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FAQs related to Medical Devices
containing DEHP |
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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. |
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(1) Which medical devices contain DEHP? |
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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
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(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.
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(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. |
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(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.
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(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
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(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.
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(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.
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