What are the dentists’ responsibilities when providing human allogeneic transplants or allografts to their patients with respect to Health Canada regulations?
This question was submitted by a general dentist: What are the dentists’ responsibilities when providing human allogeneic transplants or allografts to their patients with respect to Health Canada regulations?
The response is based on the CDA Guidance Document for Dentists Provinding Human Allogeneic Transplants.
- Many dentists routinely use a wide range of transplant products during surgeries, including autograft, allograft, xenograft and alloplastic products.
- In April 2009, the Health Products and Food Branch of Health Canada adopted a document titled Guidance Document for Cell, Tissue and Organ Establishments – Safety of Human Cells, Tissues and Organs for Transplantation based on regulations for establishments, such as dental offices involved in the transplantation of human cells, tissues and organs (CTOs).
- In contrast to autografts and allografts, xenograft and alloplastic graft products are classified by Health Canada as medical devices rather than CTOs and are regulated under the Medical Devices Regulations (please refer to the CDA Guidance Document Pertaining to Devices for Use in Dental Health Care).
The CTO Regulations are designed to minimize the potential health risks to Canadian recipients of human CTOs. The provisions of the CTO Regulations that are most applicable to dentists are:
- Source Establishment: Only obtain transplantation material that is processed from an establishment registered by Health Canada and that is determined safe for transplant,
- Informed Consent: Obtain informed consent from patients who receive CTO transplants,
- Records: Ensure that record-keeping procedures capture all the required information, which includes the donor identification code, in order to be able to trace the transplant material from its source to the recipient,
- Reporting: Report suspected errors, accidents and adverse reactions to the source establishment and its distributor and quarantine products, when applicable.
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