MASAC Document #158
MASAC RECOMMENDATIONS REGARDING EXPOSURE TO BLOOD PRODUCT DERIVATIVES AND POTENTIAL RISK OF VCJD
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The following recommendations were approved by the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation on November 6, 2004, and adopted by the NHF Board of Directors on November 7, 2004.
Recent reports have documented a second probable case of variant Creutzfeldt–Jakob disease (vCJD) acquired through blood transfusion in the UK, as well as additional cases of vCJD in countries outside the UK. In addition, manufacturers of clotting factor in the UK have reported that a few plasma donors have subsequently developed vCJD. However, notification of US recipients of implicated lots of UK factor was delayed.
Therefore MASAC recommends that hemophilia care providers develop an early response system that includes the following:
1. Manufacturers should promptly and fully disclose to all stakeholders all product names and numbers of lots that include plasma from donors who could potentially transmit vCJD.
2. All persons determined to have an exposure to a plasma product derived from UK plasma manufactured between 1980 and 1998 (which expired in 2001) should be notified of the exposure, including lot numbers and number of vial exposures and whether they have received a batch known to contain plasma from a donor who subsequently developed vCJD.
3. A public health response should be developed in consultation with the bleeding disorders community that addresses stigmatization, access to healthcare, and appropriate counseling.
4. Other measures to be taken include:
a. Development of educational materials for HTC staff and patients on the sources, transmission, prevalence, and relative risk of vCJD.
b. Development of a program of counseling for individuals exposed to potentially infectious blood products.
c. Establishment of a surveillance system through the UDC that includes banking of tissue (brains, lymph nodes, etc.) removed during surgery and at autopsy.
Relevant information is available on the WFH website (http://www.wfh.org).