The discussion concerning phthalates – and especially DEHP – continues. The Federal Institute for Drugs and Medical Devices (BfArM) too has spoken up in the form of an extensive description of the problem and assessment of risks associated with exposure to DEHP through medical products. As DEHP is not chemically bound to the PVC molecules but rather only stored in the PVC matrix, it can elute through lipophilic liquids or liquids containing lipids. A high degree of DEHP entry is therefore possible by products which are intended for supplying the organism with enteral or parenteral lipophilic liquids. These also include all tube systems and functional units in extra-corporeal circuits through which endogenous or allogeneic blood flows (oxygenators, dialysis filters). And products whose designation puts them in contact with mucous membranes, blood, wounds or invasively exposed tissue also increase exposure to DEHP while simultaneous treatment with several medical processes can also cause summation effects. As medical products are necessary for re-establishing or maintaining health or even for saving lives and cannot therefore be dispensed with entirely, a general ban on medical products containing DEHP cannot be demanded according to the BfArM. Following careful analysis of the respective exposure to DEHP by the product used and the possibility of the patient belonging to a risk group, alternative products should be sought – without restricting the quality of medical care – which contain harmless plasticizers in the PVC or no PVC at all. But it is also suggested that medical products containing DEHP should be marked suitably as such.
With a material supplier as Actega DS whose medical-grade ProvaMed® plastic compounds are free of PVC and DEHP and who is familiar with the stringent regulation environment governing the medical and health industry – medical device producer are on the safe side. The TPE compounds, e.g. for medical tubes as required in enteral and parenteral therapies or extra-corporeal circuits, offer greater visual transparency than PVC, low absorption of active agents, minimum migration potential and good processing properties permitting the extrusion of complex tube structures.
Indication of next fairs: Interpack (May 8-14 in Düsseldorf) and Fakuma (October 14-18 in Friedrichshafen).