Blood Safety Recommendations - January 1998

DATE: February 6, 1998

TO: Interested Parties

FROM: Stephen D. Nightingale, MD, Executive Secretary
Advisory Committee on Blood Safety and Availability

SUBJECT: Recommendations of the Advisory Committee on Blood Safety and Availability
regarding Transmissible Spongiform Encephalopathies

INFORMATION

The Advisory Committee on Blood Safety and Availability met in Washington, DC on January 29 and 30, 1998 to consider The Influence of Transmissible Spongiform Encephalopathies on Blood Safety and Availability. Dr. Robert Rohwer (University of Maryland), Dr. Lawrence Schonberger (CDC), Dr. Robert Will (National Creutzfeld-Jacob Disease Surveillance Unit, University of Edinburgh), Dr. Clarence Gibbs (NIH), Dr. Lola Lopes (University of Iowa), and Dr. Mark Weinstein (FDA) addressed the Committee, which then made the following recommendations:

1. We recommend that the Public Health Service coordinate an effort to develop a report within six months that will address issues of existing and emerging transmissible spongiform encephalopathies. The report should make specific reference to

• Food borne transmission, particularly through consumption of central nervous system tissues;

• Iatrogenic transmission; and

• Transmission through transfusion of blood components and plasma derivatives.

National and international surveillance of transmission in both humans and animals, education of providers and the public, needed resources for research, prevention strategies, and efforts in other countries also should be addressed in this report.

2. We recommend that the Public Health Service, professional groups, and patient advocates emphasize the importance of postmortem examination to the protection of the public health, and that they support the training of physicians to recognize new pathological patterns of emerging disease in autopsy tissues.

3. We recommend nationwide standardization of procedures for screening donors at risk for transmissible spongiform encephalopathies.

4. We recommend that the National Institute of Health specify its needs for research and infrastructure support necessary to promote research on the transmissible spongiform encephalopathies, with particular reference to human and animal tests which can discriminate among these conditions within each species.

5. We recommend that during the next year the Food and Drug Administration work with industry and appropriate consumer groups to relax current Creutzfeldt-Jacob disease guidelines on quarantine and withdrawal of blood products to the extent necessary to relieve product shortages.

FOLLOW-UP