PVC Information Council DK informs on the complex issue.
The broad agreement on a new chemical action plan, which the Danish parliament agreed on the 29th October 2009 contains a number of initiatives which may affect the marketing of phthalate contained medical devices in Denmark. The agreement states that the Environment Minister Troels Lund Poulsen will take initiatives that contribute to a voluntary withdrawal of products with endocrine disruption substances with particular focus on phthalates in medical devices. Ministry of Environment will undertake a survey of medical devices without phthalates, which can be used by the regional purchacers. The agreement states that in doing so the Ministry will draw on experiences of Swedish hospitals.
Since many of the PVC Information Council´s member companies manufacture phthalate contained products to the health care sector, the Council has dealt extensively with this issue over many years. Among other things, the Council has written several articles for the pan-European magazine, Medical Device Technology, which can be useful to read if you want to get an overview of this complex topic.
In the article "PVC and Phthalates in Medical Devices: A Never Ending Story" from 2006 the PVC Information Council general manager, Ole Grøndahl Hansen, tells among others thing, about the experiences the Swedes have had in their ten year old effort to avoid PVC and phthalates in their public hospital procurement. As can be read in the article in 2006 the Swedes was in an early stage.
In the article "Phthalate Labelling of Medical Devices" from 2007 Ole Grøndahl Hansen presents the political process underlying the EU´s decision that medical devices containing classified phthalates now must be labelled. A desire to ban hormone-disrupting substances in medical devices made by the European Parliament´s Environment Committee ended with a compromise whereby the Council of Ministers, The European Parliament and the Commission agreed that labelling of the devices were sufficient in the current situation. The article also reports on two possible new alternatives to phthalates in medical devices, namely Danisco´s Soft ´n Safe and BASF Hexamol DINCH.
The article "New Developments in PVC" from October 2008 describes the conclusions of which the EU´s own toxicology experts came forward to in 2008, in respect to the use of plasticisers in medical devices. The experts concluded that although there was no evidence that phthalates pose any risk to humans, they said anyway, that there is reason for concern for some specific applications, namely where the equipment is used on pregnant and nursing women and on premature babies.
And finally, in the article "PVC - A Broader Perspective" from October 2009 Ole Grøndahl Hansen looks at the topic of medical devices from a larger perspective. The article outlines the larger context in which the PVC and phthalate companies find themselves in when it comes to the PVC industry´s efforts to adapt the material to a sustainable society. This happens through the PVC industry´s comprehensive environmental program Vinyl 2010, on which the article talks about.
A rapid introduction to the topic can also be obtained by looking at a couple of power point presentations Ole Grøndahl Hansen has held at conferences in the last few years in Brussels. These are the following:
1st "Perspectives on PVC in Medical Devices". Presented at Plastics in Medical Devices Conference, 22 April 2009 in Brussels
2nd "Toxicological and political reasons for the labeling of DEHP contained Medical Devices". Presented at Labelling and Packaging Compliance Conference, 23 September in Brussels.
3. "PVC and Phthalates in Medical Devices". Presented at Plastics in Medical Devices Conference, 10th April 2008 in Brussels.
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