The Importance of Accurate Chemical Characterization of Medical Devices...

Full title: The Importance of Accurate Chemical Characterization of Medical Devices Extractables Chemical characterization of medical devices, involving the identification, quantification, and subsequent toxicological risk assessment of E&L compounds, is becoming increasingly accepted by regulatory agencies as a means to assess the biocompatibility of medical devices. The proper implementation of this approach requires an accurate assessment of the E&L compounds that may be released from the device. This presentation will discuss the challenges associated with accurately identifying compounds extracted from medical device materials and will illustrate the importance of accurate chemical characterization from a toxicological perspective. The presentation will underscore the need for chemists and toxicologists to work collaboratively to assess the potential risk posed by patient exposure to E&L compounds released from medical device materials.