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Bacterial proliferation is comparable in red blood cell concentrates stored in DEHT/PAGGSM and DEHP/SAGM containers.

Authors: Sandra, Ramirez-Arcos; Yuntong, Kou; Dilini, Kumaran; Geraldine M, Walsh; Anita, Howell; Chryslain, Sumian; Stefan, Reichenberg; +2 Authors

Bacterial proliferation is comparable in red blood cell concentrates stored in DEHT/PAGGSM and DEHP/SAGM containers.

Abstract

The European Union's ban on the use of di(2-ethylhexyl) phthalate (DEHP) in medical devices will take effect in 2030. DEHP is a plasticizer in polyvinyl chloride blood bags that helps stabilize the red blood cell membrane during hypothermic red blood cell concentrate (RBCC) storage. Recent studies have shown that RBCCs have acceptable in vitro quality after storage in DEHP-free containers (e.g., plasticized with di(2-ethylhexyl) terephthalate [DEHT] and stored in phosphate-adenine-glucose-guanosine-saline-mannitol [PAGGSM] additive solution). To complement quality data, in this study, we compared bacterial growth in RBCCs stored in either DEHT/PAGGSM or DEHP/saline-adenine-glucose-mannitol (SAGM).Paired ABO-matched whole blood units were collected into DEHT/PAGGSM sets, pooled and split into one DEHT/PAGGSM and one DEHP/SAGM bag set. RBCCs were produced using a top/bottom buffy coat process, tested for baseline in vitro quality and sterility, and spiked with Yersinia enterocolitica, Serratia liquefaciens and Listeria monocytogenes (~102 CFU/mL) and Cutibacterium acnes (~103 CFU/mL) (N = 3). RBCCs were stored at 1-6°C for 43 days and sampled weekly for bacterial enumeration. Bacterial counts were compared between DEHP/SAGM and DEHT/PAGGSM RBCCs over 43 days of storage.For Y. enterocolitica, S. liquefaciens and C. acnes, no differences in survival/growth between DEHP/SAGM and DEHT/PAGGSM RBCCs were observed. Y. enterocolitica and S. liquefaciens grew to 108-109 CFU/mL by day 14, while C. acnes remained at 103 CFU/mL until day 43. L. monocytogenes counts declined in DEHT/PAGGSM compared to DEHP/SAGM RBCC on days 0-7, but bacterial loads were similar (~107 CFU/mL) in both bags by day 43.These results suggest that the bacterial safety risk of RBCCs is not increased in DEHT/PAGGSM containers.

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
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