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WASHINGTON -- The U.S. Food and Drug Administration is recommending that manufacturers label medical devices made with di-2- ethylhexyl-phthalate (DEHP), a chemical linked to birth defects and other illnesses that is used to soften polyvinyl chloride (PVC) plastic. DEHP can leach from the plastic and pose a risk to some patients, particularly developing boys, FDA says.
The FDA's draft "Guidance for Industry" document issued Sept. 6 also recommends that medical device manufacturers consider replacing PVC containing DEHP with alternative materials. Devices used in Neonatal Intensive Care Units (NICUs) should be a primary focus, FDA said.
"The FDA is moving in the right direction, but has fallen far short of what is necessary to protect patients because they are recommending, rather than requiring, labeling of DEHP-containing products. How can healthcare providers protect their patients from this toxic chemical without a uniform way for them to know whether a medical device does or does not contain DEHP," said Charlotte Brody, RN, executive director of Health Care Without Harm.
"Healthcare providers need to be able to read a simple, easy-to-find label that clearly states whether or not a medical product contains PVC with DEHP. That's what the FDA should require," Brody said. "Anything less just isn't practical."
The FDA draft guidance is a follow-up to the FDA Public Health Notification issued last month, which recommended that healthcare providers use non-DEHP alternatives whenever possible on certain patients, particularly developing males.
"The new FDA document is a very important signal to medical device manufacturers that it's time to move away from PVC -- which not only leaches toxic phthalates during use, but also creates the potent carcinogen dioxin when it is manufactured and burned -- and onto the next generation of materials," Brody said.
The FDA document can be found at http://www.fda.gov/cdrh/ode/guidance/1407.pdf .
Comments and suggestions should be submitted to FDA by Dec. 5, 2002 to Docket No. 02D-0325, Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, Md. 20852.