Extractables & Leachables - Medical Device

Medical devices present a unique challenge with regards to extractables and leachables testing.  Most medical devices involve direct exposure of the device with the patient, which can include contact with the skin, eyes, mouth, tissue, blood, or bone.  Testing for leachables as done for drug product is not feasible.  Therefore, medical devices are evaluated for safety through both biocompatibility studies, and chemical characterization studies.  Chemical characterization involves exhaustively extracting the device materials followed by extract analysis to understand all potential “hazards” present within the medical device material(s).  These hazards, once identified, can then be evaluated as part of a toxicological risk assessment.  Guidance for evaluation of medical devices is governed by ISO 10993 Biological Evaluation of Medical Devices.  Chemical characterization is specifically outlined in ISO 10993 part – 18 Chemical Characterization of Medical Device Materials within a Risk Management Process.