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Commission Directive 2004/33/ECShow full title
Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (Text with EEA relevance)
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- Revised 09/01/20150.28 MB
- Revised 13/04/20110.73 MB
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Changes over time for: PART A
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PART AU.K.Information to be provided to prospective donors of blood or blood components
1.Accurate educational materials, which are understandable for members of the general public, about the essential nature of blood, the blood donation procedure, the components derived from whole blood and apheresis donations, and the important benefits to patients.U.K.
2.For both allogeneic and autologous donations, the reasons for requiring an examination, health and medical history, and the testing of donations and the significance of ‘informed consent’.U.K.
For allogeneic donations, self-deferral, and temporary and permanent deferral, and the reasons why individuals are not to donate blood or blood components if there could be a risk for the recipient.
For autologous donations, the possibility of deferral and the reasons why the donation procedure would not take place in the presence of a health risk to the individual whether as donor or recipient of the autologous blood or blood components.
3.Information on the protection of personal data: no unauthorised disclosure of the identity of the donor, of information concerning the donor's health, and of the results of the tests performed.U.K.
4.The reasons why individuals are not to make donations which may be detrimental to their health.U.K.
5.Specific information on the nature of the procedures involved either in the allogeneic or autologous donation process and their respective associated risks. For autologous donations, the possibility that the autologous blood and blood components may not suffice for the intended transfusion requirements.U.K.
6.Information on the option for donors to change their mind about donating prior to proceeding further, or the possibility of withdrawing or self-deferring at any time during the donation process, without any undue embarrassment or discomfort.U.K.
7.The reasons why it is important that donors inform the blood establishment of any subsequent event that may render any prior donation unsuitable for transfusion.U.K.
8.Information on the responsibility of the blood establishment to inform the donor, through an appropriate mechanism, if test results show any abnormality of significance to the donor's health.U.K.
9.Information why unused autologous blood and blood components will be discarded and not transfused to other patients.U.K.
10.Information that test results detecting markers for viruses, such as HIV, HBV, HCV or other relevant blood transmissible microbiologic agents, will result in donor deferral and destruction of the collected unit.U.K.
11.Information on the opportunity for donors to ask questions at any time.U.K.
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