Vinyl toys, medical devices get clean bill of health

Vinyl softeners used in medical devices and children's toys have been deemed safe by an independent, non-profit group of US researchers. The finding directly contradicts another study from an international consortium of 180 organizations, including the American Nurses Association.

The American Council on Science and Health (ACSH), which is dedicated to "helping Americans distinguish between real and hypothetical health risks," formed a 17-member expert panel in February to look at the safety of 2 plasticizers. Di2ethythexyl-phthalate (DEHP) is the primary plasticizer used in many medical devices; di-isononyl phthalate (DINP) is present in soft vinyl toys.

"Consumers can be confident that vinyl toys and medical devices are safe," stated former US surgeon general Dr. Everett Koop, who chaired the panel. "There is no scientific evidence that they are harmful to children or adults."

However, Health Care Without Harm (HCWH), whose member organizations include Greenpeace, 41 hospitals and the American Public Health Association, commissioned another comprehensive review of the scientific literature. That report, The use of Di-2ethythexyl-phthalate in PVC medical devices: exposure, toxicity and alternatives, concluded that "humans are exposed to substantial levels of DEHP through medical devices." According to Dr. Tee Guidotti of Edmonton, founder of the Canadian Association of Physicians for the Environment and a member of HCWH, "sick patients with lots of treatments are exposed to high levels of DEHP, and because they're sick, it may make them more susceptible to DEHP."

But Koop's group examined 86 scientific reports and its report, A scientific evaluation of health effects of 2 plasticizers used in medical devices and toys, concluded that DEHP in medical devices is not harmful. In fact, it "imparts a variety of important physical characteristics that are critical to the function of medical devices. Eliminating DEHP in these products could cause harm to some individuals."

Under the Canadian Environmental Protection Act, DEHP is classified as "unlikely to be carcinogenic to humans," although because of limitations in the database, classification as "possibly carcinogenic to humans" may also be appropriate.

The ACSH panel found fewer scientific reports (36) concerning DINP but concluded that it is not harmful for children in the "normal use of these toys." The panel did recommend further study to document children's contact time and mouthing behaviour involving toys and other objects, and the rates of release of DINP under realistic conditions. In November 1998, Health Canada advised parents to discard teethers and rattles made of PVC and asked toy manufacturers to phase out the use of DINP.

The full ACSH panel report is available at www.medscape.com, and a summary of the HCWH report is online at www.noharm.org.