Migration Resistant, Blood-Compatible Plasticized Polyvinyl Chloride for Medical and Related Applications (original) (raw)
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Biomaterials, 2005
Poly(vinyl chloride) (PVC) was aminated by treating the resin with a concentrated aqueous solution of ethylenediamine. The aminated PVC was then reacted with hexamethylene diisocyanate to incorporate the isocyanate group onto the polymer backbone. The isocyanated PVC was further reacted with poly(ethylene glycol) (PEG) of molecular weight 600 Da. The modified polymer was characterized using infrared spectroscopy and thermal analysis. Infrared spectra showed the incorporation of PEG onto PVC. The thermal stability of the modified polymer was found to be lowered by the incorporation of PEG. Contact angle measurements on the surface of polymer films cast from a tetrahydrofuran solution of the polymer demonstrated that the modified polymer gave rise to a significantly hydrophilic surface compared to unmodified PVC. The solid/water interfacial free energy of the modified surface was 3.9 ergs/cm 2 as opposed to 19.4 ergs/cm 2 for bare PVC surface. Static platelet adhesion studies using platelet rich plasma showed significantly reduced platelet adhesion on the surface of the modified polymer compared to control PVC. The study showed that bulk modification of PVC using PEG using appropriate chemistry can give rise to a polymer that possesses the anti-fouling property of PEG and such bulk modifications are less cumbersome compared to surface modifications on the finished product to impart anti-fouling properties to the PVC surface.
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...
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...
DEHP-plasticised PVC: relevance to blood services*
Transfusion Medicine, 2010
Phthalates are the most widely used plasticisers in the world and have been in medical use since 1955. Di(2-ethylhexyl)phthalate (DEHP) is present in many industrial and domestic products, and is a common plasticiser used in blood bags and tubing sets. Concerns have been raised by environmental groups that DEHP exposure may result in gender birth defects and the feminisation of boys although there were no studies performed of intravenous exposure to DEHP on higher mammals or humans which report similar effects. This article reports on the toxicology of DEHP and considers concerns regarding its use in the context of transfusion medicine. The benefits of using DEHP are evaluated and the use of alternative plasticisers to DEHP is explored. The article reports on international and European regulatory recommendations for DEHP use in transfusion medicine and examines the impact of legislation on the medical devices and blood industries. The article also reviews labelling considerations for blood components and offers some guidance for blood establishments in respect of DEHP use.
Progress in Polymer Science, 2013
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.
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.
Effects of flow rate on the migration of different plasticizers from PVC infusion medical devices
PloS one, 2018
Infusion medical devices (MDs) used in hospitals are often made of plasticized polyvinylchloride (PVC). These plasticizers may leach out into infused solutions during clinical practice, especially during risk-situations, e.g multiple infusions in Intensive Care Units and thus may enter into contact with the patients. The migrability of the plasticizers is dependent of several clinical parameters such as temperature, contact time, nature of the simulant, etc… However, no data is available about the influence of the flow rate at which drug solutions are administrated. In this study, we evaluated the impact of different flow rates on the release of the different plasticizers during an infusion procedure in order to assess if they could expose the patients to more toxic amounts of plasticizers. Migration assays with different PVC infusion sets and extension lines were performed with different flow rates that are used in clinical practice during 1h, 2h, 4h, 8h and 24h, using a lipophilic...
Materials science & engineering. C, Materials for biological applications, 2017
Commercial infusion tubing and blood storage devices (tubing, blood and platelets bags) made of plasticized PVC were analyzed by spectroscopic, chromatographic and microscopic techniques in order to identify and quantify the additives added to the polymer (lubricants, thermal stabilizers, plasticizers) and to put into evidence their blooming onto the surface of the devices. For all the samples, deposits were observed on the surface but with different kinds of morphologies. Ethylene bis amide lubricant and metallic stearate stabilizers were implicated in the formation of these layers. In contact with aqueous media, these insoluble deposits were damaged, suggesting a possible particulate contamination of the infused solutions.
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.
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.