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FAQs related to Medical Devices containing DEHP
Polyvinylchloride (PVC) is a plastic polymer that is used in a wide variety of products. A plasticiser is added to PVC in order to make it softer and more flexible, since unplasticised PVC is hard and brittle at room temperature. Di(2-ethylhexyl)phthalate (DEHP) is the plasticiser for most PVC medical devices.
Devices that may contain DEHP-plasticised PVC include:
DEHP is purposely added to PVC-made medical devices to make them softer and more flexible. Otherwise, medical devices can be difficult to use, more likely to cause discomfort and can even damage patients' bodies.
DEHP can leach from PVC medical devices into fatty solutions, e.g. blood or nutrition formulas. Research studies have shown that exposure to certain dose of DEHP could cause reproductive birth defects and infertility in animals.
Leading international medical device control authorities have determined that so far, there is no evidence to suggest that medical devices plasticised with DEHP present an unacceptable health risk to humans. Suffice that manufacturers should eliminate any risk where feasible or reduce them as far as possible in line with the generally acknowledged state of the art. The acceptability of any residual risks is then determined by the level of benefits that the product brings.
For some procedures, medical devices that are free of DEHP or made of other materials may be available as alternatives.
If PVC devices containing DEHP must be used, exposure may be minimised during high-risk procedures, for example, by using the freshest possible blood products stored at the lowest possible temperature, or by using heparin-coated ECMO circuits.
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Last Revision Date : 15 December 2012