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HEALTH CARE WITHOUT HARM News release

For Immediate Release:
July 25, 2007

Contact:
Stacy Malkan
510-848-5343, ext 105
smalkan@hcwh.org

HEALTH GROUPS CALL ON FDA TO REQUIRE LABELING OF MEDICAL DEVICES FOR VINYL CHEMICAL

Toxic Additive DEHP is a "Serious Concern" for Harm to Boys, says National Toxicology Program

Washington DC – Prominent health organizations asked US Food and Drug Administration today to label medical devices containing the toxic chemical di-2-ethylhexyl phthalate (DEHP). The phthalate leaches out of vinyl plastic medical devices into patients, posing risks to developing reproductive systems – including reduced fertility – of boys. The letter accompanied a legal petition to FDA from the non-profit organization Health Care Without Harm (HCWH).

Organizations joining HCWH in calling 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 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."

The findings ratified a 2000 report issued by a panel of NTP scientists.

  • "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 immediately switch to safer non-PVC medical devices that do not contain DEHP."
  • The good news is that cost-effective, non-DEHP, non-PVC medical devices are available and being used by some leading hospitals. The petition to FDA contains statements from leading health care institutions that have successfully eliminated DEHP from neonatal intensive care units (NICUs). However, the hospitals note it has not been easy to make the switch, and say it is necessary for FDA to require labeling of vinyl devices so health care institutions can make better-informed purchasing decisions in order to reduce DEHP exposure in vulnerable populations.

A letter from Kaiser Permanente notes:

  • Today, non-DEHP alternatives have replaced DEHP products in all neonatal applications for which they are available … We are proud of our phase-out of DEHP devices, but it must be said that the process would have proceeded much more quickly if labeling of DEHP devices was required by FDA.

A letter from Miller's Children's Hospital (Long Beach, CA) notes:

  • Our own experience sheds light on the difficulties hospitals face when trying to protect patients from DEHP exposure. Our Central Supply Manager reports that her queries to medical device manufacturers customer service representatives about DEHP content in their products yields the response that the customer service reps don't even know what she is talking about. They don't know what DEHP is, which requires a referral to technical support and leads to precious lost time.
  • We cannot be advocates for patient safety when vital information is unavailable. To not have information about DEHP content in devices that are commonly used in patient care is an injustice to both patients and healthcare providers.
  • The European Union recently announced mandatory labeling of DEHP-containing medical devices, and the EU is considering restricting the devices for vulnerable groups such as babies and kidney dialysis patients. The EU has already banned DEHP and other phthalates from toys and cosmetics, but the chemical is legally added to consumer products sold in the United States.

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