Beware of DEHP in Plastic Medical Devices

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What are Phthalates and how are they used?

Phthalates are chemical plasticizers used since the 1950s to soften plastics that would otherwise be brittle and crack when bent. In particular, DEHP, also known as di-(2-ethylhexyl)phthalate, is a phtalate compound used to soften many products made of polyvinyl chloride (PVC) plastic. Many medical devices are made with plastics that contain DEHP. For example:

  • IV bags and tubing
  • Umbilical artery catheters
  • Peritoneal dialysis bags and tubing
  • Tubing used during hemodialysis
  • Blood bags and tubing
  • Heart bypass machine tubing
  • Nasogastric feeding tubes
  • Respiratory tubing

Why are there health concerns regarding DEHP?

DEHP is not chemically bound to the plastic it is added to. It is continuously released into the surroundings and as a result the plastic becomes harder and more brittle over time .
Exposure to DEHP has been found to produce a series of negative effects in experimental animals. Those of most concern regard the negative effects on the development of the testicles and the production of normal sperm in young animals.

Although there are no human studies that show such effects yet, it is possible that the effects observed in animal studies could also occur in humans. Devices that contain DEHP have been used on newborn babies for years without apparent negative effects, although no studies have been conducted that can definitively rule out effects on humans. If these effects occur in humans the greatest concern would be for very young male infants who are critically ill and have prolonged exposure to multiple devices containing DEHP.

In the US, the FDA has issued a Public Health Notification to the medical community, identifying procedures that could result in exposure to relatively high levels of DEHP in sensitive patients (e.g., male neonates) and has recommended that devices made of alternative materials, or that are made of PVC that does not contain DEHP, be used for these procedures.
In 2008, the U.S. Congress banned six phthalates from children’s toys, adult toys and cosmetics. Legislators in Washington, Vermont, and California have also imposed restrictions on phthalates in children’s goods.
In 2006 European Union legislation has limited the use of DEHP in toys and childcare articles to less than 0.1%.
In February 2008, the EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published an opinion in which they said there is reason for some concern for prematurely born male neonates. They said that some other patient groups with relatively high DEHP exposures, including male foetuses of pregnant women may also result in some risk.

Despite such warnings, it appears that in certain cases the legislation is overlooked. In the US, the CDC discovered high levels of phthalates in all 289 adult Americans tested. More recently Phtalates are at the heart of an investigation in Italy by journalist Moreno Morelli of the television program “Striscia la Notizia” that demonstrates that many imported medical breathing devices for children currently in use contain up to 280 times the amount of phtalates allowed by European Legislation.

Go DEHP FREE

Many medical procedures can be done without DEHP-infused PVC materials replacing them with alternative plasticizers offering similar technical properties.
It is up to you. If you or your child must undergo medical procedures, do your best to ensure the tubing and bags do not contain DEHP.

Watch the report of “Striscia la Notizia”

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