Good morning. My name is Suzanne Kiraly, and I am the president of the Canadian Standards Association, or CSA.
I am here today to describe CSA's role in the development and maintenance of Canada's national standards for cells, tissues, and organs for transplantation.
CSA is an independent, not-for-profit, member-based association that serves business, industry, government, and consumers in Canada and around the world. Established in 1919, CSA is one of four organizations accredited by the Government of Canada to develop national standards. Our organization maintains more than 3,000 standards, codes, and information products for safety, design, and performance in a wide range of areas, including health care, the environment, and public safety. We have been developing health care standards for more than 40 years.
As a standards development organization, CSA functions as a neutral third party, providing a forum for committees of experts to work within a rigorous and accredited process. Our technical committees are created using a balanced approach that capitalizes on the combined strength and ensures that no single group dominates. The technical committee that developed the transplantation standards included health care professionals; regulators; general interest members, including a transplant recipient; and an expert on ethics.
When a draft standard has been completed, it is submitted for public review so that any interested person or organization can comment. The draft is amended if necessary and then submitted to committee for formal approval.
Once a standard is published, CSA continues to maintain it and will make amendments as needed to keep it current. Each standard is reviewed at least every five years.
CSA is not a government body and does not have the power to make a standard mandatory. A standard becomes law only if a federal, provincial, or municipal government references it in legislation. For the transplantation standards, Health Canada has referenced specific sections in its new regulations, making those sections mandatory.
Specifically, CSA began its work on these standards for cells, tissues, and organs in transplantation in 2000, at the request of Health Canada. In early 2002, the draft standards were posted on the Internet for public review, and over 1,000 comments were received. The standards were completed in early 2003, and they were approved as national standards by the government.
These standards were created to enhance safety and effectiveness for donors and recipients and health care personnel. They represent the best efforts of the leading experts in Canada, drawing on the combined knowledge and best practices of the top national and international organizations in this area.
The series consists of a general standard that applies to all cells, tissues, and organs, and five additional standards that provide requirements for specific types of transplant materials. These standards set minimum requirements for organizations or individuals involved in all aspects of transplantation. These standards are designed to provide a common management framework. Organizations can use them to develop their policies and procedures, hire and train staff, and manage their operations. The goal is for everyone involved in transplantation to safely manage their responsibilities in a consistent and organized way.
CSA standards are revised to address changing requirements and respond to emerging technologies. The technical committee is currently reviewing the documents, and new editions are slated for 2009. We are committed to maintaining and improving the standards to keep them relevant. We welcome comments and suggestions on the standards from all interested organizations and individuals.
Thank you.