THIS ISSUE
observatoryNANO website goes live
Free access to analysis of developments in nanoscience and nanotechnology is available on the observatoryNANO website. This is the main point of access to the output of the observatoryNANO project, which is funded under the European Union’s Seventh Framework Programme. The project is seeking to establish a permanent European Observatory on nanotechnologies and ongoing, independent support to decision makers. It will collate and analyse data regarding scientific and technology trends and economic realities and expectations. Users will be able to find reports on a range of subjects, including scientific and technological developments, economic and market information, health and safety issues, developments in regulations and standards, governance, communication and engagement tools. All reports can be downloaded free of charge. www.nanoforum.org, www.observatory-nano.eu/project
New considerations in the PVC debate
A peritoneal dialysis bag is the first medical device to be environ-mentally certified. It meets standards set by the Nordic Swan, which requires products to be free from poly(vinyl chloride) (PVC) and other substances such as the plasticiser di(2-ethylhexyl) (DEHP). The PVC Information Council urges caution though. It says that hospitals should not conclude that medical devices bearing the Nordic Swan are necessarily better than devices made from PVC. Material life cycle analyses (LCAs) are essential and it says the LCA for PVC conducted in 2007 shows PVC devices are the most favourable with regard to environmental performance.
The Nordic Swan ecolabel chiefly concerns the safety of product additives such as 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, a 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.” Scientifically up-to-date LCAs are required whatever material is used, whether PVC or an alternative, he says. Hansen states that 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 from the one the Nordic Swan draws for PVC.
In terms of where the ecolabel goes from here, 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.” For more information, go to http://medtechinsider.com/?p=3225
Complying with REACH legislation
BOMcheck is a web application introduced by the trade association COCIR and consultancy ENVIRON to help reduce the costs of complying with environmental legislation. The Registration, Evaluation, Authorisation and restriction of Chemicals (REACH) Regulation and the Restriction of Hazardous Substances Directive impose substance declaration requirements. BOMcheck offers a centralised master database of substance declarations from suppliers for access by all manufacturers. A free of charge detailed guide to REACH requirements is also available. www.BOMcheck.net
