04/04/2007

Toxic chemicals in medical devices must be labelled

Due to a revised EU law, manufactures of medical devices are forced to label certain chemical ingredients in their products. This decision will enable hospitals to protect their patients against harm caused by toxic devices - if they are interested in. Because alternative products of course are connected with higher costs.

Until the European Parliament fixed the new law, it was nearly impossible for hospitals to check the ingredients of medical devices for this have in general been kept secret by the manufactures. The only basis for buying-decisions have been the performance and the price of a product, a situation that has become increasingly unsatisfactory as concerns have grown about the safety of some common ingredients like the plastic softener DEHP. During an infusion for example, DEPH can leach out of the infusion bag into the liquid and straight into the human body where it can cause problems for example in the reproductive development of young boys.

The labelling requirements may help progressive hospitals to find alternatives for their medical equipments. However, it will not change the attitude of those hospitals only looking at the costs and not at the quality. Therefore it is doubtful if patients will benefit from the new law respectively from safer materials. As a spokesman of the Toxics Policy Advisor for the Health and Environment Alliance said: “The new law is a progress for those hospitals that have already been trying to avoid plastic softener but are having a hard time doing so because of a lack of information. But only a ban of those substances would force all hospitals to adopt same standards and contribute to an equal quality of care between all hospitals in the EU.”

Furthermore a ban on toxic substances in medical devices would boost the market for DEHP-free products, with the result of a price decreases of the alternatives. With the labelling obligation alone, these alternatives will still not have a chance, because they cannot compete with the cheap DEHP products.

05/14/2010