You may not have heard about it yet, but the elimination of PFAS (per- and polyfluoroalkyl substances) is a real threat to your on-market medical devices and in vitro diagnostics (IVDs). This is happening extremely fast by industry standards—faster than you can get a substitute material approved.
Regulatory actions are beginning across the globe that will likely ban some compounds, but these will take years or decades to propagate. The more immediate threat by far is the availability of PFAS through the supply chain. These materials could become unavailable in just the next 15 months as PFAS manufacturers curtail production.
And don’t think you’re safe just because you don’t have PFAS on your bill of materials. PFAS are pervasive as lubricants and processing aids in many industrial processes. These may leave trace contaminants on your components, or your components may be unmanufacturable without them.
Let’s take a deeper look at the problem and explore the actions you can take to protect your medical devices and IVDs.
What Are PFAS?
PFAS are a broad family of over 15,000 chemicals, several of which are used in the manufacture of medical devices and IVDs. They have many desirable properties, such as wear resistance, stability, high-temperature resistance, and a hydrophobic effect that prevents cells or fluids from adhering to device surfaces. Their stability and long durability are why Harvard researcher Joseph Allen coined the term “forever chemicals” in 2018. Over time, research has shown some of the compounds to be both bioaccumulative and biohazardous.
The way governments regulate chemical compounds has contributed to the problem with PFAS. Chemicals generally don’t need to be approved as safe before use. Governments only ban chemical substances once they become known to be hazardous. So, when specific compounds are found to be hazardous, the industry often substitutes chemical cousins that are not yet known to be hazardous. Then, over time, as exposure increases and health scientists gather more data, they may be shown to also be hazardous.
One well-publicized example of this type of substitution are two variants of PFAS now accepted to be hazardous, PFOA (aka C8) and PFOS. Chemical giant 3M manufactured these and supplied them to DuPont, who in turn used them in the manufacture of Teflon. After decades of use, the hazards became known. The industry eventually voluntarily phased out these variants and replaced them with close cousins, one known as Gen-X. The industry claimed it to be safer, but that is now in question. (Check out the 2019 movie Dark Waters for a dramatization of the story).
This whack-a-mole substitution has led health advocates and regulators to seek to ban the whole class of PFAS chemicals instead of just specific compounds.
So How Does This Affect MedTech?
PFAS are pervasive in MedTech products, from coatings, plastics, and packaging to bearings and bushings. One type of PFAS prevalent in medical devices today is polytetrafluoroethylene (PTFE). Its features, such as hydrophobicity, wear resistance, durability, and biocompatibility, are valuable in the design of surgical instruments, implants, stents, guidewires, and catheters, just to name a few.
And even though PTFEs and some other PFAS are water insoluble and deemed safe, they may still be banned due to environmental risks from the feedstocks used in their manufacture, which can be water soluble.
But bans and regulations are not what will affect the industry first. Lack of availability will happen much faster. For example, 3M Corporation, one of the largest producers, has announced it will cease production of PFAS by the end of 2025. Other producers are likely to follow suit. 3M feedstocks are in turn used by many subsequent companies to manufacture their products. So even manufacturers that do not buy materials directly from 3M are likely to be impacted by the phase out.
I also expect that due to recent billion-dollar settlements and the large liabilities, many insurance companies will cease to provide coverage for companies using or manufacturing PFAS and will discontinue product liability coverage for products containing PFAS. This may prevent anyone from filling the void left by 3M, even by offshoring production.
What Are Your Immediate Actions?
Investigation: The first step is to understand the depth of your issue and possible solutions. Here are some things to consider:
- Investigate where PFAS are present in your products. Go beyond the bill of materials; you will need a sampling and testing program to find where they may exist from manufacturing processes and coatings.
- Confirm material availability with your current suppliers.
- Look for alternate suppliers if necessary.
- Consider stockpiling materials to allow some time to find other solutions but weigh the shelf-life and liability risks of holding this material.
- Look for ways to eliminate or substitute PFAS where you can. This will not be easy. There are no direct substitutes available for PFAS in the medical device industry. A change in material would likely be a significant design change requiring studies and product approval amendments or registration refiling.
Remediation: If you need to remediate several products, this will be a complex program. A proper program management infrastructure will help to manage it appropriately. Here are a few things to consider:
- Gather initial information to identify available options and enable informed business decisions. Information will be imperfect so decisions should be risk-based. The first major decision will be whether to remediate, discontinue, or develop a next-generation replacement product.
- Gather further detailed information to understand the full scope. Then you can prioritize projects based on business priorities, weighing cost versus benefits, and conduct planning.
- Most organizations don’t have a dedicated function or resources for large remediation efforts and might reassign resources from other functions, especially product development. There won’t be enough people and money to do everything, so well-informed prioritization is critical to choose the most strategically important projects. Extra consultants, contractors, or outsourced staff may be added temporarily to speed up the timeline.
- Business goals are often based on revenue growth targets. Product remediation does not grow revenue. It protects the existing revenue stream from your on-market product. It may be necessary to realign reward systems to properly incentivize this important work.
Conclusion
The MedTech industry has grown accustomed to having lots of time to adjust to regulatory changes, like EU-MDR, where regulators originally granted five years for the industry to transition and remediate and subsequently extended it again and again. But PFAS elimination will be driven by the chemical suppliers and the supply chain, not regulators. These critical materials may not be available in under two years.
With the pervasiveness of these materials in medical devices and IVDs, this is a very real threat to the industry and ultimately to the quality of healthcare throughout the world.
September 17, 2024
Author
"*" indicates required fields