⚠️FDA Guidance to Reduce Sepsis Risk in Human Cells and Tissues
Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for immediate implementation 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)." FDA is issuing this guidance to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of infections due to sepsis by HCT/Ps. This notice is being issued to respond to a public health safety concern and to address the urgent need for updated recommendations in making a donor eligibility determination when screening a donor for clinical evidence of sepsis and clinical signs to consider.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The guidance provides recommendations for establishments involved in donor eligibility determinations for human cells and tissues, impacting compliance and operational processes. Business owners must adapt to updated screening practices to mitigate the transmission of infections, thereby influencing their regulatory obligations and potential liabilities.