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.”



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The extending of the donor field has been brought on for several reasons. New technology allows for more accurate donor testing, potentially eliminating the need to “continue an indefinite deferral” of this donor category, the department states.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.