PFAS or per- and polyfluoroalkyl substances have wreaked havoc in ways other synthetic chemicals haven’t. Manufactured in the 1950s, these chemicals were widely used in all processes that required grease, water, or oil resistance.
If PFAS are as dangerous as we claim, why did their risks go undetected for so long? Though manufactured in the mid-20th century, PFAS testing was unavailable until the early 2000s. Since their dangers are now known, proposals have been made for a total ban.
This will impact numerous industrial sectors since most use PFAS directly or indirectly. Will the medical device manufacturing sector be affected? Yes, and this article will discuss how to achieve regulatory compliance along with strategies.
Overview of PFAS Regulations
The European Union (EU) and the Environmental Protection Agency (EPA) are proposing to ban over 10,000 PFAS starting in early 2026. There is good reason for such a proposal, given how detrimental PFAS are for the environment and the human body.
These chemicals were primarily exposed due to their direct use in aqueous film-forming foam (AFFF). Also known as Class B firefighting foam, it is used to tackle fires caused by liquid fuels. Since firefighters and military service members were regularly exposed to these chemicals, they suffered severe health issues like cancer.
Thus, they filed the AFFF lawsuit against some of the big names in PFAS manufacturing, including 3M and DuPont. To streamline the legal process, the court consolidated all cases into a multi-district litigation (MDL).
According to TruLaw, plaintiffs have claimed that despite being aware of the risks, they failed to adequately warn them of the same. Now, the problem is that PFAS can cause harm even in their indirect forms. They can lead to liver disease, hormonal imbalances, infertility issues, and more.
Also, being ubiquitous in nature, they are used across industrial verticals, including medical device manufacturing. The health repercussions made it imperative to ban PFAS, but that would be costly in terms of regulatory compliance. Companies across industrial sectors need to adjust to the comprehensive frameworks established for chemical management.
Three Main Areas of PFAS Impact on Medical Device Manufacturers
As per the MED Institute, PFAS are used to manufacture a wide variety of medical devices. These may include implantable devices, surgical gloves, contact lenses, blood bags, and even orthopedic components.
Since worldwide regulations are expected to change soon, medical device manufacturers will need to navigate a complex array of stricter standards. The impact will extend to various areas, three of which will be notable.
Financial Impact
The first area where medical device manufacturers will face challenges is their finances. Adhering to PFAS regulatory requirements will call for considerable investments in material substitution, testing/certification, process reengineering, and international market access costs.
Manufacturers may have to upgrade their existing equipment, change quality control processes, and conduct ongoing tests to maintain compliance. PFAS-free substitutes may be available, but they won’t be cheap.
Operational Impact
Medical device manufacturers are currently accustomed to certain operational processes, all of which may require significant adjustments. For instance, they will need to scrutinize every step of the supply chain to ensure all vendors meet PFAS standards.
Procurement costs will change, and existing chains may be disrupted. Production processes may require complete reengineering to eliminate PFAS. The transition can be challenging and may lead to inefficiencies and production delays.
Also, medical device manufacturers will have to maintain detailed records of each operational change they make. Enhanced reporting may shoot up administrative costs.
Market Dynamics
In addition to the internal changes medical device manufacturers must implement, PFAS regulations will impact market dynamics. Companies that adjust speedily to the new regulations will gain a competitive advantage over those that don’t.
A novel era of innovation may usher in as manufacturers strive to develop new technologies and materials for full compliance. Since consumer consciousness is also increasing, healthcare institutions and independent clinics may favor manufacturers with better PFAS compliance.
Key Strategies to Achieve Regulatory Compliance
Since January 2024, the Environmental Protection Agency (EPA) has barred the production and processing of nearly 329 PFAS compounds. If the same are used in any medical device, it’s time for manufacturers to adopt strategies for compliance. Listed below are three ways to achieve this sooner than later.
Comprehensive Risk Assessment and Management
No matter what steps a medical device manufacturer may have in mind, they cannot escape a thorough risk assessment. This process should involve a total scrutiny of potential PFAS sources and the risks associated with them. Once this happens, it is possible to manage the sources. A comprehensive risk assessment would involve –
- Reviewing all raw materials as well as finished products for PFAS content. This would require advanced analytical techniques like spectrometry
- Evaluation of manufacturing processes to understand where PFAS may be introduced. Manufacturers must examine all coatings, chemicals used, and additives
- Supply chain analysis through vendor audits and certifications. This will help identify and mitigate PFAS risks
Material Substitution
After a medical device manufacturer has conducted a thorough risk assessment, it’s time to use PFAS alternatives wherever possible. Investments must be made in research & development to look for relevant PFAS substitutes.
In-depth industrial case studies must also be referred to. They will help medical device manufacturers understand where successful PFAS substitutions have been made.
The selected materials must undergo rigorous testing and validation to ensure they’re at par in terms of durability and efficacy. The alternatives must also be safe enough to meet all regulatory standards.
Process Optimization
Simply substituting PFAS with good alternatives is just one-half of the equation. The other half involves optimizing the manufacturing process to prevent the chemicals from being introduced midway.
This may require investing in manufacturing technologies that do not rely on PFAS. Companies may have to install real-time monitoring systems so that compliance is maintained throughout the production cycle.
A solid audit and feedback mechanism must be established to gather and analyze data on PFAS management. New findings can be used to drive ongoing process improvements for enhanced compliance.
As of 2023, around 1,006 medical device manufacturing companies were operating across the US. That’s a 2.9% increase from the year prior. Likely, the numbers will further rise this year. New players will gauge the market and strive to comply with the latest regulatory requirements.
Even existing businesses need to make the necessary changes at the earliest. The market landscape is rapidly shifting, and companies that go PFAS-free will be the only ones that will remain relevant.
To read more content like this, explore The Brand Hopper
Subscribe to our newsletter
Go to the full page to view and submit the form.