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Recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of human immunodeficiency virus transmission by blood and blood products: guidance for industry
Recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of human immunodeficiency virus transmission by blood and blood products: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, May 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Blood Donation
Blood Donors
Blood Transfusion
Donor Selection
Government Regulation
HIV Infections -- prevention & control
Mandatory Testing
United States - Genre(s):
- Guideline
Technical Report - Abstract:
- We, FDA, are issuing this guidance to provide recommendations for evaluating donor eligibility using individual risk-based questions. This guidance provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. We also recommend that you make corresponding revisions to your donor educational materials, donor history questionnaires and accompanying materials, along with revisions to your donor requalification and product management procedures. This guidance supersedes the guidance entitled, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” dated April 2020, updated August 2020 (April 2020 guidance). The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma. The revised recommendations in this guidance reflect the Agency’s current thinking on donor deferral recommendations for individuals with increased risk for transmitting HIV infection. Based on our review of the available science as discussed below, we recommend eliminating the screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Instead, we recommend assessing donor eligibility using the same individual risk-based questions relevant to HIV risk for every donor regardless of sex or gender. In addition, we recommend deferral of any individual taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP)). FDA-approved antiretroviral drugs are safe and effective and can reduce the HIV viral load of individuals to undetectable levels as determined by nucleic acid tests (NAT). However, these antiretroviral drugs do not fully eliminate the virus from the body, and donated blood from individuals infected with HIV taking ART can potentially still transmit HIV to a transfusion recipient. Although undetectable equals untransmissible for sexual transmission, this does not apply to transfusion transmission. Further, the available data demonstrate that the use of PrEP and PEP may delay detection of HIV by currently licensed screening tests for blood donations, potentially resulting in false negative results. We have not changed the other recommendations and donor deferral time periods to reduce the risk of transfusion transmission of HIV from the April 2020 guidance. Based on the Agency’s careful evaluation of the available data, including data regarding the performance characteristics of NAT, FDA expects implementation of these revised recommendations will not be associated with any adverse effect on the safety or availability of the blood supply. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 17 pages))
- NLM Unique ID:
- 9918662585906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918662585906676