Proposed changes to current FDA blood donor regulations
1) NO ONE should be banned or turned away from donating blood. This enforces lying and falsifying information to prevent disclosure of personal affairs. By denying someone the right to give their blood a social stigma is placed on that person for the reason of being refused to donate.
2) Pre-donor screening interviews should not be conducted live with another person. All forms and risk identification measures need to be completed online or computer based to ensure total confidentiality for same reasons as stated above.
3) Population demographics and lifestyle behavior need to be re-evaluated on a 3-5 year basis to determine significant changes in high risk populations. This should be completed individually by states department of health and reported to the FDA to develop risk stratification model based on the region demographics of infected population. The high risk population is going to vary across the country.
4) Assign every donor a confidential collection bag with a level of risk (only identifiable by bar code) based off their pre-screening answers. Inform recipient of donated blood the level of risk labeled on the bag, and give them or the person responsible to make emergency medical decisions the right to choose whether or not patient will receive blood. All blood supplies should be used by lowest risk first and taken from higher risk levels when supplies are low.
5) The level of risk associated with past sexual behaviors needs to be determined according to number of sexual partners, as well as the number of encounters and whether or not each partner engaged in similar behavior with others Further considerations need to include time frame since donor last engaged in risky sexual behavior, as well as the frequency of those behaviors in their lifetime.
6) Similar levels of risk need to be established among IV drug users.
7) No state or private clinic shall ever be permitted to offer incentives to blood donors, whether it is cash, favors, or small goods. Donors should not be enticed to attend for reasons other than donating blood.
8) In the end It needs to be understood that no matter how effective screening measures are in identifying high risk individuals, there are going to be hundreds if not thousands of infected samples being collected yearly. Majority of women who become infected are not even aware until the first sign of illness. By then how many times do you think it is possible for that female and her husband/boyfriend to have successfully donated at a red cross blood drive from the time their husband/boyfriend infected them.
9) Unless you remove the regulation that bans individuals from donating blood there should not be any blood drives conducted among US Military officials from any of the branches of the United States Military. By enforcing a ban of donors based on specific lifestyle behavior and a law encouraging US soldiers to deny homosexual identity, how many are providing blood donations multiple times a year?
We thank you for taking the time to read over our proposed changes and any consideration given is greatly appreciated.
Yours Truly,
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