Vinyl manufacturers work together to defend the medical application of PVC
Paris, France - the French Senate passed a new law in December 2012, unilaterally prohibiting the use of medical catheters containing PVC plasticizer - di (2-ethylhexyl) phthalate (DEHP) in pediatric, neonatal and maternal wards. The ban will take effect on July 1st, 2015. If the investigation of the European Food Safety Agency (EFSA) on DEHP finds that the French ban has no sufficient scientific basis, France may face the action taken by the European Commission. The European food safety agency is expected to release the relevant report in May
of course, this is not the first time DEHP has become the focus of attention. As a plasticizer, DEHP is used to soften PVC to avoid major accidents. Blood bags made of PVC usually contain% DEHP. Based on reports in medical journals, environmentalists claim that DEHP -- and all phthalates -- may become endocrine disruptors, which mimic human hormones, cause damage to the male reproductive tract, and lead to a decline in fertility
in March 2012, PVC free blood bag, a pressure group funded by the European Commission through the EU life+ program, released a life cycle assessment (LCA) on PVC blood bags. The organization concluded that HDPE is a relatively safe substitute, and the selection of pvc/dehp has a great potential impact on human health, including the impact of the whole life cycle and the possible impact on human health due to DEHP pollution in blood transfusion
in July 2012, the European vinyl Manufacturers Committee issued an important review. Professor adisa azapagic from the University of Manchester, UK, was entrusted to carry out this review. He found that the evaluation of VC free blood bag with high sports effectiveness was inconsistent with the provisions of the recognized ISO standard, the method adopted was unscientific, and made the assumption of "unclear, inconsistent, in some cases, it can be said to be groundless, misleading and biased"Azapagic concluded, "the purpose of this study seems to be to eliminate PVC blood bags, regardless of the actual results. Therefore, the above matters should be taken into account when understanding the results of this study."
the European Council of vinyl manufacturers said that at present, there is no ideal plastic material to replace PVC. PVC has been used to produce blood bags to avoid strain and vibration for more than 50 years. Practice has proved that the combination of pvc-dehp is very suitable for the production of blood bags, because DEHP can consolidate and stabilize red blood cells and minimize hemolysis (red blood cell rupture)
now, a number of member enterprises producing medical PVC of the European vinyl manufacturer Committee have joined forces to fight for the protection of PVC. Members of the pvcmed alliance include BASF, colorite, Eastman, oxea, Renolit and Tarkett. In addition, the Australian vinyl Association joined in January 2012
brigitte DERO, spokesman of the pvcmed alliance and general manager of the European vinyl Manufacturers Committee, said when explaining the reasons for the establishment of the alliance: "as interested enterprises, members feel that they should convey all these perceptions to stakeholders to ensure that they make a wise decision on this matter. Pvcmed believes that stakeholders need to know the information about the relevant applications of PVC in the healthcare industry."
"in addition, the application of PVC in the field of health care is often criticized by the media; but most of these criticisms are groundless and lack strong scientific evidence. Therefore, in this increasingly widespread debate, it is important to give the PVC industry a voice, which is also our original intention to establish pvcmed."
dero believes that PVC has a long-term future in the application of medical care, and through innovation and continuous improvement, the PVC industry will be able to overcome the challenges brought by the intervention of pressure groups and government regulations. "In fact, one of the purposes of establishing the PVC Med alliance is to exchange needs with different stakeholders and explore how the PVC industry and the whole plastic industry should develop and innovate."
dero was frank about the controversy caused by DEHP, saying that the PVC industry was "willing to solve these problems and have an open discussion around plasticizers." In addition, DEHP is increasingly being replaced by other materials. She said, "our industry is highly committed to innovation and continuous improvement of our products. Now there have been many innovative new plasticizers, which are no less technical and functional than DEHP when used with PVC."
"PVC medical equipment using these new plasticizers can retain the main characteristics of PVC, including kink resistance, which can be connected with hard parts without using adhesives. Various processes can be used for convenient disinfection, high clarity, good flexibility and resistance, airtight packaging, and easy processing."
dehp's alternative materials include adipate plasticizers, butyl hexyl citric acid (bthc), cyclohexane-1,2-dicarboxylic acid, diisopropyl phthalate (hexamoll DINCH), di (2-ethylhexyl) ester ethylene terephthalate (Eastman 168), polymer materials and trimellitic acid, 2-ethylhexyl ester (totm)
dero added: "when used with PVC, these alternative plasticizers have the same technical function as DEHP. Some of them (such as bthc, hexamoll DINCH and totm) have proved to be very suitable to replace DEHP in blood bags because they can stabilize red blood cells and have no effect on other important blood properties."
"hexamoll DINCH (diisopropyl phthalate) is used in intestinal nutrition, medical pipeline systems and pediatric applications, especially in platelet bags. It has been shown that the transfer rate of hexamoll DINCH is about 10 times lower than DEHP."
in addition, totm (tri-2-ethylhexyl trimellitic acid trioctyl ester) has been used in medical catheters to deliver intestinal nutritional products for many years. In terms of plasticizer durability, totm performs much better than DEHP in terms of transferability
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