FDA Guidelines
FDA Guidelines for Donors of Human Tissue
by Darlene M. Pinkerton
This document is not intended to be used as medical advice or medical instructions to any egg donor or any other person interested in donating human tissue. A Perfect Match, Inc. is providing this document to help educate women about some of the issues that may disqualify them from donation of human cells (donor eggs) temporarily or permanently.
The Federal Government has now set forth FDA guidelines that are to be used by IVF centers when determining the eligibility of the person who donates human cell tissue (HCT/Ps). FDA is trying to “adequately and appropriately reduce the risk of transmission of relevant communicable diseases”. The FDA concerns are due to the "high risk" behaviors of those who want to donate human tissue including: organs for transplant, blood products and human reproductive cells. Unfortunately, there have been some children and adults who have developed severe medical complications or have died after receiving donated tissue. In order to protect those who would be recipients of the tissue, the FDA has developed a list of “high risk” behaviors as well as mandated tests for screening the potential donors before the tissue will be accepted and allowed for use by the tissue procurement center.
This following list of required tests was last updated by FDA in February 2008, so in the future the FDA may eliminate tests, add additional tests or change the method for specific tests in the future as there are advances made in technology and knowledge. Each tissue procurement facility (IVF center) may add to the list of tests required by FDA, but all facilities are required to test for the following unless they meet specific exemptions as allowed by FDA:
Human Immunodeficiency Virus (HIV types 1 and 2)
Hepatitis B (HBV)
Hepatitis C (HCV)
Human T-lymphotropic virus (HTLV types 1 and 2)
Syphilis (treponema pallidum)
Cytomegalovirus (CMV).
They also require additional tests for donors of reproductive cells: Chlamydia and Gonorrhea.
Please keep in mind that a positive result for some of the required tests may only disqualify you for a specific period of time; whereas, positive results for other tests will permanently disqualify a person. There are also some exceptions made if the egg donor is “a known donor” to the intended parent and/or the person who will be carrying the pregnancy. The exact qualifications to be classified as a “known donor” (and therefore exempt from disqualification based on positive test results) can only be determined by each IVF center. Generally, a “known donor” is an intimate sexual partner, a family member, or a person known to the recipient for a long time. With egg donation, however, a known donor may also be a woman who has agreed to meet with and give her contact information to an intended family so they can have an ongoing relationship. Please don’t assume you will be unable to donate if you test positive under any of the categories that would normally disqualify you as a donor without first checking with your agency and IVF center through which you will donate.
FDA is not only concerned with high risk sexual behaviors (though in egg donation that is certainly the main reason for disqualification from donating eggs), FDA is also concerned with a person’s drug usage, incarceration in prison, and diseases that may be contracted during the donor’s travel outside of the U.S. Some areas of the world are on the “hot list” of places that have a high risk of exposure to such things as SARS, HIV, West Nile Virus, Malaria and Mad Cow Disease, etc. (and now Swine Flue). Some of these communicable diseases may only require deferment of the donor for a specific time period after potential exposure and/or treatment of infection; whereas, the symptoms of Mad Cow Disease may take many years to appear and exposure during the specified times listed my mean permanent deferment of the donor. Generally, the rule of thumb is that if a person has been rejected as a blood donor they will also be rejected as an egg donor or as any other type of donor of human tissue. Please see the following list of Blood Bank criteria for donors, which will include countries that are considered “hot spots” and dates for travel or residency that most blood banks use when determining the eligibility of a blood donor.
The following websites will give you information about the FDA requirements for “at risk or high risk behaviors” and will help you see if you qualify as a donor of human tissue.
FDA Guidance for Tissue Donation
The specific section is 1271.47 and 1271.75(a)
Also, you can go to www.ASRM.org and look up Summary of "Eligibility Determination for Donors of Human Cells, Tissues, And Cellular And Tissue-Based products" and ASRM BULLETIN Volume 6, Number 29, May 20, 2004
Sexually Transmitted Diseases
We have also included links to the Center for Disease Control (CDC) information regarding their studies on the trends for sexually transmitted diseases. Please read these because they are saying that STDs are far more harmful to women and that it can definitely cause infertility. Every woman should be proactive in understanding STDs as well as being proactive in protecting herself from those STDs through safe sex techniques, which includes use of condoms for any type of sexual activity.
This is 2007 stats for sexually transmitted diseases
Trends in sexually transmitted diseases
Highest risk populations: women and minority women
If you have specific questions about the FDA Guidelines please don't hesitate to call or email us: darlene@aperfectmatch.com 1-800-264-8828
