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Bacterial contamination and transfusion safety: experience in the United States
1Biomedical Safety American Red Cross, Jerome H. Holland Laboratory for the Biomedical Sciences, 15601 Crabbs Branch Way, Rockville, MD 20855, USA. dodd@usa.redcross.org <dodd@usa.redcross.org>
Abstract:
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.
Insights
Bacterial contamination in blood transfusions causes severe septic reactions and deaths. Strategies like improved collection and bacterial culture are being explored to enhance transfusion safety.
Area of Science:
- Transfusion Medicine
- Infectious Disease Prevention
- Blood Safety
Background:
- Bacterial contamination of blood components is a leading cause of transfusion-related deaths in the US.
- Reported rates indicate significant risks, with approximately 10 cases per million platelet units transfused.
- Current regulatory measures are insufficient to mitigate this serious adverse outcome.
Purpose of the Study:
- To review the incidence and impact of bacterial contamination in blood transfusions.
- To explore current and emerging strategies for detecting and reducing bacterial contamination in blood products.
- To assess the role of apheresis and potential pathogen reduction technologies in improving transfusion safety.
Main Methods:
- Analysis of FDA data on transfusion-related deaths (1985-1999).
- Review of surveillance programs and reported rates of bacterial contamination.
- Examination of ongoing research into detection methods and preventative measures.
Main Results:
- Septic reactions from bacterial contamination are the most frequent serious infectious risk in transfusions.
- Significant fatality rates are associated with contaminated blood components.
- Apheresis-prepared platelets demonstrate a lower risk due to reduced product exposure.
Conclusions:
- Enhanced methods for bacterial detection and prevention are under consideration to improve blood safety.
- Increased attention to collection protocols and advanced culturing techniques are crucial.
- Future technologies like pathogen reduction may further reduce risks, though not yet available in the US.