Advisory

2003
February 19, 2003

Health Canada is currently investigating the B.C. Ear Bank located at St. Paul's Hospital in Vancouver. Health Canada is concerned that the tissues (dura mater, pericardium and ear bones) processed and distributed by the Ear Bank do not meet basic safety requirements.

Health Canada requested that the hospital mitigate the risk that may be posed by the tissues from the B.C. Ear Bank by recalling the products and notifying physicians who have used tissue from the Ear Bank in transplantation.

Health Canada believes, based on a risk assessment, the risks associated with transmission of diseases to recipients is low for contracting Hepatitis B, Hepatitis C and HIV from tissues processed and distributed by the tissue bank. There is also a theoretical, although very low risk of contracting HTLV - I or II, Syphilis or Creutzfeld-Jacob Disease (CJD).

Health Canada has not been made aware of any disease transmission from tissues processed and distributed by the B.C. Ear Bank.

If anyone has concerns, Health Canada recommends they consult with their physician to determine the possibility of such an occurrence and what measures need to be taken.

For further information

Health Canada
Technical Requirements to address the Safety of Cells, Tissues and Organs for Transplantation Directive and Guidance document entitled Basic Safety Requirements for Human Cells, Tissues and Organs for Transplantation can be accessed at the Biologics and Genetic Therapies Directorate web page.

HIV (www.phac-aspc.gc.ca/publicat/std-mts/sti_o.html)
hepatitis B (www.phac-aspc.gc.ca/publicat/std-mts/sti_m.html)
hepatitis C (www.phac-aspc.gc.ca/hepc/hepatitis_c/index.html)