Management of Blood Product Market Withdrawals - A Single Institution's Process and Experience.

OBJECTIVE: While lookback investigations follow specific Food and Drug Administration (FDA) requirements, the management of blood product market withdrawals from suppliers varies widely. Follow-up data are limited, prompting this analysis of the types and reasons for recipient notification and their outcomes. METHODS: A single institution retrospective review of market withdrawal and lookback files from 2012-2015 included product type, reason, FDA category, notification, and turnaround time. Descriptive statistics and chi-square analysis were performed. RESULTS: Over 4 years, 796/229,549 (0.35%) blood components were implicated in supplier notifications, including market withdrawals (84.3%) and lookbacks (15.7%). Seventy-nine cases resulted in patient notification. 97% of patient notifications were achieved within 3 months. Plasma with human leukocyte antigen antibodies was the most common reason for withdrawal (20.5%). Category 1 notifications were the most commonly reported by this transfusion service, apart from in 2015 when category 4 notifications were highest. Over four years, the proportion of notifications by category remained relatively stable. CONCLUSIONS: Market withdrawal investigations involve significant effort to review, document, and appropriately notify. Standardized management and centralized reporting of recipient notification of market withdrawals may improve this process.

Duke Scholars

Author Nicholas Bandarenko III Pathology

Author Jessica Lynne Poisson Pathology