Silicone is a significant biomaterial for a variety of medical device industries due to its biocompatibility, resistance to chemical and oxidative attacks, and facile methods of manufacturing. Philips Respironics (PRI) designs and manufactures Class I and Class II medical devices for use in the sleep and respiratory field and utilizes a variety of silicone grades. These devices need to demonstrate compliance to the relevant international biocompatibility standards for medical devices, which include ISO 10993-1:2018 and in certain instances ISO 18562-1:2017, which is specific to respiratory devices. Many of the device components are classified as externally communicating with tissue/bone/dentin within the humidified gas pathway and thus are subject to a larger range of in vitro and in vivo biological endpoint testing and advanced chemical characterization testing, in order to meet the biocompatibility regulatory requirements. PRI has demonstrated biocompatibility and adherence to both ISO 10993 and ISO 18562 for devices containing silicone. Changes in silicone synthesis, grade, and formulation need to be considered by medical device manufacturers and suppliers alike, as this affects the downstream chemical identification and toxicological risk analysis of the extractables and leachables (E/L) and the volatile organic compound (VOC) profile. This talk will highlight the biocompatibility standards that are pertinent to these types of products, the typical biocompatibility results of various silicones used, and the medical device industry needs of silicone from a respiratory specific application.
SPEAKER: Laura Bering, Ph.D. Biosafety & Veriification Engineer-QR V& V Systems, Philips Respironics