1. Medical Devices in Contact with Contaminated or Potentially Contaminated Tissue Transmissible Spongiform Encephalopies Advisory Committee Ms. Lillian J. Gill, Senior Associate Director Center for Devices and Radiological Health

2. * Ensure medical device safety and effectiveness * Reduce unnecessary exposure to radiation from medical, occupational and consumer products - Premarket application review - Post Market Surveillance - Scientific Research - Field Inspections - Communicate with industry, health professionals, consumers and foreign governments

3. Medical Devices for consideration today Neurological medical devices (21 CFR 882) –Cranial drill and burrs –Implantable electrodes –Neuromuscular stimulators –Endoscopes and accessories used in central nervous system –Biopsy needles

4. Medical Devices for consideration today General indication medical devices –Surgical instruments (scalpels, scissors, retractors) –Aneurysm clip appliers (and temporary clips) –Metal suction tips –Biopsy forceps

5. Medical Devices for consideration today Medical devices used for sterilization - Sterilizers (e.g., dry-heat, steam) - Liquid chemical sterilizers - Sterilization accessory trays

6. Today’s Objective To learn what published data can be used to establish methods for decontaminating medical devices after potential TSE-exposure To learn what limitations exist in applying these data to procedures that decontaminate medical devices To discuss methods for validating the sterility of medical devices regarding bacteria and viruses To learn how these approaches (or others) can be employed in designing and interpreting TSE inactivation studies.