Perspectives on alternatives to phthalate plasticized poly(vinyl chloride) in medical devices applications

Abstract

Poly(vinyl chloride) (PVC) is one of the most important polymeric materials available today and is used to manufacture many items, ranging from packaging and toys to healthcare devices. PVC is per se a rigid material but it is made softer by compounding with plasticizers, particularly phthalate esters such as di-(2-ethylhexyl) phthalate (DEHP). In flexible plasticizer PVC (P-PVC), phthalates are not chemically bound to PVC and they are released into the external environment. In particular, prolonged contact of P-PVC based medical devices with body fluids or tissues has been shown to be associated with severe health risks. Major concerns regarding the safety of P-PVC in medical plastic items have been raised, and several alternatives to phthalates and to P-PVC itself as well as chemical/physical treatments of P-PVC to reduce DEHP migration have been proposed. This review outlines recent scientific approaches for preventing DEHP contamination of humans by P-PVC medical devices, highlighting the impact of the proposed alternative materials on human health and strategies for implementing them

Dual-Purpose Bioreactors to Monitor Noninvasive Physical and Biochemical Markers of Kidney and Liver Scaffold Recellularization

“…Unlike polyvinyl chloride (PVC) or metal composites, glass does not contain plasticizers or oils that may leach into the culture medium. 24,25 We previously described a horizontal perfusion bioreactor in which the kidney scaffold is immersed in the culture medium. 13 However, to allow for more effective media sampling and establishment of negative trans-scaffold pressure by applying vacuum to the environment surrounding the scaffold, this bioreactor was redesigned in a vertical configuration with media sampling through the chamber head (Fig.…”

Docking study: PPARs interaction with the selected alternative plasticizers to di(2-ethylhexyl) phthalate

“…The polymer will need to be flexible, biocompatible and inert during the sterilization process. Therefore, polymers considered to be suitable alternatives to PVC include the following: ethylene vinyl acetate (EVA), silicones, polyurethanes and polyolefins; the most common types of polyolefins being polyethylene and polypropylene 30 . Although most of the selected materials perfectly matched the performance of PVC, their high cost is still a major limit to their exploitation.…”

Simultaneous determination of polyvinylchloride plasticizers di(2-ethylhexyl) phthalate and tri(2-ethylhexyl) trimellitate and its degradation products in blood by liquid chromatography-tandem mass spectrometry

“…First results indicate that TOTM actually possesses a lower toxicity than DEHP [2,[18][19][20]. Moreover, a higher chemical stability can be assumed indicated by a significantly decreased leachability of TOTM from PVC medical devices into intravenous preparations [21] and into blood [10].…”

“…PVC components are often used in medical devices. Typical applications comprise bags and tubing for blood transfusions, infusions and dialysis systems [1,2]. To induce and maintain processability and flexibility technical PVC contains additives, such as plasticizers.…”

“…Since DEHP toxicity is an increasing matter of concern, there is a growing demand for alternative plasticizers [2,17], like tri(2-ethylhexyl) trimellitate (TEHTM or TOTM). First results indicate that TOTM actually possesses a lower toxicity than DEHP [2,[18][19][20].…”