It’s Time for MedTech to Recognize PFAS Urgency

By Cally Edgren
August 2, 2023


• Categories: 02-MedTech Economics, 04-Product Design & Development, 05-Quality/Regulatory, Market Access, Medical Devices, Patient Safety, RC - Device Design & Manufacturing

Over the past 85 years, perfluoroalkyl and polyfluoroalkyl substances (PFAS) have worked their way into numerous applications across countless industries. The MedTech industry is no exception. From dental floss to inhalers, ventilators, artificial heart pumps, pacemakers, contact lenses, surgical drapes and gowns, and countless other items, the family of PFAS chemicals is vital to many production processes.[1]

The use of PFAS in many medical technologies are “essential uses” because they’re tied to critical medical equipment and human health. In these cases, there are exceptions to the regulatory bans unless non-PFAS alternatives are available. For example, perfluorooctanoic acid (PFOA) is listed in the Stockholm Convention on Persistent Organic Pollutants with an exemption for “invasive and implantable medical devices.”[2] 

However, from an environmental pollution and potential clean-up liability standpoint, MedTech may have a target on its back. According to the Regulatory Management Options Analysis (RMOA) report from the UK, “medical devices and medicinal products” generate some of the highest emissions of PFAS.[3]

While the sale of products containing PFAS may be allowed for specific essential use applications, manufacturers may still face challenges related to environmental contamination caused by the manufacture of their products. In addition, even if regulations continue to support exemptions, private-party lawsuits may drive insurers to pressure manufacturers to discontinue the use of PFAS to avoid these costly liabilities. Therefore, PFAS risks should be a concern for medical device manufacturers.

Planning for Supply Chain Impacts of PFAS Regulation

Since PFAS are essential to MedTech equipment and manufacturing processes, one might think manufacturers would quickly adopt solutions to protect their supply chains in light of increasing regulations. However, this has yet to be the case.

The industry may be slow to adopt PFAS replacements because it’s become too comfortable with what it views as assumed essential use exemptions (now and in the future) for its products. Many companies view medical devices (when regulated by FDA requirements) as “out of scope” of the U.S. Toxic Substances Control Act (TSCA), overlooking the impact of rapidly emerging state and other U.S. federal PFAS regulations outside of TSCA. They also may overlook other risks of relying on PFAS, such as supply chain discontinuation and future litigation around potential environmental contamination.

Companies may be confusing regulations that restrict the use of these substances (e.g., the Stockholm Convention, EU POPs Regulation) with those that require reporting (e.g., obligations in the state of Maine). For example, even if Maine ultimately allows the continued use of PFAS in medical devices as a “currently unavoidable use,” they will still require reporting of those products into the state database, which means the manufacturers will still need to work to understand specific PFAS uses. From the restriction side, they will need to advocate with regulators for¹ those exemptions and ultimately design out the PFAS for any not exempted applications, potentially impacting their product certifications.

And, of course, we must remember, all the other nonregulatory drivers that continue to impact all industries. 3M’s announcement that they will discontinue PFAS manufacturing will generate significant supply chain challenges. The medical industry uses many of the materials that 3M is discontinuing—both for patient care, such as wound closure systems or medical tape and liners, and for materials used in the assembly of medical equipment, such as seals, lubricants, filters, gaskets, O-rings, membranes and hoses.[4]

Many materials are required for manufacturing facilities and machine maintenance. Specialized gaskets and O-rings required for manufacturing equipment may no longer be available after 2025. And, of course, any medical device with electronic functions will includes PFAS due to their prevalence in so many electrical applications.

Even if the medical industry thinks other drivers like the regulations, lawsuits or investor pressure are unlikely to impact them, those drivers are impacting chemical manufacturers like 3M, which will eventually drive more chemical companies to start discontinuing the manufacture of PFAS, so supply chain shortages will continue to grow. The bottom line: essential use exemptions will be irrelevant if companies can’t get PFAS to continue manufacturing their products.

To identify and build a defense against the rapidly growing risks posed by PFAS use, manufacturers first need to identify where they are using these chemicals in both products and manufacturing processes. Proactively identifying these applications and intervening early to prevent their impact on the company’s supply chain is the only way to ensure continued business operations and global market access in the future.

 

References:

[1] Chemsec.(n.d.). Chemsec PFAS Guide. https://pfas.chemsec.org/?sector=Medical+devices

[2] Stockholm Convention. (n.d.). ll POPs listed in the Stockholm Convention.

https://chm.pops.int/TheConvention/ThePOPs/AllPOPs/tabid/2509/Default.aspx

[3] Health and Safety Executive. (2023, March). Analysis of the most appropriate regulatory management options

(RMOA). https://www.hse.gov.uk/reach/assets/docs/pfas-rmoa.pdf 

[4] 3M. (n.d.). PFAS & Their Uses. https://pfas.3m.com/pfas_uses