Roger Y. Dodd, Ph.D.
Executive Director, Biomedical Safety
On Behalf Of The American Red Cross
Before The Blood Products Advisory Committee (BPAC)
On Detection of Bacterial Contamination
December 12, 2002
[67 Fed. Reg. 70752; Nov. 26, 2002]
Good day. My name is Roger Dodd. I’m the Executive Director, Biomedical Safety at the American Red Cross Holland Laboratory. I am speaking on behalf of the American Red Cross, which collects about half of the blood components used for transfusion in the United States. One of our strategic priorities is: “To provide high quality, safe products.” The American Red Cross thanks the Food and Drug Administration and the Blood Products Advisory Committee for this opportunity to address a topic of great importance to platelet recipients in the United States. We applaud the FDA for its attention to the issue of bacterial contamination of platelet components.
The Red Cross agrees with the AABB statement relating to the serious nature of bacterial contamination and recognizes that measures should be taken to reduce or eliminate the occurrence of transfusion-related sepsis. We recognize that an immediate, single solution is not currently available and acknowledge that attention to aseptic practice and to appropriate skin preparation continue to be a critical foundation for maintenance of bacterial safety. We further agree that it is highly desirable to implement means to detect bacterially contaminated platelet units and recognize that some approach to diversion of the initial collection volume may complement such detection.
We challenge researchers and manufacturers to develop rapid, highly sensitive tests that may be used to assure that platelets are bacterially safe: ideally, such methods could be used prior to release of products. In the meantime, we recognize that FDA’s approval of two culture-based methods for platelet quality control is a step in the right direction.
The Red Cross is in the process of determining the feasibility of implementing procedures to assure quality control for bacterial contamination of all apheresis platelets and will discuss with the FDA available options to assist hospital customers in reducing the risk of transfusing any components that fail to meet bacterial QC requirements. In common with the AABB, the Red Cross is concerned about the ability to complete such QC on random donor platelets without compromising their availability and efficacy. We hope that the FDA will be willing to consider the concerns expressed by the AABB and thus to assist the Red Cross in fulfilling its mission.
Thank you for your attention.