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The FDA has sent a to an Indiana eye bank for accepting tissue from five donors who all had a documented diagnosis or clinical evidence of sepsis, which should have rendered them ineligible, the agency said.

FDA conducted an inspection of VisionFirst Indiana Lions Eye Bank in Carmel, Indiana, between January 22, 2024, and February 1, 2024, revealing "significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCTPs)."

The five donations occurred from 2021 to 2024. One donor's cause of death was sepsis and septic shock, and had evidence of urinary tract infection and aspiration pneumonia due to Klebsiella pneumoniae; Clostridioides difficile colitis; an elevated white blood cell count, and other risk factors for sepsis.

Another donor had a diagnosis of septic shock due to bacterial (Proteus mirabilis) and viral (respiratory syncytial virus) pneumonia and clinical evidence of sepsis at the time of death, FDA said, and a third donor had been diagnosed with sepsis, was treated for "florid septic shock," and had evidence of urinary tract infection.

A fourth donor died from respiratory failure with hypoxia, with sepsis listed as a contributing factor, and a fifth donor was admitted to the intensive care unit for "undifferentiated shock" attributed to sepsis and/or hypovolemia from dehydration and third spacing of fluid.

FDA cited the eye bank for failing to determine "as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, and of the relevant communicable disease agents for which screening is required."

The agency also took issue with VisionFirst's procedures and forms for determining donor eligibility, noting these "fail to include all clinical evidence and systemic responses to infection, if unexplained, of sepsis during the donor's hospital stay immediately preceding death to appropriately evaluate a donor's sepsis risk."

FDA acknowledged the company's response from February 23, 2024, but said it was inadequate. The company had disagreed that the donors were septic at the time of death, stating "there is still only one gold standard for the diagnosis of sepsis, and that is a positive blood culture" and claiming the cultures were negative so sepsis was ruled out.

But the agency warned that positive blood cultures aren't required for a diagnosis of sepsis, as they don't identify all agents that can cause sepsis. "There are myriad reasons why blood cultures may be negative in cases of sepsis and the absence of a positive blood culture does not exclude sepsis as a cause of death," they agency wrote.

FDA also said VisionFirst's revisions to its procedures and forms don't adequately capture sepsis risk.

As of press time, VisionFirst had not responded to a 番茄社区 request for comment on the FDA's claims or whether it had responded to the FDA's letter.

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