Migrability of PVC plasticizers from medical devices into a simulant of infused solutions

Bernard, Lise; Cueff, R.; Breysse, C.; Décaudin, Bertrand; Sautou, V.

doi:10.1016/j.ijpharm.2015.03.030

Cited by 78 publications

(58 citation statements)

References 13 publications

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“…The number of MDs used for each women is often a better indicator because each MDs can release a certain amount of plasticizers after its use. In fact, the kinetics of migration of plasticizers shows that these plasticizers are mainly released in the 24 h after the first contact between the PVC device and its contents (the amount of plasticizer released remains generally stable over time) [6]. Hence, each time a PVC device is changed, women are exposed to potentially higher doses.…”

Section: Discussionmentioning

confidence: 99%

“…TOTM is released in far smaller amounts than DEHP in the same conditions of use, principally as a result of its higher molecular weight and greater steric hindrance and its lower solubility in water [6, 7, 41]. Bernard et al (2015) [6] showed that only 0.2% of the total initial amount of the TOTM present in the tubing migrated into a simulant (migration tests conducted at 40 °C in a temperature-controlled chamber for 24 h).…”

Section: Discussionmentioning

confidence: 99%

“…As they have no chemical bond with plastic materials, phthalates are easily released into the environment and DEHP can be released from MDs [6–8]. During intravenous infusion, release from MDs is enhanced by factors such as temperature, duration of use, surface contact, infusion rate and contact with lipophilic substances [6, 9–12]. …”

Section: Introductionmentioning

confidence: 99%

“…However, there is still scant documented evidence about the potential ability of these new plasticizers to migrate from PVC nor about their toxicity [6]. …”

Section: Introductionmentioning

confidence: 99%

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Exposure of hospitalised pregnant women to plasticizers contained in medical devices

et al. 2017

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BackgroundMedical devices (MDs) in polyvinyl chloride (PVC) are not a well-known source of exposure to plasticizers, in particular during pregnancy. Because of its toxicity, the di-(2-ethylhexyl) phthalate (DEHP) has been replaced by other plasticizers such as di (isononyl)-cyclohexane-1,2-dicarboxilic acid (DINCH), tri-octyltrimellitate (TOTM) and di-(isononyl) phthalate (DiNP). Our study aimed to quantify the plasticizers (DEHP and alternative plasticizers) contained in PVC medical devices used for hospitalised pregnant women and to describe which these MDs had been used (type, number, duration of exposure).MethodsThe plasticizers contained in the MDs used for daily care in the Obstetrics Department of a French University Hospital were extracted from PVC (after contact with a chloroform solution), identified and quantified by gas-chromatography-mass-spectrometry analysis. A total of 168 pregnant women hospitalised in the Obstetrics Department with at least one catheter were included in the observational study. The median number of MDs containing plasticizers used and the daily duration of exposure to the MDs were compared in three groups of pregnant women: “Pathology group” (women hospitalised for an obstetric disorder who did not give birth during this hospitalisation; n = 52), “Pathology and delivery group” (hospitalised for an obstetric disorder and who gave birth during this stay; n = 23) and “Delivery group” (admitted for planned or spontaneous delivery without obstetric disorder; n = 93).ResultsDiNP, TOTM and DINCH were the predominant plasticizers contained in the MDs at an amount of 29 to 36 g per 100 g of PVC. Women in the “Pathology group” (preterm labour or other pathology) were exposed to a median number of two MDs containing TOTM and one MD containing DiNP, fewer than those in the “Pathology and delivery group” (p < 0.05). Women in the “Pathology group” had a median exposure of 3.4 h/day to MDs containing DiNP and 8.2 h/day to MDs containing TOTM, longer than those in the “Delivery group” (p < 0.01).ConclusionsOur study shows that the medical management of pregnant women in a hospital setting entails exposure to MDs containing alternative plasticizers (DiNP, TOTM and DINCH).Electronic supplementary materialThe online version of this article (doi:10.1186/s12905-017-0398-7) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…However, there is still scant documented evidence about the potential ability of these new plasticizers to migrate from PVC nor about their toxicity [6]. …”

Section: Introductionmentioning

confidence: 99%

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Exposure of hospitalised pregnant women to plasticizers contained in medical devices

et al. 2017

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“…Other common small molecule plasticizers include terphthalates, 1,2-cyclohexane-dicarboxylic acid diisononyl ester (Hexamoll® DINCH®), epoxidized vegetable oils, citrates, mellitates, adipates, benzoates, maleates, succinates, sebacates, phosphates, isosorbide esters. Because these plasticizers are not covalently linked to PVC, they can migrate within the material and leach out when the plastic comes into contact with air [9], liquid [10][11][12][13][14][15][16][17]or some absorbent solid materials [18][19][20]. Some polymeric plasticizers such as poly(ε-caprolactone), poly(butylene adipate), and poly(epichlorohydrin) are also utilized.…”

Section: Introductionmentioning

confidence: 99%

Phthalate plasticizers covalently linked to PVC via copper-free or copper catalyzed azide-alkyne cycloadditions

Earla

Costanzo

et al. 2017

Polymer

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Plasticization of PVC was carried out by covalently linking phthalate derivatives via copper-free (thermal) or copper catalyzed azide-alkyne cycloadditions. Di(2-ethylhexyl) phthalate derivatives (DEHPether and DEHP-ester) were synthesized and appended to PVC at two different densities. The glass transition temperatures of the modified PVC decreased with increasing content of plasticizer. PVC-DEHP-ether gave lower glass transition temperatures than PVC-DEHP-ester, reflecting the enhanced flexibility of the ether versus ester linker.

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DinCH and ESBO actual migration from PVC infusion tubings used in an oncopediatric unit

Tortolano

Matmati

Bourhis

et al. 2018

J of Applied Polymer Sci

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Plasticizer leaching from poly(vinyl chloride) (PVC) tubing is a well‐studied phenomenon and is a real issue in medical care today. The present study focuses on the release of two plasticizers 1,2‐cyclohexane dicarboxylic acid diisononyl ester (DINCH) (primary) and epoxidized soy bean oil (ESBO) (secondary) from PVC extension tubings used in an oncopediatric unit. The release of plasticizers is calculated by comparison to unused tubings with the same batch number. Both the DINCH and ESBO ratio diminishes in used versus new extension tubings. The loss of plasticizers has not been related to the presence of a specific drug. Our results confirm the leaching of classic plasticizers like the DINCH and of secondary plasticizers like the ESBO from tubings in real life. It confirms too the existence of a complex phenomenon in which exchanges between drugs, lipids, PVC matrices, and the administration sequences can change the global release of plasticizers. Considering all the variables involved in real‐life data, the in vitro testing appears to be the most efficient way to confirm these observations. © 2018 Wiley Periodicals, Inc. J. Appl. Polym. Sci. 2018, 135, 46649.

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Migrability of PVC plasticizers from medical devices into a simulant of infused solutions

Cited by 78 publications

References 13 publications

Exposure of hospitalised pregnant women to plasticizers contained in medical devices

Exposure of hospitalised pregnant women to plasticizers contained in medical devices

Phthalate plasticizers covalently linked to PVC via copper-free or copper catalyzed azide-alkyne cycloadditions

DinCH and ESBO actual migration from PVC infusion tubings used in an oncopediatric unit

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