Who's
Really At Risk?
FDA fines Red Cross another $4.6 million
By KEVIN FREKING, Associated Press Writer
WASHINGTON - The Food and Drug Administration has
fined the Red Cross an additional $4.6 million for
the distribution of "unsuitable blood
products," bringing penalties against the
organization to more than $19
million in recent years.
The FDA issued a letter Wednesday stating that it
reviewed 113 recalls
of blood products by the Red Cross from April 2003
to April 2006. The
recalls involved the release of an estimated 4,094
unsuitable blood
components.
Agency officials noted that having to conduct a
recall shows that safety
protocols were breached. For example, a donor may
not have been
appropriately asked about international travel or
intravenous drug use.
FDA spokeswoman Peper Long said the agency didn't
find any evidence of
serious health consequences as a result of the
safety breaches.
Red Cross officials said it was taking several steps
to find problems in
the collection and distribution of blood supplies.
It's increasing
supervision at blood drives and consolidating
processing facilities. Its
goal is to meet the FDA's standards for quality and
safety, officials
said.
"It takes time and it takes resources, but we're
committed to doing
whatever's necessary to meet that goal," said Red
Cross spokeswoman
Stephanie Millian.
Millian stressed that the fine would not be paid
through donations but
through the operating fees that it charges those who
get blood units,
such as hospitals.
The latest fine is being added to a tally of nearly
$15 million in
previous FDA penalties for violation of blood-safety
laws, regulations
and the terms of a 2003 consent decree.
That settlement resolved charges that the Red Cross
had committed
"persistent and serious violations" of federal blood
safety rules dating
back 17 years.
In 2004, the Red Cross implemented a plan, with the
FDA's blessing, to
detect, investigate, monitor and correct the sorts
of problems
repeatedly cited by government investigators.
http://news.yahoo.com/s/ap/20080207/ap_on_he_me/red_cross_blood_fda;_ylt=AlRGxZXgbY.RXFrxduihX71Z24cA
Red Cross
Can't Say What Happened to Suspect Blood
By Pete Winn
CNSNews.com Senior Staff Writer
March 18, 2008
(CNSNews.com) - Compromised, tainted, or
questionable blood may have entered the blood supply
from 2003 to 2006, but the American National Red
Cross can't or won't say for sure.
"I can't give you a yes or no answer -- all I can
say is we are not aware of any adverse reactions,"
Red Cross spokeswoman Stephanie Millian told
Cybercast News Service.
Last month, the U.S. Food and Drug Administration
(FDA) levied more than $4.6 million in fines against
the Red Cross for recalling more than 1,000 units of
unsuitable blood and blood products during those
years.
"To our knowledge, none of the units that were
recalled, or that were transfused prior to the
recall, have caused any adverse reaction or event in
the recipient," Millian said.
The FDA cited the Red Cross for 113 instances of
failure to properly handle blood or keep appropriate
records.
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