Re: Donating Blood - FDA2

JK Sinrod is wondering about this subject:

> I was told today by the blood center rep, that you need to be in
> cancer "remission" for 2 years to donate blood. I always thought
> it was more like 5 years? Anyone have any experience with this?


Blood

The FDA is responsible for ensuring the safety of our nation's blood
supply. The Center for Biologics Evaluation and Research (CBER)
regulates the collection of blood and blood components used for
transfusion or for the manufacture of pharmaceuticals derived from
blood and blood components, such as clotting factors, and establishes
standards for the products themselves. CBER also regulates related
products such as cell separation devices, blood collection containers
and HIV screening tests that are used to prepare blood products or to
ensure the safety of the blood supply. CBER develops and enforces
quality standards, inspects blood establishments and monitors reports of
errors, accidents and adverse clinical events. CBER works closely with
other parts of the Public Health Service (PHS) to identify and respond
to potential threats to blood safety, to develop safety and technical
standards, to monitor blood supplies and to help industry promote an
adequate supply of blood and blood products. 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.

Over a period of years, FDA has progressively strengthened the
overlapping safeguards that protect patients from unsuitable blood and
blood products. Blood donors are now asked specific and very direct
questions about risk factors that could indicate possible infection with
a transmissible disease. This "up-front" screening eliminates
approximately 90 percent of unsuitable donors. FDA also requires blood
centers to maintain lists of unsuitable donors to prevent the use of
collections from them. Also, blood donations are now tested for seven
different infectious agents. In addition to strengthening these
safeguards, FDA has significantly increased its oversight of the blood
industry. The agency inspects all blood facilities at least every two
years, and "problem" facilities are inspected more often. Blood
establishments are now held to quality standards comparable to those
expected of pharmaceutical manufacturers.

In 1997, the FDA initiated the Blood Action Plan <blood/bap.htm> to
increase the effectiveness of its scientific and regulatory actions, and
to ensure greater coordination with our PHS partners. The plan was
adopted by DHHS and is revised as new concerns emerge. As biological
products, blood and blood products are likely always to carry an
inherent risk of infectious agents. Therefore, zero risk may be
unattainable. The role of FDA is to drive that risk to the lowest level
reasonably achievable without unduly decreasing the availability of this
life saving resource.

*Advisory Committees*

* Blood Products Advisory Committee
* Transmissible Spongiform Encephalopathies Advisory Committee
* Advisory Committee on Blood Safety and Availability (HHS)
<http://www.hhs.gov/bloodsafety/>


*Compliance and Surveillance <compliance.htm>*


*Establishment Registration*

* Blood Establishment Registration and Product Listing (BER)
* Blood Establishment Registration and Product Listing (BER)
Public Query Application
* NIH Human Embryonic Stem Cell Registry

*Forms* <http://www.fda.gov/opacom/morechoices/fdaforms/CBER.html>

*Frequently Asked Questions*

*ISBT Label*

*Product Listings*

*Publications*

* Consumer Update - Have You Given Blood Lately?
<http://www.fda.gov/consumer/updates/blooddonations100407.html>
* Consumer Update - Vital Facts About HIV Home Test Kits
<http://www.fda.gov/consumer/updates/hivtestkit012908.html>
* Guidances & Guidelines
* Information Sheets
* Memoranda to Blood Establishments
* Overview of the Regulation of Biological Products
* Review Checklist
* Rules - Proposed and Final

*Safety*

* Biological Product Deviation Reporting
<http://www.fda.gov/cber/biodev/biodev.htm>
* Blood Action Plan
* Bovine Spongiform Encephalopathy (BSE)
* Disseminated intravascular coagulation associated with acute
hemoglobinemia or hemoglobinuria following Rho(D) immune globulin
intravenous administration for immune thrombocytopenic purpura
* Keeping Blood Transfusions Safe: FDA's Multi-layered Protections
for Donated Blood)
<http://www.fda.gov/opacom/factsheets/justthefacts/15blood.html>
* Mercury in Plasma-Derived Products
* Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From
Plasma-Derived Products
* Reporting Adverse Events and Product Deviations
<http://www.fda.gov/cber/aereporting.htm>
* Safety of Albumin Administration in Critically Ill Patients
* Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) (Workshop)
* Severe Acute Respiratory Syndrome (SARS) Information
* Testing for Malarial Infections in Blood Donors (Workshop)
* Transfusion Related Acute Lung Injury
* Transfusion Related Fatalities and Donation Related Deaths
<http://www.fda.gov/cber/transfusion.htm>
* West Nile Virus & Blood Safety

Updated: May 28, 2008
FDA Home Page <http://www.fda.gov/default.htm>


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