Safety of medical devices containing DEHP - Need to assess alternative materials

According to SCENHIR, there are indications that exposure to DEHP in the general population has decreased over the last few years, however, medical procedures using PVC medical devices, such ascatheters, intubation tubes and intravenous catheters and other medical devices made of PVC, can lead to much higher DEHP exposures. The problem is that  DEHP, like other phthalates, leaches out of the device it is used in and dissolves into fluids, like blood or liquid nutrients. This raises concerns about possible health effects. When used in blood bags, for example, DEHP leaches into the blood being stored and acts as a stabiliser, helping to preserve the blood for a longer time. But, although DEHP helps keep blood stable in storage, what happens when DEHP gets inside the body? Well, nearly everyone already has DEHP inside their bodies, mainly from exposure through diet (from food packaging), and indoor dust and air. This amount of exposure, however, is usually well below what has been set as the Tolerable Daily Intake. Having multiple exposure sources makes it difficult to study DEHP exposure through medical devices in isolation - and all the more important to be vigilant about overall exposure levels.

Many studies have explored what effect DEHP might have on the body’s reproductive, hormonal and immunity systems as well as its potential to cause cancer or behavioural changes. DEHP also seems to have the potential to interact with the immune system under certain exposure conditions, for example when the exposure is through the blood stream, as when medical devices are used intravenously.

It is underlined that many interventions, even if they result in phthalate exposure, help to save lives, so they should not be avoided, although exposure to phthalates should be reduced as much as possible. SCENIHR indicated that alternative materials are being developed as potential replacements for DEHP; possibility of replacing DEHP with these products could be considered, taking account the efficacy of the treatment as well as the toxicological profile and leaching properties of the alternative materials.

Related Links:

• SCENHIR Scientific Opinion
• Fact sheet on DEHP