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

Abstract

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.

Exposure to endocrine disruptors promotes biofilm formation and contributes to increased virulence of Pseudomonas aeruginosa

“…P. aeruginosa biofilm is a virulence factor as it provides protection against the host immune response (Moser et al, 2021) and antibiotic treatments given during pulmonary infection (Ciofu & Tolker‐Nielsen, 2019; Hall & Mah, 2017). In addition, exposure of P. aeruginosa to EDs could promote biofilm formation in humans, as some EDs such as catheters are present in medical devices (Šimunović et al, 2022). That is why we decided to address whether EDs could modulate biofilm formation in P. aeruginosa .…”

Leaching of Phthalates from Medical Supplies and Their Implications for Exposure

“…Medical devices are used in procedures such as blood transfusion, extracorporeal membrane oxygenation, parenteral infusion, and hemodialysis. Phthalates leached from these devices are a direct source of exposure in patients, especially among preterm neonates in intensive care units . The medical devices ( n = 46; Table S2) investigated in this study were single-use products including those used in parenteral nutrition/drug administration, nasogastric intubation (plastic tube that is inserted through the nose, past the throat, and into the stomach), oxygen delivery systems, respiratory support and air filter, baby care and clinical care products (fluidized positioner/diaper/glove), and fluid drainage.…”

“…While the European Commission has set specific migration limits for plastic materials and articles in contact with food, no such limits have been set for medical devices. Efforts should be made to regulate phthalates in medical devices, and the safety of other alternative plasticizers that are currently used as replacements should be examined . The chemical safety of medical devices is of vital importance to help safeguard the health of patients, especially newborns, and efforts are needed to address the critical issue urgently.…”

“…Phthalates leached from these devices are a direct source of exposure in patients, especially among preterm neonates in intensive care units. 34 The medical devices ( n = 46; Table S2 ) investigated in this study were single-use products including those used in parenteral nutrition/drug administration, nasogastric intubation (plastic tube that is inserted through the nose, past the throat, and into the stomach), oxygen delivery systems, respiratory support and air filter, baby care and clinical care products (fluidized positioner/diaper/glove), and fluid drainage. Six of the 10 phthalates were found in >85% of the medical devices analyzed, suggesting widespread application of phthalates in medical products.…”

Phthalates are detected in the follicular fluid of adolescents and oocyte donors with associated changes in the cumulus cell transcriptome

“…We performed several subanalyses to understand if there is a particular group of individuals among adolescents or oocyte donors that drives this difference. We speculated that adolescents with a cancer diagnosis might have been exposed to phthalates more through medications or medical tubing [44]. Conversely, adolescents with gender dysphoria or who are relatively older could have been exposed to phthalates more through increased use of personal care products (PCPs) or perfumes compared to others [45,46].…”