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Government Reports In the last few years, a number of expert panels and government agencies have reviewed the safety of the plasticizer DEHP, which is used to soften PVC medical devices. Each of these agencies and expert panels has found that exposure to DEHP as a result of some medical procedures could pose a risk to patients. In the United States, the Food and Drug Adminstration has issued an FDA Safety Assessment (pdf) and a Public Health Notification (pdf) urging health care providers to use alternatives to DEHP-containing devices for certain, vulnerable patients. That report followed closely on the heels of a report by the Center for the Evaluation of Risks to Human Reproduction (pdf) of the National Toxicology Program. An NTP expert panel recently reaffirmed the group's original concern. In Canada, an expert advisory panel to Health Canada (pdf) has recommended 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 the European Union, a sweeping new risk reduction strategy for DEHP was proposed in February 2003. The strongest government indictment yet of the widely used chemical, the European Union proposal (pdf) seeks to immediately ban DEHP from medical devices used on newborn babies and toys, and would restrict the use of DEHP in food packaging and other types of medical devices. The plan was submitted by the Swedish National Chemicals Inspectorate (KEMI), the agency charged with drafting the DEHP risk reduction strategy for the 15 EU countries. Read Health Care Without Harm's summary of the KEMI report in English, French, Czech and German (pdf). |