Why Pathogen Reduction?Protection Beyond Bacteria | Improved Platelet Availability | Economic and Operational Value
Why Pathogen Reduction?
Recognized as an effective measure to reduce transfusion-transmitted infectious (TTI) risk, pathogen reduction for platelet components provides a holistic solution to blood centers and hospital clients, ultimately benefiting patients who need it most. Not only does pathogen reduction comply with FDA’s guidance on addressing bacterial contamination, it reduces risk beyond bacteria with mitigation of TTI due to viruses and parasites, as well as TA-GVHD due to T-Cells. Furthermore, pathogen reduction can be used as an alternative to bacterial testing, CMV testing, and gamma irradiation which helps streamline operations.
Treat versus Test
PR is proactive – not reactive like testing. A proactive approach enables TTI risk reduction of a broad spectrum of pathogens, including emerging pathogens for which tests may not yet be available. Furthermore, false positive results, and associated product re-calls are avoided with PR, which can be inherent with testing.
Improve Platelet Stewardship / Availability
Blood Centers and hospital transfusion services are the essential stewards of the blood supply – effectively managing availability of blood products is imperative for patient health.
Pathogen reduction (PR) offers:
- Potential release of product on day one. Early release provides added flexibility for managing inventory and may enable hospitals to attain platelets sooner.
- A transfusion-ready product. This single-step strategy requires no primary or secondary testing.
- Help ensure blood supply continuity with its ability to mitigate TTI risk due to emerging pathogens.
Economic / Operational Value
Operational savings can be realized with PR via the ability to replace certain tests and procedures, including bacterial detection, CMV and Babesia testing, as well as irradiation, in apheresis platelet components. Furthermore, PR is a single-step process – no primary or secondary bacterial testing is needed, resulting in minimal operational disruption to hospitals.
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*Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.
1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry, December 2020. 2. The INTERCEPT Blood System for Platelets Package Insert, Cerus Corporation; May 28, 2019