Bacterial contamination and transfusion safety: experience in the United States.

In the United States, septic reactions from bacterial contamination of blood components are considered to be the most frequent and serious infectious outcomes of transfusion, reflecting 77 of 694 transfusion-related deaths reported to the FDA, during the period 1985-1999. A number of recent surveillance programs have emphasized this, with nationally reported rates of about 10 per million platelet units transfused and about 1.4 per 10,000 transfusions in one hospital: significant fatality rates were noted in each setting. Although there is currently no regulatory requirement to undertake additional measures to reduce this adverse outcome, a number of approaches are under consideration. These include increased attention to skin preparation, diversion of the initial volume at phlebotomy, and the use of automated bacterial culture. A number of research studies are directed towards accessible methods for the detection of bacterial contamination. These include a modified culture approach for use in the blood center and tests that may be applied to platelet units shortly before transfusion. In addition, there is clear evidence that platelets prepared by apheresis offer lower overall risk to recipients as a result of the lower number of discrete products received by each patient. It is anticipated that pathogen reduction procedures may also impact bacterial contamination, but such procedures are not yet available in the US.