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# Guide on Reducing Sepsis from Cell/Tissue Products
- URL: https://www.fdaweb.com/guide-on-reducing-sepsis-from-cell-tissue-products/
- Published: 2025-01-31T12:00:00.000Z
- Updated: 2026-09-14T14:52:09.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158586

FDA has posted a [final guidance](https://www.fda.gov/media/184898/download?ref=fdaweb.com) entitled “Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” The document updates recommendations for making a donor eligibility determination when screening a donor for clinical evidence of sepsis and clinical signs to consider.

FDA says it is implementing the guidance without prior public comment because it has determined that prior public participation is not appropriate due to an urgent public health need for updated recommendations. “FDA identified a public health safety concern when investigating reports of *Mycobacterium* tuberculosis (Mtb) infections in recipients of allograft bone products,” the agency says. “These multi-state outbreaks indicate that there is a risk of transmission of Mtb infection by HCT/Ps, and Mtb is a disease agent that can cause sepsis.”

Additionally, FDA says various bacterial, fungal, and viral agents have been shown to be transmissible via use of HCT/Ps, and these agents have sufficient incidence and/or prevalence to affect the potential HCT/P donor population. Bacterial infection potentially resulting in sepsis with associated morbidity and mortality is a recognized risk from transfused blood and blood components, and from transplanted organs, it adds.