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Health Canada Panel Warns That Plasticizer in PVC Medical Devices May Harm Developing Babies, Infants, Boys.

WASHINGTON -- A Health Canada Expert Advisory Panel recommends that health care providers not use DEHP containing devices in the treatment of pregnant women, breastfeeding mothers, infants, males before puberty and patients undergoing cardiac bypass, hemodialysis or heart transplant surgery. In a report that was finalized on January 11 and posted on the Health Canada website today, the expert panel also named certain patient groups and medical procedures that require urgent action:
 Alternate measures are immediately justifiable and should be
 introduced as quickly as possible to protect those sub-populations
 at greatest risk, namely the fetus, newborns, infants and young
 children receiving transfusions, ECMO, cardiopulmonary by-pass,
 exchange transfusion, hemodialysis, TPN {Total Parenteral Nutrition}
 and lipophilic drug formulations.

The Health Canada report follows a September 2001 FDA Safety Assessment on DEHP (di-2-ethylhexyl-phthalate), the plasticizer used to soften PVC medical products such as bags and tubing. The US report found that DEHP may not be safe for infants, children and adults receiving certain medical treatments that involve PVC medical devices.

"The Health Canada expert panel report is the strongest call to action yet on PVC medical devices softened with DEHP," said Charlotte Brody, RN, Director of Health Care Without Harm. "The FDA assessment said there is a problem. The Health Canada panel report tells health care providers what to do about the problem-to label all products with DEHP and to do what we can to keep it away from certain patient groups and all pregnant women, babies and boys."

The expert panel recognizes that "alternative products are already available" for some DEHP-containing products and encourages research into alternatives for other products.

"The Health Canada panel is wisely recommending a course of action that insures that patients receive needed medical therapies," said Ted Schettler, MD, Science Director of the Science and Environmental Health Network. "But when we have alternatives to DEHP softened medical devices, and in nearly all cases we do, we should be using them."

The full report is posted on the Health Canada website: dehp-final-report-2002-jan-11_e.pdf .

For more information, visit or call Health Care Without Harm at +1-202-234-0091.


Contact: Charlotte Brody, RN, of Health Care Without Harm, +1-202-234-0091; or Rich Whate of the Toronto Environmental Alliance, +1-416-596-0660

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Publication:PR Newswire
Date:Jan 24, 2002
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