News Coverage
FDA Issues Public Health Notification on Phthalates in Medical Devices
Alternatives to PVC Should Be Used for Patients Receiving Certain Medical Treatments, Agency Says
Published July 14, 2002
Late last Friday, the Food and Drug Administration issued a Public Health Notification recommending that health care providers take precautions to limit the exposure of the developing male to di-2-ethylhexyl-phthalate (DEHP) -- a chemical softener used in medical devices made of polyvinyl chloride (PVC).
The FDA document said that alternatives to DEHP-containing PVC medical devices should be used when possible for certain medical procedures. However, the FDA failed to require labeling of DEHP-containing medical devices, leaving health care providers with no way of knowing which products are leaching potentially unsafe doses of DEHP.
"FDA's Public Health Notification falls far short of what is needed to protect patients from DEHP in medical devices," said Charlotte Brody, RN, Executive Director of Health Care Without Harm. "While FDA acknowledges that certain patients may be receiving unsafe doses of DEHP, and acknowledges that there are alternatives to DEHP-containing products, FDA does not give health care providers the one tool they need to protect their patients -- a labeling requirement for all products that contain this harmful chemical."
FDA's long-awaited Public Health Notification -- issued July 12, 2002 and posted at http://www.fda.gov/cdrh/safety/dehp.pdf -- is a follow up to the agency's September 2001 safety assessment on DEHP in medical devices. The safety assessment found that some medical products made from PVC may expose patients to unsafe amounts of the toxic chemical DEHP, which is used to soften PVC medical devices such as bags and tubing used to administer fluids, medication, blood, oxygen, and nutritional formulas to patients.
The FDA notification states: "Exposure to DEHP has produced a range of adverse effects in laboratory animals, but of greatest concern are effects on the development of the male reproductive system and production of normal sperm in young animals. We have not received reports of these adverse events in humans, but there have been no studies to rule them out. However, in view of the available animal data, precautions should be taken to limit the exposure of the developing male to DEHP."
FDA acknowledged that there are alternatives to DEHP-containing PVC medical devices and recommends "considering such alternatives when these high- risk procedures are to be performed on male neonates, pregnant women who are carrying male fetuses, and peripubertal males." It lists the following high- risk procedures:
* exchange transfusion in neonates
* ECMO in neonates
* total Parenteral Nutrition (TPN) in neonates (with lipids in PVC bag)
* multiple procedures in sick neonates (high cumulative exposure)
* hemodialysis in peripubertal males
* hemodialysis in pregnant or lactating women
* enteral nutrition in neonates and adults
* heart transplantation or coronary artery bypass graft surgery (aggregate dose)
* massive infusion of blood into trauma patient
* transfusion in adults undergoing ECMO
FDA recommends a website associated with the University of Massachusetts Lowell for information on alternative medical devices that do not contain DEHP-plasticized PVC: http://www.sustainablehospitals.org .
The FDA Public Health Notification comes right on the heels of new information released last week by Health Care Without Harm, the Environmental Working Group and Coming Clean about the presence of phthalates in cosmetics. In response to a report released by the groups July 10, more than 3,000 letters have already been sent to FDA demanding that the agency require labeling of phthalates in consumer products.
"The FDA's notification about phthalates in medical devices not only ignores the concerns raised in those letters but also ignores common sense," Brody said. "How can women protect themselves from phthalates in cosmetics, how can doctors and nurses protect their patients from phthalates in medical devices, when they have no way of knowing which products contain phthalates?"
Health Care Without Harm represents more than 360 organizations worldwide that are working to reduce the environmental and public health impacts of the health care industry. For more information on phthalates in cosmetics, see http://www.nottoopretty.org . For more on phthalates in medical devices, see http://www.noharm.org .
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SOURCE Health Care Without Harm
CONTACT: Stacy Malkan of Health Care Without Harm, +1-202-234-0091, or +1-202-321-6963 (cell)