Medical Devices and PFAS: Navigating Regulatory Compliance

PFAS Regulations

Per- and poly-fluoroalkyl substances (PFAS) are a group of fluorinated compounds characterized by carbon-fluorine bonds. While some PFAS are no longer made in the United States, they are still made in other countries, and several other new-generation PFAS compounds are continuing to be developed. PFAS are widely used in many different industries including cookware, food packaging, and medical devices. PFAS are stable chemicals and can be helpful in making products that resist water, oil, and heat. Many consumer products including cooking pans, water-repellent fabrics, fast food containers, microwavable products, furniture upholstery, carpets, shampoos, cosmetics, etc. contain PFAS.

Many medical devices, including implanted devices, orthopedic components, surgical devices, contact lenses, surgical gloves, catheters, tubing, and blood bags are made of PFAS. For example, a commonly used PFAS in medical devices is Polytetrafluoroethylene (PTFE). PTFE coverings/coatings on stents and catheters prevent wear and corrosion while improving flexibility and durability because of their unique properties. PTFE coverings/coatings make implants and orthopedic components more biocompatible and reduce microbial contamination, inflammation, and tissue damage.

At present, medical device manufacturers and innovators are moving away from PFAS due to growing concerns that PFAS does not break down easily and may be linked to various illnesses. Further, PFAS accumulates in soil, water, and marine organisms, which is why they are sometimes referred to as “forever chemicals”. Increasing regulatory pressure and consumer demand for alternatives are also driving the need for PFAS-free options. While there is strong opposition by some against PFAS usage in medical devices, it is crucial to recognize that PFAS still continues to play a significant role in the effectiveness and durability of existing medical devices.

According to the US EPA Computational Toxicology Dashboard, nearly 15,000 synthetic chemicals belong to the group of PFAS. Many of the PFAS compounds do not have essential toxicology data. The lack of toxicology information poses a significant challenge, as it distorts our current understanding of the health risks associated with the widespread usage of PFAS. The absence of comprehensive dose-response data for even critical PFAS (priority list from EPA and other international communities) complicates the efforts to establish safety standards and regulations, assess cumulative health effects, and protect vulnerable populations. This has also been reflected by the disparities in toxicity reference values among various regulatory agencies and the recent quick shift in concern levels.

This year alone, many PFAS regulations have been proposed globally. In the US, the EPA announced the proposed National Primary Drinking Water Regulation (NPDWR) for six PFAS chemicals including perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorononanoic acid (PFNA), hexafluoropropylene oxide dimer acid (HFPO-DA, alias GenX), perfluorohexane sulfonic acid (PFHxS), and perfluorobutane sulfonic acid (PFBS). In the European Union, the Environmental Chemical Agency made a proposal to ban the manufacturing and use of more than 10,000 PFAS. Germany and Sweden submitted a restriction proposal for a group of perfluorinated carboxylic acids in addition to several PFAS which were already restricted under Registration, Evaluation, Authorization and Restriction of Chemicals’ Regulation.

Manufacturers are desperate to find environmentally safer alternatives because of the increasing regulation and growing public anxiety. Fast-paced innovation can potentially create a situation where regulatory agencies are unable to keep up with new technologies and products, potentially resulting in a regulatory lag or lack of adequate oversight. Striking a balance between innovation and consideration for safety assessment is crucial for innovators, manufacturers, and regulators, as well as those who do risk assessment to address these challenges. It is all the more important that the new alternatives should be protective of both human health and the environment.

Traditional toxicology assessments involve systematic evaluations of chemical substances, including dose-response studies, acute and chronic toxicity testing, and investigations into carcinogenicity, genotoxicity, reproductive, developmental, and neurotoxic effects, and their potential harm. In the absence of chemical-specific toxicology data for PFAS, New Alternative Methods (NAMs), Read Across Approaches and other predictive toxicology methods may offer innovative and alternative assessment of chemical safety. The reliability of predictive toxicology methods may need to be evaluated by an expert in the field to ensure an accurate assessment.

It is critical to involve a toxicologist early in the medical device development and biological safety risk assessment processes in order to analyze and manage any hazards or risks associated with materials or compounds that are being considered for use in the manufacture of the device. To determine if the newly developed PFAS alternatives are safe, a thorough understanding of their physical-chemical properties, intended clinical use, and patient contact is required, as well as the expert opinion of a toxicologist. This proactive strategy ensures that any toxicity concerns are addressed as soon as possible, improving patient safety and regulatory compliance. To learn more about how PFAS regulation may impact your medical device development plan and biocompatibility evaluation please contact us today 855.463.1633 | askmed@medinstitute.com | medinstitute.com.