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Health care groups warn about IV bags

By TOM ROBERTS
NCR Staff

A broad coalition of health care organizations has launched a campaign to end the manufacture of what the group claims is a dangerous type of plastic IV bags and tubing used to deliver medicine and fluids intravenously.

The group issuing the warning, Health Care Without Harm, warns that a chemical used in making the bags could cause cancer and other health problems.

The organization claims 159 member organizations in six countries. It specializes in environmental issues. Membership includes an array of Catholic and other religious institutions that have joined in warning that bags made of PVC (polyvinyl chloride), and used by most U.S. hospitals, contain a chemical that can leach into blood or medication being administered into a patient’s veins.

Health Care Without Harm will launch the campaign at a variety of news conferences across the country scheduled for Feb. 23.

The danger, they say, comes from additives called phthalates (pronounced thal-lates) that make the stiff plastic more flexible.

“The chemical added to PVC, di-2-ethylhexylphthalate (DEHP), has been identified by the United States Environmental Protection Agency as a probable human carcinogen,” according to a health alert issued by Health Care Without Harm, based in Falls Church, Va.

The campaign calls for lobbying health care providers to use PVC-free and DEHP-free IV bags and other medical equipment. Further information can be obtained from the Health Care Without Harm Web site: www.noharm.org

Charlotte Brody, co-coordinator of Health Care Without Harm, said the organization was founded two and a half years ago in response to concerns about hospital incineration of medical supplies containing PVC. At the time, medical waste incineration was the leading source of highly toxic dioxins, which is the result of chlorine combustion, said Brody.

The work of Health Care Without Harm “initially was based on our goal of minimizing dioxin exposure. We originally were concerned with incineration of PVC bags.”

But the organization soon became aware of the additional problem of the leaching of phthalates -- often referred to as “plasticizers.”

Similar concerns arose within Catholic Healthcare West, a California-based hospital system, according to Sr. Susan Vickers, director of advocacy for the system. She said Catholic Healthcare West had already determined to reduce as much as possible, the use of PVC plast supplies in the system’s 48 hospitals when it hosted a presentation by Health Care Without Harm. The system then approved joining the national effort to reduce the use of PVC plastic supplies in hospitals.

Health Care Without Harm was alerted by a pharmacist in one of the member hospitals who pointed out that certain drugs contain warnings against using them in PVC bags because of possible leaching of DEHP.

According to those involved in the issue, there are three major manufacturers of IV bags and tubing: Baxter Healthcare Corp., Deerfield, Ill.; Abbott Laboratories in North Chicago, Ill.; B. Braun McGaw Inc., Irvine, Calif. Of those, Baxter and Abbott are the largest providers of the supplies. The major portion of IV bags they manufacture contain PVC. Only McGaw regularly supplies non-PVC bags.

All three have bid on a massive contract to supply “IV solutions and sets” -- bags containing medication and other fluids as well as the tubing and needles used to administer the fluids -- for the 296 Catholic hospitals and 138 Catholic nursing homes that are represented by Consorta Inc.

Consorta was formed in May when two Catholic purchasing groups merged to form the country’s sixth largest health care group purchasing organization.

“The value of the contract will be $480 million over eight years,” said John Strong, Consorta’s president and chief executive officer.

The contract for IV bags was one of the first actions of the new purchasing group, and that development attracted the attention of Health Care Without Harm.

The activist group, said Strong, was “instrumental in helping us understand the issues around PVC.”

Those concerned with the questions of environmental safety as well as phthalate leaching from the bags would prefer to see McGaw land the contract. However, other clinical and economic issues will be part of the consideration, said Strong.

No matter which firm lands the contract, Health Care Without Harm has significantly influenced the negotiations. If the contract goes to Baxter or Abbott, said Strong, Consorta would include language in the agreement that would provide for education on the PVC issue at member hospitals; information on proper disposal techniques and an assurance that the manufacturer would work toward reducing the amount of PVC in the supply chain over the course of the contract.

He said Consorta expected to reach terms with one of the suppliers within 60 to 90 days. One of the terms will spell out the supplier’s intention to move as quickly as possible toward non-PVC bags and tubing.

Some discount the dangers of DEHP because there has been little evidence of “significant adverse effects” and because the amount of DEHP that can leach from IV bags is too small to be associated with any health effects.

Other medical experts respond, however, that even though there is no conclusive proof of a cancer connection in humans, the evidence is strong enough to warrant a ban on PVC plastic.

Health Care Without Harm contends that “lack of significant evidence of health damage in humans does not mean that there is significant evidence that DEHP is safe. Thalidomide and DES were both used by millions of pregnant women before researchers made the link between birth defects, cervical cancer and the effects of these two drugs in utero.”

James Huff, a toxicologist with the National Institute of Environmental Health Sciences, said tests performed by the institute left “no doubt” that DEHP causes cancer in laboratory animals, although there is so far no evidence of cancer in humans caused by DEHP.

However, he said, “In my opinion, any result in lab animals that is positive in that direction” is reason for caution in humans. He thinks hospitals should use alternatives to PVC bags.

Dr. Ted Schettler of Boston, science director for Science and Environmental Health Network, said that, based on the scientific evidence, “it would not be irresponsible to say that DEHP is not a human carcinogen.” The evidence shows that while DEHP quickly causes a reaction in the liver of rodents, it does not do so in humans. But Schettler said that the evidence would suggest a strongly cautionary approach to DEHP.

Schettler finds far more interesting and worrisome DEHP’s effect on reproductive organs, particularly testicles, and on the heart.

Recent evidence shows that the developing organs of fetus and infant rodents were highly sensitive to even low level doses of DEHP, he said. He added that further longer-term experiments on mammals showed that DEHP affected lung function in children and, over a prolonged period of time, caused liver changes in monkeys that researchers had found to occur more quickly in rodents.

National Catholic Reporter, February 19, 1999