Health Groups Call on FDA to Require Labeling of Medical Devices for Vinyl Chemical

WASHINGTON, July 25 /PRNewswire-USNewswire/ -- Prominent health organizations sent a letter to the US Food and Drug Administration today requesting labeling of medical devices containing the toxic chemical di-2-ethylhexyl phthalate (DEHP). The chemical DEHP leaches out of vinyl plastic medical devices into patients, posing risks to the reproductive systems of developing males. The letter accompanied a legal petition to FDA from the non-profit organization Health Care Without Harm; see http://www.noharm.org/.

Organizations joining the call for mandatory labeling of DEHP-containing medical devices include the American Medical Association; American Nurses Association; American Public Health Association; Association of Women's Health, Obstetric and Neonatal Nurses; Physicians for Social Responsibility and American College of Nurse Midwives.

"Despite FDA warnings about the health risks of DEHP-containing medical devices, these products are still being used in many hospitals to treat at- risk patients, even though safer alternatives are available for most," said Ted Schettler, MD, MPH, of the Science and Environmental Health Network. "Labeling of products containing DEHP is crucial to enable health care facilities to heed safety directives."

In 2002, FDA warned that sick baby boys and other vulnerable patients may be harmed by DEHP exposure from PVC ("vinyl") medical devices. In 2006, the National Toxicology Program reviewed the science and concluded that:

  -- "There is serious concern that certain intensive medical treatments of
     male infants may result in DEHP exposures levels that affect
     development of the male reproductive tract."

  -- "There is concern for adverse effects on development of the
     reproductive tract in male offspring of pregnant and breastfeeding
     women undergoing certain medical procedures that may result in
     exposure to high levels of DEHP."

"There is no reason that pregnant women and parents of sick infants should have to worry about toxic chemicals leaching out of vinyl medical devices," said Anna Gilmore Hall, RN, executive director, Health Care Without Harm. "We urge FDA to require labeling, and we urge hospitals to protect their patients by immediately switching to non-PVC medical devices that do not contain DEHP. Fortunately, cost-effective, safer alternatives are available."

For more information: http://www.noharm.org/us/pvcDehp/issue FDA warning: http://www.fda.gov/cdrh/safety/dehp.html NTP report: http://cerhr.niehs.nih.gov/chemicals/dehp/DEHP-Monograph.pdf