Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia.
Arh Hig Rada Toksikol. 2022 Sep 30;73(3):179-190. doi: 10.2478/aiht-2022-73-3639. eCollection 2022 Sep 1.
Phthalates are a group of phthalic acid esters used as plasticisers in a large number of products to improve their flexibility, softness, and extensibility. Their wide use in medical devices, however, raises a lot of concern, as they can enter the organism and have toxic effects on human liver, thyroid, kidneys, lungs, reproductive, endocrine, nervous, and respiratory system and are associated with asthma, obesity, autism, and diabetes. The aim of this review is to summarise current knowledge about phthalate migration from medical devices during different medical procedures and possible impact on patient health. It also looks at alternative plasticisers with supposedly lower migration rates and safer profile. Not enough is known about which and how many phthalates make part of medical devices or about the health impacts of alternative plasticisers or their migration rates.
邻苯二甲酸酯是一类邻苯二甲酸酯,用作许多产品中的增塑剂,以提高其柔韧性、柔软度和可扩展性。然而,它们在医疗器械中的广泛使用引起了很多关注,因为它们可以进入生物体,对人类肝脏、甲状腺、肾脏、肺、生殖、内分泌、神经和呼吸系统产生毒性作用,并与哮喘、肥胖、自闭症和糖尿病有关。本综述的目的是总结目前关于医疗器械在不同医疗程序中邻苯二甲酸酯迁移及其对患者健康可能产生的影响的知识。它还研究了据称迁移率更低、安全性更高的替代增塑剂。关于哪些和多少邻苯二甲酸酯构成医疗器械的一部分,或者替代增塑剂的健康影响及其迁移率,人们了解得还不够多。