Food and Drug Administration

Blood Products Advisory Committee

December 12, 2002

Briefing Information

Committee Updates

Medical Device User Fees and Modernization Act of 2002 (MDUFMA), Dr. Mary Jacobs, PhD (HTM) (PPT)

Bacterial Contamination

Bacterial Contamination-Background and Introduction, Dr. Alan Williams, PhD, FDA (HTM) (PDF) (Word)

Proposed approach to clearance of bacterial detection devices for screening of platelet products prior to transfusion, Dr. Jaro Vostal, MD, PhD, FDA (HTM) (PDF) (Word)

Experience With Universal Bacterial Culturing to Detect Contamination of Apheresis Platelet Units in a Hospital Transfusion Service, Dr. James Aubuchon, MD (PDF)

Growth of Bacteria in Inoculated Platelets: Implications for Bacteria Detection and the Extension of Platelet Storage (PDF)

Evaluation of an Automated Culture System For Detecting Bacterial Contamination of Platelets: An Analysis With 15 Contaminating Organisms (PDF)

Evaluation of a New Generaltion of Culture Bottle Using an Automated Bacterial Culture System for Detecting Nine Common Contaminating Organisms Found in Platelet Components (PDF)

Human Parvovirus B19 NAT Testing for Whole Blood and Source Plasma

Introduction and Background, Dr. Mei-ying Yu, PhD (HTM) (PPT)

Parvovirus B19 NAT for Whole Blood and Source Plasma, Dr. Mei-ying Yu, PhD (HTM) (PDF) (Word)

In-Process Control Measures for Management of
Non-Chronic Diseases in Plasma Fractionation: Parvovirus B19, Dr. Susan Stramer, PhD, American Red Cross (HTM) (PDF) (Word)

PPTA Approach to Reducing Parvovirus B19 Load In Fractionation Pools, Dr. Barbee Whtiaker, PhD, Plasma Protein Therapeutics Assoc. (HTM) (PPT)

In-process Control Testing of Source Plasma, Dr. Steve Petteway, PhD, Plasma Protein Therapeutics Assoc. (HTM) (PPT)

Public Health Impact of Donor Notification and Counseling, Dr. Edward Gomperts, MD, Plasma Protein Therapeutics Assoc. (HTM) (PPT)

Parvovirus B19 and HAV Screening of Whole Blood Donations, Dr. Andrew Conrad, PhD, National Genetics Institute (HTM) (PPT)

An Analysis of Parvo B 19 In Source Plasma, Dr. Andrew Conrad, PhD, National Genetics Institute (HTM) (PPT)

Open Public Hearing

Chlorhexidne and the Blood Donor, FDA (HTM) (PPT)

Testimony, Dr. Roger Dodd, PhD, on behalf of the American Red Cross (HTM) (PPT)

Bacterial Contamination of Platelet Components, Kay Gregory, American Assoc. of Blood Banks (HTM) (Word)

Statement of the American Assoc. of Blood Banks, the Americas Blood Centers, and the American Red Cross presented by Kay Gregory (HTM) (PDF) (Word)

FDA Perspective and Questions for the Committee, Dr. Mei-ying Yu, PhD (HTM) (PPT)