Genotoxic compounds can be released from some medical devices during their clinical use. The ISO 10993-17:2002 standard outlines steps to assess the risk posed by patient exposure to genotoxic compounds released from device materials. It is important to note; however, that the ISO 10993-17 standard is currently undergoing revision and the procedures for conducting a toxicological risk assessment of genotoxic compounds are likely to change following revision of the standard. This talk will outline the proposed changes to the ISO 10993-17 standard regarding methods to assess the risk posed by patient exposure to genotoxic compounds released from medical devices and will describe steps to mitigate the risk using risk management strategies. The talk will also briefly address how Carcinogenic, Mutagenic, and Reproductive (CMR) compounds will be handled in Europe under the new Medical Devices Regulation 2017/745/EU.
ON THE ORIGIN OF EXTRACTABLE SPECIES
Presented by Piet Christieans, PhD, Scientific Director at Nelson Labs
The presentation will give an overview – for the most common materials used in the construct of container/closure systems or medical devices – of the main classes of compounds that are often detected in extractable studies and will explain why they are there, what their functions are (in case of the intentionally added substances) or what their sources are or how they have been formed (in case of unintentionally added substances).
Understanding the composition of a material and what the impact is on the extractables profile is an important and necessary first step in performing a proper evaluation of data and for a subsequent risk assessment. In addition, a good understanding of the material composition allows one to “fine tune” the analytical methods to guarantee that all compounds were properly picked up in the screening methods, guaranteeing the broad detection of extractable compounds and an associated correct identification.