Blood safety: Time to revise blood donor criteria.

[Guest guest]

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

countries to revise blood safety procedures

Joe

(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, 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, 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, J, Lin CK. HIV- related behaviours among voluntary

blood donors in Hong Kong. AIDS Care 2002; 14: 481-49

Cross posted

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