A blood banker who works in Boston inquired about new policies for deferring donors for traveling to Europe. He asked if non-Red Cross blood centers planned to adopt the FDA's recommendations for donor deferral (to 'prevent' blood borne transmission of vCJD), or if they planned to follow the policy the American Red Cross (ARC) will be implementing. Is it felt that the Red Cross' policy will constitute the standard of care?

N.B.The Aug. 2001 FDA document described below has been SUPERSEDED by the Revised FDA Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease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 (PDF file) (Text file)

The following replies were received in response to the above question:

1. The Editor suggests that the e-Network read the following:

• 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Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products (FDA, Aug. 2001) - SUPERSEDED (see above)
• Letter to HHS - Can we afford to lose more donors for a theoretic benefit of preventing vCJD from blood transfusion?
• FDA Briefing Document for June 28, 2001 TSEAC Meeting
• ARC Report of June 28, 2001 TSEAC Meeting
• Next TSE Advisory Committee Meeting (Oct 25-26, 2001)

2. A blood banker in the Northwestern USA reports that ABC has taken the position of supporting the FDA position. However individual Centers are free to make their own decisions.

3. A blood banker in Texas commented that a large south central blood center intends to follow the FDA recommended deferral criteria, even if they differ from ARC.  That center currently does not plan to implement any changes until the FDA issues final rules. The center leadership believes FDA has access to many experts in this field and has made decisions based on best available information.

4. According to Celso Bianco, MD Executive Vice President America's Blood Centers (ABC), 74 of the 75 ABC member center (including the center responding in reply #1) will adopt the FDA recommendations. ABC member centers collected 6.77 million units in 2000. The only center that decided to adopt the ARC approach collects about 40,000 units a year. FDA performed a careful analysis of the theoretical risk of exposure to the vCJD agent by travel, and concluded that its approach offers 91% protection with a donor loss of 4-5%. The ARC approach offers 92% protection with 8-9% donor loss. Obviously, there is no statistical difference between the protection from theoretical risk offered by the two approaches, However, there is a substantial difference in donor loss. ABC members strongly believe that the FDA proposal constitutes an adequate balance between theoretical risk of exposure to the vCJD agent and the real risk of blood shortages, support the FDA recommendation and will adopt the final guidance when issued. ABC members strongly believe that FDA establishes the standard of care. In addition, HemaQuebec, the collecting agency for the Quebec Province in Canada, is a member of ABC and will adopt a deferral policy similar to ARC.  However, Canadian Blood Services, the agency that collects blood in all Provinces of Canada outside Quebec will follow a policy close to that proposed by FDA. It is suggested that interested blood bankers consult the briefing document presented by FDA to the Transmissible Spongiform Encephalopathies Committee on June 28, 2001 (as above). This document describes the FDA analysis of the issue in great detail.

5. A blood banker in Minnesota commented "it would set a very dangerous precedent if any of the non-ARC centers were to simply grant 'deemed status' as it were to any unilateral decisions made by ARC. The concept that ARC policies should become 'standard practice' merely by virtue of the magnitude of ARC or the fact that they collect ~ 50% of the nation's blood, does not hold water in a democracy. If we were to be bullied (by fear of possible litigation) into accepting that concept, we would be surrendering our freedom and independence of decision-making to the 'wisdom' of one private organization or possibly to one dominant person in that organization. I do not think important public policy decision-making should be held hostage in that fashion".

6. A blood banker who works near beautiful beaches warmed by the Gulf Stream commented that her facility plans to implement the FDA guidance. Her center may implement the guidance sooner than the FDA implementation deadline dates, if the guidance is finalized and her center is ready to go. She commented that "it is of very interesting that we as a nation now have many units of blood, including frozen units, that will not meet the new criteria. Some of the millions that will be spent on implementation could be better spent on very focused yet basic research to learn more about pathogenesis, so we could make more rational decisions".

7. According to a Medical Director of a Naval Medical Center in California, the department of defense has decided to exclude donors with a travel history of 3 months in Great Britain and six months in Western Europe during the same period cited by the Red Cross. The military had intended to begin this policy on the 14th of September but delayed it until the 29th of October due to the terrorist events on the 11th of September. Additionally, there is some talk about future extension of the deferral to travelers to Japan given the recent report of vCJD in a Japanese cow. Due to the high frequency of military travel overseas it is estimated that the military may lose up to 25% of their donor population. This estimate was prior to any speculation about the impact of a deferral based upon travel to Japan. The loss of these donors together with the potential need to collect many more units of blood per day by military donor centers increases the likelihood that civilian donor centers may have increased limits placed upon their access to military bases near military donor centers.

8. A hospital, not affiliated with ABC or ARC, located in California, where they think a tree can be a college mascot, plans to implement the FDA recommendations when they are finalized.

9. A blood center in Texas reported that they will adopt the FDA's recommendations when they become final. They will not follow the Red Cross policy.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator