Food and Drug Administration

Transmissible Spongiform Encephalopathies Advisory Committee

July 18, 2003


TSE Decontamination: Studies Relevant to Facility and Equipment Cleaning, Dr. Christoph Kempf, PPTA TSEWG (PDF)

Decontamination Practices for Plasma Product Facilities, Dr. Christoph Kempf, ZLB for PPTA TSEWG (PDF)

Medical Devices in Contact with Contaminated or Potentially Contaminated Tissue, Lillian J. Gill, FDA (HTM) (PPT)

Validating Sterilization of Medical Devices, Martha O’Lone, FDA (HTM) (PPT)

Methods to Decontaminate Facilities and Equipment Used in Recovery and Processing of HCT/Ps to Prevent Contamination and Cross-Contamination by TSE Agents, Dr. Ruth Solomon, MD, DHT/OCTGT (HTM) (PPT)

Theoretical vs. Actual in Risk Reduction for Eye Banks, Ellen Heck, Transplant Services Center (HTM) (PPT)

Plasma Derivatives: Cleaning Procedures and Clearance of TSE Agents During Manufacturing, Dr. Dorothy Scott, MD, Laboratory of Plaxma (HTM) (PPT)

Open Public Hearing

Decontamination of Surfaces Contaminated with Prions, Dr. Gerald McDonnell, MD (HTM) (PPT)

STERIS Corporation Comments - Concerns Regarding Current Decontamination Procedures and Recommendations (PDF)

AdvaMed's Testimony Presented by Dr. Peter Burke, PhD, STERIS Corp. (PDF)

European Industrial Example of BSE Risk Management Policy for Implantable Collagen of Bovine Origin, Symatese Biomatériaux (HTM) (PPT)