Following Germany’s tainted blood scandal last year, Horst Seehofer,
the federal health minister, and the health ministers of the 16 German states
have issued a set of recommendations for improving the safety of blood
products. If all the measures are implemented, they will be the strictest
The move comes after last year’s revelations that a small German company
failed to follow proper purification procedures and marketed blood products
contaminated with HIV. The scandal led German medical organisations to demand
that the government tighten up the regulations.
One of the difficulties in guaranteeing that blood is free from HIV
is that it can take six months for someone infected with the virus to test
positive. Since January, one blood transfusion centre in Hamburg has kept
plasma intended for use in making blood products, such as the clotting factors
needed by haemophiliacs, ‘in quarantine’, until the donor has had a second
test after six months and is given the all clear.
Ministers now want this ‘quarantine’ to be mandatory for all plasma
to be used in making blood products in Germany from next January. They
also want to minimise the risk of contamination by introducing strict regulations
on the choice of donors, and by building up a ‘bank’ of regular donors who
are prepared to be tested repeatedly.
To increase the amount of plasma that can be taken from such ‘approved’
donors, the federal health ministry will spend DM1.5 million ( £625
000) on pilot projects testing the further use of plasmaphoresis, in which
only plasma is taken from donors. A donor can give 2.5 times as much plasma
as whole blood in a year.
Germany is the only country in the European Union that allows blood
donation from paid donors. The International Federation of Red Cross Societies
says this can increase the risk of infected blood, by encouraging donations
from more deprived social groups. The health ministers made no mention of
ending this practice, but Seehofer says that within five years it will be
possible for Germany to get all the blood and blood products it needs from
carefully screened regular donors.
However, this will be possible only if German doctors cut the amount
of blood and blood products they use by 20 per cent, says Seehofer. German
doctors prescribe far more blood products than their counterparts elsewhere
in Europe, and officials at the WHO say much of it is unnecessary.