New California Bill Seeks to Ban Medical Devices Containing Chemical DEHP

LOS ANGELES -- Today, Assemblymember Alan Lowenthal introduced landmark state legislation to ban the sale and distribution of medical devices containing the chemical DEHP -- a phthalate linked to reproductive birth defects in babies. DEHP is used to soften PVC plastic medical devices, and the chemical leaches out of the product and into patients' bodies.

The new DEHP bill was one of two winners of a contest sponsored by Lowenthal called "There Oughta Be A Law," which sought legislation ideas from constituents. The bill was created after Lowenthal met with Arthur Strauss, MD, a pediatrician at Miller Children's Hospital in Long Beach, Calif.

Assembly Bill 1139 would prohibit the sale and distribution of any medical device containing DEHP in California except when there is no alternative device approved by the U.S. Food and Drug Administration (FDA). It sets a compliance date of Jan. 1, 2005.

The international coalition Health Care Without Harm praised the bill as a timely and necessary step to protect patients from DEHP, a chemical that FDA has warned may be harmful to some patients, particularly pregnant women and baby boys. "The California Bill will provide healthcare practitioners with the cure for the DEHP problem. It will give them a choice of medical devices made of safer materials that do not contain DEHP," said Charlotte Brody, RN, executive director of Health Care Without Harm.

The bill comes on the heels of a new European Union proposal that calls for an immediate ban on DEHP-containing medical devices used on newborns. Last month the EU banned two phthalates, DEHP and dibutyl phthalate (DBP), from cosmetics because the chemicals are classified as reproductive toxins.

"Chemicals known to cause reproductive damage do not belong in medical products used to treat babies, pregnant women, or women of childbearing age," said Johanna Congleton, pubic health associate for Physicians for Social Responsibility-Los Angeles (PSR-LA). "In the last several years, many health care institutions have been moving away from DEHP products due to concerns for patient health. This bill is the next logical step."

Strauss recently spearheaded a program to eliminate DEHP products from the shelves of Miller Children's Hospital, a member of MemorialCare Health System. Strauss is working with MemorialCare to implement a DEHP elimination plan systemwide. Other healthcare systems such as Kaiser Permanente are also working to replace PVC medical devices containing DEHP. In addition, major manufacturers such as Baxter have committed to moving away from PVC devices.

Public health groups including HCWH and PSR-LA have repeatedly called on the FDA to require DEHP product labeling, but the agency has thus far refused. While the agency has issued draft recommendations for voluntary labeling, that effort falls far short of what is needed to protect patients.

"This is a classic example of the failure of federal agencies to protect public and patient health," Brody said. "In the absence of safeguards for all Americans, states like California and Massachusetts are stepping up to provide protections for their citizens."

Massachusetts is currently considering legislation that calls for the substitution of safer alternatives for DEHP-containing medical devices and other products.

Source: Health Care Without Harm