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The impact of discontinuation of 7‐day storage of apheresis platelets (PASSPORT) on recipient safety: an illustration of the need for proper risk assessments
Author(s) -
Kleinman Steven,
Dumont Larry J.,
Tomasulo Peter,
Bianco Celso,
Katz Louis,
Benjamin Richard J.,
Gajic Ognjen,
Brecher Mark E.
Publication year - 2009
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2008.02048.x
Subject(s) - apheresis , discontinuation , medicine , plateletpheresis , risk assessment , platelet transfusion , platelet , transfusion related acute lung injury , intensive care medicine , emergency medicine , lung , computer science , pulmonary edema , computer security
BACKGROUND: Seven‐day stored apheresis platelets (APs) were withdrawn from the US market after detection of two culture‐positive units from 2571 tested at outdate in the PASSPORT surveillance study. The impact of this discontinuation on recipient safety was explored using mathematical modeling. STUDY DESIGN AND METHODS: Risk models for septic transfusion reactions (STRs) and transfusion‐related acute lung injury (TRALI) were developed. Key assumptions were 400,000 annual APs transfused, equivalent STR risk for platelets (PLTs) stored for 5 days or more and zero for PLTs stored for less than 5 days, whole blood–derived PLTs (WBplts) administered in 5‐unit pools, a 4.6‐fold higher risk of false‐negatives with surrogate versus culture‐based bacterial testing, an AP TRALI risk between 1 per 1000 and 1 per 10,000, and a delay in TRALI risk reduction implementation in some centers by 6 to 12 months due to limited PLT availability. RESULTS: STR risk could increase, decrease, or remain the same depending on the percentage of inventory replaced by surrogate‐tested WBplts versus culture‐tested apheresis or whole blood PLTs. A delay in TRALI risk reduction implementation is likely to result in a comparable or greater risk during the delayed implementation period than the safety achieved with regard to STRs, even in the most favorable case scenario. CONCLUSION: A comprehensive risk assessment should have been conducted before the decision to discontinue PASSPORT. Risk assessments using accepted methods (and actual data when available) should precede any major blood safety decisions.