The medical device industry can take steps right now on PFAS for safety, sustainability and to steer other industries in the right direction.
By Shalene Thomas, Battelle
Medtech manufacturers are increasingly launching PFAS-free catheters and other medical devices. [Photo by JFontan via Stock.Adobe.com]
Certain chemical properties of PFAS like durability, stiffness, biocompatibility, and resistance to water and temperature are beneficial for use in medical devices. Unfortunately, these same properties turn PFAS into “forever chemicals,” so named because they do not break down easily in either the body or the environment. Exposure to PFAS is linked to chronic human health effects including cancers and organ and tissue damage.
While there isn’t significant federal regulatory pressure on the medical device industry right now, it is all but inevitable in the future. Furthermore, increased conversation around the issue will prompt customers and patients to demand change. Better to begin now before the issue intensifies. But how?
Challenges facing manufacturers
Let me back up a bit. I have experience managing PFAS across a variety of sectors and industries. I’ve worked in government, energy, transportation, and the commercial and industrial sectors.
Why can’t companies simply replace PFAS-containing materials with other less hazardous alternatives? If only it were that simple. There are alternatives on the market — such as medical-grade silicone — but none have completely replicated the performance properties of PFAS used in many medical device applications. Some even come with their own safety concerns.
And yet, regulatory updates that may be enacted over the next few years will propel change for the medical device industry. While there has been relatively limited federal movement on PFAS regulation, actions are emerging in nearly two dozen states, including California, Maine, Minnesota and New Mexico. This is further complicated by the regulations around medical devices writ large, as even minor changes to device components can trigger extensive, multi-year FDA reviews, increasing costs and delays. Decisive actions must be taken quickly, a tricky imperative when the path forward appears hazy at best.
Opportunities for proactive action
While there has not been a comprehensive replacement strategy for PFAS usage in medical devices to date, there are several steps medical device companies can take.
One of those steps is a material audit to identify non-essential PFAS uses. This process focuses on function and fit-for-purpose by finding low-hanging fruit where alternatives can be implemented with minimal impact, such as adjusting the adhesive or absorbent pad on a bandage. This may be a half-measure, but it demonstrates that a company is taking the issue seriously.
Another way to make progress in the eventual move away from PFAS is investing in research that tests and validates PFAS-free materials. Other industries have done this successfully. For example, outdoor brands that traditionally used PFAS-coated materials for water repellency and durability have switched to PFAS-free treatments for their fabrics while reporting no performance loss.
The medical device industry has made some progress in research already, with several PFAS chemicals phased out entirely. Still, there’s plenty of work to do. For example, polytetrafluoroethylene (PTFE, a kind of PFAS) remains vital for the function of catheters, surgical implants and other key medical devices.
Perhaps most important is to collaborate with manufacturers and other industry partners. Meet with industry associations, regulatory bodies and stakeholders to share knowledge and move forward on safer alternatives. This drives progress and is vital for demonstrating transparency and cooperation, particularly with regulators.
This has worked previously to drive sustainability in the pharmaceutical industry. The Pharmaceutical Supply Chain Initiative (PSCI) was established over a decade ago and has made industry-wide improvements, like creating the PSCI Code of Conduct setting supplier standards for sustainability, safety and labor rights.
The road toward an eventual resolution will be long and difficult. But this opportunity to improve safety and sustainability in medtech while encouraging other industries to adopt similar measures can improve the health of the entire country. In the healthcare industry, there is no better reason to make a change.
Battelle Emerging Contaminants Program Manager Shalene Thomas [Photo courtesy of Battelle]
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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.
