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Last updated January 1, 2014

National Toxicology Program Confirms HWH's Assertions about Vinyl Medical Products

Healthcare Without Harm

MINNEAPOLIS, Dec. 17 -/E-Wire/-- Today, the National Toxicology Program (NTP) confirmed Health Care Without Harm's assertion that di-ethylhexyl-phthalate (DEHP) is a hazard to human development and fertility. DEHP is a phthalate plasticizer used to make polyvinyl chloride (PVC) medical products soft and flexible. Patients are exposed to DEHP when it leaches out of PVC medical devices such as IV bags, tubing, enteral (intestinal) feeding tubes and some feeding bags, and blood bags.

The expert panel also expressed strong concern about the level of DEHP in the foods we eat every day -- especially dairy, meat, fish and oils.

NTP, a division of the National Institutes of Environmental Health Sciences, convened a panel of experts to review toxicity data on phthalates. Data on health effects of DEHP in animals showed that oral exposure can cause miscarriage, birth defects, reduced fertility, abnormal sperm counts and testicular damage.

"The weight of evidence from animal studies indicates that DEHP exposure can cause serious reproductive and developmental problems," said Ted Schettler, MD of Science and Environmental Health Network. "The developing organism is the most susceptible, and unfortunately, some young patients -- especially premature infants receiving extracorporeal membrane oxygenation (ECMO) therapy or exchange blood transfusions -- are receiving doses at or near the levels causing adverse effects in animals. We simply don't know if the children are being harmed, and studies to clarify that would be extremely difficult to do."

The panel used animal studies to judge human risk, as is common in the pharmaceutical industry. The agency reaffirmed that laboratory animal studies were "relevant to judging hazard to human reproduction and development." There are very limited human data available. Rather than delaying a decision until additional human health data are collected, Health Care Without Harm advocates the replacement of PVC medical devices where alternatives are available now.

"Here is the federal government saying that the phthalates in PVC medical products may pose a threat to the ability to bear healthy children. Now health care professionals and patients need to insist that if we can make the same products out of materials that do not contain this reproductive and developmental poison, let's do it," said Charlotte Brody, RN, co-coordinator of Health Care Without Harm.

The U.S. health care industry uses more than 500 million IV bags each year. About 20 percent of those are made of a blend of plastics free of PVC or plasticizers.

Phthalates have come under increasing international scrutiny in the past year and many companies have acted accordingly. Baxter Healthcare, the nation's largest maker of IV bags, promised shareholders that it will establish timelines to phase out its use of PVC. Major health care companies Tenet Healthcare, Universal Health Services, Kaiser Permanente and Catholic Healthcare West are also shifting away from vinyl.

Earlier this month, the European Union (EU) enacted a ban on the use of phthalates in PVC children's toys in 15 countries, due to concerns about the health risks of phthalate exposure.

Health Care Without Harm, an international coalition of more than 240 groups in 15 countries, works for the elimination of environmental and public health threats from health care practices, including the industry's use of PVC plastic. Member groups include more than 60 hospitals, the Ambulatory Pediatric Association, the American Nurses Association, the Intravenous Nursing Society, and many others. To learn more about HCWH, visit the web site at




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