Nursing Alert: Warming IV Bags

Alabama Nurse,  Jun-Aug 2006  by Sattler, Barbara

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What to Ask Before Wanning an IV Bag:

Does it contain DEHP [di(2-ethylhexyl) phthalate]?

This chemical-DEHP-is used in IV bags (and tubing) to make them more malleable, not stiff. It also readily leaches out of the bag into the IV fluids (including blood products). By warming the IV bags, we inadvertently accelerate the leaching process-creating greater risk for patient exposure to DEHP via IV fluids. So what's so bad about DEHP?

* DEHP is a reproductive toxicant. It alters development of the male reproductive system in laboratory animal studies, causing a spectrum of health effects including birth defects and infertility. (It should be quickly noted that almost all of our knowledge regarding the toxicity of chemicals and products comes from animal studies.)

A Health Canada Expert Advisory Panel 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. They recommended that alternative measures be introduced "as quickly as possible."

Researchers from the Harvard School of Public Health, two Harvard-affiliated hospitals, and the U.S. Centers for Disease Control and Prevention found high levels of DEHP in infants treated in NICUs-an average of 25 times higher than levels found in the general population and up to 50 times higher for the most exposed infants. (Green et al, 2005) This study adds new urgency to ongoing efforts in the health care industry to switch to DEHP-free substitutes, particularly in Neonatal Intensive Care Units (NICUs).

The US Food and Drug Administration issued a notification to health care providers recommending that DEHP-free medical devices be used on certain at-risk patients, including intensively treated male infants and pregnant women carrying male fetuses.

FDA Safety Assessment of DEHP from PVC Medical Devices

"The FDA/CDRH has examined this [DEHP] issue and has concluded that children undergoing certain medical procedures may represent a population at increased risk for the effects of DEHP.

"This decision is supported by three findings:

1. Children undergoing some medical procedures receive a greater dose of DEHP, on a mg/kg basis, than adults do,

2. Pharmacokinetic differences between children and adults may result in greater absorption of DEHP, greater conversion of DEHP to MEHP (the toxic metabolite of DEHP), and reduced excretion of MEHP in children compared to adults, and

3. Children may be more pharmacodynamically sensitive to the adverse effects of DEHP than adults are."

FDA web site, see: www.fda.gov/cdrh/ost/Jehp-pvc.pdf. This conclusion is consistent with that reached by the expert panel convened by the Center for the Evaluation of Risks to Human Reproduction of the National Toxicology Program.

The National Toxicology Program's Expert Panel who reviewed DEHP studies only looked at reproductive and developmental effects. Based on animal studies, there are concerns that there may also be effects on the liver, kidneys, and lungs, as well as effects on heart rate and blood pressure. (see insert "Relevant Animal Studies" for review of animal study results.) Nonetheless, the Expert Panel noted the following:

DEHP Health Risks by Population

Critically Dl Infants:

"The available reproductive and developmental toxicity data and the limited but suggestive human exposure data indicate that exposures of intensivelytreated infants/children can approach toxic doses in rodents, which causes the Panel serious concern that exposure may adversely affect male reproductive tract development" (page 101).

Healthy Infants and Toddlers:

"If healthy human infant/toddler exposures is severalfold higher than adults, the Panel has concern that exposure may adversely affect the male reproductive tract development" (page 101).

Pregnant and Lactating Women:

"(T)he Panel has concern that ambient oral DEHP exposures to pregnant or lactating women may adversely affect the development of their offspring" (page 102).

(Source Document: U.S. Department of Health and Human Services. 2000.)

Many health care providers have responded by replacing DEHP-containing vinyl medical devices with alternatives. Kaiser Permanente, the largest non-profit health plan in the United States, is using PVCfree/DEHP-free alternatives for IV bags, tubing, catheters and feeding tubes. The change is being driven largely by nurses. By consulting the following resources and working with your purchasing team, you can help to identify safer and healthier alternatives to the DEHP-containing products.

Resources to help nurses identify DEHP medical devices and find cost-effective alternatives.

FDA public health notification:

http://www.fda.gov/cdrh/safety/dehp.html

Harvard study abstract:

http://ehp .niehs .nih .gov/docs/2005/7932/abstract .html

Health Care Without Harm resources: scientific studies, alternatives charts, PVC *audit tool:

http://www.noharm.org/pvcDehp/issue