Analysis of plasticizers in PVC medical devices: Performance comparison of eight analytical methods

Bernard, Lise; Bourdeaux, Daniel; Pereira, Bruno; Azaroual, Nathalie; Barthélémy, Christine; Breysse, C.; Chennell, Philip; Cueff, R.; Dine, T.; Eljezi, Teuta; Feutry, Frédéric; Genay, Stéphanie; Kambia, Nicolas; Lecoeur, Marie; Masse, Morgane; Odou, Pascal; Radaniel, T.; Simon, Nicolas; Vaccher, Claude; Verlhac, Camille; Yessaad, Mouloud; Décaudin, Bertrand; Sautou, V.

doi:10.1016/j.talanta.2016.10.033

Cited by 20 publications

(15 citation statements)

References 14 publications

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“…A PVC DLT contains a plasticizer material such as dioctyl phthalate, so it is flexible and retains the transformed shape temporarily. [26] If the DLT tip is further bent and kept with a stylet inside before intubation, the more concave curvature can be maintained while it passes the trachea even after removal of the stylet. The more curved tip is further extended to the left bronchial opening over the carina (Fig 6).…”

Section: Discussionmentioning

confidence: 99%

Augmentation of curved tip of left-sided double-lumen tubes to reduce right bronchial misplacement: A randomized controlled trial

et al. 2019

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BackgroundDuring intubation with a blind technique, a left-sided double-lumen tube (DLT) can be misdirected into the right bronchus even though its curved tip of the bronchial lumen turns to the left. This right bronchial misplacement may be associated with the tip angle of DLTs. We thus performed a randomized trial to test the hypothesis that the DLT with an acute tip angle enters the right bronchus less frequently than the tube with an obtuse tip angle.MethodsWe randomized surgical patients (n = 1427) receiving a polyvinyl chloride left-sided DLT. Before intubation, the curved tip was further bent to an angle of 135° and kept with a stylet inside in the curved-tip group, but not in the control group. After the tip was inserted into the glottis under direct or video laryngoscopy, the stylet was removed and the DLT was advanced into the bronchus with its tip turning to the left. We checked which bronchus was intubated, and the time and number of attempts for intubation. After surgery, we assessed airway injury, sore throat, and hoarseness. The primary outcome was the incidence of right bronchial misplacement of the DLT.ResultsDLTs were misdirected into the right bronchus more frequently in the control group than in the curved-tip group: 57/715 (8.0%) vs 17/712 (2.4%), risk ratio (95% CI) 3.3 (2.0–5.7), P < 0.001. The difference was significant in the use of 32 (P = 0.003), 35 (P = 0.007), and 37 (P = 0.012) Fr DLTs. Intubation required longer time (P < 0.001) and more attempts (P = 0.002) in the control group. No differences were found in postoperative airway injury, sore throat and hoarseness.ConclusionsBefore intubation of left-sided DLTs, augmentation of the curved DLT tip reduced the right bronchial misplacement and facilitated intubation without aggravating airway injury.

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Section: Discussionmentioning

confidence: 99%

Augmentation of curved tip of left-sided double-lumen tubes to reduce right bronchial misplacement: A randomized controlled trial

et al. 2019

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“…The limit of quantification (LOQ) for each analyte was determined in accordance with ICH guidelines [ 39 ]. The calculated LOQs ranged from 54.1 to 76.3 ng/g, and they were approximately 20 times lower compared with the results from the latest study which was performed to determine LOQ by the GC/MS method [ 18 ]. To validate the accuracy and precision of the analytical method, three replicate analyses of matrix blank samples spiked with the known amounts of the analytes at low and middle concentration levels (17 and 100 ng/g) were prepared and determined by the analytical procedure.…”

Section: Resultsmentioning

confidence: 88%

“…Due to the expanding use of phthalates and assimilated analytes in medical devices, the analytical methods for plasticizers from infusion sets are increasing in order to create plans for safety. Several analytical methods capable of detecting and quantifying the alternative plasticizers in medical devices have been developed and validated by means of separative and nonseparative methods up to date [ 18 ]. The separative methods have been adopted with gas chromatography, supercritical fluid chromatography [ 19 ], and liquid chromatography combined with various detectors such as mass spectrometer, flame ionization detector, evaporative light scattering detector, or UV techniques.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Gas Chromatography-Triple Quadrupole Mass Spectrometric Method for Quantitative Determination of Regulated Plasticizers in Medical Infusion Sets

Jeon

Kim

Kho

et al. 2018

Journal of Analytical Methods in Chemistry

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A method for the quantitative determination of dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), bis(2-ethylhexyl) adipate (DEHA), bis(2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DNOP), dioctyl terephthalate (DOTP), diisononyl phthalate (DINP), and diisodecyl phthalate (DIDP) in medical infusion sets was developed and validated using gas chromatography coupled with triple quadrupole mass spectrometry (GC-MS/MS) in the multiple reaction monitoring (MRM) mode. Solvent extraction with polymer dissolution for sample preparation was employed prior to GC-MS/MS analysis. Average recoveries of the eight target analytes are typically in the range of 91.8–122% with the relative standard deviations of 1.8–17.8%. The limits of quantification (LOQs) of the analytical method were in the ranges of 54.1 to 76.3 ng/g. Analysis using GC-MS/MS provided reliable performance, as well as higher sensitivity and selectivity than GC-MS analysis, especially for the presence of minority plasticizers at different concentrations.

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“…Limitations on use with restrictions for toys and childcare articles, food contact plastics as well as medical devices have been decided. These successive regulations on phthalates coupled with rising concern about their human health effects have encouraged the use of alternative plasticizers with lower toxicity (e.g., long-chain phthalates, adipates, terephthalates) [ 6 , 7 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

Analysis of Phthalates and Alternative Plasticizers in Gloves by Gas Chromatography–Mass Spectrometry and Liquid Chromatography–UV Detection: A Comparative Study

Poitou

Rogez-Florent

Lecoeur

et al. 2021

Toxics

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Gloves represent an essential feature for hand protection because it is a requirement in the professional framework to comply with both hand hygiene standards and the principles of good laboratory practice. Despite their wide use, there is a knowledge gap regarding their composition, including phthalates. The purpose of the present study was to develop two orthogonal methods, GC–MS and HPLC–DAD, for the screening of plasticizers in gloves. Performances of these two methods were compared in terms of ease of use, number of analyzed plasticizers, and sample preparation. The two methods were validated and applied for the identification and quantification of plasticizers in ten gloves made with different materials (vinyl, nitrile, latex, and neoprene). Results revealed the presence of three main ones: DEHP, DEHT, and DINP. Additionally, the contents of plasticizers were extremely variable, depending on the glove material. As expected, the results point out a predominant use of plasticizers in vinyl gloves with an amount that should be of concern. While DEHP is classified as a toxic substance for reproduction 1B, it was, however, quantified in the ten different glove samples studied. This study provides new data regarding the plasticizers’ content in protective gloves, which could be useful for risk assessment.

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Analysis of plasticizers in PVC medical devices: Performance comparison of eight analytical methods

Cited by 20 publications

References 14 publications

Augmentation of curved tip of left-sided double-lumen tubes to reduce right bronchial misplacement: A randomized controlled trial

Augmentation of curved tip of left-sided double-lumen tubes to reduce right bronchial misplacement: A randomized controlled trial

Development and Validation of Gas Chromatography-Triple Quadrupole Mass Spectrometric Method for Quantitative Determination of Regulated Plasticizers in Medical Infusion Sets

Analysis of Phthalates and Alternative Plasticizers in Gloves by Gas Chromatography–Mass Spectrometry and Liquid Chromatography–UV Detection: A Comparative Study

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