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Joint Statement Before BPAC on Maintaining a Safe and Adequate Supply of Donated Blood During a Severe Emergency

Joint Statement Before the Blood Products Advisory Committee

Maintaining a Safe and Adequate Supply of Donated Blood During a Severe Emergency

03 August 2011

M. Allene Carr-Greer, Director, Regulatory Affairs, AABB

Today we have heard presentations related to many aspects involved in maintenance of a safe and adequate supply of donated blood during a severe emergency. Preparedness and planning has received much attention in recent years, and rightly so. However, preparation of a robust preparedness plan is hampered by a facility's inability to write the necessary standard operating procedures and train staff under acceptable cGMP (current Good Manufacturing Practices) conditions during an emergency. In previous venues we have discussed with FDA the necessity of pre-determining certain donor criteria that could be relaxed in order to alleviate inventory shortages.

A consideration of modifications to the current Whole Blood interdonation intervals for manual blood collections that establishments may enact during a severe emergency is a significant step forward, and we appreciate that the discussion is being held. We encourage the FDA to move the results of the discussion into the guidance process as quickly as possible, thereby enabling blood establishments to update their preparedness plans.

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

Founded in 1962, America's Blood Centers is North America's largest network of community-based blood programs. Seventy-five blood centers operate more than 600 collection sites in 45 U.S. states and Canada, providing half of the United States, and all of Canada's volunteer donor blood supply. These blood centers serve more than 180 million people and provide blood products and services to more than 4,200 hospitals and health care facilities across North America. ABC's U.S. members are licensed and regulated by the U.S. Food & Drug Administration. Canadian members are regulated by Health Canada.

The American Red Cross, through its 36 Blood Services Regions and five National Testing Laboratories, supplies more than 40% of the nation's blood supply. Over six million units of whole blood were collected from nearly four million Red Cross volunteer donors, separated into 9.5 million components, and supplied to approximately 3,000 hospitals and transfusion centers to meet the needs of patients last year.