Extractables and Leachables: A Powerful Tool in Qualifying your Product as Medical Grade.

Brightcove Video: 

All materials used in medical device manufacturing must be proven to be safe. With improvements in device effectiveness comes more intricate, unique, novel and specialized technologies. As these advancements evolve, understanding their impact on safety becomes more critical. A primary measure of the safety associated with a device or material is biocompatibility. There are specific tests that are recommended by the regulations to determine the overall biocompatibility of the device. Upon successful completion of this testing, a device can be submitted for use in the industry. Select biocompatibility tests can be utilized as a screening tool prior to that biocompatibility testing used to meet the regulatory requirements. Understanding how the change of a material can impact the biocompatibility of the overall system can be achieved by determining the extractable and leachable profile of the device. Extractable and leachable determination essentially models the interacting compounds between device and patient. Understanding these interactions allows one to predetermine the expected impact. Additionally, identification of these compounds allows one to determine the source that may be affecting the biocompatibility of a material/device. Ultimately, this chemical characterization can be implemented to determine the source of a failure, as a screen measure to ensure optimized material selection during product development, maximize the efficacy of specialized devices, and/or to provide key input in a toxicological risk assessment. Along with demonstrating the usefulness of extractable and leachable determination, an overview of how this determination is made will be presented.