'Tangled web' of PFAS landscape poses challenges for medical device industry

The medical device industry faces unique challenges as PFAS begins to face regulation in the U.S. and Europe despite exceptions for medical products in most phase-out requirements.

So far, regulation of the chemical class has been a "tangled web" due to the nature of the definition of PFAS, said Shalene Thomas, senior emerging contaminants program manager at nonprofit R&D organization Battelle.

"The technical and regulatory definitions of PFAS tend to vary," Thomas said. "There's great debate about what's included in the family of chemicals. There's no universally accepted definition … (and it) varies substantially, based on the country you're in, based on the regulatory requirement that you're trying to comply with, or the customer demand. That's where the confusion starts."

Hundreds of thousands of different chemicals can be categorized as PFAS, now including fluoropolymers, which "really didn't come into debate or become a concern until recently," she said. In the last few years, the class has "been picked up from a regulatory, legislative and litigative perspective."

"Now that polymers … have been pulled into the discussion from a regulatory perspective, (which) make up about 50 percent of use in the medical device industry … it's requiring more and more reporting, more and more regulatory application," Thomas said.

That was not the case four to five years ago, she said, adding that, in 2011, just 200 chemicals were classified as PFAS. Now, more than 900,000 chemicals are potentially considered under the classification.

While regulation of the chemical class is slow moving at the federal level, Thomas said, more than a dozen states now have regulations or requirements related to the phase-out of products that contain PFAS. Maine and Minnesota, for example, are now phasing out PFAS from all products except in the medical market, which must report the use of PFAS in its products.

Known for chemical and heat resistance, durability, lubricity and biocompatibility, PFAS are used in medical devices like diagnostic laboratory testing equipment, implants, packaging, electronics and metered-dose inhalers. Medical products aren't included in state regulated phaseouts because of their essentiality, but the market will still be affected by them.

"From a medical device perspective, the concern should not be primarily about regulatory requirements," Thomas said. "It's more about the concern for obsolescence."

If the chemicals used to make the materials in medical devices are phased out of manufacturing due to decreased demand, there could be stalls in supply chains or a lack of alternative chemicals or appropriate substitutions, she said.

Suppliers should consider regulatory requirements and the PFAS definition within that context with its customers to work ahead on solutions to avoid disruptions or operational concerns, Thomas added. If suppliers haven't already, then their customers will soon begin asking for products that are PFAS-free, and companies need to have benchmarks in place to meet "different regulatory definitions as well as the different industry standards."

"Key manufacturers are ceasing PFAS manufacturing in the U.S.," she said. "3M announced just over a year or so ago that they are exiting the fluoroal chemistry business by the end of 2025. Regulations are tightening also for the domestic and imported supply."

Substitutions need to be identified to assess the demand and for them as "every industry is trying to do the same requalification process," Thomas said. They will also need to be tested for effectiveness, risk to human health and environmental aspects, like waste management for the end product.

"(End product) users (are) potentially patients," she added, and there could be litigious implications for an inappropriate replacement chemical in those use cases. "As it relates to PFAS, we're seeing a lot of litigation in that space."

Added PFAS vs. unintentional byproducts are also a consideration for the medical device market, she said. "Because of the ubiquity of PFAS, even when one transitions to a PFAS-free process or PFAS-free product, if it was in a facility that had PFAS previously, it's difficult to get rid of. You can have cross contamination."

Suppliers should be looking at the chemicals documented in their formulations and safety data sheets and determining if the specific PFAS are persistent, bioaccumulative, toxic and mobile, and what their impacts are across the product life cycle.

"Not all (PFAS) are equally toxic, cumulative and persistent," Thomas said. "PFAS are often considered as one group or class and treated, from a risk perspective, similarly.

"There is definite data on a handful of PFAS, chemicals that sit in the nonpolymer class … that there's enough toxicity information around, in that small subgroup, to make informed decisions," she said. "Some precursor compounds, polyfluorinated nonpolymers or polymers can break down into terminal products such as PFOS and PFOA. These are the biggest concern from a human health perspective."

"PFAS in medical devices, almost 40 percent are PTFE (polytetrafluoroethylene), which are these polymers (that have been referred to as) low concern … in some studies because they have high molecular weights and are extremely stable," Thomas said. "If you include the full definition, that's the biggest area of use, and to me, that's quite a low risk from an exposure perspective. One of the other areas, which I think is in around 27 to almost 30 percent of med devices, is the fluorine gases. Fluorine gas is that next step of concern. There's a lot more that needs to be learned around (them)."

Treating every PFAS chemical equally is an "extreme" way to regulate them, she said.

"But if regulations are based "on a chemical-by-chemical basis, it becomes substantially challenging. We don't have enough resources or time to do it that way. … The middle ground is trying to be make more informed decisions based on maybe structural definition or functional definition, so that you can put groups of chemicals into a bucket and identify them collectively as persistent, bioaccumulative or toxic."

Existing regulations don't have "a risk-based process in terms of evaluating these chemicals specifically," Thomas said, and cast "a broad net."

"The broad definition and the manner in which a lot of the states are pushing out these product regulations, they're using a totals approach," she said. "In the product space, a lot of the analytical testing is around total organic fluorine, so it's not specifically looking at the bad actors … but rather all fluorine compounds."

But regulators may not have the bandwidth to look at each chemically individually, Thomas said. "They all had regular, full-time day jobs before PFAS came about. And there are many, many contaminants out there that we have to manage, monitor (and) clean up, and they simply don't have the resources to support what they need to get done. … Depending on the state, there are challenges in how (the regulatory bodies) are structured, as to what authority they have and how they can operate and implement new criteria to support evaluation of PFAS.

"In some in some states, (regulators) have to go through this very long, drawn-out process that's anywhere from three to five to eight years to create regulations," she said. "Organizations are overwhelmed because PFAS is so ubiquitously used. It's really difficult trying to find where to start.

"I think initially with PFAS, a precautionary principle was used quite substantially, and the whole risk message got lost," Thomas said. "So just because we have a hazard does not mean we have risk. You need to have exposure to complete that equation. You have to have both hazard and exposure before you have risk. The precautionary principle just assumes every hazard is also a risk."

This "precautionary principle," she said, "in theory, is a good thing to practice when in doubt, … but it can't be at the cost of business where it's not going to have (a positive) environmental impact."

"I don't see that (blanket evaluation of PFAS) is going to go away in the near term," she said, "because (regulators) are trying to do the right thing and they don't really have another or better way to do it right now.

"I do think we will see a sort of transition point where (evaluations) will be more risk-based. … I think you're already seeing a shift," Thomas said, in some regulations in Europe prioritizing PFAS known to be toxic and changing timelines around chemicals of lower concern.

"There are a lot of industry associations and a lot of great efforts going on across industries right now to try and push a risk-based approach and framework," she added. "I'm hopeful that those things will gain momentum and gain support of the regulators."