A zoonosis is an infectious disease caused by bacteria, fungi, viruses, parasites or transmissible spongiform encephalopathies (TSE) that have jumped from vertebrate animals to humans (also known as spillover). Most of the newly identified infectious diseases are zoonoses, as well as many of the already known diseases. Zoonotic pathogens can spread to human through different routes, either after contact with domestic, agricultural or wild animals. Another route of exposure could be the use of animal derived materials in medical devices. For example, collagen of bovine origin can be used as tissue fillers, and as support matrices for matrix-rich tissues. These animal derived materials can cause zoonotic infectious diseases to human and therefore must be evaluated.
In medical device field, the zoonosis risk assessment shall be carried out in accordance with ISO 22442 series. The identified risks shall be assessed within a risk management process. Information on starting material, pathogen burden, production process and susceptibility of pathogens to the production process are retrieved and evaluated. The result of the assessment gives the probability of pathogen infection and the potential impact on product safety. Depending on the quality and relevance of retrieved information, the residual risk can be negligible, acceptable or not acceptable. In the latter, further investigation shall be carried out.”
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