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Have You Given Blood Lately? by FDA

Discussion in 'Action Alerts and Advocacy' started by *GG*, Oct 20, 2010.

  1. *GG*

    *GG* senior member

    Concord, NH

    Get Consumer Updates by E-mail2

    On this page:

    FDA Oversight

    Five Layers of Safety

    Ongoing Safety Efforts

    The Process of Donating Blood

    Am I Eligible to Donate Blood?
    Every day, hospitals throughout the United States are challenged by large numbers of people who need blood. These people include victims of fires, motor vehicle accidents, and other emergencies.

    But it's not just accidents or trauma that prompt the need for blood. Blood is required for many people, ranging from those with life-threatening illnesses to others undergoing routine surgeries.

    In fact, every two seconds, someone in America needs blood. This includes

    cancer patients undergoing chemotherapy

    people with sickle cell disease or other types of inherited anemia

    organ transplant recipients

    people undergoing elective surgery

    women during and following labor and delivery

    "Blood products are often lifesaving or life-enhancing," says Karen Midthun, M.D., director of the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER). "FDA strongly encourages people who are in good health to donate blood and to become regular blood donors.

    FDA Oversight
    FDA, through CBER, is responsible for ensuring the safety of the more than 15 million units of blood and blood components donated each year in the United States. FDA's standards and regulations regarding blood donor selection, blood donation, and processing help protect the health of both the donor and the recipient.

    “Some people are concerned that they might get an infection by donating blood,” says Midthun. “Donating blood is a safe procedure.”

    FDA’s oversight of the blood industry includes

    approving licenses for blood products

    approving devices used for blood collection and infectious disease testing

    developing and enforcing quality standards

    inspecting all blood facilities at least every two years

    inspecting “problem” facilities more often

    monitoring reports of errors and adverse events

    taking regulatory or legal actions if problems are found

    Five Layers of Safety
    FDA’s blood safety efforts focus on minimizing the risk of transmitting infectious diseases, while maintaining an adequate supply of blood for the nation. “While a blood supply with zero risk of transmitting infectious disease may not be possible, the blood supply is safer than it has ever been,” says Midthun.

    This safety record is based on five layers of overlapping safeguards:

    Donor screening. Donors are asked specific and direct questions about their medical history and other factors that may affect the safety of their blood. This “up-front” screening eliminates ineligible donors.

    Donor deferral lists. Blood establishments must keep current a list of deferred donors. They must also check all potential donors against that list to prevent the use of blood from deferred donors.

    Blood testing: After donation, blood establishments are required to test each unit of donated blood for the following infectious disease agents:
    Hepatitis B

    Hepatitis C

    Human immunodeficiency viruses (HIV) 1 and 2

    Human T-cell lymphotropic viruses (HTLV) I and II

    Treponema pallidum, which causes syphilis

    In addition, FDA recommends that each unit of donated blood used for transfusion be tested for the West Nile virus.

    Quarantine. Donated blood must be quarantined until it is tested and shown to be free of infectious agents.

    Problems and deficiencies. Blood centers must investigate manufacturing problems, correct all deficiencies, and notify FDA when product deviations occur in distributed products.

    If a violation of any one of these safeguards occurs, the blood product is considered unsuitable for transfusion and is subject to recall.

    Ongoing Safety Efforts
    Emerging threats to the blood supply and other potential risks mean FDA’s Blood Safety Team never stops looking for ways to improve blood safety. “We need to continually work to preserve the safety and integrity of blood and blood products,” says Midthun.

    FDA scientists are working to develop sensitive donor screening tests to detect emerging diseases and bioterrorist agents in blood donations. They are also working to improve blood donor testing kits to detect variant strains of HIV, West Nile virus, and hepatitis viruses. In addition, FDA’s Office of Blood Research and Review regularly looks at donor deferral issues to update eligibility requirements when appropriate.

    Also, FDA is a member of an interorganizational task force on domestic disasters and acts of terrorism that includes blood organizations, government agencies, and device manufacturers. As such, it works with others to help assure that blood facilities keep safe and adequate inventories at all times in case of a disaster.

    The Process of Donating Blood
    Blood is critically needed every day, yet only a small percentage of the eligible U.S. population donates blood in any given year.

    The entire procedure takes about an hour and includes

    registering at the donation site

    answering questions about your health and travel history

    getting a limited physical examination

    donating the blood (This takes about 15 to 20 minutes)

    having a light refreshment to boost your energy level before leaving the facility

    Am I Eligible to Donate Blood?
    To meet the basic requirements for giving blood, you must be healthy (feel well and be able to perform normal activities) and

    have a blood pressure within normal limits

    have a normal temperature

    be free from acute respiratory diseases

    be at least 16 years old

    have a normal blood hemoglobin level

    not have donated blood in the last 56 days

    A number of conditions, which will be discussed with you at the donation site, may cause you to be temporarily or permanently ineligible to give blood. These conditions include

    not feeling well

    past use of needles to take drugs that were not prescribed by a health care professional

    being a male who has had sexual contact with another male since 1977

    getting tattooed in the last year (unless done under sterile conditions and at a state-licensed facility)

    living in or visiting certain countries during designated periods of time; for example, living for a period of time in a country where bovine spongiform encephalopathy (also known as mad cow disease) is found, or visiting an area where malaria is found.

    The rules for eligibility are less strict when making donations before surgery for your own use (autologous donations).

    This article appears on FDA's Consumer Updates page4, which features the latest on all FDA-regulated products.

    Revised October 19, 2010
  2. RivkaRivka

    RivkaRivka Senior Member

    so i see nothing here about people with cfs. right?
  3. glenp

    glenp "and this too shall pass"

    Vancouver Canada suburbs
  4. Wayne

    Wayne Senior Member

    Ashland, Oregon
    I didn't read all the information, but did a quick search of "cfs" and didn't find it. So, I don't understand why this was posted. Could you provide a little context?

    Thanks much.

  5. Valb626


    Barfing at the irresponsibility.

    Wayne, it's irresponsible and posted because there's such a HUGE likelihood that 100's of thousands of people have been and are being exposed to a nasty previously unrecognized retrovirus that's likely the thing that's making us sick.

  6. *GG*

    *GG* senior member

    Concord, NH

    The poor unknowing public, these hacks are like nothing to see here, all is "Safe", just carry along as usual people!
  7. *GG*

    *GG* senior member

    Concord, NH
    Yeah, Wayne, the FDA could not find XMRV correct? and they are "safeguarding" the blood supply? Do you feel confident?!

    This was sent to me in an email, this is information they are disseminating to the public! Not a word on XMRV etc... Perhaps grossly irresponsible?!

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