The US Food and Drug Administration (USFDA) has warned against the transmission of the Zika virus by surgeries, especially the ones involving donation of umbilical cord blood, placenta and other gestational (growth) tissues. The USDFA said Tuesday the new guidelines have been issued to reduce the potential transmission risk of the Zika virus from human cells, tissues and cellular and tissue-based products(HCT/Ps).
"There is a potential risk the Zika virus can be transmitted by HCT/Ps used as part of a medical, surgical, or reproductive procedure." an official statement said.
HCT/Ps include corneas, bone, skin, heart valves, gestational tissues and reproductive tissues such as semen and oocytes.
The USFDA had issued recommendations Feb. 16 to reduce the risk of Zika virus spread via blood transfusion.
"Though there is more to be learned about the transmission of the Zika virus, we must address the potential risk of its transmission by human cells and tissues," said Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research. "Providing donor eligibility recommendations in procedures involving HCT/Ps will help reduce the potential risk."
As per the recommendations, donors should be considered ineligible if they were diagnosed with Zika infection, have travelled to Zika-affected areas or had sexual intercourse with males who show Zika symptoms.
The guidelines said donors of umbilical cord blood, placenta, or other gestational tissues should be considered ineligible if they have had any of the risk factors at any point during their pregnancy.
For deceased (non-heart beating) donors, the USFDA recommends the donors be considered ineligible if they were diagnosed with Zika virus infection in the past six months.
The USFDA said it would monitor the Zika virus infection risks to recipients of HCT/Ps during surgeries as more information comes in.
The agency said it would prioritise the development of blood donor screening and diagnostic tests for identification of Zika infection, evaluation of safety and efficacy of the developing vaccines and therapeutics and review of technology to suppress the mosquito population that can spread the virus.
There is no specific treatment for Zika virus infection, although a few countries have started studying the links of Zika with microcephaly — a congenital disorder characterised by abnormally small heads in babies.
The World Health Organisation (WHO) has said it will take at least 18 months before any vaccine is tested in large-scale clinical trials.
