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ORM will follow CDC guidelines and any American Society of Reproductive Medicine guidelines that are released regarding the Zika Virus.
March 4 , 2016
by: ASRM Office of Public Affairs
Published in ASRM Bulletin Volume 18, Number 13
FDA Issues New Guidance on Zika Virus, Includes Reproductive Tissues
The Food and Drug Administration (FDA) this week issued a new Guidance Document on the Zika virus. Donors considered at risk of transmitting Zika virus should be deemed ineligible.
According to the FDA press release:
“There is a potential risk that the Zika virus can be transmitted by HCT/Ps (donated tissue) used as part of a medical, surgical, or reproductive procedure. HCT/Ps include products such as corneas, bone, skin, heart valves, hematopoietic stem/progenitor cells (HPCs), gestational tissues such as amniotic membrane, and reproductive tissues such as semen and oocytes.
According to the Centers for Disease Control and Prevention, Zika virus can be spread by a man to his sexual partners. And to date, there have been several cases of sexual transmission in the U.S. Current information about Zika virus detection in semen suggests that a period of ineligibility longer than the waiting period that has been recommended for donors of Whole Blood and blood components is necessary for HCT/P donors.
Recommendations for living donors of HCT/Ps: Donors should be considered ineligible if they were diagnosed with Zika virus infection, were in an area with active Zika virus transmission, or had sex with a male with either of those risk factors, within the past six months. Donors of umbilical cord blood, placenta, or other gestational tissues should be considered ineligible if they have had any of the above risk factors at any point during their pregnancy.”
The entire FDA press release with links to other FDA documents, can be found here
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