New FDA Recommendations to Reduce the Risk of Transmission of Infectious Agents Associated with Sepsis

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.