Approach to safety assessment of extractables and leachables in the medical device

Abstract

International standards such as ISO is positively adopted in worldwide regulations of medical devices. Medical devices that come into contact with the human body must be evaluated for biological safety according to the ISO 10993 series. ISO 10993-1, " Evaluation and testing within a risk management process" requires the collection of information on the chemical properties of medical materials. The concept of toxicological threshold of concern (TTC) may be able to promote animal welfare and reduce the testing costs. Safety assessment methods using chemical analysis are expected to be increasingly used in the near future. The U.S. Food and Drug Administration is actively promoting the use of chemical analysis. In Japan, some medical device manufacturers and contract research organizations are attempting to use chemical analysis. Chemical analysis is very useful for assessing the amount of elution from medical devices and exposure amounts to human when the analysis target chemical is known. On the other hand, the information available for chemical analysis is limited because raw material suppliers do not disclose the full composition including impurities. Therefore, the TTC approach can be used for a comprehensive assessment of medical devices. However, there are several problems in the current extractables and leachables analysis used for the approach. In this presentation, we propose a strategic analytical package that is available as an alternative for genotoxicity and sensitization testing according to the TTC and the dermal sensitization threshold approaches.