Skip to content
America's Blood Centers
  • About
    • Team
    • Board of Directors
    • Committees
    • ABC Strategic Plan
    • ADRP
    • Partners
    • Foundation
  • Advocacy
    • Value Framework
    • 2021 Advocacy Agenda
    • Comments & Letters
    • Resources
  • Events
    • Sponsors
      • Sponsorship Opportunities
    • Awards
  • News
    • January is National Blood Donor Month
    • ABC Publications
    • ABC Coronavirus Resources
  • Membership
    • Join Us
    • Member Resources
    • Membership Directory
    • Get Involved
    • Careers
  • For Donors
    • Convalescent Plasma Donation
    • Blood Donation FAQs
    • Blood Donation 101
    • Blood Donation Types and Collection Procedures
    • Journey of Blood
    • America’s Blood Supply
    • Find a Blood Center
    • Why Donate
  • Contact
FacebookTwitterYoutubeFlickr
  • Member Login
America's Blood Centers
  • About
    • Team
    • Board of Directors
    • Committees
    • ABC Strategic Plan
    • ADRP
    • Partners
    • Foundation
  • Advocacy
    • Value Framework
    • 2021 Advocacy Agenda
    • Comments & Letters
    • Resources
  • Events
    • Sponsors
      • Sponsorship Opportunities
    • Awards
  • News
    • January is National Blood Donor Month
    • ABC Publications
    • ABC Coronavirus Resources
  • Membership
    • Join Us
    • Member Resources
    • Membership Directory
    • Get Involved
    • Careers
  • For Donors
    • Convalescent Plasma Donation
    • Blood Donation FAQs
    • Blood Donation 101
    • Blood Donation Types and Collection Procedures
    • Journey of Blood
    • America’s Blood Supply
    • Find a Blood Center
    • Why Donate
  • Contact
March 8, 2019

ABC Submits Comments on Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Draft Guidance

By America's Blood Centers

In April 2017, we provided comments to the FDA including additional important information intended to reinforce positions stated in our May 2016 comments. This information was intended to identify specific critical concerns important to both blood collection establishments and transfusion services and to alert FDA to adverse, unintended consequences expected to impact the blood supply and, ultimately, patient care. At the July 2018 Blood Products Advisory Committee (BPAC) meeting the agency discussed the scientific evidence and operational considerations of all available strategies to control the risk of bacterial contamination of platelets with 5-day and 7-day dating, including testing strategies using culture-based devices, nonculture-based rapid bacterial detection devices, and the implementation of pathogen reduction technology (PRT). We presented a statement at the meeting, to assist FDA in evaluating the multiplicity of effective approaches that are available to enhance the safety of the blood supply. The allowance for multiple approaches balances the need to improve safety with economic and logistical considerations that may influence decision-making in different institutions.

Read the Statement
Posted in Statements
Share this

Recent Posts

  • Joint Statement on the Widespread Snow and Ice Disrupting Nation’s Blood Supply
  • Joint Comments Submitted – Most Favored Nation (MFN) Model (CMS-5528-IFC)
  • Blood Community Encourages Individuals to Donate Blood, Convalescent Plasma During National Blood Donor Month and Beyond
  • ADRP has been awarded a grant from Terumo Blood and Cell Technologies
  • Joint Letter to FDA Regarding COVID-19 Convalescent Plasma (CCP) Emergency Use Authorization (EUA) Implementation

Categories

  • Advocacy News
  • Letters
  • Letters and Comments
  • News
  • Press Releases
  • Statements

Subscribe for Updates

Sign up to receive updates from America’s Blood Centers.

* indicates required

America's Blood Centers
1717 K Street NW, Suite 900
Washington, DC 20006

Tel: 202-393-5725

Fax: 202-899-2621

  • About
    • Team
    • Board of Directors
    • Committees
    • ABC Strategic Plan
    • ADRP
    • Partners
    • Foundation
  • Advocacy
    • Value Framework
    • 2021 Advocacy Agenda
    • Comments & Letters
    • Resources
  • Events
    • Sponsors
      • Sponsorship Opportunities
    • Awards
  • News
    • January is National Blood Donor Month
    • ABC Publications
    • ABC Coronavirus Resources
  • Membership
    • Join Us
    • Member Resources
    • Membership Directory
    • Get Involved
    • Careers
  • For Donors
    • Convalescent Plasma Donation
    • Blood Donation FAQs
    • Blood Donation 101
    • Blood Donation Types and Collection Procedures
    • Journey of Blood
    • America’s Blood Supply
    • Find a Blood Center
    • Why Donate
  • Contact
  • Sitemap
  • Privacy Policy
  • Terms of Use
Become a Member
Member Login

Copyright © 2021 © America’s Blood Centers. All Rights Reserved.

Website by Yoko Co

Scroll To Top