4 - A practical approach to analytical chemistry of medical devices

Abstract

The importance of materials to the medical device industry cannot be over emphasized and the value of chemical and material characterization in the biological evaluation of medical devices is clearly recognized in the International Organization for Standardization (ISO) harmonized standards. The main theme throughout ISO 10993-1 and the corresponding 2016 FDA guidance document on biocompatibility is that every medical device should be assessed for its specific risk to the end user. Since it is difficult to address all possible risks associated with a medical device, extractable and leachable testing can be used to help fill in gaps and fulfill the risk evaluation. Extractable and leachable testing and a scientifically sound assessment of this data is the main proposed method to minimize unnecessary in vivo testing. When conducted properly, this approach should result in a safe device while at the same time, achieve significant cost savings and decreased time-to-market. Chemistry is very important to medical device evaluations and Parts 18 and 19 of ISO 10993 are receiving greater emphasis as an integral part of the biological evaluation of devices. Considering the intrinsic worth of chemical and materials characterization, it seems likely that both will receive even more attention in the future.