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Consumer Update
DEHP in Plastic Medical Devices

• What is DEHP and how is it used?
• Why are there health concerns regarding DEHP?
• Is there evidence that these effects occur in humans?
• If these effects occur in humans, which patients would be at most risk?
• What has been done to date to assess the potential risk?
• What is the next step?

What is DEHP and how is it used?

DEHP, also known as di-(2-ethylhexyl)phthalate, is a compound used as a plasticizer (softener) in many products made of polyvinyl chloride (PVC) plastic, including some medical devices. Among these are:

Why are there health concerns regarding DEHP?

Exposure to DEHP has produced a range of adverse effects in experimental animals, but those of greatest concern involve effects on the development of the testicles and the production of normal sperm in young animals.

Is there evidence that these effects occur in humans?

It is possible that the effects observed in animal studies could occur in humans. However, there are no human studies to date that show such effects. DEHP-containing devices have been used on newborn babies for many years without apparent ill effects, although studies have not been conducted which would rule out effects on humans.

If these effects occur in humans, which patients would be at most risk?

The FDA believes the greatest concern would be for very young male infants who are critically ill and have prolonged exposure to multiple devices containing DEHP. The National Toxicology Program, a component of the National Institutes of Health, has recently reached a similar conclusion. In contrast, there is little concern for adults receiving intravenous solutions or undergoing peritoneal dialysis.

What has been done to date to assess the potential risk?

FDA has examined the potential risks posed by patient exposure to DEHP by comparing the doses of this compound that patients may receive to a Tolerable Intake (TI) value for DEHP. A TI value is the dose of a compound that is not expected to produce adverse effects in exposed patients. For more information on how the safety assessment for DEHP was performed, as well as the potential risks of exposure to DEHP from various procedures, see the document at http://www.fda.gov/cdrh/ost/dehp-pvc.pdf or http://www.fda.gov/cdrh/ost/dehp-pvc.doc

What is the next step?

FDA will communicate the availability of its safety assessment to health care providers across the country. FDA is also evaluating ways to address the potential risks that may be associated with use of DEHP-containing devices in certain procedures. For example, FDA is investigating the availability of medical devices made from alternatives to DEHP-containing PVC plastics, particularly for procedures performed on newborn boys. The agency will continue to make new information available on this website.

(Uploaded September 5, 2001)

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