Phthalates are used mainly as plasticizers for soft PVC. The chemical industry in Western Europe produces more than 900,000 tons of phthalates for the production of soft PVC every year. But, since these substances are not firmly bound by chemical bonds, they can evaporate from products, can be leached out or escape due to the abrasion of plastic particles.

Especially DEHP, DBP and BBP are important plasticizers for many medical products made of soft PVC (BUND and HCWH 2004). Currently, these plasticizers are still permissible in medical devices; but restrictions on the use of these substances are being discussed in the EU. The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in Bonn recommends replacing DEHP, DBP and BBP in medical devices.

Numerous studies investigating the toxicity of phthalates in animals demonstrated various adverse effects of DEHP, DBP and BBP. There are no studies yet to demonstrate a similar adverse effect of these substances in humans, but the evidence is growing. Accordingly, at least with a view to preventive health protection, we see a clear need to minimize the exposure to these troubling substances during the use of medical devices.

For this reason, we’ve been producing our masks, nasal cannulas and oxygen sure flow tubing since 2010 without adding DEHP, DBP, BBP or any other plasticizers of the REACH list that are subject to a labeling requirement!