Health risks from PVC plastic

A new University of Massachusetts report confirms health risks of vinyl IV bags and other vinyl medical products.

provided by Health Care Without Harm

ollowing the release of a comprehen- sive study of the scientific literature on di-ethylhexyl phthalates (DEHP), a coalition of more than 180 health, religious, labor and environmental organizations today petitioned the FDA to warn patients and health care providers about the potential health risks from this toxic chemical.

More than 500 million IV bags are used in the United States every year to deliver blood, medication and other essential fluids to sick and injured patients. Eighty percent of these are made of polyvinyl chloride (PVC), which requires a plasticizer to make them soft and flexible. DEHP -- the softener used in PVC products -- has been shown to leach from IV bags into the solutions they contain and directly into patients.

The peer-reviewed report, released today by the University of Massachusetts' Lowell Center for Sustainable Production, evaluated more than 100 studies on DEHP. The review confirmed that the toxic chemical leaches, potentially causing damage to the heart, liver, ovaries, testes, lungs and kidneys, and interfering with sperm production.

The Lowell report was commissioned by Health Care Without Harm (HCWH), the same coalition who today called on the FDA to take the following actions:

  • Require all PVC medical devices that leach plasticizers to include a warning label and additional information on the potential health risks caused by DEHP leaching and FDA-approved alternatives.
  • Warn pregnant women, infants, hemophiliacs, dialysis patients and others receiving long-term intravenous or tube-feeding treatment that they are more likely to receive high doses of DEHP.
  • Expedite the development of safer, PVC-free alternatives to all PVC medical devices that leach plasticizers.

While the FDA has not set any limits on plasticizer leaching from medical devices, the agency does restrict the amount of plasticizer to 30 percent of the weight of food containers. PVC IV bags, blood bags and tubing all contain more than 30 percent DEHP by weight.

"Current FDA regulations make no sense," said Charlotte Brody, RN and Co-Coordinator of HCWH. "Why should plastic food containers be regulated more strictly than plastic medical products? And why should the FDA warn cancer patients of DEHP leaching with certain medications, but not infants or hemophiliacs, who may be even more exposed?"

The medications Brody refers to include the chemotherapy drugs Taxol and Taxotere, which come with warnings from the drug manufacturer against using PVC equipment for their administration because of increased leaching of DEHP.

HCWH's petition comes in the wake of increased public scrutiny of DEHP's use in vinyl IV bags, children's toys and certain other flexible PVC medical products. It also precedes two other reviews of DEHP. One will be released by the American Council on Science and Health, whose panel is chaired by former Surgeon General Koop. Another by the FDA itself will be released later this year.

"Humans are exposed to substantial levels of DEHP through medical devices" said Joel Tickner, the primary author of the Lowell DEHP report. "Given this exposure, along with other health and environmental concerns of PVC, it's important to investigate alternative materials for medical purposes."

Indeed, an increasing number of hospitals and medical equipment providers are phasing out PVC products and replacing them with safer alternatives. Recent examples include Baxter International, Inc., the nation's leading producer of IV bags; Universal Health Services, Inc., the country's third largest hospital management company; and Kaiser Permanente, America's largest nonprofit health maintenance organization.

In addition to disclosing the susceptibility of patients to DEHP exposure, the coalition noted that vinyl IV bags have a high chlorine content. Consequently, vinyl manufacturing and disposal by incineration create dioxin -- one of the world's most toxic chemicals.

Health Care Without Harm has more than 180 member organizations, including 41 hospitals, such as Beth Israel Medical Center, New York; New England Medical Center; and the hospitals of Catholic Health Care West. Other members include the American Nurses Association, Oncology Nursing Society, American Public Health Association, Breast Cancer Fund, Endometriosis Association, the Sierra Club and many other environmental and social action organizations.

The complete Lowell report as well as the FDA petition can be found on Health Care Without Harm's website: