Sampson J, de Korte D
Department of Quality Assurance, Welsh Blood Service, Pontyclun, Mid Glamorgan, UK.
Transfus Med. 2011 Apr;21(2):73-83. doi: 10.1111/j.1365-3148.2010.01056.x. Epub 2010 Dec 8.
Phthalates are the most widely used plasticisers in the world and have been in medical use since 1955. Di(2-ethylhexyl)phthalate (DEHP) is present in many industrial and domestic products, and is a common plasticiser used in blood bags and tubing sets. Concerns have been raised by environmental groups that DEHP exposure may result in gender birth defects and the feminisation of boys although there were no studies performed of intravenous exposure to DEHP on higher mammals or humans which report similar effects. This article reports on the toxicology of DEHP and considers concerns regarding its use in the context of transfusion medicine. The benefits of using DEHP are evaluated and the use of alternative plasticisers to DEHP is explored. The article reports on international and European regulatory recommendations for DEHP use in transfusion medicine and examines the impact of legislation on the medical devices and blood industries. The article also reviews labelling considerations for blood components and offers some guidance for blood establishments in respect of DEHP use.
邻苯二甲酸盐是全球使用最为广泛的增塑剂，自1955年起便应用于医学领域。邻苯二甲酸二（2-乙基己基）酯（DEHP）存在于许多工业和家用产品中，是血袋和输液管中常用的增塑剂。环保组织已提出担忧，认为接触DEHP可能导致出生性别缺陷以及男孩女性化，不过尚无针对高等哺乳动物或人类静脉接触DEHP的研究报告有类似影响。本文报告了DEHP的毒理学，并探讨了在输血医学背景下对其使用的担忧。评估了使用DEHP的益处，并探索了DEHP替代增塑剂的使用情况。本文报告了国际和欧洲关于输血医学中DEHP使用的监管建议，并审视了相关法规对医疗器械和血液行业的影响。本文还回顾了血液成分的标签注意事项，并就DEHP的使用为血液机构提供了一些指导。
