Design Alley: An Alternative to PTFE

Medical Design Briefs INSIDER

SABIC will feature new and existing material solutions for potential use in critical medical devices at MD&M West 2024 (Booth #3287). (Credit: SABIC)

SABIC will feature new and existing material solutions for potential use in critical medical devices through the company’s exhibition (booth #3287) and in two presentations at MD&M West. On Tuesday, February 6, at 12:30 pm PST, Ed Williams, senior product manager, LNP Compounds, will give a presentation in Design Alley. Titled “Solving Thermoplastic Wear and Friction Problems in Medical Devices without Intentionally Added PFAS,” the presentation will focus on new material technology that is well suited for wear and friction applications.

SABIC’s specialty compounds can also help solve restrictions or bans on per- and polyfluoroalkyl substances (PFAS). Internally lubricated LNP LUBRILOY™ compounds, featuring a patented olefinic additive, provide an attractive alternative to materials lubricated with PTFE, a type of PFAS. The portfolio is being expanded with new base resins.

The company will spotlight specialty-engineered thermoplastic materials that can help the device industry address pressing issues, including withstanding increasingly harsh healthcare disinfectants; providing effective lubrication without the use of polytetrafluoroethylene (PTFE); and finding alternatives to EtO sterilization in the face of upcoming U.S. Environmental Protection Agency (EPA) regulations.

"Regulators are making significant progress in ensuring the medical device industry uses safe and sustainable practices and materials. However, upcoming restrictions are creating challenges for device makers," says Maureen MacDonald-Stein, director, Portfolio Strategy and Marketing, SABIC’s Specialties Business.

"SABIC is proactively developing new specialty materials to help customers achieve compliance. For example, our new LNP LUBRILOY compounds avoid the use of PTFE lubrication, and our high-performance ULTEM HU resins are compatible with many sterilization alternatives to EtO, including vaporized hydrogen peroxide," she says. "This is important for medical device makers, as the FDA now considers VHP an established Category A sterilization process. In everything we do, the goal is to offer attractive options that assist the industry in navigating the fast-evolving regulatory landscape.”

Coping with Healthcare Chemicals

The frequent application of highly aggressive disinfectants can cause environmental stress cracking (ESC) in plastic medical device housings and components. Degradation of the material could interfere with patient care or result in costly premature device failure and warranty claims. SABIC’s ULTEM™ HU resin series and LNP™ ELCRES™ CRX copolymer resins deliver best-in-class chemical resistance, helping to mitigate or prevent ESC and extend the useful life of devices.

Anticipating EtO Sterilization Restrictions

Another device challenge is the ability to withstand multiple sterilization methods and repeated sterilization cycles. Anticipated EPA restrictions on EtO sterilization emissions are prompting demand for versatile thermoplastics – like ULTEM HU resins – which are compatible with the most common sterilization methods including steam autoclave and vapor hydrogen peroxide (VHP) sterilization, and gamma/E-beam radiation, to name a few – and can withstand repeated sterilization cycles.

Also at the show, Paul Nugent, SABIC’s senior business manager, will give a presentation, titled “How thermoplastic material selection impacts durability and sterilization of medical devices.” His presentation will take place on Wednesday, February 7 at 3:30 p. PST in Design Alley. Nugent will discuss trends such as stricter regulations and the strong demand for sustainability and extending the life of parts, which affect the selection of materials for medical devices. He will also explain how the properties of ULTEM HU resins align with these trends and can surpass those of competitive materials.