WASHINGTON — A coalition of medical and environmental groups launched a campaign Feb. 23 to convince health-care facilities not to use vinyl IV bags, arguing that toxic softening agents called phthalates can leach into fluids.
But industry officials said there is no evidence of health risks to people. The Food and Drug Administration said it cannot say how big the danger might be until it completes a review later this year.
The Health Care Without Harm Coalition kicked off its effort by releasing a Greenpeace test of vinyl medical tubes, syringes, bags and catheters that found that the products were, by weight, between 29 percent and 81 percent made from di-2-ethylhexyl phthalate, or DEHP.
``We believe that there is enough demonstrated evidence of harm in animals [from DEHP exposure] that we should take action for people,'' said Jackie Hunt Christensen, co-coordinator of the Fall Church, Va.-based effort.
The coalition said animal studies indicate that DEHP can damage the heart, liver, testes and kidneys, and harm fetal development and reproduction. The Environmental Protection Agency considers it a low carcinogenic hazard.
Mel Stratmeyer, chief of the health sciences branch in FDA's medical device center, said that until the agency completes its risk assessment, ``it will be difficult to say if there is a health risk and how big it is.''
He said that the carcinogenicity of DEHP will not be a focus of the agency review because it is hard to extrapolate cancer risk from the animal studies on rats. Rodents react much differently to DEHP than people, he said.
HCWH said there is evidence of liver problems in people outside of cancer risk, based on biopsies of dialysis patients, who are frequent users of PVC medical products. And it said DEHP has not been the subject of comprehensive epidemiological studies or intravenous exposure studies in people.
But Stratmeyer said the amount of research on DEHP is ``quite considerable compared with a lot of other compounds.''
Carol Talacki, an adviser to the Vinyl Institute, said ``this issue of leaching out of the plasticizers has been known for 40 years and there have not been any health effects.''
A 1996 review of 500 studies found no increase in cancer risk from DEHP exposure in patients undergoing dialysis, Talacki said.
DEHP acts as a preservative in blood, stabilizing the membranes and letting the blood sit in storage longer, she said. Talacki, a medical doctor, was head of the American Red Cross Blood Services in Peoria, Ill., from 1994-98.
HCWH noted that drugs such as taxol and taxotere come with warnings not to use with PVC because of DEHP leaching.
Since alternatives are readily available for some uses — such as IV bags — health-care providers should phase out PVC as a precaution, the coalition said.