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Commission Experts evaluate the hazardous of DEHP in Medical Devices
EU Experts recommend no limit Values for the Contents of the Phthalate, DEHP, in Medical Devices
28-10-2002
PVC plasticized with DEHP has for several decades been used in the production of medical devices. This year it is now fifty years ago the first blood bag was manufactured in DEHP plasticized PVC. A notable characteristic of the phthalate plasticized PVC is the flexibility of the material, which is a condition for the manufacture of many different products for medical applications.
The European Commission Scientific Committee on Toxicity, Ecotoxicity and Environment (CSTEE) has just released a review on the questions regarding the use of DEHP in medical devices. The review, “Medical Devices containing DEHP plasticized PVC” states that the positive properties of DEHP containing PVC shall be taken into account, when the potential risks of the material is being analysed.
The European Commission draw in their report the attention to the fact that for a long time it has been known that DEHP might migrate from the plasticized medical devices. The use of DEHP in medical devices has therefore been subject to much attention, since PVC is here in direct contact with the inner of humans. The DEHP separated from PVC has among other things been suspected to influence negatively on especially very weakened infants.
In the review, “Medical Devices containing DEHP plasticized PVC”, there is a reference to a number of animal experiments in mice and rats, which show, that DEHP in big dozes can be very harmful to the organs of the rodents. Most exposed are liver, kidney and testicle. The committee, however, points out that similar studies in monkeys do not show any proves of negative influence – even after a heavy DEHP exposure. So the European Commission report concludes that it is not likely DEHP has any harmful effect neither in infants nor in adults. Thus it is recommended that there should not be put limit values for the contents. Even though, the present showing no basis for a limitation of the DEHP application in medical devices, the expert committee cannot rule out that there might be a risk.
In the report of the European Commission it is said that there are alternatives available to DEHP containing PVC, but it is pointed out that it is always necessary to compare and analyse advantages as well as disadvantages of the alternatives.
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