It’s a First: Dialysis Bag Receives Environmental Certification

The Nordic Swan ecolabel chiefly concerns the safety of product additives such as di(2-ethylhexyl) (DEHP) phthalate and the difficulties of handling PVC as a waste material. Swan labelled devices cannot be made from PVC or contain endocrine disruptors and persistent, biocumulative and toxic substances. The first medical device to be certified with this environmental standard is a peritoneal dialysis bag manufactured by Fresenius, the global supplier of products and services for people with kidney failure.

However, according to the PVC Information Council, the motivation for this certification – that it is preferable to use a PVC-free product rather than a PVC based product – cannot be rationally justified. Its General Manager, Ole Grøndahl Hansen, says that, “Many analyses in recent years show that from a life cycle and sustainable development perspective, PVC products can often be preferable and should never be substituted with alternatives without a thorough assessment.”

Hansen also questions the science on which the Nordic Swan ecolabel is based. He says its main reference source is a Danish book, titled “Plast og miljø” (Plastics and Environment) by Lars Borch Pedersen, which was published in 1999. The book contains a categorisation, assessment and prioritising of plastic materials with the aim of helping companies to determine which materials should be selected to minimise harm to the environment. But a decade has now passed and the book’s science is outdated, he says. He cites as an example phthalates:

The book states that the phthalate DEHP is carcinogenic to humans. This is no longer the scientific position, he says, “the World Health Organisation removed DEHP from the known carcinogen list some years ago.” The book also states that phthalates are included in the Danish Environmental Protection Agency’s list of undesired substances. This is also no longer true, he continues, “Only specific phthalates that are classified as harmful are included on the list, among them DEHP. For example, the most commonly used plasticiser, dsi-isononyl phthalate, is not included in the list of undesired substances. Because the book is almost ten years old it also fails to mention that a whole range of new plasticisers have been developed in the last ten years that can be used in medical applications to replace DEHP and thereby eliminate any potential for hazard.”

He reminds us that scientifically up-to-date life cycle analyses are required whatever material is used, whether PVC or an alternative. A full PVC LCA exists if the industry wants to compare a PVC medical device with alternatives and the conclusion in that analysis is completely different, he states, from the one the Nordic Swan draws for PVC.

Meanwhile, Magnus Hedenmark, Director of the environment consultancy Hedenmark Ecoprofits, who has been working on developing the Swan criteria, says that the fact that “the Swan has been approved for a dialysis bag proves that environmental criteria are not unrealistic for medical devices.”

It will be interesting to see where the industry goes from here.