DEHP-plasticized medical devices have become vital to modern healthcare. DEHP-plasticized PVC is a popular choice for many medical applications because it is clear, affordable, strong, flexible, easily sterilized and, unlike alternative plastics, won't ‘kink’ restricting the flow within the tube.
In Europe it is the only plasticiser recommended for use in blood bags by the European pharmacopoeia.
The US Food and Drug Administration recently issued a "Consumer Update" stating concern for very young male infants who are critically ill and have prolonged exposure to multiple devices containing DEHP." However, whilst noting that studies have not been conducted which would rule out effects on humans it stated that DEHP-containing devices have been used on newborn babies for many years without apparent ill effect. The FDA expressed little concern for adults receiving medical treatments such as intravenous or dialysis. The concerns about possible risks are based on the effects seen in rodents. However, tests on primates, which are much better predictors of effects of DEHP in humans than rodents, have demonstrated that they are much less susceptible to effects from DEHP than rodents.
Regulatory agencies in many countries that have approved DEHP-plasticized vinyl for use in medical devices make the point that substitutes may expose patients to hazards not present with devices made with DEHP. Any alternative to DEHP in vinyl would have to undergo scientific scrutiny and receive approval from such authorities before it could be used.
The medical device industry is one of the most highly regulated in the world. All such products, including their components, therefore have to conform to rigorous safety standards.
For more information please refer to Plasticisers in Medical Devices and to the DEHP Information Centre
