Bulletin 18-7

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Update to March 2016 FDA Guidance Document Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus (ZIKV) by HCT/Ps: Guidance for Industry

Bulletin 18-7

June 15, 2018

This guidance updates information in the March 2016 guidance by:

  1. providing findings from more recent epidemiological studies including impact on public health;
  2. reporting new data that informs the potential for transmission of ZIKV;
  3. discussing the current status of availability of ZIKV tests;
  4. updating sexual contact risk factors;
  5. updating when an area is considered to have an increased risk for ZIKV transmission; and
  6. providing additional scientific references.

The recommendations are as follows (changes highlighted in yellow):

Recommendations for Living Donors of HCT/Ps (updated May 2018) in effect Recommendations for Living Donors of HCT/Ps (March 2016) no longer in effect

Living donors of HCT/Ps should be considered ineligible if they have any of the following risk factors: 

1. Medical diagnosis of ZIKV infection in the past 6 months. 

2. Residence in, or travel to, an area with an increased risk for ZIKV transmission within the past 6 months. 

Sex within the past 6 months with a person  who has either of the risk factors listed in items 1 or 2, above. 

Living donors of HCT/Ps should be considered ineligible if they have any of the following risk factors: 

1. Medical diagnosis of ZIKV infection in the past 6 months. 

2. Residence in, or travel to, an area with active ZIKV transmission within the past 6 months. 

 
Sex within the past 6 months with a male  who is known to have either of the risk factors listed in items 1 or 2, above.
Additionally, donors of umbilical cord blood, placenta, or other gestational tissues should be considered ineligible if the birth mother who seeks to donate gestational tissues has any of the following risk factors: 
  1. Medical diagnosis of ZIKV infection at any point during that pregnancy. 

5. Residence in, or travel to, an area with an increased risk for ZIKV transmission at any point during that pregnancy. 

 
Sex at any point during that pregnancy with a person who has either of the risk factors listed in items 1 or 2, above. 

Additionally, donors of umbilical cord blood, placenta, or other gestational tissues should be considered ineligible if the birth mother who seeks to donate gestational tissues has any of the following risk factors: 

  1. Medical diagnosis of ZIKV infection at any point during that pregnancy. 

5. Residence in, or travel to, an area with active ZIKV transmission at any point during that pregnancy. 

 
Sex at any point during that pregnancy with a male who is known to have either of the risk factors listed in items 1 or 2, above. 
Recommendations for Non‐Heart-Beating (Cadaveric) Donors of HCT/Ps (updated May 2018) Recommendations for Non‐Heart‐Beating (Cadaveric) Donors of HCT/Ps (March 2016)      

The following non‐heart‐beating (cadaveric) donors should be considered ineligible: 

1.Persons with a medical diagnosis of ZIKV infection in the past 6 months. 

The following non‐heart‐beating (cadaveric) donors should be considered ineligible: 

1. Persons with a medical diagnosis of ZIKV infection in the past 6 months. 

IMPLEMENTATION

FDA recommends that you implement the recommendations in this guidance as soon as feasible, but not later than 4 weeks after the guidance issue date.

A link to the updated Zika virus guidance can be found here.