A blood banker in a rural area needs help. Today her hospital received notification from a blood supplier regarding six different blood components that had been previously distributed. It was determined that the donors of these blood components should all have been deferred at the time of donation because they had spent greater than six months in England during a time period that would exclude the donors from being eligible to donate. Her blood supplier has given no recommendation regarding notification of the recipients or their physicians, or what message to convey. According to the inquiring blood banker, the blood supplier has placed the entire responsibility for determining what action should be taken squarely on the hospital's shoulders. The inquiring blood banker wants to know what others are doing as far as recipient and/or physician notification when a blood product is recalled because the donor time spent in England (or any other country that causes a donor to be deferred for vCJD concerns). If you are making a notification, what do you say?

The following responses were submitted. I think we have a consensus of opinion, which should be very helpful to the inquiring blood banker:

(N.B. The Aug. 2001 FDA document described in response #1 below has been SUPERSEDED by the Revised FDA Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease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) Jan. 10, 2002)

1. The Director of Regulatory Affairs for the AABB suggests that the inquiring hospital refer to the August 2001 FDA Draft Guidance for Industry Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease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. Section VI discusses Recommendations for Recipient Tracing and Notification. It says "For transfusible components from a donor with risk factors for vCJD (due to geographic risk deferral, transfusion in the UK between 1980 and the present, or due to injection of bovine insulin), we believe it is not appropriate to conduct tracing and notification of recipients of prior donations." She goes on to add that although this is only a draft guidance, this section is unlikely to change.

2. A blood bank physician at a major institution of higher learning in New Hampshire commented that his reading of the FDA draft guideline is that no recalls/withdrawals are necessary for donations given by individuals who have spent time in vCJD countries. Consequently, there should be no need to inform recipients of blood products that were donated by individuals who spent time in vCJD countries. He quotes the following: In Section VI (page 17), it clearly states that withdrawal/recipient notification should occur in cases of vCJD. Importantly, it omits any such "recommendation" in cases of travel deferral. (The language used to differentiate travel deferral from a vCJD case in a donor is quite specific throughout the document.)

3. A San Francisco blood bank physician and scientist states that "It is inappropriate to notify recipients about this extremely remote, theoretical risk. The FDA draft guidance clearly distinguishes between efforts to retrieve in date product from donors subsequently deferred for vCJD travel exposure (which they recommend but has been opposed through formal comment by many blood organizations), from prior recipient notification (which FDA agrees is not warranted). Even in Britain, when a vCJD case is diagnosed in a former donor, prior recipients are not notified of this fact due to concern over the psychological ramifications of this information and lack of any therapeutic intervention to reduce the recipients remote probability of disease, and the lack of evidence for secondary transmission. It is disturbing that the blood supplier in question would 'pass the buck' on this issue to the transfusion service/physician." The responding blood banker (who is well connected and well respected) says that he will be notifying FDA of this issue, in the hope they will quickly and clearly disseminate a policy that will prevent serious negative consequences for hospitals and patients.

4. A blood bank physician in Sacramento says that with regards to donations made by individuals who spent time in vCJD countries, he would attempt to recall donated products if they were still in inventory, but he would not notify hospitals or make any recommendations to notify recipients of this information. His center currently files a Biologic Product Deviation Report to document this type of situation for the FDA.

5. A blood bank physician in Virginia said that his institution does not notify recipients' physicians or recipients under the circumstances described. The fright/confusion/benefit ratio is clearly against such notification.

6. A medical director of a large University Hospital blood bank with an active transfusion committee said the following: "I will not notify recipients or transfusing physician when the donors are found to have been in the UK, nor will I when we are told that the donor died of CJD, for several reasons:

• CJD is not known to be transmitted by blood
• There no test for a recipient to take for diagnosis, thus causing unwarranted anxiety.
• There is no treatment available, thus no benefit of early diagnosis
• CJD is not transmitted to close contacts of recipient, thus no need for intervention to prevent spread; there is no public health benefit of notification.

If the hospital transfusion medical director does not feel empowered to make this decision, the transfusion committee should be consulted for advice. The blood center notification should not be passed on to the transfusing physicians for a decision whether the recipient should be notified.

7. A blood bank medical director in Pennsylvania says that he thinks there are three possible approaches one can take in this situation concerning vCJD. Since there is no test that can be performed to rule in or out CJD, the incubation period is probably years, and the evidence for transmission by blood transfusion is minimal at best, one approach is to not say anything to the transfusing physician or the recipient. This first approach may not be viewed by some as ideal, and may be viewed as being too paternalistic by some, but the responding blood banker thinks the line is sometimes very blurred between being too paternalistic and the other extreme of giving out too much needless information that will only cause anxiety and undo worry. The ethical approach has always been to give all the information to the patient so that the patient can make an autonomous decision about what course of action to take. But, to the responding blood banker's knowledge, those who are staunch defenders of patient autonomy have not dealt with transfusion medicine issues, such as CJD. According to the Pennsylvania blood banker, a second approach is to discuss the donor deferral information with the transfusing/attending physician and based on his/her knowledge of the patient make a decision to explain the situation to the patient. This approach, and the first approach noted above, may be warranted, for example, if the recipient has terminal cancer and is not expected to live for many more months. What is to be gained by informing such a patient that she/he may now have CJD but, "don't worry, we don't think you do, but we just thought you should know." The third approach is to inform both the transfusing/attending physician and the patient and now you have completed your responsibility and it will be up to them to deal with it. Over the years, at one time or another, and for one test or for one recall or another, the responding blood banker says that he has used all three approaches. After years of experience he says that he still does not know which approach is better, but it is probably somewhere between all three. In any event, he recommends that a local "registry" or file of patients who received blood products recalled for vCJD risk be created in the event that a blood test is developed in the coming years so that such individuals can be notified and tested.

8. A Canadian blood banker wrote "This is a difficult decision only because of the THEORETICAL RISK that is involved. If the donor had spent 5 months and 29 days in England, the blood would be perfectly good. However, if that same donor had spent 6 months plus 1 day in England then the blood is not acceptable??? Come on now, that time frame is completely arbitrary, with not one single bit of experimental or clinical data to back it up. It may as well be one year or 1 month.......I say use the blood if all other infectious disease tests are negative and not create an unnecessary problem (in other words, don't inform anyone, just use it). Let's face it, no cases of vCJD due to blood transfusion documented ever!!!, even in England!!!!, so how can this blood be a problem? Use it as the donor intended it to be used. Stand up for reality as opposed to ambiguous theoretical nonsense."

9. A blood bank physician in Minnesota says that "In the circumstances described in this setting, we would simply notify the blood center that the units had been transfused. There is a dearth of credible data on the actual risks associated with a donor's domicile in UK are such ( no cases of transmission ever described, no epidemiological data to suggest transmission from donors who subsequently get vCJD etc. ). Therefore, in my opinion it would be potentially misleading and frightening to recipients to notify them of some risk when there are absolutely no clinical cases to support such an allegation. In fact , to do so would be downright irresponsible! " He goes on to add: "In fact , it is irresponsible of the blood supplier not to give the hospitals some guidance and help relative to decisions about notification of recipients."

ADDENDA Nov. 5, 2001

10. A blood bank physician in Chicago, replied that according to section VI of the above cited FDA Draft Guidance for Industry document, he does not notify physicians or recipients about geographical CJD deferrals.

11. A blood bank physician in Virginia wrote that her facility does nothing with respect to physician or patient notification. However, she files the information.

ADDENDA Nov. 6, 2001

12. Another blood banker wrote that the FDA has guidance available for notification of consignees for CJD risk and vCJD risk on their website. The FDA does not recommend notification of consignees for vCJD risk due to travel. The blood bank should review the guidance, (but so should the blood center!).

13. The blood who responded in #7 above had more to say. "An addendum to my previous post on this topic. In the current issue of The Journal of Clinical Ethics (Summer 2001, Vol. 12, pages 134-140) is a paper by David Steinberg entitled, "Informing a recipient of blood from a donor who developed Creutzfeldt-Jakob Disease: the characteristics of information that warrant its disclosure." In addition, two commentaries accompany this paper. One by Roger Dodd, "Comment: dilemmas of dementia", pages 141-142; and, one by Edmund G. Howe, "Comment: limiting toxic information", pages 143-149. For those who do not have ready access to The Journal of Clinical Ethics, the three authors can be reached by e-mail at: david.steinberg@lahey.org; dodd@usa.redcross.org; and ehowe@usuhs.mil"

Please submit comments to the e-Network Forum.

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