BD, Franklin Lakes, NJ, has announced that the company’s Bactec platelet quality control media are now available globally. The products enable microbiology laboratories, blood banks, and transfusion services to identify contaminated platelet units.
An estimated 12 million apheresis platelet donations are collected each year.1 Platelets are associated with a higher risk of sepsis and related fatality than any other transfusable blood component.2 The American Association of Blood Banks, FDA, and the World Health Organization have all introduced guidelines and protocols for the detection of bacterial contamination in platelet donations, helping to reduce septic transfusion reactions and related fatalities by an estimated 50% to 70%.3–5
The Bactec culture system offers a scalable footprint to help clinicians diagnose bloodstream infections, using a range of blood culture media and instrumentation. Coupled with a wide variety of culture media formulations, BD provides screening for microorganisms present in blood and blood components. Bactec platelet quality control media are part of a comprehensive solution leveraging the automated Bactec FX technology and BD Synapsys microbiology informatics solution to help laboratories meet culture-based platelet testing requirements.
“The availability of the BD Bactec platelet quality control media allows clinicians the opportunity to identify potentially contaminated platelet donations by using a culture-based methodology, helping to reduce the risk of sepsis,” says Gerald Denys, PhD, senior research professor of pathology and laboratory medicine at Indiana University School of Medicine.
FDA’s recent 510(k) clearance of Bactec platelet quality control media adheres to FDA guidelines for culture-based methods and the meets requirements of the European Union’s CE-IVD directive. The product can be used for quality control testing of leukocyte-reduced apheresis platelet units, leukocyte-reduced single units, and a pool of up to six units of leukocyte-reduced whole blood platelet concentrates.
“The addition of BD Bactec platelet quality control media builds on our legacy of offering accurate and cost-effective solutions through our BD Bactec portfolio,” says Steve Conly, vice president and general manager for microbiology at BD. “By offering this FDA-cleared product, we hope to help our customers better serve some of their most vulnerable patients while minimizing the health and financial burdens associated with sepsis.”
For further information, visit BD.
- Global Status Report on Blood Safety and Availability Report, 2016. Geneva: World Health Organization, 2017. Available at: https://apps.who.int/iris/bitstream/handle/10665/254987/9789241565431-eng.pdf;jsessionid=B0C62CECED367B973302E78CE7CCC22D?sequence=1. Accessed June 2, 2019.
- Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry. Silver Spring, Md: Center for Biologics Evaluation and Research, FDA, 2018. Available at: www.fda.gov/media/123448/download. Accessed June 2, 2019.
- Topic I: strategies to control the risk of bacterial contamination in platelets for transfusion [online]. Materials presented at the FDA Blood Products Advisory Committee Meeting, Silver Spring, Md, July 18–19, 2018. Available at: www.fda.gov/media/114327/download. Accessed June 2, 2019.
- Fuller AK, Uglik KM, Savage WJ, Ness PM, King KE. Bacterial culture reduces but does not eliminate the risk of septic transfusion reactions to single-donor platelets. Transfusion. 2009;49(12):2588–2593; doi: 10.1111/j.1537-2995.2009.02348.x.
- Eder AF, Kennedy JM, Dy BA, et al. Bacterial screening of apheresis platelets and the residual risk of septic transfusion reactions: the American Red Cross experience (2004–2006). Transfusion. 2007;47(7):1134–1142; doi: 10.1111/j.1537-2995.2007.01248.x.