The European Council of Vinyl Manufacturers (ECVM) has contested a PVC blood bag life cycle assessment (LCA) carried out by a consortium of companies based mainly in Scandinavia. The consortium, called the PVCfreeBloodBag project, includes the Karolinska University Hospital and the Jegrelius green chemistry research institute, both based in Sweden, Finnish medical packaging films extruder Wipak OY, medical tubing maker Totax and medical custom compounder Melitek, both based in Denmark, and Italian fluid bag and tubing contract manufacturer Haemotronic.
The consortium has concluded that PVC blood bags “pose a significant risk to human health” and should be phased out in favour of PVC-free alternatives. But ECVM's critical review finds that the study fails to fulfill basic scientific methodology and quality criteria; and that its conclusions may be misleading and highly questionable.
ECVM stresses that the LCA conclusions contradict findings by the European Commission’s Scientific Committee on the Emerging and Newly Identified Health Risks (SCENIHR). In 2008 the committee stated that, while “there is reason for some concern for prematurely born male neonates for which the DEHP exposure may be transiently above the dose inducing reproductive toxicity in animal studies, there is no conclusive scientific evidence that DEHP exposure via medical treatments has harmful effects in humans”. ECVM welcomes the recent Commission's request to the SCENIHR "to review and, if appropriate, update the opinion adopted in 2008” in light of the PVCfreeBloodBag study, and is committed to provide any relevant scientific information.
A critical review commissioned by ECVM and conducted by LCA expert Professor Adisa Azapagic from Manchester University, UK, strongly questions the validity of the PVCfreeBloodBag study methodology and conclusions. The review indicates that the PVCfreeBloodBag LCA lacks consistency with LCA’s state of the art and recognised ISO standards; and some of the methods used are not scientifically valid. In addition to this, the Manchester University expert found that the assessment is based on “unclear, inconsistent and in some case unjustifiable, misleading and biased” assumptions and on old or incomplete data.
Professor Azapagic concluded that “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 urges caution when disseminating potentially alarming information on the safety of PVC in blood bags which is not scientifically validated. PVC has been used to manufacture blood bags for more than half a century and it is currently the only plastic material which is suitable for the manufacturing of this kind of medical device. PVC blood bags have been instrumental in delivering high standards of safety and quality healthcare to patients.
Medical Plastics News understands, thanks to a number of reliable sources, that one of the key advantages of using DEHP-plasticised PVC in blood bags is that DEHP is a natural preservative, and without it the blood would not remain useable in the bag. However, the length of time that DEHP Is able to preserve the blood and exactly how it does this has not been independently verified.
Medical Plastics News will publish a full independent investigation into the use of DEHP in PVC blood bags in the September-October edition.
Click here for more information on the critical review of the study Life Cycle Assessment, LCA, study of PVC blood bags.
For more information about the PVCFreeBloodBags project please click here