Medical matters has developed a risk management (RM) tool that allows to calculate risk scores for chemical constituents. Risk scores are based amongst others on a constituent’s physicochemical properties and its quantitative structure-activity relationship (QSAR) assessment outcomes. Risk scores therefore reflect the patient safety risk posed by a detected leachable/extractable or any other constituent, by consideration of the following two factors: the hazard presented by a compound (reflecting its toxic potential) and the likelihood that a patient would be exposed to sufficient quantities of the compound to pose a hazard. This approach is equivalent to the concept that risk is a combination of the probability of the occurrence of harm and the severity of the harm, as described in ISO 14971.
The RM tool allows to establish a quick and easy quantitative ranking of extractables thereby raising alerts for critical candidates and allowing to focus risk management measures to reduce risks to an acceptable level or further reduce residual risks associated with the extractables of a device. Constituents assessed with the tool are not limited to compounds detected in chemical analytical testing but may also include material or manufacturing aid constituents. Therefore, the tool may be applied to facilitate decision-making when new manufacturing aids and/or materials are introduced. The tool may further be customized to link data from chemical analytical testing with chemical characterization, manufacturing and toxicological risk assessment data to allow for a non-statistical correlation analysis within and among product families. Thereby allowing to address questions such as concomitant exposure and root cause analysis for potential sources of surface contaminants. Please reach out to MM in case of further interest.