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» LymeNet Flash » Questions and Discussion » Medical Questions » American Red Cross Fined $4.2 million by FDA over Blood Collection Practices

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Author Topic: American Red Cross Fined $4.2 million by FDA over Blood Collection Practices
treepatrol
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I read this in the local newspaper last week.

10 Sep 2006
American Red Cross Fined by FDA over Blood Collection Practices

The U.S. Food and Drug Administration has charged the American Red Cross yet again with a whopping fine because they did not adhere to the stipulation of safe blood collection techniques. The Red Cross (ARC), which is responsible for nearly 45 percent of the nation's requirement of blood, has been under the vigilance of the government since 1993, to adopt adequate measures to make the blood safe by enhancing the quality control system.

This fine slapped on the Red Cross is to the tune of $4.2 million. 'The safety of the blood supply is extremely important,' said Margaret Glavin, the FDA's associate commissioner for regulatory affairs. 'The safety of the blood supply requires a rigorous quality control system at all points along the supply chain,' she added.

According to her, the FDA has instructed ARC to audit its quality assurance system and to quote the words of Glavin, 'FDA does not consider the current situation acceptable. It is not acceptable that the quality system has failed in this way. We will continue to work to make sure that the quality system is improved in its design and in its implementation so that these kinds of problems do not continue to occur.
From:
American Red Cross Fined by FDA over Blood Collection Practices

They dont go into details here as much as they did in the paper artical last week in that artical it states some of the reasons one was letting people donate blood who have traveled to other countries that have major outbreakes of malaria and other nasty diseases.

So much for screening the bad out how about this country lyme, babsiosis,and other assorted nasties geez! [loco]

[ 13. September 2006, 11:04 AM: Message edited by: treepatrol ]

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Do unto others as you would have them do unto you.
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Posts: 10564 | From PA Where the Creeks are Red | Registered: Jun 2003  |  IP: Logged | Report this post to a Moderator
lymemomtooo
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Tree, I had a friend recently taking abx for the bite of a lone star tick..Of course they aren't in MD..Right..

He is a regular donor..I took him some literature and he said I am to donate next week..He called to cancel and they told him it was ok to donate!!! That unless he was into aggressive abx that it was ok..

Thank God, he has a brain and told them he would not take a chance giving this to someone else.

And he has been lyme positive in the past with Bell's palsy and never was told not to donate.

So I think yes, many people may be getting this without knowing they had a tick bite..They may be getting a transfusion bite..

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treepatrol
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Good for your friend!!! not donating when he new it would spread.
They better wake up they {ARC} are going to lose all confidence in them.

And we need good clean blood suply's badly but not badly enough to infect people.

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Do unto others as you would have them do unto you.
Remember Iam not a Doctor Just someone struggling like you with Tick Borne Diseases.

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Virgil and Mary
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Treepatrol,

Very good point! Getting a blood transfusion these days is like playing Russian Roulette not knowing if the gun is loaded or not.

Definitely not what you want to do unless your life depended on it. And if it did (Who else gets a blood transfusion?)your immune system would definitely be compromised and you would be vulnerable to anything that blood might contain.

The Red Cross knows this (or should) and it is to their shame that they are not being more diligent.

And likewise the FDA for not being more selective in the guidelines they set.

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Virgil and Mary

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KMP
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Amen!!

Since getting this disease I have gotten back into reading articles about politics and health.

Cave, you are right...this is the mid 80's all over again, just with a different disease! [cussing] Since that time I have never trusted Red Cross. I have been donating to a state Blood bank (till I found out I had Lyme), but they also did not have any questions on the questionare relating to Lyme or ticks! I have been thinking I should get with my state Lyme Assoc to see if they have spoken or presented any literaature to this blood bank, but have been too busy learning about my disease and trying to make decisions about the direction of my medical care.

Mary & Virgil...I have been thinking that maybe the Jehovah Witnesses aren't wrong on this point....no blood transfusions! [Frown]

Are there any documented cases of Lyme from a transfusion. I believe there are probably cases, but they are probably misdiagnosed and/or not under the care of a LLMD, so there will be no documentation in those cases. [toilet]

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God's mercies are new every morning.

Karla

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Carol in PA
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Tree,
This is interesting.
After all I've learned, I hope I'm never in the situation of needing a blood transfusion.

Also, I'm removing the "Organ Donor" info from my driver's license.

Carol

Posts: 6947 | From Lancaster, PA | Registered: Feb 2004  |  IP: Logged | Report this post to a Moderator
bettyg
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Also if you signed a written paper to donate organs, tissue, blood, etc. notify them in WRITING you are VOIDING that paper due to your chronic lyme.

In LYME UPDATE: SCIENCE, POLICY, & LAW; it states the American Red Cross goes by the Dept. of Defense's rules:

If you have been free of lyme symptoms for 12 months, you CAN DONATE BLOOD! This isn't verbatim but from my lyme memory!

WRONG WRONG WRONG!

If you are going to have surgery, donate blood FOR YOURSELF, and have it clearly marked to SAVE FOR YOURSELF. DISCARD IT IF YOU DO NOT NEED IT!

I taped a NO on my driver's license organ donator until next time I renew my license.

See Treepatrol's newbie links for more comments.

We do NOT want to donate any part of our body! You wouldn't want anyone getting what WE HAVE; would you? Not me!!
Bettyg [cussing]

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treepatrol
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Good points Cave!!! [woohoo]

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Do unto others as you would have them do unto you.
Remember Iam not a Doctor Just someone struggling like you with Tick Borne Diseases.

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Posts: 10564 | From PA Where the Creeks are Red | Registered: Jun 2003  |  IP: Logged | Report this post to a Moderator
northstar
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I was in conversation with a lady last week. She mentioned being anemic, and having to "prime" her diet with iron rich foods to get the minimum hemog. count to donate.

Through later conversation, also I found out she had GERD (with surgery), fibromalygia, insomnia, neuropathy, etc.

Her blood is in the national blood supply now.

I later brought her literature (lymepa.org booklet) and doctor referral name to be checked for lyme.


Northstar

Posts: 1331 | From hither and yonder | Registered: Sep 2005  |  IP: Logged | Report this post to a Moderator
   

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