065
Facsimile: (416) 922-7538
Email: info@mssociety.ca