UNOS DonateLife

April 23, 2003

Notice to Transplant Community Regarding Severe Acute Respiratory Syndrome (SARS)

The Health Resources and Services Administration (HRSA), Office of Special Programs (OSP), Division of Transplantation (DoT) is issuing this notice to organizations associated with organ and hematopoietic stem cell transplantation about the continued spread of Severe Acute Respiratory Syndrome (SARS) and the need to assess potential donors for possible transmission of SARS.

The Food and Drug Administration (FDA) has issued a document titled "Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS." This document is available at http://www.fda.gov/cber/gdlns/sarsbld.htm and http://www.fda.gov/cber/gdlns/sarsbld.pdf. To date, neither the Centers for Disease Control and Prevention (CDC) nor the FDA has issued formal recommendations for organ procurement organizations, marrow donor and collection centers, tissue banks, or transplant programs to assess potential donors for signs and symptoms of SARS. However, FDA suggests that tissue establishments consider implementing donor screening practices similar to those in the FDA guidance for industry for donors of blood and blood products. We are providing you with the following links to the CDC Web site where you may obtain information about SARS and have access to the most current information available.

Resources for Updated Information:

The following Internet-based resources provide additional information about SARS and will continue to be updated as more becomes known in this ongoing investigation:

The CDC case definition of SARS can be found on the CDC Web site: http://www.cdc.gov/ncidod/sars/casedefinition.htm

The most recent CDC Press Release, the updated list of case reports by geographic area in the U.S., and telebriefing transpcripts can be found on the CDC Web site: http://www.cdc.gov/od/oc/media/index.htm

A full description of the clinical features and other guidelines and recommendations regarding SARS can be found on the CDC Web site: http://www.cdc.gov/ncidod/sars/

HRSA will continue to monitor the situation with the CDC and the FDA and provide periodic updates to the transplant community as warranted.