New York hospital used unapproved product in surgeries before FDA warning: NYT

NewYork-Presbyterian Weill Cornell Medical Center used a fluid, known as BioBurst, created from umbilical cord blood in spine surgeries, but the fluid had not been approved for this purpose by the FDA, according to a Sept. 20 report from The New York Times

The 862-bed medical center in New York City used it for this procedure, which according to the FDA had found that, "its Idaho manufacturer had been cited for possible contamination problems and inadequate screening of donors, making the product potentially unsafe," the Times reported.

A visiting researcher at the New York hospital, Pravesh Gadjradj, MD, saw the FDA's February 2022 warning letter about the fluid and raised concerns to a surgeon, Roger Härtl, MD, a senior surgeon and professor at Weill Cornell who had been overseeing the procedures for research purposes. According to the Times, 40 patients had undergone procedures with the fluid used prior to the FDA's warning. However, an FDA warning letter does not require notification of patients.

Upon raising the concern to Dr. Härtl, Dr. Gadjradj allegedly told him to delete the research file about the project and not bring it up again. Dr. Gadjradj proceeded to file an internal complaint. 

A spokesperson for NewYork-Presbyterian Weill Cornell Medical Center told the Times that the hospital had ceased use of the product even prior to the FDA's warning coming out about it but did not comment about whether it decided to notify affected patients about the product's possible issues.

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