By Ethan Covey
Several U.S. eyebanks have accepted donations from patients who had a clear infection.
The FDA sent a warning letter to two eye banks regarding allegations of significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products, which were documented during recent inspections. The latest was the VisionFirst Indiana Lions Eye Bank.
The letters note that both VisionFirst and New Mexico Lions Sight Conservation Foundation Inc., which is based in Albuquerque, N.M., and does business as New Mexico Lions Eye Bank, failed to determine as ineligible those donors who had a documented diagnosis or clinical evidence of sepsis.
In both cases, the FDA said, the donors had two or more systemic responses to infection, documented within available medical records during the hospital stay immediately preceding their deaths.
The FDA also stated that the eye banks’ existing procedures for determining a donor’s risk for sepsis and whether an infectious disease consult is required were not in compliance with donor eligibility requirements.
“These procedures 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,” the FDA wrote.
The letters gave the eye banks 15 days to respond to the allegations.
