Perspectives on alternatives to phthalate plasticized poly(vinyl chloride) in medical devices applications (original) (raw)
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Migration of phthalate-based plasticizers from PVC and non-PVC containers and medical devices
Journal of the Brazilian Chemical Society, 2012
A presença de cinco plastificantes derivados de ftalatos em equipamentos para administração intravenosa de soluções e em hemodialisadores (HD), que são feitos tanto de policloreto de vinila (PVC) quanto de outros materiais poliméricos, foi investigada. Destes ftalatos, o único autorizado por agências reguladoras é o di-(2-etilhexil) ftalato (DEHP) em equipamentos de PVC. A determinação foi feita por chromatografia líquida de alta eficiência (HPLC) com detecção UV. Os resultados mostraram que as bolsas para infusão que são feitas tanto de PVC quanto de etil vinil acetato (EVA) contêm apenas DEHP. Entretanto, as mangueiras dos equipos de infusão e dos HD, bem como as fibras capilares dos HD feitas de celulose, contêm não só DEHP, mas também ftalato de dibutila (DBP). Todos os cinco ftalatos investigados foram encontrados nos capilares dos HD feitos de polisulfona. A migração de DEHP para soluções (aminoácidos, glicose e salina) armazenadas em bolsas ocorreu com taxas diferentes para os dois polímeros. Enquanto que para as bolsas de PVC o DEHP foi encontrado em soluções já nos primeiros dias de contato, para as bolsas de EVA a migração iniciou após aproximadamente 6 meses de armazenamento. Como os dispositivos analisados, com exceção das bolsas, contém, além do DHEP, outros ftalatos, o risco posto aos pacientes deve ser motivo de preocupação. The presence of five plasticizer phthalates in bags and sets for intravenous administration and hemodialyzers (HD), which are made of polyvinyl chloride (PVC) and of other polymeric materials, was investigated. Di-(2-ethylhexyl) phthalate (DEHP) in PVC is the only authorized phthalate by regulatory agencies. Phthalate determination was carried out by high resolution liquid chromatograph (HPLC) with UV detection. The results showed that the infusion bags that are made of both PVC and ethylene vinyl acetate (EVA) contained only DEHP. In contrast, the tubing of infusion sets and of HD (as well as the cellulose capillaries of HD) contained not only DEHP but also dibutyl phthalate (DBP). Moreover, all five investigated phthalates were found in HD polysulfone capillaries. Migration of DEHP into the stored solutions (amino acids, glucose and saline) in bags occurred at different rates from one polymer to another. While DEHP from PVC bags was found in solutions within the first days of contact, the migration from EVA bags started only after approximately 6 months of solution storage. Since PVC and non-PVC devices (as well as capillaries of HD sets) contain DEHP and other phthalate-based plasticizers, the extent of the risk that they pose to patients remains a matter of concern.
Reducing the migration of di-2-ethylhexyl phthalate from polyvinyl chloride medical devices
International journal of …, 2005
We attempted to determine the processing conditions for decreasing the migration of phthalate esters, particularly di-2ethylhexyl phthalate (DEHP), from polyvinyl chloride (PVC) products using a drug solvent after dilution based on the package insert. PVC sheets and PVC tubing were subjected to optical irradiation (ultraviolet (UV), visible light irradiation) and heat treatment to determine whether they are deteriorated by these treatments. UV irradiation to one side of the PVC sheet decreased the levels of DEHP migration from the sheets by almost 50%, although the amount of DEHP content in PVC sheet was observed no significant change. On the other hand, the levels of DEHP migrating from the inner surface of PVC tubing UV-irradiated from the outer surface were not decreased compared with the control. Therefore, the surface structure was examined by conducting Fourier transform infrared spectroscopy (FT-IR), electron spectroscopy for chemical analysis (ESCA) and static angle of contact measurement. In FT-IR analysis, we found that the UV-irradiated PVC sheets were exhibited broadened absorption bands with time. In ESCA analysis, the chlorine content was decreased and the oxygen content was increased with time in UV-irradiated PVC sheets. Moreover, the other treated PVC sheets shows no significant change compared with the non-UV-irradiated PVC sheet. Therefore, the surface structure of the UV-irradiated PVC sheet was changed. As a result, the migration of DEHP from PVC products can be decreased with simple treatment, such as UV-irradiation. This could be a useful method to develop novel PVC products.
Leaching and Exposure of Phthalates from Medical Devices; Health Impacts and Regulations
Environmental Contaminants Reviews, 2019
Phthalates (PAEs) are widely used as plasticizers in medical devices to make polyvinyl chloride flexible and soft. However, PAEs can be leached out from plasticizers undesirably and can migrate within the material and end up with direct exposure to humans. Therefore, a number of studies have been conducted globally focusing on their leaching from medical devices like blood bags, infusion tubing, peritoneal dialysis bags and tubing, catheters etc. In current review an attempt is made to gather information related to leaching, exposure, health implication of PAEs along with the regulation used in different countries. Toxic health effects with the exposure of PAEs includes neurological effects, DNA damage, oxidative stress, asthma with negative impact on lungs, effects on reproductive system, liver impairment and gastrointestinal effects. In addition, leaching studies has shown the presence of DEHP about 31-34 % in peritoneal dialysis set like bags and tubing. DEHP leached out from medical apparatus depends upon temperature, storage time, amount of DEHP present in devices and shaking of device while in touched with medical solution. The exposure of plasticizers for pregnant hospitalised women and infants has also highlighted. In addition, PAEs alternates introduced in market are also discussed like Trioctyltrimellitate/tri-(2-ethylhexyl) trimellitate) along with various regulations regarding the use of PAEs in medical devices and other products. was poor.
An in vitro evaluation of a new plasticizer for polyvinylchloride medical devices
Transfusion, 1980
The rate of leaching from polyvinylchloride (PVC) by serum is one-hundredth that of di-2-ethylhexyl phthalate (DEHP) as determined by radioassay. There is a proportional decrease in leachability of DEHP but not of H-200 as the plasma proteins are diluted. Saline extracts of DEHP demonstrated a low but progressive rate of leaching with an accumulation of 11 pg/ml after seven weeks whereas H-200 showed only a constant residue of 035 pg/ml. Normal human serum incubated for three weeks at 37 C with PVC strips plasticized with DEHP produced significant growthinhibition of human diploid fibroblasts. Human serum incubated in an identical manner with PVC plasticized with H-200 for up to four weeks demonstrated no effect on tissue culture. These studies indicate that H-200 deserves further evaluation as a replacement for DEHP in PVC biomedical devices.
IIUM Engineering Journal, 2022
The use of phthalates as a plasticizer in plasticized polyvinyl chloride (PVC) always poses the threat of migration of phthalates into the environment through medical equipment. Phthalates can be used with natural-based plasticizers, such as Epoxidized soybean oil (ESBO) known as phthalate’s scavenger and PVC stabilizers. PVC formulations were characterized by different combinations of di (2-ethylhexyl) phthalate (DEHP) 30-40% with 5% ESBO. PVC flexibility increased significantly in the presence of ESBO, without a change in strength (tensile test). The decrease of the Tg temperature by adding ESBO in Differential Scanning Calorimetry indicated that ESBO preserved DEHP in the polymer. Also, it was shown that the sterilization process with Ethylene Oxide, similar to ESBO, decreased the Tg of polymer. DEHP migration was evaluated at a maximum level to the environment using the Gas Chromatography test. Samples containing ESBO showed less hemolysis. ABSTRAK: Penggunaan phthalates sebagai...
Determination of di(2-ethylhexyl) phthalate in plastic medical devices
Chemical Industry, 2016
The presence of DEHP in dialysis and infusion sets for peritoneal dialysis and parenteral nutrition, which are made of PVC and other plastic polymeric materials, were investigated. Phthalate determination was carried out by gas chromatography - mass spectrometry method (GC-MS). The results showed that the peritoneal dialysis set (bag and tubing) made of PVC contains DEHP in significant amount, about 31 - 34%. Solution for peritoneal dialysis which was stored in the investigated PVC bag, contains low amount of DEHP, about 3.72 ?g dm-3. Infusion bottles which are made of LDPE, also contain DEHP but in lower amount than PVC bags. LDPE bottle for packaging physiological saline solution (0.9% NaCl) showed higher amount of DEHP than LDPE bottle for packaging Ringer?s solution. In contrast, solution stored in bottle with lower DEHP level, i.e. Ringer?s solution contained about three times higher concentration of DEHP than physiological saline solution stored in bottle with higher DEHP leve...
Journal of the Serbian Chemical Society, 2018
The influence of ultraviolet (UV) radiation on the leaching of di(2- -ethylhexyl) phthalate (DEHP) from 8 different parts of plastic medical devices made of poly(vinyl chloride) (PVC) that are used in two important medical procedures (peritoneal dialysis and transfusion) was investigated. The investigation was performed for three different extraction times (6, 15 and 30 days). DEHP determination was realized by gas chromatography?mass spectrometry (GC-EI? ?MS). All the investigated samples contained a significant amount of DEHP. The results showed that some of the set for peritoneal dialysis contained DEHP in higher amounts than samples from the transfusion set. All samples of tubing material showed higher concentration levels of DEHP than the coupled bags. Results obtained after UV treatment showed that UV radiation has a certain influence on DEHP leaching from samples of PVC medical devices. The smallest difference was in the case of the quadruple blood bag from the transfusion se...
Revisiting analysis of phthalate plasticizers concentration in poly(vinyl chloride)
Journal of Vinyl & Additive Technology, 2014
The method of the efficient analysis of di(2-diethylhexyl) phthalate, tri(2-ethylhexyl) trimellitate, di(2-ethylhexyl) terephthalate, and other phthalate plasticizers concentrations in plasticized poly(vinyl chloride) (PVC) was developed. The method is based on quantitative dissolution of the PVC sample in methyl ethyl ketone with the consequent precipitation of PVC with hexane and concentration of phthalate in an organic layer. A capillary column-based gas chromatographic technique for phthalates separation and quantification was developed and used in conjunction with the PVC and phthalates dissolution technique. The developed method of phthalate plasticizers analysis proved to be relatively fast, reproducible, and straightforward. J.
Toxicology and Biodegradability of a Phthalate-Free and Bio-Based Novel Plasticizer
Journal of Toxicology, 2021
Phthalate esters, mainly di-ethylhexylphthalate (DEHP), represent a class of chemicals primarily used as plasticizers for polyvinyl chloride in a wide range of domestic and industrial applications. These phthalate esters are low-toxicity environmental contaminants. To address these drawbacks, POLYSORB® ID 37, a blend of diesters obtained from esterification of isosorbide with plant-based fatty acids, was developed. The company can now offer PVC manufacturers a new product which competes with phthalates and other such chemicals. The market for plasticizers is very important, and ROQUETTE intends to provide a more sustainable and safer product. Isosorbide diester is bio-based (made from glucose and vegetable fatty acids). This plasticizer is registered in REACH regulation for high volumes (>1000 T/year). Risk assessment was obtained by conducting a wide range of biodegradability and toxicological protocols, using rodent models, according to established guidelines. Overall, all of t...
International journal of pharmaceutics, 2012
Irradiation with 20-25 kGy (kiloGray) is a process commonly used for sterilizing poly(vinyl chloride (PVC) medical devices. Moreover, whole blood and blood components undergo additional irradiation with 25-50Gy (Gray) to inhibit the proliferative capacity of lymphocytes and reduce the risk of transfusion-associated graft-vs-host disease (GVHD). Di-(2-ethylhexyl)-phthalate (DEHP) plasticized PVC is extensively used for the production of flexible medical devices including blood bags, but since DEHP is not covalently bound to PVC, it tends to migrate and leach out of the medical device, with harmful consequences for the patients. In this study, the effects of different doses of gamma irradiation on DEHP migration from PVC blood bags was investigated using Differential Scanning Calorimetry (DSC) analysis. Our findings indicate that irradiation with 25 to 100Gy reduces the ability of DEHP to migrate from the blood bags, and in the case of a primary container a correlation between the dos...