Previous Changes To Blood Donation Rules
The emergence of AIDS in the early 1980s and the recognition that it could transmit via blood changed the U.S. blood system.
Due to a lack of effective screening methods, a poor understanding of potential risk factors, and heterosexist perceptions, the U.S. implemented a lifelong ban on MSM, preventing them from donating blood between 2015 , the FDA changed the indefinite deferral to a 12-month deferral from the most recent sexual contact with another male. The organization selected this time window to allow adequate time to detect potential infections present in the blood. Research notes that this change did not result in an increase in HIV incidence among first-time donors.
In April 2020, in light of COVID-19-related blood shortages, the FDA further reduced the deferral to 3 months to respond to the urgent need for safe blood products.
Researchers have suggested that the current criteria rely on old biases and that scientists should advocate for policies rooted in science and against ones that unnecessarily marginalize groups of people.
Groups such as the Human Rights Campaign advocate for the FDA to revise donation eligibility to evaluate the risk of sexual behaviors equally, without regard to sexual orientation or gender identity.
The FAIR steering group in the United Kingdom suggests the following changes to ensure a fair and safe screening system for everyone:
According to general blood donation criteria, donors must:
What Should The Federal Policy Be
Human Rights Campaign believes that the updated policy, like its precursors, does not treat persons with like risks in a similar way. It also believes that donors are deferred based on their membership in a group in this case, all men who have sex with men rather than engagement in risky behavior, such as unprotected sex. For example, a man who has had protected oral sex with another man once in the 3 months currently barred from donating blood. Yet a woman who has had unprotected sex with multiple partners over the same time frame with no knowledge of their personal histories remains in the donor pool.HRC believes that the integrity and safety of the blood supply in this country should be preserved, strengthened and maintained. Any change or alteration in the regulations governing donor suitability must be based in science. The federal government must invest in new research to study risk behavior. HRC has strongly encouraged FDA to revise the donor questionnaire based on an individual risk assessment of sexual behaviors upon which all donors are evaluated equally, without regard to sexual orientation or gender identity.
As part of its announcement of the revised deferral policy, the FDA indicated was undertaking the research necessary to modernize the donor questionnaire.
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Medical Care And Treatment
It is very important that you have a full medical check-up. This should be arranged at a specialist centre or voluntary counselling and testing centre for the care of people with HIV infection. The centre will arrange a full medical assessment which will give much more information about your health. You will also have access to support for other problems which may arise as a result of the infection, such as informing partners and family.
There is no cure for HIV infection, but modern treatments aim to keep people with HIV healthy for as long as possible. HIV can be suppressed by combination antiretroviral therapy consisting of three or more antiretroviral drugs. ART does not cure HIV infection but controls viral replication within a person’s body and allows an individual’s immune system to strengthen and regain the power to fight off infections. With ART, HIV-infected individuals can live healthy and productive lives.
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Who Writes The Policy
The FDAs Center for Biologics Evaluation and Research regulates and establishes standards for the collection of blood and blood products. The center receives advise on this issue by the Blood Products Advisory Council, which meets regularly to consider issues such as altering the pool of potential blood donors.
What More Needs To Be Done
As well as reviewing the rules that apply as three-month deferral , there’s currently a lifetime exclusion for anyone who has ever injected drugs, regardless of when this took place. This is clearly an unnecessary exclusion affecting anyone with historical use of injecting drugs. This rule is in part dictated by EU Directive. However, there is precedent for deviating from directives when they are unnecessarily exclusionary and there is evidential basis for doing so. We would therefore like to see an urgent review of this, with changes made to the law if necessary.
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What Happens After Donation
To protect patients, blood is tested for transfusion transmissible diseases. If a donors blood tests positive, it will not be transfused to a patient. Donors will be notified about test results that may disqualify them from donating in the future.
Do not donate to be tested for HIV, hepatitis, or any other infections.
What Are The New Rules Fair Recommended
The new donor questions will no longer consider the gender of the person donating or that of their sexual partners. Instead, they will consider the sexual behaviour itself to assess whether there is a risk of a recent blood-borne infection that wont be picked up in post-donation screening .
Under the new rules someone will be asked to defer their donation if they report anal sex with a new or multiple partners in the past three months. Anal sex with one partner in the past three months, when that is not a new sexual partner , will not exclude a person from donating blood. This means gay and bisexual men in long-term relationships will be able to give blood when that person is the only person they have had anal sex within the three months prior to donating.
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Us Public Health Service Guidelines For Testing And Counselingblood And Plasma Donors For Human Immunodeficiency Virus Type 1 Antigen
ConsultantsCelso Bianco, M.D. Council of Community Blood Centers New York, NYMichael Busch, M.D., Ph.D. Irwin Memorial Blood Center SanFrancisco, CARichard Davey, M.D. American Red Cross Arlington, VASteven Kleinman, M.D. American Association of Blood Banks LosAngeles, CASusan Stramer, Ph.D. American Red Cross Atlanta, GA
The following CDC staff members prepared this report:Eve M. Lackritz, M.D.Robert S. Janssen, M.D.Helene D. Gayle, M.D., M.P.H.Division of HIV/AIDS PreventionNational Center for Prevention ServicesCharles A. Schable, M.S.Harold W. Jaffe, M.D.Division of AIDS, STD, and TB Laboratory ResearchNational Center for Infectious Diseasesin collaboration withJay S. Epstein, M.D.Paul A. Mied, Ph.D.Sharon J. Geyer, Ph.D.Office of Blood Research and ReviewCenter for Biologics Evaluation and ResearchFood and Drug Administration
U.S. Public Health Service Guidelines for Testing and CounselingBlood and Plasma Donors for Human Immunodeficiency Virus Type 1Antigen
Summary
This report provides PHS guidelines for a) interpretingp24-antigen-assay results, b) counseling and follow-up of blooddonors who have positive or indeterminate p24-antigen-test results,and c) using p24-antigen testing in settings other than bloodbanks.
INTRODUCTION
P24-ANTIGEN-TEST ALGORITHM AND INTERPRETATION OF TEST RESULTS
DONOR COUNSELING, FOLLOW-UP, AND DEFERRAL
Donors Who Have Positive P24-Antigen-Test Results
IMPLICATIONS FOR OTHER HIV TEST SITES
If Officials Can Test For Hiv In Blood Why Dont They Allow Anyone To Donate And Then Destroy Tainted Units
Every donated unit of blood undergoes a rigorous series of tests to determine any possible presence of HIV, hepatitis, syphilis and other blood-borne disease. None of these tests, however, are 100 percent accurate, and they can produce faulty results. For instance, despite current restrictions and testing of approximately 12 million units donated each year, 10 HIV-infected units have slipped through. To ensure the safety of blood and other tissues for donation, the FDA uses scientific data to automatically defer certain populations. Because gay and bisexual men have higher incidence of disease, they are eliminated from the donor pool immediately.
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How And Where To Donate
The need for blood donation is critical and ongoing. From the time of donation, blood can be stored in a refrigerator for only 42 days. Moreover, blood centers typically run out of types O and B, placing patients with these blood types at risk during public health emergencies.
If you are least 16 years of age in most states, are in good health, and weigh at least 110 pounds, you are eligible to be considered as a blood donor. You can find where to donate blood near you by accessing the American Red Cross website.
From start to finish, the blood donation process takes around the hour, including 10 minutes to draw one pint of blood.
How Do I Know If The Blood Transfusion/transplant Im Receiving Is Safe
In most cases, its fine to assume the blood product you are receiving is safe. But if you are worried, it is your right to ask the healthcare professional whether it has been tested for HIV or not.
Blood donors are asked a set of standard questions just before donating blood to help determine if they are in good health or if they have been at risk of HIV infection in the past.
Some groups of people who are considered more statistically at risk of HIV infection are not eligible to donate blood products in some countries – either for set time periods or for life. These groups include:
- Men who have sex with men
- Sex workers
- People who inject drugs
If you fall into one of these groups of people, and you want to donate blood, talk to your healthcare professional who can advise you on whether its safe and legal to donate blood or not.
Other activities may also require you to postpone your blood donation, such as having a tattoo or body piercing or if you are living with a certain health condition.
If you want to know more about donor eligibility, check the guidelines in your country as they are different all over the world.
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Important Information About Your Test Results
The tests performed on your donation have given positive results for the antibodies and the virus particles in your blood, which means that you are infected with HIV. Antibodies are the body’s reaction to infection, but unlike antibodies to other infections, HIV antibody is unable to overcome the virus and eliminate it from the body. Because the virus is also in the blood, it can be passed on to the recipient of blood transfusion. The tests do not give any information about when or how you became infected, or the state of your immune system. The positive test result does not mean that you have AIDS. Other tests must be performed which will give much more information about your health.
Your test results are regarded as strictly confidential and will not be disclosed to anyone without your consent. However, we could refer you to a hospital or an HIV/AIDS centre for further medical care and treatment. Furthermore, you are infectious to your sexual partner and should seek treatment for both yourself and your partner. If you do not want to, or are unable to inform your partner, the HIV/AIDS centre may be able to help you with that.
We advise you to think very carefully before telling anyone, particularly in the first few days after hearing the news, when the initial reaction may be to take others into your confidence without thinking of the possible consequences.
Art And Science Of Keeping Hiv Out Of The Blood Supply
Richard Kaufman ART and science of keeping HIV out of the blood supply. Blood 2020 136 : 12231224. doi:
In this issue of Blood, Grebe et al report that changing the US blood donation policy for men who have sex with men from an indefinite deferral to a deferral of 12 months from last sex did not significantly increase the risk of transfusion-transmitted HIV. In an accompanying article, Custer et al demonstrate that HIV-positive individuals on antiretroviral therapy and individuals taking HIV preexposure prophylaxis are donating blood, potentially increasing the risk of transfusion-transmitted HIV.
HIV window period. Following HIV infection, HIV RNA becomes detectable by standard NAT after 9 to 10 days . HIV antibody is detectable by immunoassay after 21 days . Blood donations made in the HIV NAT window period are responsible for most of the residual risk of transfusion-transmitted HIV. Adapted from Busch with permission from the author and publisher.
HIV window period. Following HIV infection, HIV RNA becomes detectable by standard NAT after 9 to 10 days . HIV antibody is detectable by immunoassay after 21 days . Blood donations made in the HIV NAT window period are responsible for most of the residual risk of transfusion-transmitted HIV. Adapted from Busch with permission from the author and publisher.
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Why Blood Donation Is Important
Since there is not an artificial substitute for blood, physicians rely on blood donation to save the lives of approximately 4.5 million people each year.
Blood transfusions are used in surgery, for traumatic injuries, cancer patients, chronic diseases, and for those with blood disorders such as sickle cell anemia and hemophilia.
Medical facilities rely on a consistent supply of blood from donors to meet the needs of its patients and to ensure they are prepared for emergencies.
What Is The Current Federal Policy On Gay And Bisexual Men Donating Blood
On April 2, 2020, the Food and Drug Administration announced that it was updating its policy regarding blood donations from men who have sex with men , reducing the deferral period from 12 months to three months. Blood centers nationwide screen potential donors by asking a set of questions written to determine risk factors that could indicate possible infection with a transmissible disease, such as HIV or hepatitis. According to the Food and Drug Administration, this pre-screening eliminates up to 90 percent of donors who may be carrying a blood-borne disease.
On June 8, the American Red Cross implemented the changes to donor eligibility criteria announced earlier this spring by the FDA. They encourage individuals who believe they may now be eligible to give under the new guidelines to visit RedCrossBlood.org to learn more about donor eligibility requirements that help ensure the safety of both blood donors and blood recipients.
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Continue Learning About Hiv And Aids
Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.
Can Hiv Be Transmitted Through Blood Transfusions
Yes but this is very rare. In the unlikely event that a person who is HIV-positive donates blood products that are not tested, the person who receives the blood product is likely to develop an HIV infection too.
If youre thinking about donating blood but are not sure about your HIV status, you can request an HIV test in advance of donating at your local clinic.
In order to prevent this, international health regulations require all blood products, such as organs or tissues, to be screened for a number of viral or bacterial contaminations before they are used.
During the screening process any blood products which contain HIV, hepatitis B, hepatitis C, or syphilis will be disposed of.
This means that the transmission of HIV through blood products is very rare, but examples have occurred in some low-income countries which lack the equipment to test all blood.
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About Blood Donation Rules
While all blood donations are screened for HIV before they enter the blood pool, all laboratory tests have a window period in which very recent HIV infections cannot be detected. For the most sensitive RNA assays used by blood collection agencies, this may be between 10 and 16 days. As a result, a small number of infected samples still make it through. Since men who have sex with men have much higher rates of HIV than the general population, regulators have generally asked MSM not to donate blood. Many gay and bisexual men feel that such restrictions are stigmatising and discriminatory.
In 2015, US policy changed from a lifetime ban on donations from any man who reported having sex with another man after 1977, to a 12-month deferral period. This means that men who last had sex with another man more than a year ago are eligible to donate blood, while men who have had sex more recently are not.
The policy remains controversial, with some advocates arguing that more detailed questions about sexual behaviour could be asked of all donors, that the deferral period is far longer than the window period of any test and that restrictions are counter-productive given the shortage of blood donors.
Art And Prep May Present Challenges In Detecting Hiv Infection In Blood Donations
While antiretroviral drugs and pre-exposure prophylaxis are effective tools to help reduce the burden of HIV, a new study published in Blood cites their use by blood donors as a potential cause for concern, as it may hinder the detection of HIV in donated blood. According to the study, approximately 15% of HIV-positive individuals who donated blood took ARVs within days of donation, and nearly 5% of men who have sex with men who donated blood reported taking PrEP within the same period as blood donation.
Use of antiretroviral therapy causes HIV-infected persons to exhibit modified biomarkers of infection such as undetectable RNA by nucleic acid test/viral load assays and may result in undetectable antibodies by third- and fourth- generation serological screening assays, the authors, led by Brian Custer, PhD, MPH, from the University of California San Francisco, explained. In addition to suppression of viremia, ART is known to alter biomarkers of HIV infection progression and may result in antibody seroreversion, the ability to detect HIV infection through current blood donation screening.
Simultaneously, the investigators screened the blood donor samples from male infection-nonreactive first-time blood donors for the presence of ARV drug analytes, focusing on emtricitabine and tenofovir. De-identified blood donations from MSM with self-reported PrEP use during a close timeframe to donation also were assessed.
The authors report no relevant conflicts of interest.
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