Environmental Standard In First Application To Medical Device

Main Category: Medical Devices / Diagnostics
Article Date: 04 Dec 2008 - 7:00 PDT

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For the first time a medical device has been certified with a tough environmental standard guaranteeing the product free from substances believed to cause harm to human health and the environment.

The standard, set by the Nordic Swan, requires products to be free from PVC plastic, endocrine disruptors and persistent, biocumulative and toxic substances. DEHP, a suspected reproductive toxin used in many medical devices including dialysis equipment, is one of the excluded substances.

Paul Whaley, Communications and Development Director of Health Care Without Harm Europe, welcomed the extension of the Nordic Swan to medical devices, saying: "A clear, independent standard for environmental performance makes it easier for hospitals to identify products which minimise potential harm to health and the environment."

The certified device is a peritoneal dialysis bag manufactured by Fresenius, the world's largest supplier of products and services for people with kidney failure.

Because the Swan-certified bag is PVC- and DEHP-free, it prevents peritoneal dialysis patients being exposed to DEHP and minimises the risk of dioxin production during manufacturing and disposal. Since the label also sets limits on packaging, it reduces the waste associated with peritoneal dialysis bags by approximately 20%.

Magnus Hedenmark, Director of the environment consultancy Hedenmark Ecoprofits and who has been working on developing the Swan criteria, said: "That the Swan has been approved for a dialysis bag proves that environmental criteria are not unrealistic for medical devices."

Paul Whaley, Communications and Development Director
Health Care Without Harm Europe
http://www.noharm.org