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.
(1) Which medical devices contain DEHP?
Devices that may contain DEHP-plasticised PVC include:
- Intravenous (IV) bags and tubing
- Blood bags and infusion bags
- Enteral nutrition feeding bags
- Nasogastric tubes
- Peritoneal dialysis bags and tubing
- Tubing used in cardiopulmonary bypass (CPB) procedures
- Tubing used in extracorporeal membrane oxygenation (ECMO)
- Tubing used during hemodialysis
(2) Why is DEHP used in medical devices?
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.
(3) Why are people worried about DEHP in medical devices?
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.
(4) Is it safe to use medical devices containing DEHP?
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.
It cannot be emphasised enough that medical procedures should not be avoided simply because of the possible health risk associated with DEHP exposure when the benefits of these procedures outweigh any possible health risk associated with DEHP exposure.
(5) What are the procedures with the highest potential risk of exposure to DEHP ?
- exchange transfusion in neonates
- ECMO in neonates
- total Parenteral Nutrition (TPN) in neonates
- multiple procedures in sick neonates
- hemodialysis in peripubertal males
- hemodialysis in pregnant or lactating women
- enteral nutrition in neonates and adults
- heart transplantation or coronary artery bypass graft surgery
- massive infusion of blood into trauma patient
- transfusion in adults undergoing ECMO
(6) Are there any alternatives to DEHP-containing medical devices?
For some procedures, medical devices that are free of DEHP or made of other materials may be available as alternatives.
However, it should be noted that the availability of an alternative medical device that is free of DEHP does not necessarily mean that it can be a substitute in a particular clinical procedure without compromising the safety of the patient. Alternatives to DEHP should not be introduced unless there is adequate data on their safety and efficacy.
(7) What if there are no safe 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.