{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T02:28:55Z","timestamp":1786328935137,"version":"build-2736575974"},"reference-count":23,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,5,24]],"date-time":"2026-05-24T00:00:00Z","timestamp":1779580800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,5,24]],"date-time":"2026-05-24T00:00:00Z","timestamp":1779580800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100006432","name":"Terumo BCT","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006432","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Objectives<\/jats:title>\n                    <jats:p>Di(2\u2010ethylhexyl) phthalate (DEHP) has been used in blood bag manufacturing for decades, but concern about its potential toxicity has prompted regulatory efforts to eliminate it from medical devices, including blood bags. As manufacturers transition to non\u2010DEHP materials, evaluation is required to ensure blood component quality in modified bag systems. Investigational Trima Accel disposables were developed using plasticizers approved as DEHP alternatives per the European Pharmacopoeia. Red blood cells (RBCs) were collected, and two consecutive studies evaluated in vitro quality and in vivo RBC recovery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Design and Methods<\/jats:title>\n                    <jats:p>Leukoreduced RBCs (LR\u2010RBCs) were stored in Additive Solution 3 (AS\u20103) at 2\u20136\u00b0C for 42\u2009days. In vitro quality parameters measured on days 0, 35 and\/or 42 were assessed against US Food and Drug Administration (FDA) and European Directorate for the Quality of Medicines &amp; HealthCare (EDQM) acceptance criteria. A radiolabelling study evaluated in vivo 24\u2010h RBC recovery using the FDA criteria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Key FDA criteria were met, including haemolysis, which remained below the acceptable limit throughout 42\u2009days of storage. All EDQM criteria were met except Day 0 haematocrit, with 8 units outside the specified range and the confidence interval (CI) lower bound at 77.6%. All FDA criteria for in vivo 24\u2010h RBC recovery were met.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Apheresis LR\u2010RBCs collected with Trima Accel systems using non\u2010DEHP disposables and stored for 42\u2009days met key FDA and EDQM criteria, with any in vitro parameter failures considered artefactual. Products also met FDA's 24\u2010h in vivo RBC recovery criteria, supporting their use as acceptable transfusable products.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/vox.70289","type":"journal-article","created":{"date-parts":[[2026,5,25]],"date-time":"2026-05-25T01:49:35Z","timestamp":1779673775000},"page":"1173-1180","source":"Crossref","is-referenced-by-count":0,"title":["In vivo recovery and in vitro quality assessment of apheresis red blood cells stored for 42\u2009days in non\u2010\n                    <scp>DEHP<\/scp>\n                    disposable sets"],"prefix":"10.1111","volume":"121","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8595-8856","authenticated-orcid":false,"given":"Bethany L.","family":"Brown","sequence":"first","affiliation":[{"name":"American Red Cross Biomedical Services, Medical and Scientific Office  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samatha E.","family":"Mack","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  Denver Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Mason","sequence":"additional","affiliation":[{"name":"Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Wellington","sequence":"additional","affiliation":[{"name":"American Red Cross Biomedical Services, Medical and Scientific Office  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neeta","family":"Rugg","sequence":"additional","affiliation":[{"name":"Hoxworth Blood Center  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7862-6201","authenticated-orcid":false,"given":"Susanne","family":"Marschner","sequence":"additional","affiliation":[{"name":"Vitalant Research Institute  Denver Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Gloor","sequence":"additional","affiliation":[{"name":"Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca L.","family":"Sedjo","sequence":"additional","affiliation":[{"name":"Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nero","family":"Evero","sequence":"additional","affiliation":[{"name":"Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Rice","sequence":"additional","affiliation":[{"name":"Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremiah","family":"Gorman","sequence":"additional","affiliation":[{"name":"Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jack P.","family":"Rhodes","sequence":"additional","affiliation":[{"name":"Terumo BCT, Inc.  Lakewood Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Cook","sequence":"additional","affiliation":[{"name":"Lifetime Scientific, Inc.  Dundas Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9352-2585","authenticated-orcid":false,"given":"Caroline","family":"Alquist","sequence":"additional","affiliation":[{"name":"Hoxworth Blood Center  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,5,24]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"Commission E.Draft Commission Regulation amending Regulation (EC) No1907\/2006 of the European Parliament and of the Council as regards the substance bis(2\u2010ethylhexyl) phthalate (DEHP) in medical device. G\/TBT\/N\/EU\/977.2023. Available from:https:\/\/members.wto.org\/crnattachments\/2023\/TBT\/EEC\/23_09429_01_e.pdf. Last accessed 6 Mar 2026."},{"key":"e_1_2_9_3_1","volume-title":"Feedback from: Blood Transfusion Association (BTA). Harmful chemicals \u2013 updated list of endocrine disrupting substances (REACH regulation)","author":"BTA","year":"2021"},{"key":"e_1_2_9_4_1","unstructured":"(EU) CR.Commission Regulation (EU) 2023\/2482 of 13 November 2023 amending regulation (EC) No 1907\/2006 of the European Parliament and of the Council as regards the substance bis(2\u2010ethylhexyl) phthalate (DEHP) in medical devices. C\/2023\/7567: Official Journal of the European Union;2023. Available from:https:\/\/eur-lex.europa.eu\/eli\/reg\/2023\/2482\/oj. Last accessed 6 Mar 2026."},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12479"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.1985.tb00162.x"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.13384"},{"key":"e_1_2_9_8_1","unstructured":"deKorteD.Reclassification of DEHP: impact on BEs European Blood Alliance.2020. Available from:https:\/\/www.edqm.eu\/documents\/52006\/247256\/reclassification\u2010of\u2010dehp\u2010impact\u2010on\u2010bes\u2010by\u2010dirk\u2010de\u2010korte\u2010phd.pdf\/23e835c0\u2010294b\u20103457\u20108742\u20108977b01d7664?t=1635406047608. 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Available from:https:\/\/www.edqm.eu\/en\/\u2010\/the\u2010ph.\u2010eur.\u2010revised\u2010its\u2010general\u2010chapters\u2010on\u2010plasticised\u2010pvc\u2010materials. Last accessed 6 Mar 2026."},{"key":"e_1_2_9_15_1","unstructured":"Annex XIV to Regulation (EC) No. 1907\/2006 concerning the Registration Evaluation Authorisation and Restriction of Chemicals (REACH).2006. Available from:https:\/\/eur\u2010lex.europa.eu\/legal\u2010content\/EN\/TXT\/?uri=CELEX%3A02006R1907\u201020251023. Last accessed 6 Mar 2026."},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.1975.tb02756.x"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.1984.24284173339.x"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.18468"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.14583"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.13344"},{"key":"e_1_2_9_21_1","article-title":"Evaluation of SOLX\u00ae red blood cells stored in DINCH plasticized PVC container","volume":"52","author":"Dabay MKL","year":"2012","journal-title":"Transfusion"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12870"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12982"},{"key":"e_1_2_9_24_1","first-page":"55","article-title":"49 Tage Lagerung von Erythrozytenkonzentraten in Blutbeuteln mit der Konservierungslosung PAGGS\u2010Mannitol [49 day storage of erythrocyte concentrates in blood bags with the PAGGS\u2010mannitol solution]","volume":"26","author":"Walker WH","year":"1990","journal-title":"Beitr Infusionsther"}],"container-title":["Vox Sanguinis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/vox.70289","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/vox.70289","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/vox.70289","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T01:50:58Z","timestamp":1786326658000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/vox.70289"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,24]]},"references-count":23,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["10.1111\/vox.70289"],"URL":"https:\/\/doi.org\/10.1111\/vox.70289","archive":["Portico"],"relation":{},"ISSN":["0042-9007","1423-0410"],"issn-type":[{"value":"0042-9007","type":"print"},{"value":"1423-0410","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,24]]}}}