HEALTH CANADA PANEL WARNS THAT PLASTICIZER IN PVC MEDICAL DEVICES MAY HARM DEVELOPING BABIES, INFANTS, BOYS

Health Canada Expert Advisory Panel issues strong warning about the risks of DEHP-containing PVC medical devices.

FOR IMMEDIATE RELEASE - January 24, 2001
CONTACT: Charlotte Brody, RN, 202-234-0091; Rich Whate, Toronto Environmental Alliance, 416-596-0660; Dr. Ted Schettler, 617-536-7033

January 24, 2002 - 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 was 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 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, Executive 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," explained 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."

Health Canada joins the FDA and other governmental agencies in finding that animal studies suggest the need for concern about the risks to humans from PVC medical devices that leach DEHP. In October 2000, the National Toxicology Program Center for the Evaluation of Risk to Human Reproduction's expert panel report expressed "serious concern" that exposure to DEHP may adversely affect male reproductive tract development in critically ill infants and "concern" over the levels of DEHP exposure to pregnant women, breast-feeding mothers and healthy infants and toddlers.

In July, the Swedish Chemical Inspectorate, acting on behalf of the European Union, reported that people "are exposed to DEHP during their entire lifetime, via the environment, consumer products and medical equipment" and that there is a need to institute measures to reduce exposure now.

Health Care Without Harm is an international coalition of 350 organizations in 38 countries working to transform the health care industry so it is no longer a source of environmental harm. The Health Canada panel report can be found at:
http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/advcomm/eap/dehp/eap-dehp-final-report-2002-jan-11_e.pdf
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