Final guidance document on bacterial safety standards for platelet collection and transfusion
Cerus Corporation applauds the publication of the FDA final guidance document titled Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Guidance for Industry. The FDA has formally recognized the risk of transfusion transmitted bacterial infections and the need for additional safety measures, including the use of pathogen-reduction technology, to protect patients.
“This is an important day for patients that require platelet transfusions,” said Dr. Richard Benjamin, Cerus’ chief medical officer. “It is estimated that approximately one in every 1,500 platelet units contain bacteria despite current testing protocols, thereby putting these often immunocompromised patients at risk of sepsis, including the possibility of death. The publication of the final FDA guidance document and the implementation of its recommendations will enhance the safety for platelet transfusions.”
The FDA guidance document published today outlines approaches that blood centers and hospitals will need to implement over the next 18 months to reduce the risk of transfusion transmitted bacterial sepsis. One approach that offers comprehensive protection against not only bacteria, but also emerging viruses like Zika, is pathogen reduction. Cerus’ INTERCEPT Blood System is currently the only FDA approved pathogen-reduction technology to treat platelet components. The INTERCEPT system uses amotosalen, a well characterized photochemical compound that specifically binds to DNA and RNA of bacteria, viruses, and other pathogens, rendering them inactive. Many of the nation’s largest blood centers and major academic hospitals, including the American Red Cross, have deployed the INTERCEPT system in advance of this final FDA guidance document.
