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Review
. 2022 Sep 30;73(3):179-190.
doi: 10.2478/aiht-2022-73-3639. eCollection 2022 Sep 1.

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

Antonela Šimunović  1 , Siniša Tomić  1 , Krunoslav Kranjčec  1
Affiliations
Review

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

Antonela Šimunović et al. Arh Hig Rada Toksikol. .

Abstract
in English, Croatian

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.

Ftalati su esteri ftalne kiseline, koji se koriste kao plastifikatori u velikom broju proizvoda kako bi poboljšali njihovu fleksibilnost, mekoću i rastezljivost. Uvelike se primjenjuju u proizvodnji medicinskih proizvoda, što stvara zabrinutost zbog migracije ftalata s proizvoda i njihova utjecaja na ljudsko zdravlje. Pregled objavljenih znanstvenih radova upućuje na povezanost ftalata s poremećajem reproduktivnog i endokrinog sustava, astmom, pretilošću, poremećajima u neurološkom razvoju, negativnim učincima na dišni sustav i toksičnim učincima na nekoliko organa, uključujući jetru, štitnjaču, bubrege i pluća. Cilj je ovoga preglednog rada sažeti dostupne zaključke članaka o migraciji ftalata s medicinskih proizvoda tijekom različitih medicinskih postupaka te o mogućem utjecaju na ljudsko zdravlje. U istraživanje su uključeni i članci o alternativnim plastifikatorima s nižom stopom migracije i sigurnijim profilom kako bi se utvrdio mogući sigurniji pristup medicinskim postupcima. Zaključci upućuju na otpuštanje ftalata u velikom broju različitih kritičnih, čak i kroničnih medicinskih postupaka, što može ozbiljno utjecati na zdravlje pacijenata. Za sada nema dovoljno podataka o udjelu pojedinih ftalata u proizvodnji medicinskih proizvoda ni o migracijskoj stopi i utjecaju na zdravlje alternativnih plastifikatora.

Keywords: human exposure; ljudska izloženost; plasticisers; plastifikatori; poremećaj reproduktivnog sustava; regulation; reproductive system disorders; toksikologija; toxicology; zakonska regulativa.

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Conflict of interest statement

Conflicts of interest

None to declare.

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