The answer is as follows:
a) On October 9, 2002, Health Canada received information that the Vancouver St. Paul's Hospital B.C. Ear Bank, under the responsibility of Providence Health Care, may have been processing and distributing tissues which do not meet basic safety requirements. Providence Health Care is a legal entity providing health care services on eight sites in Vancouver, B.C.
b) A question period note was provided to the minister’s office on December 17, 2002.
c) Under its authority, Health Canada asked St. Paul's Hospital to recall the products and to notify the physicians who have used tissues from the Ear Bank in transplantation. St. Paul's Hospital complied. On February 19, 2003, Health Canada notified acute care hospitals, tissue banks and health professionals across the country of the situation in the B.C. Ear Bank and has recommended that recipients of tissue from the bank be tested for infectious diseases, as a precautionary measure.
d) On October 9, 2002, Health Canada received information that the Ear Bank may have been processing and distributing tissues which do not meet basic safety requirements, and that the distribution of tissues had been discontinued. Within 24 hours, Health Canada acted on the information received and subsequently initiated an investigation. As part of its investigation, Health Canada obtained from the Ear Bank information on their processing and distribution activities. Due to poor record-keeping, Providence Health Care provided most of the requested information in January 2003. Based on this information, Health Canada immediately undertook a risk assessment. This Health Canada risk assessment was completed on February 5, 2003.
On February 7, 2003, based on its risk assessment, Health Canada asked St. Paul's Hospital to mitigate the risk that may be posed by the tissues by recalling the unused tissues and notifying the physicians who have used tissue from the Ear Bank in transplantation. On February 14, 2003, St. Paul's Hospital complied. On February 19, 2003, Health Canada advised all establishments and individuals in Canada handling and/or processing human cells, tissues and organs for transplantation. Health Canada’s investigation is still on-going at St. Paul’s Hospital.
e) Moreover, Health Canada has published three additional documents respecting tissue and organ safety: Guidelines for Organ and Tissue Donation Services in Hospitals; Guideline for the Prevention of HIV infection in Organ and Tissue Transplantation; and Guidelines for Basic Safety Requirements for Human Cells, Tissues and Organs for Transplantation.
Health Canada also developed and published the standard Technical Requirements for Therapeutic Donor Insemination, which is required, by regulation, to be followed by processors of donor semen for assisted conception.
There are currently many sets of standards available to tissue banks in Canada. The American Association of Tissue Banks Standards for Tissue Banking, the Eye Bank Association of America Standards and the Foundation for the Accreditation of Hematopoietic Cell Therapies Standards provide comprehensive information on safety requirements for specific tissue types and are used internationally. These three organizations also provide accreditation services at the international level. Many tissue banks in Canada are accredited by one of these organizations.
On January 28 and 29, 2003, Health Canada issued a directive entitled Technical Requirements to address the Safety of Cells, Tissues and Organs for Transplantation (directive and guidance Document) and its corresponding guidance document entitled Basic Safety Requirements for Human Cells, Tissues and Organs for Transplantation to establishments and individuals in Canada who are involved in the handling and/or processing of human cells, tissues and organs for transplantation.
The purpose of the directive and guidance document is to advise these establishments and individuals of the importance of adhering to basic standards of safety with respect to the manufacture and use of these products for transplantation. These documents are based on the content of the National Safety Standards being developed by the Canadian Standards Association in consultation with medical experts from the field of transplantation and Health Canada. These are minimum standards that should be met by all establishments and individuals in Canada who are involved in the handling and/or processing of human cells, tissues and organs for transplantation in order to minimize the risk of disease.
f) Safety standards for Canada are available and have been communicated to stakeholders. In 1996, Health Canada appointed and funded a working group of experts in the field of tissue and organ transplantation to develop a set of standards for the safety of tissues and organs which would encompass all of the requirements of the documents referenced above and address any additional Canadian specific requirements. A General Standard on the Safety of Cells, Tissues and Organs, and five separate standards for specific tissue types were completed by this group of experts in 2001. Health Canada subsequently funded the Canadian Standards Association (CSA) to transform these six sets of standards into National Standards as recognized by the Standards Council of Canada. CSA has completed these standards in December 2002, and it is expected that the national standards will be published in the spring of 2003. These national standards will be maintained by the CSA under the terms of an agreement with Health Canada, to reflect new technological or safety issues which may arise in the future.
g) There was no prior Health Canada inspection of the B.C. Ear Bank. It is important to note that in Canada, the primary responsibility related to product safety lies with the manufacturer which is in this case, the tissue bank/hospital.
Health Canada has an important role in protecting the health and safety of Canadians; however, it is but one component of a complex system of health protection, which includes, among others, various levels of government, government agencies, the health care and medical professions, the academic and health sciences research and development communities, manufacturers and importers, patient groups, and individual Canadians.
Where Health Canada identifies or is notified of a potential problem, Health Canada will take steps to determine whether non-compliance has occurred.
h) Health Canada is conducting a national review of all establishments handling and/or processing human cells, tissues and organs for transplantation with the objective of assessing adherence to basic safety standards and to take appropriate action to prohibit the distribution of unsafe products. Health Canada will initiate investigations upon receipt of information of situations where cells, tissues, and organs may not have been handled and/or processed in accordance to basic safety standards.
In general, problems may be identified by consumer complaints, industry complaints, referrals from other provincial and federal regulatory agencies, international partners or Health Canada's compliance monitoring program. Investigations may also be triggered by the identification of problems via other Health Canada organisational units and various post-market surveillance programs.
Also see f) above.
i) Please see h) above.