December 4, 2018
“Blood and blood components are some of the most critical medical products American patients depend upon. The U.S. has one of the world’s safest blood supplies. But there remains risk, albeit uncommon, of contamination with infectious diseases, particularly with blood products that are stored at room temperature,” said FDA Commissioner Scott Gottlieb, M.D. “While we’ve made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations and blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products. In addition to microbial testing of blood, the application of safe and effective pathogen reduction technologies is an important part of the agency’s blood safety efforts. Today’s updated guidance further advances the potential for technology to be used to reduce the risk of contamination of the blood supply from known and emerging pathogens, and to measurably increase the availability of safe blood products while ultimately reducing cost overall.”
Today the U.S. Food and Drug Administration updated a draft guidance entitled, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion.” The draft guidance provides recommendations for additional measures to help control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. Helping ensure that the U.S. has one of the safest blood supplies in the world is one of the FDA’s most important priorities. The recommendations in the draft guidance, which incorporate feedback from discussions held during the July 2018 Blood Products Advisory Committee meeting and update the previous draft guidance from 2016, reflect broader FDA efforts to advance and encourage new developments to enhance product safety. Last week, the agency held a public workshop to encourage a scientific discussion on a range of pathogen reduction topics, including the development of novel technologies.
The FDA remains committed to working with industry and other stakeholders to ensure the safety of the blood supply and facilitate the development of pathogen reduction technology, which could include innovative technologies not yet on the market. The ideal pathogen reduction technology would: be relatively inexpensive, be simple to implement on whole blood, allow treated blood to subsequently be separated into components or alternatively could be performed on apheresis products, inactivate a broad range of pathogens, and would have no adverse effect on product safety or product yield.
•Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry
•Blood & Blood Products
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.