Materials Degradation in PVC Medical Devices, DEHP Leaching and Neonatal Outcomes

Abstract

Polymeric materials play a key role in the production of medical and clinical devices thanks to their special features such as flexibility, easy processing and good price/performance ratio. Among the different polymeric matrixes, one of the most used is Poly(vinyl chloride) (PVC). At room temperature PVC is hard and brittle, thus great amounts (40-50%) of phthalate esters that act as plasticizers are added to the polymer to make it flexible and appropriate for medical use. Di-(2-ethylhexyl)-phthalate (DEHP) is the most widely used plasticizer in PVC medical devices. However, DEHP is not chemically bound to PVC and migrates from medical devices with time and use. The potential for DEHP to produce adverse effects in humans has been the subject of considerable discussion and debate in the scientific community. In particular, newborns in the new environment have to be considered at particularly increased risk, because of their small body size and the multiple medical device-related to the DEHP exposure. The major factors determining the degree to which DEHP migrates from medical devices are temperature, amount of DEHP in the device, storage time, shaking of the device while in contact with the medical solutions and degree of PVC degradation.

Mycelial fungi completely remediate di(2-ethylhexyl)phthalate, the hazardous plasticizer in PVC blood storage bag

“…They contained an average of 34% (w/w) DEHP. Most of the studies related to the plasticizer used in PVC medical products reported DEHP as the principal plasticizer being used [6,28], but no reliable statistics available on the quantity of phthalate used in such devices. Ruzickova et al [29] performed an exhaustive study in various European countries on the 48 medical devices -ranging from blood storage bags, injection sets, infusion and nutrition sets to tubing and masks -made of PVC plastics and found that DEHP used in such devices varied between 17% and 41% by weight.…”

Невидимі Ризики: Що Ми Знаємо Про Них?

“…-трансплантація серця або в коронарній хірур-гії шунтування артерій (сумарна доза); -масивне вливання крові при травмі пацієнта; -переливання у дорослих, під час процедури ЕКМО [13][14][15][16].…”

A monograph on the remediation of hazardous phthalates

“…Most of the studies related to the plasticizer used in PVC medical products reported DEHP as the principal plasticizer being used [56]. An exhaustive study conducted in various European countries on the 48 medical devices -ranging from blood storage bags, injection sets, infusion and nutrition sets to tubing and masks -made of PVC plastics showed that DEHP content in such devices varied between 17 and 41% by weight [57].…”