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FDA draft guidance on platelet safety

FDA Draft Guidance, December 2018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Disclosures: The draft guidance was issued by officials in the Centers for Biologics Evaluation and Research at the FDA.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.

Citation:

FDA draft guidance, December 2018.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.”

https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM627407.pdf