Largest US IV products manufacturer to phase out vinyl IV bags

The largest US producer of intravenous (IV) bags, Baxter International, announced on April 6 that it is to develop alternatives to PVC for their products, including IV bags.

The Baxter announcement comes amid increasing awareness of two major hazards associated with PVC: the leaching of toxic additives from vinyl products such as IV bags and children’s toys, and the release of the carcinogen dioxin when vinyl is manufactured and incinerated.

Eighty percent of the 500 million IV bags used in the US are made of PVC. These vinyl IV bags have been shown to leach the toxic chemical di-ethylhexyl phthalates (DEHP) into the liquids they contain.

Plastic PVC products require a softener to make them flexible, which is why they are manufactured with DEHP. DEHP has been classified by the US EPA as a probable human carcinogen. Studies have shown that DEHP can damage the heart, liver, testes and kidneys and interfere with sperm production.

A February 1999 Greenpeace investigation showed that PVC medical products produced by Baxter and Abbott Laboratories contained from 29%-81% DEHP. In contrast, DEHP could not be detected in another plastic IV bag – one made from polyolefins manufactured by B. Braun McGaw.

Vinyl IV bags also have a high chlorine content. Consequently, vinyl manufacturing and disposal by incineration create the toxic chemical, dioxin.

Baxter’s announcement follows public pressure to eliminate patients’ exposure to chemicals such as DEHP when safe alternatives exist. Baxter joins medical supplier B. Braun McGaw, and companies such as Lego toys and IKEA in embracing alternatives to vinyl.

The health risks associated with vinyl IV bags were highlighted when Health Care Without Harm (HCWH), a coalition including 41 hospitals, the American Nurses Association, Greenpeace and more than 100 health and environmental organizations launched a public education campaign around the issue.

The Baxter decision comes after negotiation with HCWH, the Interfaith Centre on Corporate Responsibility (ICCR), representing 275 religious institutional investors and the Service Employees International Union, the largest union of health care employees in North America. Baxter did not specify when the phasing out process would be completed.

“I welcome Baxter’s initiative. I think it is appropriate that a medical device manufacturer should use the precautionary approach to avoid the problems of PVC given the availability of alternatives. I plan on watching closely how it develops in practice over the next several years,” said Dr. Peter Orris, Professor of Preventive and Internal Medicine at the University of Illinois School of Public Health and the American Public Health Association’s representative to HCWH.

Greenpeace welcomed Baxter’s announcement, “This is great news,” said Joseph Di Gangi, a scientist with the Greenpeace Toxics Campaign. “Baxter is joining the ranks of forward thinking companies who recognise there is no future in PVC. We believe this will encourage more businesses to take action to phase out vinyl.”

The potential dangers of PVC products may be news to the general public, but it’s not to some in the medical community. In fact, certain medications, including the chemotherapy drugs Taxol and Taxotere, come with warnings against using PVC equipment for their administration.

In addition, Abbott Laboratories, another large manufacturer of PVC IV bags, warn that these products have not been tested for carcinogenicity, mutagenicity or fertility effects, and that children and nursing mothers should be particularly cautious when using the product.

Alternatives to vinyl plastics are increasingly being used in Europe, particularly in Austria and Germany. (Baxter recently purchased Bieffe, a Swiss maker of non-PVC IV products.)

Baxter’s decision to phase out PVC IV bags came despite attempts by chemical trade associations to refute claims that these devices needlessly expose patients to toxic chemicals. Their claims, however, are largely unsubstantiated, according to HCWH.

Baxter will also disassociate itself from a one million-dollar advertising campaign being waged by the Vinyl Institute and the Chlorine Chemistry Council, two leading vinyl industry associations. Baxter agreed to tell the trade groups to “refrain” from using Baxter medical products in the ads, which are running in US magazines, newspapers, and on CNN. The ads claim that “people who save lives…depend on vinyl.”

Chlorine and vinyl industry associations claim that the quality of health care will decline if vinyl medical products are replaced. However, HCWH contends that eliminating exposure to DEHP and dioxin improves public health, without increasing costs.

Meanwhile, The Vinyl Institute has said that vinyl plastic “will continue to play a major role in quality healthcare” and that “statements made by Greenpeace that the material will be replaced are grossly exaggerated.”

“Once again, Greenpeace and Health Care Without Harm are issuing misleading statements in their efforts to attack anything made of vinyl,” said Vinyl Institute executive director Tim Burns.

Burns pointed out that Baxter International had said it will offer an alternative to PVC products “in instances where the overall performance and safety of another material is proven superior to PVC and regulatory clearance is obtained.”

Burns said, “Baxter choose materials that offer the best performance and safety characteristics. If another material offers that, then Baxter should select it. But we know there is no better, safer or more time-tested product than vinyl for many types of medical use. We’re confident that vinyl has a long life ahead of it improving health and saving lives.”

Burns also said that Greenpeace and HCWH refuse to see “the enormous benefits” that vinyl IV bags, blood bags and other medical devices render to the healthcare profession and patients.

“All we expect from any industry considering using vinyl is that they give us a level playing field and judge vinyl alongside other competitive materials – based on a track record of safe and reliable performance.”

Baxter International’s R&D department, says Burns, evaluate materials according to ” basic performance criteria: clarity and transparency, strength, flexibility, sterilizability, centrifugability and barrier capability. PVC is one of the only materials that can consistently meet all of these criteria; however, it may not be optimal for all products.”

Burns urged healthcare product manufacturers, healthcare professionals and healthcare consumers to demand the best performing materials, not materials selected due to political agendas.

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