Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA draft guidance on platelet safety

FDA Draft Guidance, December 2018

Key clinical point: The Food and Drug Administration issued recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for infusion.

Major finding: For apheresis platelets and prestorage pools stored for 5 days, FDA recommended an initial primary culture followed by a secondary culture on day 3 or 4; or an initial primary culture followed by secondary testing with a rapid test. For aspheresis platelets, the agency also recommended using pathogen reduction alone.

Study details: The guidance is based on data presented at a July 2018 meeting of the FDA Blood Products Advisory Committee meeting and the committee’s recommendations.

Disclosures: The draft guidance was issued by officials in the Centers for Biologics Evaluation and Research at the FDA.

Read the article here.


FDA draft guidance, December 2018. “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion.”