Are you ready for FDA’s bacterial contamination guidance?

Oct. 18, 2019

Cerus Corporation, a pathogen reduction technology company whose INTERCEPT Blood System is currently the only FDA approved pathogen-reduction technology to treat platelet components, also is hosting a workshop, “Are You Ready for FDA’s Bacterial Contamination Guidance?” at the American Association of Blood Banking (AABB) annual meeting in San Antonio, October 19-22. The workshop will include speakers from the Swiss Red Cross, OneBlood, the Mayo Clinic and the University of California San Diego.

An estimated one in every 1,700 platelet components contain bacteria despite current testing protocols, making immunocompromised patients who need a blood transfusion at risk of sepsis, and the possibility of death. Pathogen reduction technology has shown to reduce the risk of bacterial contamination, and as of August 2019, no confirmed fatality has been reported from the over 4 million units of pathogen-reduced platelets that have been used in over 30 countries worldwide.

FDA has the release.