A toxicological risk assessment (of a medical device) is the process of gathering all possible toxicity data about the materials of construction, processing materials and potential contaminants, and using this information to provide a risk profile. In the case of delivery devices, the interaction of materials with the contents of the vessel must also be considered, including the interaction between materials as well as any post-assembly processes, such as sterilisation.
The toxicity of many materials has been documented. This information, combined with knowledge of the application of the device, can be used in the safety assessment. In many cases, sufficient data on materials is available from public sources alongside the historic use of a product to allow an assessment and provide a positive conclusion. However, with more invasive or chronically used devices, materials characterisation of the final device is usually required. This may be carried out according to ISO 10993-18 (in the case of medical devices) and through extractables and leachables studies (when considering drug delivery devices).
The analysis should take into account the maximum available daily dose of all chemicals, which should subsequently be considered, along with a safety factor which often means multiplying the delivered dose by a factor of ten.
MET provides a toxicological risk analysis either as a unique service or in combination with analytical studies. Get in touch to hear about our registered toxicologist.