Health Canada's National Review of Establishments Involved in the Handling and/or Processing of Cells, Tissues and Organs for Transplantation

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Q1: What is the the National Review?

The National Review is a Health Canada initiative, which began in March 2003, to assess the compliance of Canadian establishments that handle and/or process cells, tissues and organs for transplantation with basic safety requirements. These requirements are set out in Health Canada's Directive, Technical Requirements to Address the Safety of Cells, Tissues and Organs for Transplantation (Directive), and its corresponding Guidance Document, Basic Safety Requirements for Human Cells, Tissues and Organs for Transplantation (Guidance Document). The Health Canada Directive and Guidance Document are available at:
http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/cto_directive-eng.php

The National Review consists of two stages: a documentation assessment stage and a compliance inspection stage. As part of the compliance inspection stage, Health Canada is inspecting establishments to verify their compliance with four critical elements: donor suitability assessment; serological testing; bacteriological testing; and sterilization.

Q2: What is Health Canada's role in the safety of cells, tissues and organs?

Health Canada is the national authority that regulates the safety, effectiveness and quality of therapeutic products, including cells, tissues and organs, in Canada. Health Canada works with provincial and territorial governments, other regulatory agencies, trade associations, health professionals and their associations, and consumers and their associations to fulfill its mandate for helping Canadians maintain and improve their health.

Health Canada derives its statutory authority for safety and risk management primarily from the Food and Drugs Act and Regulations. Where evidence shows that cells, tissues and organs have not been processed in accordance with basic safety requirements, Health Canada will exercise its authority under the Food and Drugs Act to prohibit the distribution on these products.

Q3: What have Health Canada's inspections uncovered to date?

The inspections conducted to date have uncovered some deficiencies in the area of donor screening. As with all biological products, there is always a small risk of contracting infectious diseases even after appropriate screening and testing have been done. Inadequate screening and/or testing of donors could result in an increased risk of disease transmission. Based on the deficiencies identified, Health Canada requested that six establishments quarantine their available inventory of cells and tissues to eliminate any risks to patients. However, Health Canada determined that the risks to the health of patients were very low.

Q4: What is Health Canada doing about the cells and tissues that have been quarantined?

Health Canada has performed a risk assessment on the donor screening deficiencies that were identified during the compliance inspections and that led to the quarantining of cell and tissue inventories. Based on this risk assessment, Health Canada has determined that, in most cases, the establishments in question may be able to release their inventory, on the condition that they applied other donor screening criteria, such as asking general health questions that would lead to the detection of the relevant risk factor. On June 30, 2005, Health Canada informed these establishments of the findings of this risk assessment.

In a few cases where establishments are not able to release cells and tissues from quarantine based on Health Canada's risk assessment, they may still be able to release quarantined inventory by re-qualifying the donor or by meeting the exceptional release criteria as described in section 7.2 of the Guidance Document.

Q5: What happens if Health Canada finds deficiencies in future inspections?

As with previous inspections, if deficiencies identified during a compliance inspection suggest that cells and tissues pose a serious risk of being unsafe because they are not being processed in accordance with the the Guidance Document, then the establishment in question will be viewed as not being compliant with the Food and Drugs Act. As a result, Health Canada will conduct risk assessments as required, and during this time, Health Canada may request that the implicated cells and tissues in inventory be quarantined as a precautionary measure.

Q6: Should transplant recipients be concerned?

Based on the results of the inspections conducted to date, Health Canada determined that the risks to the health of patients were very low. However, if anyone has concerns, Health Canada recommends they consult with their physicians to determine the possibility of any risk to their health and discuss what measures, if any, need to be taken.

Q7: Is Health Canada aware of any disease transmission resulting from the transplantation of cells, tissues or organs from any inspected establishments?

No, Health Canada has not been made aware of any disease transmission from cells and tissues processed and distributed by any of the establishments inspected.

Q8: Is the donation and transplantation system for cells, tissues and organs in Canada safe?

Canada's donation and transplantation system for cells, tissues and organs involves many people, professionals, services, functions and levels of government. Health Canada, along with all involved parties, are working to make Canada's donation and transplantation system as safe as possible.

Q9: What has Health Canada done to help make the donation and transplantation system in Canada as safe as possible?

In December 2000, Health Canada signed an agreement with the Canadian Standards Association (CSA) whereby the CSA, in consultation with stakeholders, would formalise safety standards for cells, tissues and organs for transplantation. The need for national standards was supported by all stakeholders - physicians, patient groups and other health care professionals - at the National Consensus Conference on Safety of Organs and Tissues for Transplantation, October 29-31, 1995, organized by Health Canada. The development of the national standards also follows recommendations in the 1997 Krever report on blood safety.

The national standards guide physicians, hospitals and the provinces in their areas of responsibility. The National Standards for Cells, Tissues and Organs for Transplantation and Assisted Reproduction are available through the Canadian Standards Association at the following website.

In January 2003, Health Canada issued the Directive and Guidance Document to all establishments and individuals in Canada that handle and/or process human cells, tissues and organs for transplantation. The intent of the documents issued is to advise these establishments and individuals of the importance of adhering to the basic safety requirements, as outlined in the Guidance Document.

In March 2003, Health Canada initiated a National Review of the facilities in Canada involved in the activities mentioned above. The objective of the National Review is to verify the adherence of these facilities with critical safety requirements.

Health Canada is in the process of developing a new regulatory framework that will maximize the safety of cells, tissues and organs for transplantation. The national standards will serve as the basis for the regulatory framework and will deal with the safety issues of cells, tissues and organs from donation through transplantation. Health Canada is undertaking this regulatory initiative to fullfill its mandate of safeguarding the health of all Canadians.