[ 24 October 2002 ]

EU Scientific Committee says there are no grounds on which to restrict the use of di(2-ethylhexyl) phthalate (DEHP) in medical devices

The European Union’s Scientific Committee on Medicinal Products and Medical Devices has published an Opinion on the use of di(2-ethylhexyl) phthalate (DEHP) in medical devices saying that it can make no recommendations to limit its use, even for the most highly exposed patients.

Although the scientific committee report proposes that additional research is conducted to monitor the situation, it says "there are no reports concerning any adverse effects in humans following exposure to DEHP-PVC, even in neonates or other groups of relatively high exposure."

The Scientific Committee's Opinion, adopted at their meeting on September 26, 2002, had been produced at the request of the European Commission's enterprise directorate, following concerns expressed by patient care groups.

"DEHP plasticised PVC has been used for several decades in medical devices. The functional characteristics and processibility of the material makes it very suitable for the construction of a wide variety of these devices, some of which are crucial to the delivery of care to critically or chronically ill patients", says the report. "The contribution of DEHPPVC to the delivery of health care should be taken into account in the consideration of the potential risks of adverse effects of DEHP in these patients."

• Conclusions and Opinion
• Full Report