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PARIS -- In December 2012 the French senate passed a law unilaterally banning the use of tubing containing di (2-ethyhexyl) phthalate (DEHP) from pediatric, neonatal and maternity wards. The ban will come into force on July 1, 2015, though France may yet face action from the European Commission if the European Food and Safety Authority (EFSA)'s investigation into DEHP finds that France's ban cannot be scientifically justified. EFSA is expected to report on the matter in May.
It is, of course, not the first time DEHP has made the news. A plasticizer, DEHP is used to soften PVC. Blood bags made from PVC contain typically 30-40 percent DEHP. Environmental campaigners have leapt on reports from medical journals that suggested DEHP — and phthalates in general — might be endocrine disruptors (EDs), chemicals that mimic human hormones, causing damage to the male reproductive tract leading to decreased fertility.
In March 2012 the pressure group PVCfreeBloodBag, which is funded by the European Commission through its EU Life+ initiative, released a Life Cycle Assessment (LCA) of PVC blood bags. The LCA concluded that HDPE would be a safer alternative and that "the PVC/DEHP choice has a substantially higher potential impact on human health, both with regards to the overall life cycle impact and with regards to the potential health impact caused by DEHP contamination in the transfused blood".
In July 2012, the European Council of Vinyl Manufacturers (ECVM) released a critical review of the LCA. Prof Adisa Azapagic from Manchester University in England was commissioned for the review and he found the LCA lacked consistency with recognized ISO standards, used unscientific methods and was based on "unclear, inconsistent and in some cases unjustifiable, misleading and biased" assumptions.
Azapagic concluded: "The goal of this LCA study appears to be motivated by a desire to phase out PVC blood bags, regardless of the actual LCA results and therefore the results of the study should be interpreted with the above in mind."
ECVM claims that there is currently no viable plastic material that could be used to replace PVC Ð which has been used for manufacturing blood bags for over 50 years. The PVC-DEHP combination has proven itself highly suitable for the manufacture of blood bags because DEHP stabilizes red blood cells, minimizing hemolysis (the rupturing of red blood cells).
Now a group of ECVM-affiliated companies, that produce PVC for medical applications, is aiming to fight for PVC's corner. The PVCMed Alliance includes BASF, Colorite, Eastman, Oxea, Renolit and Tarkett and has been joined, as of January 2012, by the Vinyl Council of Australia.
PVCMed Alliance spokesperson Brigitte Dero, general manager of ECVM, explained the reason behind the alliance's formation: "As responsible companies, the members of PVCMed feel that they should communicate all this knowledge to stakeholders in order to ensure that they can make informed decisions on this matter. PVCMed is convinced that there is a demand for information among stakeholders about the use of PVC within the healthcare sector.
"Furthermore, the use of PVC in healthcare applications is often being criticized in the media; however these criticisms are generally unfounded and lack scientific justification. It is therefore important that the industry makes its voice heard in the wider debate, this is also why PVCMed was established.
Asked what the PVCMed Alliance would do to allay the fears of the public regarding PVC, Dero replied: "Despite the fact that the use of PVC in healthcare applications has significantly contributed to the high level of patient treatment and safety that benefits everyone, it has also been criticized by unfounded claims that are seriously lacking scientific justification. In this sense, the PVCMed Alliance was created to communicate about PVC-based healthcare applications and to establish an effective platform to share best practice and scientific-based data.
"We hope the alliance will strengthen dialogue with all involved stakeholders about the use and value of PVC in healthcare applications and its role in ensuring quality and safety in healthcare."
Dero suggested that PVC has a long future in healthcare applications and that through innovation and continuous improvement, the industry will be able to meet the challenges faced by pressure group intervention and governmental regulation. "In fact," she continued, "one of the objectives of the PVCMed Alliance is to engage with different stakeholders on how the industry and the sector as a whole should develop and continue to innovate."
Dero recognizes the DEHP controversy but says that the PVC industry is "willing to address these issues and open the debate on plasticizers". Also, DEHP is increasingly being replaced. She said: "The strong willingness of the industry to innovate and to continuously improve its products has led to new and innovative plasticizers that perform their technological function with PVC just as well as DEHP did.
"PVC medical equipment plasticized with these innovative products keep the key properties of PVC. These include kink resistance, bonding to rigid components without the need for adhesives, ease of sterilization using various processes, high clarity, flexible and resistant, hermetic sealing properties and ease of processing."
Alternatives to DEHP include adipate plasticizers, Butyryltrihexylcitrate (BTHC), Cyclohexane-1,2-dicarboxylic acid, diisononylester (Hexamoll DINCH), Di(2-ethylhexyl)terephthalate (Eastman 168), polymerics and trimellitic acid, 2-ethylhexylester (TOTM).
Dero continued: "These other plasticizers perform their technological function with PVC just as well as DEHP did. Some of them (for example BTHC, Hexamoll DINCH and TOTM) have been shown to be suitable substitutes for DEHP in blood bags as they are capable of stabilizing red blood cells and have no effect on the other essential blood properties.
"Hexamoll DINCH (diisononylester) is used in enteral nutrition, for medical tubing systems and in pediatric applications, especially in platelet bags. Migration of Hexamoll DINCH has been shown to be about 10-fold lower when compared to DEHP.
Also, TOTM (tri-2ethylhexyl trimellitate) has been used in medical tubing for enteral nutrition products for a few years. TOTM has an excellent migration profile outperforming DEHP with regards to the permanence of the plasticizer."