Danilova Elena, Ezligini Farshid, Stöckel Connie, Asakawa Masafumi, Hetland Geir
Department of Immunology, Oslo University Hospital, Oslo, Norway.
Asahi Kasei Medical Europe GmbH, Asahi Kasei Medical Co., Ltd., Chiyoda, Japan.
Transfus Med. 2025 Feb;35(1):82-90. doi: 10.1111/tme.13091. Epub 2024 Sep 7.
Di (2-ethylhexyl) phthalate (DEHP) plasticizer must be removed from polyvinylchloride (PVC) medical devices due to toxicity. DEHP/PVC blood bags were shown to provide stable quality under blood component production and to create good storage conditions for red blood cells concentrate (RBC). It is important that substitution of the DEHP maintains the RBC quality during storage, which should be achieved with Di (isononyl) cyclohexane-1,2-dicarboxylate (DINCH), although substitution of the plasticizer has been challenging.
A DEHP-free Top & Bottom in-line RBC set was validated in a tertiary hospital blood bank facility. Volunteer blood donors were randomly allocated for blood collection into DINCH/PVC or DEHP/PVC set. The groups were additionally divided according to additive solution/filter combination: PAGGS-M + DINCH/PVC filter (only with DINCH/PVC set), and SAG-M + DINCH/PVC filter and SAG-M + DEHP/PVC filter (only with DEHP/PVC set). Processing and storage effects were assessed in all components.
RBC concentrates, platelet concentrates and plasma that was processed and stored in DEHP-free set fulfilled European requirements for quality. The cells stored in PAGGS-M after filtration through DEHP-free PVC filter showed the same low haemolysis compared with conventional set at 49 days of storage. Platelets stored in DINCH/PVC bag provided a sufficient quality of platelets after 7 days of storage. Plasma maintained the coagulation factors during 12 months of storage.
A new DINCH/PVC set allows production of blood components of satisfactory quality in DEHP-free environment.
由于具有毒性，邻苯二甲酸二（2-乙基己基）酯（DEHP）增塑剂必须从聚氯乙烯（PVC）医疗设备中去除。已证明DEHP/PVC血袋在血液成分生产过程中能提供稳定的质量，并为红细胞浓缩液（RBC）创造良好的储存条件。重要的是，用邻苯二甲酸二（异壬基）环己烷-1,2-二羧酸酯（DINCH）替代DEHP能在储存期间维持RBC质量，尽管增塑剂的替代一直具有挑战性。
在一家三级医院血库设施中对一种不含DEHP的上下串联RBC装置进行了验证。将志愿献血者随机分配，分别使用DINCH/PVC装置或DEHP/PVC装置进行采血。这些组还根据添加剂溶液/过滤器组合进一步划分：PAGGS-M + DINCH/PVC过滤器（仅与DINCH/PVC装置搭配使用），以及SAG-M + DINCH/PVC过滤器和SAG-M + DEHP/PVC过滤器（仅与DEHP/PVC装置搭配使用）。对所有成分评估其加工和储存效果。
在不含DEHP的装置中加工和储存的红细胞浓缩液、血小板浓缩液和血浆均符合欧洲质量要求。在通过不含DEHP的PVC过滤器过滤后，储存在PAGGS-M中的细胞在储存49天时与传统装置相比显示出相同的低溶血率。储存在DINCH/PVC袋中的血小板在储存7天后提供了足够质量的血小板。血浆在储存12个月期间维持了凝血因子。
一种新的DINCH/PVC装置能够在无DEHP的环境中生产出质量令人满意的血液成分。
