As Organ-Transplant Industry Draws Scrutiny, FDA Alleges Eye Bank Accepted Donors With Sepsis
The Food and Drug Administration said five donors either had a sepsis diagnosis or showed clinical signs of sepsis. But the Indiana Lions Eye Bank countered that blood cultures from all five tested negative. "There is still only one gold standard for the diagnosis of sepsis, and that is a positive blood culture," it said.
July 08, 2024 at 03:58 PM
6 minute read
Health CareThe nation's organ transplant industry for decades received warm-and-fuzzy news coverage of its life-saving successes. But it suddenly finds itself facing unprecedented regulatory scrutiny—with a 65-year-old Indiana eye bank the latest player caught in the glare.
U.S. Food and Drug Administration records show that the agency's late January inspection of the Indiana Lions Eye Bank found that in the prior three years it had accepted donations from five people with a "documented diagnosis or clinical evidence of sepsis."
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