Phthalates and DEHP

At home, at work, and in hospitals, people are repeatedly exposed to phthalates — a family of industrial chemicals that are used as softeners in PVC plastic and as solvents in cosmetics and other consumer products.

According to animal studies, phthalates can damage the liver, kidneys, lungs, the hormone system and the reproductive system, particularly the developing testes.

Medical devices made of flexible PVC, such as IV bags and tubing, can contain over 50% of a phthalate called DEHP. This can leach from the products directly into the body of the patient. The most vulnerable patients — babies in Neonatal Intensive Care Units (NICUs) — get the highest doses.

Doctors at Harvard School of Public Health found that infants in intensive care treated with several DEHP medical devices had 5 times more DEHP residues in their blood than those that did not. Another study found that babies in American NICUs had seven times more DEHP residues in their blood than ordinary adults.

Scientists are now publishing the first correlations between exposure and effects in babies. One study found a link between the prenatal phthalate exposure and alternations in reproductive organs in boys; another linked decreased sex hormones in baby boys to higher concentrations of phthalates in their mothers' milk.

Government agencies from the Philippines, EU, USA, Germany and Canada all now recognise that DEHP exposure from medical devices is a potential hazard. The greatest concern is for unborn and newborn baby boys, though there is also some concern for boys whose mothers undergo medical treatment while pregnant or breastfeeding; male infants over one year old; and male babies whose mothers are exposed to DEHP via non-medical routes.

On October 28th 2008, DEHP was added to the European Union List of Substances of Very High Concern because of its reproductive toxicity. New EU legislation dictates that, from 2010, all medical devices that contain phthalates will have to be labelled, so doctors and nurses can make informed decisions about the products they are using.

In the United States, the Food and Drug Administration has issued a Public Health Notification urging health care providers to use alternatives to DEHP-containing devices for certain vulnerable patients. In Canada, an expert advisory panel to Health Canada has recommended that health care providers not use DEHP containing devices in the treatment of pregnant women, breastfeeding mothers, infants, males before puberty and patients undergoing cardiac bypass hemodialysis or heart transplant surgery.

See our resources page for government reports and scientific research on PVC, DEHP and phthalates.

HCWH is working with health care providers and manufacturers to identify products that contain DEHP and replace them with safer, affordable alternatives. The number of alternatives increases all the time and manufacturers are offering them in more and more regions of the world. As well as medical devices, PVC can be present in building materials, furnishings and office products. Replacing it in these products as well can reduce the overall burden on the environment.

Outside the health care setting, people are exposed to DEHP and other phthalates from a variety of sources, including beauty products, PVC toys, vinyl shower curtains, car seats, wallpaper and many other consumer products. HCWH has compiled a comprehensive report about the risks associated with aggregate exposure to phthalates.