Extra Extra Read All About Our Sepsis Review!
Thanks for joining us! As we’ve been following the Food and Drug Administration (FDA), another hot topic is the release of the guidance document with a delayed implementation of May 4, 2025, “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)”. This information supersedes the previous sepsis information in the guidance document “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Guidance for Industry, August 2007”. This guidance update came in response due to safety concerns of transmission of Mycobacterium tuberculosis (Mtb) in recipients of bone products, and guess what? Mtb is a disease agent that can cause sepsis (check out our other blog on Mtb)!
As defined by the Centers for Disease Control, “Sepsis is the body’s extreme response to an infection. It is a life-threatening medical emergency. Sepsis happens when an infection you already have triggers a chain reaction throughout your body. Infections that lead to sepsis most often start in the: Gastrointestinal tract, Lung, Skin or Urinary tract. Without timely treatment, sepsis can rapidly lead to tissue damage, organ failure and death.” Per the FDA, “sepsis includes but is not limited to, bacteremia, septicemia, sepsis syndrome, systemic infection, systemic inflammatory response syndrome (SIRS) when due to infection, or septic shock” and have been caused by bacterial, mycobacterial, fungal, and viral pathogens.
Sepsis has been identified as a relevant communicable disease agent or disease (RCDAD) by FDA as the risk of transmission has been shown through HCT/P donors from transfused blood and blood components and transplanted organs. Sepsis is life-threatening and can be fatal resulting in permanent damage or impairment requiring medical or surgical intervention. There are no specific tests that detect sepsis, as it is a clinical diagnosis. However, testing for pathogens that may cause sepsis is available. Recommendations for establishments determining eligibility is for those who are performing review to be qualified with appropriate medical training and be qualified to identify the risk factors and conditions, clinical evidence, and physical evidence consistent with those who are higher risk for sepsis.
Establishments must review relevant medical records for clinical evidence and ask questions about the donor’s medical history and relevant social behavior including risk factors for RCDADs, as well as screen birth mothers when an infant donor is less than one (1) month of age.
Ineligible Donors:
Any potential donor identified as having a risk factor for sepsis, currently has a medical diagnosis of sepsis, or suspicion of sepsis.
Any donor who exhibits clinical evidence of sepsis such as medical records from their current hospital stay or other healthcare facility stays prior to HCT/P recovery, that documents sepsis, bacteremia, septicemia, sepsis syndrome, systemic infection, systemic inflammatory response syndrome (SIRS) due to infection, or septic shock.
Any donor with clinical evidence that is consistent with risk of systemic infection and whose immune system was weakened and unable to respond to infection (i.e., immunocompromised or immunosuppressed, such as due to age, a medical condition, or medication), or who is a sepsis survivor. In this scenario, you should document your communication with the patient’s primary treating physician to obtain additional information regarding their patient’s potential for a higher risk of sepsis.
If available medical records did not document sepsis risk as described above, and your communication with the patient’s primary treating physician (above) was not conclusive, you should consider the following indicators of higher risk for sepsis when making a donor eligibility determination:
Possible signs of sepsis may include altered mentation, hypoxemia, elevated lactate, oliguria, hypotension, renal dysfunction, elevated bilirubin, and/or multi-system organ failure.
Prolonged stays (> 7 days) in an intensive care unit.
Positive blood cultures, although sepsis may be present without a positive blood culture.
Having a risk factor for or clinical evidence of sepsis with unexplained generalized rash or fever.
If a living donor appears healthy and does not have a recent history of sepsis or suspicion of sepsis, the donor is not considered to have risk of sepsis.
Check back next time for more updates!
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