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State regulations are tightening around the use of ortho-phthalates in medical devices, and manufacturers are racing to keep up. After California passed the Toxic-Free Medical Devices Act, many states are expected to follow with similar restrictions on Di(2-ethylhexyl) phthalate (DEHP)-containing IV bags and tubing over the next few years.
Why More Device Manufacturers Are Seeking DEHP Alternatives
DEHP is a plasticizer commonly used in PVC to provide the softness, flexibility and kink resistance required for applications such as IV bags and tubing.
However, according to the National Library of Medicine, studies have shown that DEHP gradually leaches out of products after repeated use, heating or cleaning of the product.1 In medical environments where frequent sterilization takes place, the risk of DEHP exposure increases.
Beyond the health concerns, evolving state regulations are creating new compliance considerations for healthcare providers and device manufacturers. As requirements change, OEMs and CMOs are increasingly looking for materials that can support both performance expectations and regulatory objectives.
Meanwhile, manufacturers are caught in the middle. Customers and healthcare providers increasingly want DEHP-free products, but they still expect the same clarity, flexibility and performance they've relied on for years. Finding materials that satisfy both demands without disrupting development timelines or manufacturing processes can be challenging.
Meeting the Need for Flexible, Non-DEHP Medical Components
Helping manufacturers navigate this transition has become a priority for Foster, Geon’s medical division. That’s what led to the development of NexMed™ MF, a non-DEHP medical PVC platform designed for medical tubing and molded components, IV solution bags and blood and plasma storage bags and systems.
NexMed MF is a flexible, high-clarity, medical-grade PVC material that supports OEMs and CMOs developing Class I and Class II medical devices. It targets two primary applications: tubing and molded components.
- NexMed MF3000 ER supports a wide range of medical tubing applications, from fluid management systems and IV to blood transfer and storage.
- NexMed MF3000 MR is designed for injection molding applications that require flexibility, dimensional consistency and regulatory-focused performance such as surgical device components, medical connectors and fittings, and diagnostic device parts.
Both NexMed MF series are formulated without ortho phthalate/DEHP ingredients making them safer material choices for patients. The MF3000 series instead leverages DOTP (dioctyl terephthalate), a non-ortho phthalate, eco-friendly solution that’s safe for humans and the environment.
Standard Grades for Faster Development—Customization When Needed
Product teams often face lengthy development cycles when evaluating new materials. NexMed MF helps accelerate qualification with pre-formulated grades that are available for immediate sampling, while a range of Shore A hardness options provides flexibility for different device requirements.
However, if a customer has specialized needs, NexMed MF can also be customized to fulfill unique needs such as a specific hardness or color. It can also be enhanced with radiopaque fillers for use in critical applications such as interventional radiology, neurology, central venous catheters, guide wires and more.
Manufactured Under ISO 13485 Quality Standards
NexMed MF compounds are produced to Foster’s exacting ISO 13485 standards, giving OEMs and CMOs confidence in process controls and traceability while supporting regulatory documentation requirements. This proactive approach saves manufacturers time and resources during audits and the critical regulatory submission phase.
Request a Sample
As more states move to restrict DEHP-containing devices, manufacturers need materials that support evolving requirements without compromising performance or slowing development timelines. NexMed MF was created to help OEMs and CMOs navigate that transition with a flexible medical PVC platform available in standard or custom formulations.
Manufacturers interested in tubing or injection molding applications can request samples or download specification sheets to explore the platform further.
NexMed MF is available in North America through our dedicated sales team, and globally through our network of distribution partners.
About the Author
Derek Laffey is senior manager of business development at Foster, Geon’s medical division, and a seasoned commercial leader in the medical polymers industry. Derek focuses on driving growth through advanced medical-grade PVC and TPE solutions, with expertise in fluid and drug management, blood management, and dialysis applications. Known for combining market insight with technical expertise, he helps customers navigate evolving industry requirements while accelerating the development of next-generation medical devices.
