WASHINGTON — Concerns about phthalates leaching from PVC toys is about to broaden to the medical industry, with a health-care organization set to launch a consumer education campaign.
The Falls Church, Va.-based Health Care Without Harm Coalition, whose members include the American Nurses Association, hospital chain Catholic Healthcare West and Greenpeace, plans to launch a campaign later this month about what it sees as the danger of phthalates leaching from PVC IV bags.
``We're launching a public education effort to alert health consumers that PVC IV bags have similar problems to PVC toys,'' said Charlotte Brody, co-coordinator of the coalition.
Brody declined to provide details. HCWH has tried to convince hospitals to move away from PVC, mainly citing concerns about dioxin emissions.
One of the largest makers of PVC IV bags, Baxter International Inc. in Deerfield, Ill., said there is overwhelming evidence that the primary phthalate used in its bags, di(2-ethylhexl) phthalate, is safe.
``We have gotten questions from customers, but the reality is that there is no scientific data that shows any problems with this material that has been used extremely effectively for decades,'' said Deborah Spak, spokeswoman for Baxter.
Some studies have found liver tumors in rats exposed to DEHP, but recent studies question whether it will cause cancer in people because humans metabolize it differently, Baxter said.
The International Agency for Research on Cancer, the U.S. National Toxicology Program and the Environmental Protection Agency consider DEHP a potential or probable human carcinogen. EPA considers it a low carcinogenic hazard.
An advisor to HCWH, Peter Orris, said there is a ``great deal of debate'' about how much risk there is in IV bags, but said alternatives should be used since they are relatively available.
``When we know this stuff can leach out and we know it is a probable human carcinogen and we can't identify thresholds [of exposure], we know we are raising the risk,'' said Orris, who is a medical doctor and director of research for the Great Lakes Center for Occupational and Environmental Health and Safety at the University of Illinois School of Public Health in Chicago.
Spak, however, said that most of the alternatives to PVC have problems with sterilization. Baxter bought an Italian maker of polyolefin IV bags last year, but its bags do not meet U.S. Food and Drug Administration requirements for sterilization.
B. Braun McGaw, based in Bethlehem, Pa., makes a non-PVC, nonplasticizer IV bag for the U.S. market from a blend of polypropylene, polyethylene, polyester and synthetic elastomers.
An FDA spokeswoman said the agency is conducting a risk assessment of DEHP in IV bags, prompted by the concerns European governments have raised about phthalates leaching from PVC toys.
The subject of alternatives to PVC also was widely discussed at a large medical device trade show in California last month, where a few companies touted PVC alternatives.
Kuraray America Inc. said a blend of pp and thermoplastic rubber it makes has replaced PVC in some medical tubing in Europe and in meat packaging in three Japanese grocery chains. In Japan, the push has come from concerns about dioxin from trash incinerators.
The blend is cost-effective, compared with PVC, said Ronald Foster, director of market development for Kuraray, which is a unit of Osaka, Japan-based Kuraray Co. Ltd. He spoke at a seminar at the Medical Design and Manufacturing West '99 show in Anaheim, Calif.
Custom injection molder Brevet Industries started molding a urethane tubing connector in late 1998 as an alternative to PVC. The connector is more expensive than PVC but could be designed cheaper, said Richard Manning, director of sales and marketing for Irvine, Calif.-based Brevet.
``We know we have a lot of homework to do before we make this a commercial material, but with what you see in the papers, we are looking at alternatives,'' he said.
Doug Powell, medical industry market manager with Bayer Corp.'s plastics division in Pittsburgh, said research has not found any problems with phthalates but the industry is interested in alternatives.
``The ship may or may not be sinking, but companies are standing by the lifeboats,'' he said.
The HCWH effort comes as the European Commission is again considering restrictions on phthalates in toys.
There was strong support for a ban at a Feb. 1 EC consultative meeting of lower level officials, and the consumer affairs regulator Emma Bonino wants to meet with other commissioners to discuss a ban, said Tim Edgar, deputy director with the European Council of Plasticizers and Intermediates in Brussels, Belgium.
The EC department that advocates for industry is pushing migration limits for diisononyl phthalate and effective bans on DEHP and four other phthalates, Edgar said. But the EC's chief scientific committee only recommended limits, and not all member states favor a ban, he said.