After pushing for DEHP ban, B. Braun offers tips on toxin’s removal from devices

B. Braun is celebrating the California Legislature’s passage of a ban on Di(2-ethylhexyl) phthalate (DEHP) plastic in IV bags and tubing.

“Chemicals that were removed from children’s toys nationally in 2008 still remain in 70% of the IV bags in our communities today — it’s really crazy,” B. Braun Senior Director of Healthcare Strategy and Innovation Stephanie Pitts said in an interview.

Of the more than 33 million patients hospitalized in the United States each year, about 90% receive some form of IV treatment, she told Medical Design & Outsourcing.  Of those IV bags, 70% contain DEHP, with that chemical accounting for 40% of the bag’s weight.

DEHP has been linked to cancers of the liver, lung, breasts and testicles, as well as endocrine disruption and potentially causes drug resistance in cancer patients.

When signed into law, California’s Toxic Free Medical Devices Act will require IV bags manufactured, sold or used in the state to be free of DEHP by 2030 and the same for tubing by 2035. Device manufacturers will not be allowed to replace DEHP with a different ortho-phthalate.

B. Braun says it’s currently the only supplier that offers a full line of IV irrigation containers free of DEHP or PVC, which is softened by DEHP. The B. Braun products primarily use polypropylene instead.

“If you ever feel bags that contain DEHP and ours that don’t, you can feel the difference,” Pitts said. “I’m super excited that California has taken the lead, and we hope to see this cross the United States, state by state, as we start moving this across the board. … Over 40 years ago, B. Braun made the decision to remove these harmful chemicals. Patient safety and long-term sustainability is really in B Braun’s DNA.”

Melsungen, Germany-based B. Braun Melsungen is the world’s 15th-largest medical device company, according to MDO‘s 2024 Medtech Big 100 ranking by revenue.

Tips for identifying and eliminating DEHP from medical devices

Making medical devices without PVC and DEHP is easier said than done. There have been at least two device recalls in 2023 and 2024 for products incorrectly labeled as DEHP-free, including B. Braun’s recall of a nerve stimulator that had traces of the chemical in the product’s glue.

Asked for advice on identifying and eliminating DEHP from medical devices, Pitts deferred to B. Braun Sustainability and Packaging Leader Christian Hutter.

“The first thing manufacturers can do is educate themselves on the potential harms of DEHP and where this chemical shows up across medical devices,” Hutter said in an email. “… When it comes to identifying uses of DEHP, remember that the use of DEHP in plastics is driven largely by the need to modify PVC to be more flexible since unmodified PVC is rigid and brittle. Any use of PVC should be a sign that a plasticizer is also present, so start by focusing on PVC use or where PVC can come in contact with your non-PVC packaging or product.”

“There are cost-effective and safe alternatives to DEHP and PVC medical devices available right now,” he continued. “These alternatives provide the same level of functionality without the associated health risks, making the transition both feasible and safer for patients, healthcare providers and the environment.”

B. Braun considered several materials and combinations to replace DEHP, including polyethylene and nylon (polyamide), Hutter said. “The final design was driven by patient safety and functionality.”

DEHP and PVC resources for device designers and engineers

In response to an inquiry by MDO, the FDA said device manufacturers should no longer rely on the “Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices” document that was previously available on the agency’s website.

An FDA spokesperson said that content “may not align with toxicological risk assessment practices used by the FDA today,” but pointed manufacturers toward Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.

Hutter offered his own list of resources for device developers and manufacturers to help them understand the risks of DEHP and PVC and design devices without them:

• CDC: DEHP in the Agency for Toxic Substances and Disease Registry
• EPA: National Emissions Standards for PVC and copolymers production
• NIH: Materials degradation in PVC medical devices, DEHP leaching and neonatal outcomes
• California: DEHP exposure warning under California Proposition 65
• Breast Cancer Prevention Partners: Toxic-Free IV: Getting harmful chemicals out of IV bags and tubing
• Practice Greenhealth: Guidance providing manufacturers ways to eliminate DEHP and PVC
• B. Braun: Resource page on DEHP and PVC