Bacterial Contamination of Platelet Units is an Under-Recognized Contributor to Healthcare-associated infections (HAIs)

Abstract

BACKGROUND HAIs create a major logistical, financial and patient safety concerns within the healthcare system. Bacterial contamination of platelet components (PCs) is the most common, under recognized, infectious risk of transfusion and contributor to HAIs. Contaminated PCs can lead to central line-associated bloodstream infections, bacteremia, and sepsis, with major long term complications and/or death. While US blood centers employ primary bacterial culture screening (pBCS) today, FDA's Draft Guidance and Blood Products Advisory Committee recommend additional approaches to reduce continued risk including FDA-approved pathogen reduction technology (PRT). Our objective is to determine whether PRT is an effective means to reduce the infectious risk of PCs. METHODS We compiled national hemovigilance (HV) data (2006-2016) from the UK, France, Switzerland, Belgium and the US to examine use of pBCS and PRT with amotosalen/UVA and their associated reports of PC bacterial contamination and sepsis. RESULTS Introduction of pBCS decreased HV reports of PC bacterial contamination in the US by 72.5% (p 700,000 PRT PCs over the same time period. CONCLUSIONS pBCS does not eliminate the risk of bacterial contamination; In its Draft Guidance, FDA acknowledges this shortcoming and recommends further measures. In contrast, PRT inactivates a broad spectrum of pathogens present in PCs, regardless of low level contamination, eliminating the need for pBCS. PRT provides clinicians and patients with transfusion-ready PCs, mitigating the risk of transfusion-transmitted infections and representing an approach to increase hospital safety while reducing the financial challenges of transfusion-related HAIs.