News Release
2003-69
September 5, 2003
For immediate release
Minister McLellan welcomes National Standards for Cells, Tissues and Organs for Transplantation and Assisted Reproduction
OTTAWA - The Honourable Anne McLellan, Minister of Health, today congratulated
the Canadian Standards Association (CSA) for its hard work in developing the National Standards
for Cells, Tissues and Organs for Transplantation and Assisted Reproduction announced yesterday.
"The CSA standards will help promote both the harmonization of safety practices for transplantation
across the country, and the safety of transplant patients - both donors and recipients," said
Minister McLellan. "I would like to thank the Canadian Standards Association for its work,
and acknowledge the role that the various stakeholders, including Canadian experts in the
field of transplantation, have played in the development of the Standards."
Health Canada contracted the Canadian Standards Association in 2000 to formalize National
Standards for cells, tissues and organs in response to the National Consensus Conference
of 1995 and the 1999 House of Commons Standing Committee on Health report entitled Organ
and Tissue Donation and Transplantation. The new CSA standards are based on a set
of draft standards that were initially developed by a working group of experts in the field
of transplantation and assisted reproduction, a group that was actively supported by Health
Canada.
The standards set out minimum safety requirements in the field of transplantation. These
requirements are in respect to donor selection, cell, tissue or organ collection, processing,
packaging, testing, labelling, storage and recall. They also deal with record keeping,
adverse event reporting and lookback/traceback. The CSA Standards will help establish and
maintain safe practices and serve as the basis of a modern, flexible regulatory framework.
Health Canada will use the standards as one of several tools in the development of new
federal health regulations for cells, tissues and organ safety. Health Canada has made
significant progress in the development of the regulatory framework. The first phase of
the framework, addressing cell, tissue and organ safety, will be published in Fall, 2003
for comment. The full framework, addressing safety, compliance and enforcement and adverse
event reporting is targeted for implementation by Spring 2005.
In January, 2003, Health Canada developed a Directive and associated Guidance Document
for establishments involved in cell, tissue and organ processing, to provide interim guidance
until the standards were published. The Directive and Guidance Document, which were distributed
to approximately 1200 clinics, hospitals, physicians and other stakeholders, identified
the key safety components of the pending CSA standards.
On August 5, 2003, Health Canada issued a Notice to Stakeholders that included transplant
establishments, clinics and physicians to inform them of the intended new regulatory framework
and the release of the standards.
Health Canada is currently conducting a national review of establishments that collect,
process and distribute cells, tissues and organs, to determine their level of compliance
with the Guidance Directives. Should there be an issue of non-compliance, Health Canada
will take appropriate actions to address the issue, to ensure the safety of the cells,
tissues or organ products used in Canada.
As part of its mandate under the National Standards System of Canada, the CSA consulted
extensively with stakeholders during the development of the standards, including physicians,
consumers, manufacturers, regulatory authorities and the provinces and territories. The
standards were also made available for a public review period, during which comments and
suggestions for changes from any interested party were welcome. The standards are available
through the CSA, at the following web site:  www.csa.ca
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Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2988
Alex Swann
Office of Anne McLellan
Minister of Health
(613)946-3890
Public Inquiries:
(613) 957-2991
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