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From: TSS ()
Subject: FDA Fines American Red Cross $4.2 Million (BLOOD CJD)
Date: September 8, 2006 at 6:04 pm PST

CJD WATCH MESSAGE BOARD
TSS
FDA Fines American Red Cross $4.2 Million (BLOOD CJD)
Fri Sep 8, 2006 20:01
71.248.154.242


FDA Statement
FOR IMMEDIATE RELEASE
Statement
September 8, 2006
Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Fines American Red Cross $4.2 Million for Failure to Meet Established Blood Safety Laws

The U.S. Food and Drug Administration (FDA) announced today that the American Red Cross (ARC) is being fined $4.2 million for failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products. These fines were assessed under an amended 2003 consent decree that calls for significant financial penalties when ARC fails to comply with FDA regulations and consent decree provisions designed to ensure the safety of the nation's blood supply.

The fines stem from a recently completed FDA review of recalls conducted by ARC between 2003 and 2005 that found these events were preventable by ARC. The violations include breaches of Good Manufacturing Practice (GMP) such as a failure to ask appropriate donor screening questions and failure to follow manufacturer test protocols. We have no evidence that these violations resulted in serious health consequences.

Because receiving blood products always carries a degree of risk, it is important that the blood industry complies with the full set of safeguards in Federal laws and FDA regulations to minimize that risk. However, any particular breach of the safeguards does not necessarily translate into unsafe blood products, because the safeguards designed to protect the blood supply are to some extent overlapping. The FDA continues to advise care providers and consumers that rigorous protections are in place and that the blood supply is safe. Patients in need of a transfusion should continue to follow the advice of their physicians. The risks of receiving a transfusion are far less than the risk of failing to receive a transfusion when blood treatment is indicated.

Improvements in donor screening procedures and the use of a variety of new tests in the last few years have made the national blood supply safer from infectious diseases and other risks than it has been at any other time. However, because there is always some degree of risk in receiving blood products, each individual safeguard is considered critical to minimizing that risk. Although the failure of an individual safeguard does not automatically translate into the release of unsafe products, it may increase the potential for risk. It is the potential risk that FDA insists the Red Cross Board of Directors prioritize and support its new management's ability to immediately address and work to improve its approach to quality.

The amended consent decree requires ARC to:

Establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions;
To enhance training programs; and
To improve computer systems, records management, and policies for investigating and reporting problems, including adverse reactions
Since entry of the 2003 consent decree and prior to this action, FDA has issued the American Red Cross seven similar letters and assessed a total of $5.7 million in penalties.

While achieving a blood supply with zero risk of transmitting infectious disease is the ultimate objective, we recognize based on the available science that this may not be realistic. Therefore, the FDA requires blood processors to adopt and strictly follow a multi-layered safety program to protect and enhance the safety of blood products at each stage of their manufacture. At the blood collection stage, these measures generally include:

Accurate and complete educational material for donors so that they can assess their risk and decline to donate if that is appropriate;
Administration of donor screening questions to identify safety risks;
Checking of lists to prevent use of blood from persons known to be ineligible to donate;
Quality controlled infectious disease testing procedures;
Inventory controls to prevent the release of units that are unsuitable;
Appropriate handling and distribution of blood and blood products for patient use; and
Investigation and correction of deviations from standards
ARC is responsible for approximately 45% of the nation's blood supply; other independent community-based blood centers together provide another 45%, and hospitals collect most of the remaining 10%.

Blood donations are critically needed every day to save lives, and blood donation is a safe procedure. FDA encourages persons who are in good health to donate blood and to become regular blood donors.

####

http://www.fda.gov/cber/talkpapers.htm#arc

Red Cross fined $4.2 mln over blood safety

By Lisa Richwine

WASHINGTON (Reuters) - The U.S. government fined the American Red Cross $4.2 million for failing to ask blood donors proper screening questions and skipping other steps meant to keep the blood supply safe, officials said on Friday.

The fine, the largest ever levied by the Food and Drug Administration for a blood safety violation, follows a multiyear battle between the FDA and the Red Cross, which collects about 45 percent of the blood donated in the United States each year for transfusions.

The agency said it had no evidence that any blood collected by the Red Cross harmed people who got transfusions.


But FDA officials said the failure to follow multiple safeguards increased the risk that patients could receive blood tainted by an infectious disease.

"It is not acceptable that the quality systems failed in this way," Margaret O'K. Glavin, FDA associate commissioner for regulatory affairs, told reporters.

The FDA said its investigation found that several Red Cross recalls of blood between 2003 and 2005 could have been prevented if it had taken a series of mandatory steps to ensure donations are free of HIV or other infectious agents.

One way the Red Cross erred was by failing to ask donors about travel history that could increase the chances of having malaria or the human version of mad cow disease, FDA officials said.

The problems involved 12,000 units of blood and blood components, FDA officials said. None of the units was found to be contaminated after they were recalled.

The latest fine was issued as part of a legally binding consent decree reached in 2003 in which the Red Cross promised to improve its blood safety system. Previously, the FDA had fined the organization a total of $5.7 million.

The 2003 deal revised a 1993 agreement that allowed the FDA to fine the Red Cross for blood collection lapses.

The Red Cross said it would review the FDA's letter outlining its new concerns and respond within 20 days.

"American Red Cross's senior management takes (the letter) seriously and is committed to full compliance with the amended consent decree and all applicable federal regulations," the organization said in a statement.


The FDA said the blood supply remained very safe.

http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-09-08T224834Z_01_N08403053_RTRIDST_0_HEALTH-REDCROSS-DC.XML

http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-09-08T224834Z_01_N08403053_RTRIDST_0_HEALTH-REDCROSS-DC.XML&pageNumber=1&imageid=&cap=&sz=13&WTModLoc=NewsArt-C1-ArticlePage1

TSS

----- Original Message -----
From: Terry S. Singeltary Sr.
To: Bovine Spongiform Encephalopathy
Cc: cjdvoice@yahoogroups.com ; BLOODCJD@YAHOOGROUPS.COM ; madcow@lists.iatp.org
Sent: Monday, August 07, 2006 10:28 AM
Subject: [BLOODCJD] MAD COW BLOOD HUMANS RECALL (these are dime a dozen)


CJD WATCH MESSAGE BOARD
TSS
MAD COW BLOOD HUMANS RECALL (these are dime a dozen)
Mon Aug 7, 2006 10:24
71.248.132.189

PRODUCT
a) Red Blood Cells, Recall # B-1587-6;
b) Cryoprecipitated AHF, Recall # B-1588-6;
c) Recovered Plasma, Recal # B-1589-6
CODE
a), b) and c) Unit: 2016719
RECALLING FIRM/MANUFACTURER
Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on
March 13, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and Germany

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;
b) Fresh Frozen Plasma, Recall # B-1591-6
CODE
a) and b) Unit: 2443595
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June
30, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;
b) Fresh Frozen Plasma, Recall # B-1593-6
CODE
a) and b) Unit: 2545596
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on
December 14, 2004 and January 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased
risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________

http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html

these usa mad cow blood for humans are a dime a dozen, the come out just
about every week ;

http://disc.server.com/discussion.cgi?disc=167318;article=2971;title=CJD%20WATCH

http://disc.server.com/discussion.cgi?disc=167318;article=2972;title=CJD%20WATCH

TSS



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