Guidance Title:
Amendment (Donor Deferral for Transfusion in France Since 1980) to “Guidance” for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products”
Status:
Draft guidance
Date of Guidance:
August 2006
Organizations Releasing Guidance:
United States Food and Drug Administration (FDA) and the United States Department of Health and Human Services (HHS)
Link to the Guidance:
http://www.fda.gov/BiologicsBloodBaccines/SafetyAvailability/BloodSafety/ucm095
Target Audience:
Blood collection center personnel and healthcare providers
Laws and Regulations Referenced:
21CFR 607.3 Definitions, November 27, 2002
21CFR 610.41 Donor deferral, August 24, 2007
Definitions:
“Blood and blood product means a drug which consists of human whole blood, plasma, or serum or any product derived from human whole blood, plasma, or serum, hereinafter referred to as ‘blood product’” (21CFR 607.3)
Creutzfeld-Jakob Disease (CJD)-A rare and fatal degenerative disease in humans which has no cure at the present time and is related to, but not the same as, Mad Cow Disease, know as Bovine Spongiform Encephalopathy (BSE), found in cows.
Variant Creutzfeld Jakob Disease (vCJD)-A different type of Creutzfeld-Jakob Disease (BSE)
Donor deferral-The refusal to accept blood products from a potential donor
A blood transfusion-Here, transfer of blood from one person to another
Background:
This amendment was published after new findings were presented at a meeting of the Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC). Studies showed that contaminated meat originating from the United Kingdom (U.K.) during the peak epidemic period caused deaths due to contaminated human blood from transfusions in France (see draft guidance amendment). The incubation period of up to 38.5 years determined the starting date of 1980 as the date after which potential donors should be deferred if they received transfusions in France. Other European countries were not considered as a threat for infection. Non injectable blood products from these donors may be used and should be labelled as such.
Summary:
This draft guidance, when finalized, will act as a means for blood collecting centers to prevent the transmission of CJD/vCJD from blood donors to other persons.
Rationale:
CJD/vCJD is suspected to have infected beef imported to France from the U.K. starting from1980, resulting from an epidemic of BSD in cows. Since cases of BSD transmission have been reported in the U.K. from donors having had blood transfusions in France, FDA has decided to defer potential donors in the U.S. with this history.
Resulting Recommendations:
FDA recommends that blood collection centers defer potential blood donors who have received blood transfusions in France since 1980. However, non injectable products may be used and should be labelled as such.
Impact
This amendment will enable American blood collection centers to prevent patients from being infected with CJD/vCJD. Deaths have already occurred in the U.K. due to this fatal and incurable disease and FDA would like to keep it out of the U.S.
Organizations Releasing Guidance:
United States Food and Drug Administration (FDA) and the United States Department of Health and Human Services (HHS)
Link to the Guidance:
http://www.fda.gov/BiologicsBloodBaccines/SafetyAvailability/BloodSafety/ucm095
Target Audience:
Blood collection center personnel and healthcare providers
Laws and Regulations Referenced:
21CFR 607.3 Definitions, November 27, 2002
21CFR 610.41 Donor deferral, August 24, 2007
Definitions:
“Blood and blood product means a drug which consists of human whole blood, plasma, or serum or any product derived from human whole blood, plasma, or serum, hereinafter referred to as ‘blood product’” (21CFR 607.3)
Creutzfeld-Jakob Disease (CJD)-A rare and fatal degenerative disease in humans which has no cure at the present time and is related to, but not the same as, Mad Cow Disease, know as Bovine Spongiform Encephalopathy (BSE), found in cows.
Variant Creutzfeld Jakob Disease (vCJD)-A different type of Creutzfeld-Jakob Disease (BSE)
Donor deferral-The refusal to accept blood products from a potential donor
A blood transfusion-Here, transfer of blood from one person to another
Background:
This amendment was published after new findings were presented at a meeting of the Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC). Studies showed that contaminated meat originating from the United Kingdom (U.K.) during the peak epidemic period caused deaths due to contaminated human blood from transfusions in France (see draft guidance amendment). The incubation period of up to 38.5 years determined the starting date of 1980 as the date after which potential donors should be deferred if they received transfusions in France. Other European countries were not considered as a threat for infection. Non injectable blood products from these donors may be used and should be labelled as such.
Summary:
This draft guidance, when finalized, will act as a means for blood collecting centers to prevent the transmission of CJD/vCJD from blood donors to other persons.
Rationale:
CJD/vCJD is suspected to have infected beef imported to France from the U.K. starting from1980, resulting from an epidemic of BSD in cows. Since cases of BSD transmission have been reported in the U.K. from donors having had blood transfusions in France, FDA has decided to defer potential donors in the U.S. with this history.
Resulting Recommendations:
FDA recommends that blood collection centers defer potential blood donors who have received blood transfusions in France since 1980. However, non injectable products may be used and should be labelled as such.
Impact
This amendment will enable American blood collection centers to prevent patients from being infected with CJD/vCJD. Deaths have already occurred in the U.K. due to this fatal and incurable disease and FDA would like to keep it out of the U.S.
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