The US FDA to revise blood donor criteria. An impetus for Asian countries to

Published on AIDS-ASIA mailing list on December17,2007

Joe Thomas

(AAeF) The US Food and Drug Administration (FDA) proposes to revise and update
the regulations applicable to blood and blood components, including Source
Plasma and Source Leukocytes, to add donor requirements that are consistent with
current practices in the blood industry, and to more closely align the
regulations with current FDA recommendations. Perhaps, the blood transfusion
systems in various Asian countries should take the cue from the FDA's move and
take additional steps to ensure blood safety.

In many Asian countries blood transfusion system is inadequate to ensures the
safety of the donors and the recipients. In the 1990s, hundreds of thousands of
Chinese villagers were infected with HIV through state-run blood collection
centers. A blood safety scandal in Japan forced them to enact a blood law and
amendments in the Pharmaceutical Affairs Law were enforced in 2003 for the
purpose of securing a stable supply of blood based on domestic voluntary
donations and promoting the appropriate use.

1,872 haemophiliacs in Japan were infected with HIV, through transfusion of
contaminated blood and blood products.

About 11%of the male respondents from Hong Kong blood donations centres have
practiced `deferrable risk behaviours' (e.g sharing syringes, commercial sex
networking, or having sex with another man)Lau, Thomas and Lin 2002).

The prevailing severity of stigma and discrimination associated with HIV
infection may be the reason for many to use the blood transfusion centres
discreetly, rather than using HIV testing centres. Studies from Hong Kong and
Japan reported that people visit blood service centers for getting tested on HIV
infection instead of visiting VCT. (Sugimoto et al 2002,Lau, Thomas and Lin
2002)

FDA, believes that developing drastic exclusion criteria may help ensure the
safety of the national blood supply and to help protect donor health by
requiring establishments to evaluate donors for factors that may adversely
affect the safety, purity, and potency of
blood and blood components, or the health of a donor during the donation
process.

The FDA Notice of Proposed Rulemaking discusses the recommendations contained
in current guidance that fall under the proposed regulation, including donor
eligibility and screening for HIV and certain other transfusion-transmitted
infections.

According to FDA, the proposed rule will more explicitly describe donor
eligibility standards and will clarify the relationship between the regulations
and the applicable recommendations. The proposed rule, among other things,
provides for the establishment of minimum criteria for the assessment of donor
eligibility, and the suitability of the donation of blood and blood components.

The rule is expected to have a minor net impact on blood establishments because
it is already usual and customary business practice in the blood industry to
assess donors for eligibility, and donations for suitability. FDA believes the
primary impact of the rule will be the one-time review of current SOPs that the
proposed rule would require each blood collecting establishment to conduct.

FDA is suggesting the blood collection establishments to determine whether a
donor has engaged in social behaviors associated with increased risk of
infection with relevant transfusion-transmitted infections. According to the FDA
good guidance practices
participation in social behaviors associated with relevant
transfusion-transmitted infections would cause the donor to be ineligible to
donate and to be deferred.

Some examples of social behaviors associated with increased risk of exposure to
HIV and viral hepatitis identified in current guidance are men who have had sex
with another man even one time since 1977; exchanging sex for drugs or money; or
intravenous drug use. FDA included assessment of certain social behaviors
because of the risk that testing alone would not detect infection due to testing
error, the early stage of the donor's infection (the window period), or the
donor's low antibody level or intermittent viremia.

Notes and References:

Written or electronic comments on the proposed rule, may be submitted to the
agency until February 6, 2008
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=link\
log&to=http://www.regulations.gov.

Written submissions could be send by FAX: 301-827-6870. Or by mail/Hand
delivery/Courier to Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

U.S. Food & Drug Administration (FDA). http://www.fda.gov/
(http://www.fda.gov/cber/rules/reqbldtrans.htm)

Sugimoto K, Takanishi Y, Nakaishi T, Kimura K, Imai M. Donor select for blood
safety from HIV contamination. Int Conf AIDS. 2002 Jul 7- 12; 14: abstract no.
MoPeD3672.

Lau JT, Thomas J, Lin CK. HIV- related behaviours among voluntary blood donors
in Hong Kong. AIDS Care 2002; 14: 481-49