Key words: risk assessment, modeling, research, toxicity
Systemic toxicity tests, as they are currently conducted for medical device materials may have limited utility for regulatory decision making because of their inability to detect all but the most overt signs of toxicity. In addition, a lack of knowledge of the chemical constituents that are released from a device may lead to unfocused or unnecessary systemic toxicity testing. To address these limitations, OST and ODE scientists are working to develop an extension of the existing approach, the hallmarks of which are: 1) identification of the compounds released from the device, 2) assessment of the dose of the compounds received by the patient, and 3) assessment of the risk posed by exposure to these compounds.
Before such an approach can be implemented, a number of significant scientific issues must be addressed. For example, within OST, DLS and DMMS scientists are working collaboratively to develop science-based but practical thresholds for the detection and identification of compounds released from devices. In addition, a number of risk assessment tools must be developed before such an approach can be broadly implemented. Once this chemical characterization/risk assessment approach is developed, both Center scientists and submitters will have access to an approach that will provide information to better assess the potential for systemic toxicity to occur and will potentially reduce unnecessary testing and animal use.