The Food and Drug Administration (FDA) has issued new guidelines to reduce the risk of transmission of infectious agents associated with sepsis through human cells, tissues and cellular tissue-derived products (HCT/Ps). This guidance aims to strengthen safety in the donation of human tissues and cells by addressing the need for rigorous donor screening and appropriate testing for sepsis.
Main recommendations:
Donor screening: Assessment of risk factors and detailed clinical history to identify possible signs of sepsis.
Clinical and Physical Evidence: Check for symptoms indicating systemic infections or septic shock.
Diagnostic tests: Tests for pathogens that can cause sepsis.
The FDA emphasizes that these measures are essential to protect public health and ensure the safety of HCT/Ps recipients.
For more information, see the full document below.
