California’s ban on toxic IV bags marks a shift for health care plastics
The new law, which will go into effect in 2030, will end the use of intravenous medical supplies that contain between 30 percent to 80 percent toxic chemicals. Read More
For decades, most U.S. medical patients getting intravenous therapies have probably also been absorbing carcinogens into their veins, even when receiving chemotherapy treatments. That’s because many IV bags contain toxic chemicals that can leach out of the plastic and into the medicines meant to improve people’s health. Sometimes those chemicals comprise nearly one-third of the weight of the bag,
This scenario is about to change — at least in California where Gov. Gavin Newsom signed into law Sept. 25 a ban on certain IV bags and tubes in health care. The Toxic Free Medical Devices Act passed in the California Senate and Assembly unanimously Aug. 26.
By 2030, under the new law, IV supplies in the state can no longer contain Di(2-ethylhexyl)phthalate (DEHP). Mixed with polyvinyl chloride (PVC) plastic to soften it, DEHP is among the suspected cancerous chemicals known as phthalates.
The law is a win long in the making for activists, including much of the medical establishment. The American Academy of Pediatrics, the American Medical Association and others have rallied against intravenous products with DEHP for two decades.
The California law is certain to create momentum for similar laws across the country, as laws protecting consumers that are passed in California, the world’s fifth-largest economy, often do.
“We hope this historic victory will inspire healthcare institutions nationwide to make this switch immediately to eliminate DEHP exposures that are jeopardizing the health of breast cancer patients and other vulnerable populations,” said Janet Nudelman, Breast Cancer Prevention Partners’ senior director of program and policy, in an Aug. 28 statement. The San Francisco nonprofit sponsored the bill and was among 50 groups backing the ban.
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Because it’s impractical to customize one product for the Golden State and another for 49 others, the effect will likely roll across the U.S. market state by state. A bill is pending before Pennsylvania lawmakers, for example, that would end DEHP IV bags for pediatric and cancer care starting in 2026, with an eventual phaseout for other applications.
The European Union already has a similar ban with a 2030 deadline, pushed back last year from an original 2025 target.
The global market for IV bags is expected to grow from 2023 to 2030 by 71 percent, reaching $8.4 billion annually, according to Coherent Market Insights. North America makes up 36 percent of global sales, followed by Europe at 26 percent and Asia Pacific at 20 percent. IV bag manufacturers include Baxter, B. Braun and Fresenius-Kabi.
Injections of toxic chemicals
Hospitals and other medical centers routinely hook up patients to DEHP-laced IV bags for chemotherapies, medication, nutrition and hydration.
- Up to 90 percent of hospital patients receive intravenous therapies.
- Seventy percent of IV bags and tubes are made of polyvinyl chloride with the DEHP additive, according to Breast Cancer Prevention Partners (BCPP).
- These bags contain 30 percent DEHP by weight, according to Clean Production Action of Somerville, Massachusetts.
- Eighty percent of the weight of the IV tubes being banned comes from DEHP, according to BCPP.
The alternatives to PVC with DEHP are polyolefins, made from either polypropylene or polyethylene. These reduce the number of chemicals of concern from 30 percent to zero, according to Clean Production Action. Instead of polyolefins, manufacturers can opt for PVC with a plasticizer other than DEHP.
Early movers against toxic IV bags
Most of the healthcare industry uses intravenous products with DEHP. Medical supplies giant Baxter, the largest supplier, has been criticized for selling IV bags and tubes both with and without DEHP. Yet the Deerfield, Illinois-based company applauded the new California law’s 2030 timeline for protecting “supply chain continuity.”
Other suppliers, however, phased out DEHP from their IV gear years ago. These include IV bag maker B. Braun of Melsungen, Germany; ICU Medical of San Clemente, California; and Fresenius-Kabi of Bad Homburg, Germany.
“B. Braun has invested more than $1.2 billion over the last several years to establish a manufacturing infrastructure in the U.S. that can help healthcare systems comply and meet the demand for non-DEHP IV bags now that AB 2300 is signed into law and will take effect,” said Stephanie Pitts, B. Braun’s vice president of strategic programs innovation, The company, which began moving away from DEHP 40 years ago, had lobbied for the law. “We are encouraged to see others recognizing the importance of these choices and will continue to push for change,” she added.
The 12.5-million-member Kaiser Permanente health network based in Oakland, California, stopped using the toxic IV bags in favor of polypropylene ones 12 years ago.
“We hope that this new law will be the motivation needed for manufacturers to truly innovate in the medical products space and develop solutions that will reduce the chemicals of concern that are in the products we purchase, and the amount of waste generated — especially related to single-use plastics,” said Seema Wadhwa, executive director for environmental stewardship at Kaiser Permanente.
To pioneer that effort nationally, Kaiser partnered in the late 1990s with the sister nonprofits Practice Greenhealth and Health Care Without Harm. The health care group had internal support from the C-suite down, according to Ted Schettler, a medical doctor, science advisor of Healthcare Without Harm and science director of the Science and Environmental Health Network.
“They had their own champions who took the ball and ran with it in the purchasing and sustainability department,” said Schettler, who advised Kaiser at the time on the chemicals phaseout.
Kaiser developed an environmental purchasing policy in 2006. In 2010, it created environmental criteria for rating medical supplies by eco-friendliness and lack of toxicity. As a result, Kaiser has removed supplies containing DEHP and other chemicals of concern from much of its purchasing. The shift involved 100 tons of medical equipment and led to annual cost savings of $5 million. Adopting DEHP-free analgesia sets, for instance, also eliminated the annual use of 18.8 miles of PVC tubing, according to the organization.
“Providing a mechanism for suppliers to clearly indicate what is in the products they produce allows us to make informed decisions about what organizations purchase, and to identify opportunities to work with suppliers to drive innovation,” Wadhwa said.
Kaiser was unable to say whether DEHP is in its plastic bags for irrigation, ventilation or nutrition. The organization is working with suppliers to get the remaining DEHP out of its supply chain, Wadhwa said. She did not share whether non-DEHP products cost less than alternatives but said pricing should “become even more competitive” as demand rises.
Kaiser has some company in eliminating DEHP from IV supplies. San Francisco-based Dignity Health’s phaseout happened between 2008 and 2013. It eliminated the use of more than 673,023 pounds of DEHP, according to Clean Production Action.
Loma Linda University Health and City of Hope are among the other healthcare systems that have rid their IV bag supply chains of DEHP.
The Chemical Footprint
The properties of plasticizers
Scientists recognize that DEHP and other phthalate plasticizers introduce serious health risks. Phthalates flow out of everyday products into dust, wastewater systems and the food chain. It’s nearly impossible to avoid them.
- IV drips provide a targeted internal path for the chemicals to infiltrate human bodies.
- Just as a person’s bloodstream absorbs IV fluids at a rate of 90 to 100 percent, it also readily draws in DEHP, according to Breast Cancer Prevention Partners.
- Ironically, cancer patients get a steady drip of the potential carcinogen through the invasive IV treatments, Pregnant women and infants in intensive care are also especially vulnerable, according to watchdogs.
Regrettable substitutions?
Before there were IV bags, there were glass IV bottles. These could break, posing cutting risks. Plastics became more attractive in 1970 and 1971 after 50 people died from sepsis. Faulty seals of glass IV bottles made by Abbott Laboratories were blamed, leading to a rare criminal indictment of company leaders in 1973.
At the time, Baxter emerged as an early producer of PVC IV bags, and plastic overtook glass.
However, scientists raised flags about DEHP as a carcinogen even in the 1970s. A drumbeat of research has since built a damning case around the plasticizer’s connections to cancers, neurotoxicity and reproductive harm.
- The U.S. Environmental Protection Agency in 1986 called DEHP a probable carcinogen.
- Twenty-two years ago, the US Food and Drug Administration warned doctors that DEHP can escape from PVC in medical devices and pose specific risks to developing babies and children, especially boys. “But the wheels kept turning and device manufacturers kept turning out DEHP PVC products,” Schettler said. “The FDA didn’t step in to stop it or recommend alternatives.”
- California banned DEHP phthalates in toys in 2008 at levels higher than a tenth of 1 percent.
- In 2020, the state barred DEHP, alongside mercury and formaldehyde, from beauty and personal care products.
How to move to safety and circularity
“Healthcare is deeply involved in this, and has a real opportunity and responsibility to take a look at their own activities, and do an inventory,” Schettler said of industry efforts to use safer plastics and reduce waste.
However, he warned that sustainability leaders seeking to grow circular economy efforts in healthcare should avoid recycling plastics laced with toxic additives such as DEHP.
“If you can use a plastic polymer that is inherently less toxic, then it’s much easier to recycle and reuse, and you’re moving toward a circular economy,” he said. “If you have a plastic that is inherently really toxic because of all the additives in it, it’s really hard to see that as being part of the circular economy, because you just carry the toxicity with it whenever you try to recycle it.”
Schettler advised companies to develop criteria for evaluating the safety or the toxicity of any plastic in healthcare centers.
“The toxicity (and) circularity issues go hand in hand, in the sense that if you redesign using safer polymers, you then get away from the toxicity, and you begin to open up the opportunities for reusing those safer plastics.”
Updated: This story was updated to include clarifications from Kaiser Permanente.
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