FDA updates recommendations for human cell or tissue-based products
The Food and Drug Administration (FDA) does not recommend testing asymptomatic donors of human, cells, tissues or other cellular or tissue-based product (HCT/P) for COVID-19, the agency said in a press release.
Noting that routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors, the agency said that SARS-CoV-2 has only been detected in blood samples of a small percentage of severely ill patients.
The agency also said it is aware that some HCT/P establishments in the United States are considering additional donor screening and testing measures in response to the COVID-19 outbreak.
The FDA said an HCT/P establishment should evaluate whether a donor in the 28 days prior to the HCT/P procedure:
• Cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or
• Been diagnosed with or suspected of having a COVID-19 infection.
“While respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of human cells, tissues, or cellular or tissue-based products (HCT/Ps), the potential for transmission of COVID-19 by HCT/Ps is unknown at this time. There have been no reported cases of transmission of COVID-19 via these products,” the FDA said.
FDA said it will continue to monitor the situation and will issue updates as information becomes available.
