Nurses: Taking Precautionary Action on a Pediatric Environmental Exposure: DEHP

Anna Gilmore Hall


Pediatr Nurs. 2006;32(1):91-93. 

In This Article

Government Actions

Several government agencies have concluded that some patients are likely to be exposed to potentially unsafe amounts of DEHP while receiving medical care. The U.S. Food and Drug Administration (FDA) has issued an FDA Safety Assessment and a Public Health Notification on DEHP-containing PVC devices, urging health care providers to use alternatives for certain vulnerable patients (U.S. Food and Drug Administration, 2001).

According to the FDA Public Health Notification: "Two factors determine the degree of risk posed by exposure to DEHP in a medical setting. The first is the patient's sensitivity to DEHP. Based on the evidence cited above, the male fetus, male neonate, and peripubertal male would appear to be high-risk groups. The second factor is the dose of DEHP received by the patient. This is determined largely by the type of procedure performed, as well as the frequency and duration of these procedures."

FDA identified the following procedures as posing the highest risk of exposure to DEHP:

  • Exchange transfusion in neonates

  • ECMO in neonates

  • Total Parenteral Nutrition (TPN) in neonates (with lipids in PVC bag)

  • Multiple procedures in sick neonates (high cumulative exposure)

  • Hemodialysis in peripubertal males

  • Hemodialysis in pregnant or lactating women

  • Enteral nutrition in neonates and adults

  • Heart transplantation or coronary artery bypass graft surgery (aggregate dose)

  • Massive infusion of blood into trauma patient

  • Transfusion in adults undergoing ECMO

The initial FDA safety assessment followed closely on the heels of an October 2000 report by the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction. The expert panel report expressed "serious concern" that exposure to DEHP may adversely affect male reproductive tract development in critically ill infants and "concern" over the levels of DEHP exposure to pregnant women, breast-feeding mothers and healthy infants and toddlers (U.S. Department of Health and Human Services, 2000). In Canada, an expert advisory panel to Health Canada, the Canadian equivalent to the U.S. FDA, 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 (Health Canada, 2003).


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