Subject : In response to your correspondence to the Minister of Health - 07-000404 EH
Date : Tue, 6 Mar 2007 14:29:00 -0500
Linked to : Tony Clement
From : CST <cst@hc-sc.gc.ca>
To : <danpage@planetoxygen.ca>
Cc : <Verner.J@parl.gc.ca>

Dear Mr. Page and Dr. Stoller:

Thank you for your correspondence of January 15, 2007,
concerning hyperbaric therapy for children. The offices of the Prime
Minister and of the Honourable Josée Verner, Minister of International
Cooperation and Minister for La Francophonie and Official Languages, have
also written on your behalf.

In response to your statement that Health Canada has been
harassing representatives, manufacturers, potential customers, parents of
children with autism and licensed physicians through the Quebec College of
Physicians for the past six years, and your contention that many of them
have been using portable chambers in their private clinics or homes, or may
simply be promoting the benefits of hyperbaric therapy, I would like to
inform you that the role of Health Canada’s Health Products and Food Branch Inspectorate is to ensure that the regulated parties comply with all
applicable regulatory requirements, including device licensing. Where the
Inspectorate identifies or is notified of a potential non-compliance, steps
are taken to verify compliance and further action may be requested of the
non-compliant party. Rest assured that, in all cases, compliance and
enforcement actions taken by Health Canada are carried out in a fair and
consistent manner.

With respect to your assertion that the Department is obstructing the certification process of portable hyperbaric chambers, I disagree with this statement. Health Canada’s mandate is to help the people of Canada maintain and improve their health, while respecting individual choices and circumstances. The Department works under the authority of the Food and Drugs Act, and in the case of medical devices, including hyperbaric chambers, the Medical Devices Regulations. Under the Regulations, a manufacturer must apply for a medical device licence to legally sell such devices. The submission must provide detailed scientific evidence of safety and effectiveness that will be evaluated by Health Canada. If the information submitted meets the safety and effectiveness requirements of the Regulations, a licence will be issued for that device.

The portable chambers that you mention are all unlicensed in Canada and, as
such, their sale or use would contravene the Regulations.

You should be aware that the classification scheme for medical devices used in Canada, as well as in Europe and Australia, is not the same as the one used in the United States. The level of review, however, is similar for these types of medical devices. In the U.S., many Class II devices are reviewed in a similar manner to Health Canada’s Class III designation with regard to risk. In Canada, all hyperbaric chambers are classified as Class III devices. Manufacturers of these licensed devices can submit appropriately documented scientific evidence which demonstrates that these hyperbaric chambers are effective for the treatment of autism.

Among the many criteria that Health Canada recognizes to license new
hyperbaric chambers are the 13 internationally recognized indications for
use of the Undersea and Hyperbaric Medical Society (UHMS).

Currently, the treatment of autism in hyperbaric chambers has not been proven scientifically. Information contained in non-peer reviewed scientific articles not subjected to a rigorous scientific review or anecdotal evidence is not sufficient as proof of safety and effectiveness; therefore, Health Canada cannot consider this indication for use under a licence for a hyperbaric chamber. If the manufacturers of the chambers you refer to apply for medical device licences and submit the appropriate data supporting this indication, Health Canada would review it.

You also state that the risk associated with hyperbaric chambers is relevant only to hard shell chambers that utilize pure oxygen at much higher pressures. You assume that these portable chambers use very low pressure and compressed room air and do not present significant risks.
Without reviewing the evidence provided by a manufacturer, Health Canada
cannot agree with your conclusions. It should also be clarified that these
portable chambers have not been demonstrated to comply with any recognized safety standards, such as the National Fire Protection Association. It is also known that these portable chambers are being utilized with oxygen
concentrators (which are sold separately), and that this combination
presents a significant fire risk to the user.
You refer to testimonials by professional athletes who claim to use these devices as further evidence of their benefits. Again, the advertisements are simply anecdotal stories that do not provide any scientific evidence as to the product’s safety and effectiveness.
Furthermore, these may simply be paid endorsements.

The information that is contained in Health Canada’s It’s Your
Health and posted on its website is correct and up-to-date. The document
is based on internationally accepted published scientific data. Until the
UHMS decides to include the treatment of autism and cerebral palsy as
further indications, and/or manufacturers of hyperbaric chambers request to
include it as an indication for use, supported by scientific data, Health
Canada will not be in a position to license the chambers for this
indication. If you believe you have the required evidence to support the
addition of treatment of autism and cerebral palsy as an indication for use
for hyperbaric chambers, I encourage you to lobby the manufacturer to
include it in its licence application. You may also wish to lobby the UHMS
by addressing your concerns to Dr. Laurie Gesell, Chairperson, UHMS
Hyperbaric Oxygen Therapy Committee by telephone at: (513) 558-5281, or by
e-mail at: Laurie.Gesell@uc.edu, and to Mr. Tom Workman, Director, Quality
Assurance and Regulatory Affairs, UHMS Satellite Office, 18111 Copper Ridge
Drive, San Antonio, Texas U.S.A. 78259-3612l; by telephone at: +1(210)
404-1553; by facsimile at:+1(210) 404-1535; or by e-mail at:
Uhmsqara@aol.com.

Thank you for writing.

Yours sincerely,

Tony Clement

c.c. Office of the Honourable Josée Verner, P.C., M.P.