WASHINGTON — A coalition of health-care groups and environmentalists is asking the Food and Drug Administration to require labels on PVC medical devices that leach di-ethylhexyl phthalates, and to set up a program to move manufacturers away from vinyl.
The petition from Health Care Without Harm came as the group released a report June 15 saying that animal studies and limited human data suggest people are exposed to significant levels of DEHP, although the report says it is difficult to determine what specific human health risks there may be.
Animal studies have found damage to livers, kidneys, reproductive organs, hearts and lungs, but there are debates about the relevance of some of those studies.
The report came one week before a panel chaired by former Surgeon General C. Everett Koop is expected to release a long-awaited review of the safety of phthalates.
FDA plans to issue its own report later this year, and said it does not see a need for immediate action.
``There is a gap on scientific knowledge on this issue,'' said an FDA spokeswoman who asked not to be identified. ``However, if we felt there was an obvious present danger, we would certainly be taking corrective action. There is a lot of different interpretation of the data.
HCWH said DEHP in intravenous bags have not undergone detailed FDA review because the agency is not required to evaluate devices that were in use before 1976. Nevertheless, agency officials have said DEHP has been studied widely. The spokeswoman added that the agency can pull a pre-1976 device if it finds problems.
The coalition said FDA regulations with DEHP are inconsistent, with the phthalate limited to 30 percent by weight of food packaging, but unlimited in medical devices. PVC IV bags, tubing and blood bags all contain more than 30 percent DEHP, HCWH said.
``We found the current situation is not the result of vigorous testing of PVC, but rather that it was grandfathered in,'' said HCWH co-coordinator Charlotte Brody. ``The FDA, like most government agencies, defends past practices with a knee-jerk response.''
Phthalates are among the most-studied chemicals in the world, and the IV bags, blood bags and other PVC products they are used in have been found safe by the FDA, according to a statement from the Phthalate Esters Panel of the Chemical Manufacturers Association.
Jack Maurer, a spokesman for phthalate manufacturer Aristech Chemical Corp. in Pittsburgh, said the HCWH report does not contain any new scientific data, but came out now only because the group is worried about the Koop report.
The Health Industry Manufacturers Association, which represents medical-device makers, said HCWH ignores relevant science. A 1996 review of 500 studies found that the risk of cancer from DEHP exposure is extremely unlikely. All material, including glass, metal and plastic, leach from containers, HIMA said.
``In more than four decades of use, there have been no reports of significant adverse health effects in patients, even those with acute and chronic exposure to DEHP,'' Washington-based HIMA said in a statement. ``The best science to date demonstrates that any safety allegations concerning patient exposure ... are unfounded.''
HCWH officials said considerable uncertainty exists about human health risks, and said there is only limited human data. The report, a review of more than 100 studies, said that people undergoing long-term medical treatment may receive doses of DEHP at or near that which causes adverse effects in lab animals.
``At levels of exposure that are entirely reasonable for people, you see effects that are relatively subtle but could impede'' the recovery of sick patients, said Dr. Tee Guidotti, chairman of the department of environmental and occupational health at George Washington University Medical Center in Washington, and the American Public Health Association representative to HCWH.
A researcher from Boston Children's Hospital said at the HCWH news conference that a study found that long-term pediatric transfusion patients were exposed to 10-20 times the amount of DEHP that harmed the livers of monkeys.
``This lack of human evidence does not mean it is safe,'' said Joel Tickner, a University of Massachusetts-Lowell researcher who wrote the study for HCWH. ``It means it has not been studied.''