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Updated: Oct 7, 2025

Preparation and Pathogen Inactivation of Double Dose Buffy Coat Platelet Products using the INTERCEPT Blood System
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Preparation and Pathogen Inactivation of Double Dose Buffy Coat Platelet Products using the INTERCEPT Blood System

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Economic implications of FDA platelet bacterial guidance compliance options: Comparison of single-step strategies

Katherine M Prioli1, Ilze Abersone1, Patricia M Kopko2

  • 1Center for Health Outcomes, Policy and Economics, Rutgers University, Piscataway, New Jersey, USA.

Transfusion
|January 8, 2022
PubMed
Abstract

Insights

Pathogen reduction (PR) strategies for platelets are more cost-effective than large volume delayed sampling (LVDS) over 5 and 7 days. PR strategies also offer longer shelf life, optimizing transfusion center costs and safety.

Area of Science:

  • Transfusion Medicine
  • Public Health
  • Health Economics

Background:

  • Bloodborne pathogens present significant risks in transfusion medicine.
  • The FDA has updated guidance on bacterial risk control strategies (BRCS) to minimize contamination in platelet units.
  • This analysis evaluates budget impacts of pathogen-reduced (PR) and large volume delayed sampling (LVDS) BRCS.

Purpose of the Study:

  • To present results of a budget impact model for 5- and 7-day PR and LVDS bacterial risk control strategies.
  • To compare the hospital budget and shelf-life impacts of different BRCS scenarios.

Main Methods:

  • A budget impact model was developed using data from scientific literature, a hospital survey, and expert opinion.
  • Model inputs included parameters for 5- and 7-day LVDS and PR units.
  • Three scenarios were analyzed: 100% LVDS, 100% PR, and a 50% LVDS/50% PR mix.

Main Results:

  • Total annual costs were highest for 100% LVDS platelets (US$2.325M) and lowest for 100% 7-day PR units (US$2.170M).
  • Net budget impact was lower for 5-day PR platelets compared to 5-day LVDS (5.5% reduction).
  • 7-day PR platelets offered the longest shelf life (4.63 days), while 5-day LVDS had the shortest (2.00 days).

Conclusions:

  • The model highlights opportunities to reduce costs for 5- and 7-day platelet transfusions.
  • Budget impact models are crucial for understanding financial implications of new platelet technologies and FDA guidance.
  • Pathogen reduction strategies demonstrate potential for cost minimization and improved shelf-life in platelet transfusion safety.

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