MODERATOR
(S):
SPEAKER
(S):
Patrick Ooley, MS, MT(ASCP), CQA(ASQ)CMQ/OE, Corporate Director Quality, Blood Systems, Inc.
Mindy Goldman, MD, Medical Director, Canadian Blood Services
Nicola Anderson, FRCPath, Consultant Haematologist, NHS Blood and Transplant
Description
Recalls/market withdrawals of blood components occur when blood centers act on additional information or discover manufacturing deviations after the time of component issue. Unfortunately, recalls occur fairly commonly; major recalls may impact blood availability, and even minor recalls cause distress in the hospital blood bank, as components have often already been transfused. Recall regulations and policies differ between countries and organizations, and international comparisons may assist in the development of best practices. Case examples of recalls will be presented, and the recall strategies used by different blood centers will be discussed.
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Apply the concepts governing recalls to determine appropriate actions after evaluating the impact of failures or nonconformances on blood components and recipient safety.
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Describe the regulatory requirements in different countries governing market withdrawal and recall actions taken by blood centers.
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Identify the regulatory and possible safety considerations in developing a recall strategy.
CE Category | CE Value |
---|
California Clinical Laboratory Personnel |
1.5 |
California Nurse |
1.8 |
Florida Laboratory Personnel |
1.8 |
General Attendee |
1.5 |
Physician |
1.5 |
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.