

HHS weighs accepting men who have sex with men as blood donors
The Health and Human Services Department (HHS) is seeking comments on designing a pilot program to create “alternative donor deferral criteria” for gay men.
Currently, men who have had sex with other men (MSM) since 1977 cannot donate blood due to “higher levels of certain transfusion-transmissible infections” among that population, the notice explains. Members of Congress’s interest and increased accuracy among donor testing have made the department reconsider the ban.
“[T]he increased effectiveness of donor testing for [Human Immunodeficiency Virus (HIV)], [Hepatitis B Virus (HBV)], syphilis and other infectious agents has greatly enhanced blood safety,” the department states in the notice, which will be published in the Federal Register Tuesday.
“As a result, questions have been raised about the need to continue an indefinite deferral of all MSM and whether there could be blood donation by MSM who may not be at increased risk.”
HHS specifically is calling on the public to evaluate how the department could design an “innovative and cost effective” pilot program to evaluate “alternative blood donor acceptance criteria for MSM.”
The department’s goal “is to conduct a ... study, in which MSM who meet specified criteria would be permitted to donate blood, with additional safeguards in place to protect blood recipients during the course of the study.”
In addition, the risk of infection from a blood transfusion is “extremely low,” with less than one in 1 million units transfused causing HIV infections and less than one in 280,000 units transfused causing HBV, the department explained.
Despite this information, the department still has concerns regarding the switch in policy to allow gay men to donate. There is a “theoretical concern” that donors at higher risk of being infected by sexually transmitted diseases could also be at higher risk to receive future “sexually and blood transmitted infections” that cannot be identified through existing tests.
But the department has received positive feedback from advisory committee meetings, public hearings, advocacy groups and congressmen, prompting HHS to move forward on the potential pilot program.
Certain “funded studies” are already occurring that will “help re-evaluate the ... deferral policy.”
The studies examine existing and potential problem areas for inappropriate releases of blood with current and possible donor policies. Other reviews are investigating the prevalence of different pertinent infections and donor understandings and actions involving blood history questionnaires, among other issues.
The comment period will be open for 90 days, starting Tuesday.








