14-17 June 2021
The FDA is working closely with the CDC and other federal and international authorities concerning coronavirus to monitor the evolving outbreak of the new type of coronavirus (COVID-19) first identified in Wuhan, Hubei Province, China.
Although so far no transmission of respiratory viruses by implantation, transplantation, infusion, or transmission of human cells, tissues, or cell- or tissue-based products (HCT/Ps) is known or expected, the potential for transmission of COVID-19 by HCT/Ps is currently unexamined and cannot be completely excluded. Up to now, however, no cases of COVID-19 transmission via HCT/Ps have been reported. However, there are already routine screening measures to evaluate clinical evidence of infection in HCT/Ps donors.
The FDA indicates that there is awareness that some HCT/P facilities in the USA are considering additional donor screening measures in response to the COVID-19 outbreak. As long as there is only limited knowledge and information about actual risks, those responsible for evaluating a donor may wish to consult and consider the following historical information (within the last 28 days):
More details and follow-up updates on the coronavirus and measures can be found on the FDA website.