Infusing More Than Medicine: DEHP Exposure from Medical Grade Plastic

The current saline shortage reported by news outlets is due to the devastating effects of Hurricane Helene and Milton, which shut down factories in the United States. Patients needing medical care receive saline and other medicines with the help of medical-grade plastic. In fact, it's estimated that 2.5 million intravenous (IV) bags are used every day in the United States. IV bags and other medical-grade tubing and devices are typically made with the use of DEHP – also known as Di(2-ethylhexyl) phthalate. But that's going to change, at least in California.

A groundbreaking step

California's Toxic-Free Medical Devices Act, a landmark piece of legislation, is poised to usher in a significant change in the medical device industry. Scheduled to take effect in 2030, this law aims to ban the use of DEHP, a plasticizer commonly found in IV fluid containers and tubing, amongst other medical devices. Research has found that DEHP can leach from the bags and tubings and into the medications being delivered via the IV over time. DEHP has raised concerns over its potential health risks, including carcinogenicity, reproductive toxicity, and endocrine disruption.

By restricting the use of DEHP in medical devices, California is taking a proactive stance to protect the health and well-being of its citizens. As in other industries, legislation in California can influence the national policy approach due to the size of the population and economy of the state, which in this case could potentially lead to a national and global shift towards safer alternatives.

What are plasticizers and why are they included in products? 

Plasticizers are additives that enhance the flexibility, durability, and performance of various plastic materials, including polyvinyl chloride (PVC). They play a critical role in numerous industries, from healthcare (IV bags, blood storage) to food packaging (extended shelf life) and construction (fire resistance). In the medical sector, plasticizers ensure functional and reliable medical supplies for patient care.

However, concerns regarding the unseen long term health risks of certain plasticizers, particularly DEHP, have led to stricter regulations and a search for safer alternatives. While plasticizers offer clear benefits like cost-effectiveness and reliable functionality in crucial environments, the growing scientific evidence reveals the need for a cautious approach and a focus on developing safer chemical substitutes.

What are the health risks of DEHP and other plasticizers? 

Despite their utility, plasticizers like DEHP have come under fire for their toxic effects. Research has shown that certain phthalates, the family of chemicals to which DEHP belongs, are endocrine-disrupting compounds (EDCs). These chemicals can interfere with the body's hormonal system, leading to potential long-term health issues. Exposure to these substances has been linked to a variety of reproductive and developmental disorders.

Studies indicate that males exposed to phthalates may face declines in reproductive capability, and an increased risk of testicular or prostate cancer. In females, phthalate exposure has been associated with endometriosis, ovarian dysfunction, and even reproductive cancers. Furthermore, the impact on early life stages is concerning, with evidence suggesting that embryonic or childhood exposure may lead to developmental issues. These findings raise alarms, especially in sensitive populations such as those who are pregnant, infants, and cancer patients, who may be exposed to these chemicals through medical devices like IV bags.

Do safer alternatives to DEHP exist? 

The potential health risks of plasticizers, particularly in healthcare settings, have prompted regulatory bodies to act. In addition to California’s Toxic Free Medical Devices Act, there is a broader global effort, with the European Union also setting a 2030 deadline to phase out such toxic materials. Interestingly, the California law not only bans the use of DEHP in IV’s and medical tubing, but it also prohibits the substitution of DEHP with other phthalates. This clause represents an acknowledgement that manufacturers can’t just take the easy way out by slightly tweaking the structure of the chemical used in manufacturing to avoid regulation, as is the case for other organic compounds. It’s a step towards regulating classes of chemicals that are known to harm humans instead of playing whack-a-mole with new chemical structures. 

Fortunately, alternatives to DEHP already exist, such as polyolefins (made from polypropylene or polyethylene), which do not require DEHP. However, as we replace DEHP, we must ensure that these alternative plasticizers are thoroughly evaluated for human and environmental toxicity. Past efforts to remove harmful chemicals have sometimes led to the use of substitutes that, though seemingly safer, later proved to be just as harmful—a phenomenon known as regrettable substitution. Therefore, ongoing research and regulation are critical to ensure that safer materials are developed and used. The continued occurrence of regrettable substitution also raises the question if the ways in which we innovate and create new products and technologies should be re-envisioned to better safeguard the health of  future generations and the planet.

How might we balance innovation with safety?

While plasticizers have revolutionized many industries, their potential health risks are a concern. The move away from DEHP in medical devices is a significant step forward, but it is only the beginning. Finding safe, effective alternatives and ensuring they are free from endocrine-disrupting properties is crucial as we continue to rely on plastics in essential areas like healthcare and food production.

Innovation in materials science, coupled with a growing body of epidemiological research, will play a critical role in identifying new solutions. In the meantime, it is vital for manufacturers, regulators, and healthcare providers to work together to ensure that patient safety remains a top priority while maintaining the benefits that plasticizers bring to modern life. Overall, we are at a critical juncture in how we view product innovation as a society. Previous generations linked innovation to economic rewards with a more limited focus on impacts to people and the planet. We must rethink our innovation system and tie it more closely to what we intrinsically value as humans. This means retraining our scientists and engineers about the toxicology of certain chemistries and teaching them to integrate sustainable design principles as they seek to innovate.

How might RTI help?

RTI International has made substantial contributions to the body of knowledge surrounding the health implications of DEHP. Our 2021 collaborative report presents the findings of a comprehensive chronic carcinogenicity bioassay conducted of DEHP exposure. The in vivo study aimed to evaluate the potential for long-term DEHP exposure to induce cancer. 

Furthermore, at RTI, we offer comprehensive solutions for organizations facing challenges related to chemicals of concern. Here are some of our key capabilities:

• Ingredient Identification and Risk Assessment: We identify and evaluate ingredients with potential to cause consumer backlash or regulatory issues.
• Sustainable Alternative Research: We develop and research environmentally friendly replacement chemistries.
• Policy Advocacy: We assist clients in advocating for sustainable chemical policies and regulations.
• Partnership Facilitation: We connect clients with relevant partners to drive collaboration and innovation.
• Regulatory Landscape Expertise: We have in-depth understanding of regulatory trends and requirements.
• Technological Advancement: We stay updated on emerging technologies and their potential applications.
• Holistic Approach: We consider both environmental and consumer safety factors in our solutions.

Additionally, RTI is currently working to synergize its work across groups within the institute who focus on chemicals of concern such as DEHP. We are working to build a process that helps to create better, safer alternatives and stops the continuous cycles of regrettable substitution.