Critical review contests allegations on the potential health risks linked to PVC blood bags

Brussels, 31 July 2012
A recent critical review commissioned by the European Council of Vinyl Manufacturers (ECVM), contests a life-cycle assessment (LCA) carried out by the PVCfreeBloodBag project, which concluded that PVC blood bags “pose a significant risk to human health” and should be phased out in favour of PVC-free alternatives. The critical review finds that the PVCfreeBloodBag 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.”1 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, 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.

For more information on the critical review of the study “Life Cycle Assessment, LCA, study of PVC blood bags.”

Contact :
Brigitte Dero,
ECVM General Manager:, Tel.

Ole Grøndahl Hansen, General Manager PVC Information Council Denmark:, Tel. 00 45 3330 8630 and 0045 4073 4014