Medical devices as a source of phthalate exposure: a review of current knowledge and alternative solutions

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.