Di (2-ethylhexyl) phthalate or DEHP is a synthetic chemical belonging to a family known as phthalates, which is used to make plastics more flexible. One of these plastics, polyvinyl chloride or PVC, is widely used in medical applications: IV infusion medication bags, IV lines, catheters, blood bags or enteral feeding bags and a wide range of tubes as well.
In addition, DEHP is used in multiple plastic products in our environment, such as wall covering, tablecloths, shower curtains, garden hoses, toys…
Why should we care about DEHP?
Some studies on animals indicate that DEHP may have toxic effects on reproduction and fetal development, as well as the development of the reproductive tract in the early stages of life.
DEHP is present in the environment due to human action, so we are all exposed to it on a daily basis. However, children and pregnant women are especially vulnerable to its actions.
Medical procedures can expose patients to higher levels of DEHP because this chemical can seep from the plastics used into the solutions that are in contact with those plastics. In the case of patients with severe pathologies undergoing multiple medical procedures, exposure to DEHP may be even greater. In addition, there are other factors that can increase the DEPH filtration from medical accessories containing it, such as high temperatures, high lipid content of some medications (because DEHP is fat soluble), high DEHP concentration in the plastic or extended contact time between the used liquid and the plastic that contains it.
What do the authorities say about DEHP?
Many regulatory authorities around the world, including in Australia, have evaluated the safety of plastic medical devices containing DEHP and continue to authorize its use. However, the EU has carried out a scientific review of medical products containing phthalates, in particular DEHP, and introduced special labeling requirements for these products, since DEHP has been classified in the group of carcinogenic, mutagenic or nephrotoxic agents (CMR).
France has been restricting the use of DEHP in tubes used in pediatrics and delivery rooms since 2015. In the United States, Canada, and Europe, all supervisory agencies have established that when considering possible limitations in the use of medical products containing DEHP, it is important to assess the risk/benefit equation for the patient.
Are there alternatives to DEHP?
There are several ways to limit or even eliminate patient exposure to DEHP. In the United States, the FDA states that for procedures in high-risk patients, DEHP-free materials should be used. There are other alternative plastic polymers that can be used for the manufacture of accessories, IV lines and other medical products without the need to include DEHP as a flexibilizing agent.
DEHP Free products at Hisern Medical
Most of the medical consumables from Hisern Medical, can be made of DEHP free PVC or other materials such as Polyethylene, Polypropylene… also DEHP free. At Hisern Medical we take the patient’s safety very seriously in all possible aspects, so we have advanced to legal regulation and eliminated DEHP from our entire range of products.