Regulations in both the EU and US are rapidly changing in order to address the health and environmental risks posed by per- and poly-fluoroalkyl substances (PFAS). Through the EU REACH regulation, it has been proposed to restrict PFAS which will preclude manufacturers from placing PFAS-containing devices on the EU market 2030 onwards. Similarly, in the US the states of Maine and Minnesota have enacted restrictions and registration requirements on products known to contain PFAS.

These regulations, as well as those likely to come in the future, will cause medical device manufacturers to assess and possibly remove PFAS containing materials from their devices. In turn, new materials will be added to the devices as replacements. The expectation from regulators when this type of change occurs is to reassess the biocompatibility and toxicological risk posed of new leachable chemicals for the device with these new materials. We will discuss here the steps that can be taken to efficiently perform this type of assessment for on-the-market devices undergoing material change.

What are per- and poly-fluoroalkyl substances (PFAS)?

In order to determine if a device might need to be considered for a material change, it’s important to understand what PFAS are and how they are used in medical devices. PFAS represent a large series of related chemicals (with more than 15,000 known) with alkyl functionality, but where some (polyfluoroalkyl) or all (perfloroalkyl) hydrogen atoms are replaced with fluorine. The most common of these materials is polytetrafluoroethylene (PTFE), often referred to by the trade name Teflon. This material has a number of advantageous properties, including high thermal and chemical resistance as well as high lubricity.

Other materials common for medical devices that may contain PFAS include processing and manufacturing aids, lubricants, and coatings. A thorough examination of the bill of materials for a device may be sufficient to determine the presence or absence of these materials. However, there are laboratory methods that can be used to screen for PFAS to confirm.

Navigating Material Changes in Medical Devices

If a material change is found to be the best course of action to avoid potential regulatory problems associated with PFAS, regulators will expect a reassessment per the ISO 10993 series of recommendations. The general guidance section of ISO 10993-1:2018 states: “It is important to understand that although material changes do trigger the need for re-evaluation, the scope of that re-evaluation should be appropriate to the nature of the change and should focus on the specific materials changed, the nature and use of the medical device and the potential interactions.”  

One of the more complex aspects of such re-evaluation is the chemical characterization performed with recommendations in ISO 10993-18.  In this context the standard states “The purpose of such a comparison would be to establish whether the new or modified medical device is biologically equivalent to the existing medical device since if biological equivalence can be established then the existing medical device’s biocompatibility can be extended to the new or modified medical device.”

This type of comparison, between a current (predicate) device and a device with modified materials (proposed), can be challenging. This is especially true for more complex devices (resorbable, those containing biological materials) or permanently contacting devices. In these cases, it is common for there to be a larger overall number of extractables that may need risk assessment. For all studies attempting to support the equivalence of predicate and proposed devices, it is critical that a robust process is in place allowing efficient comparison of observed extractables.

Jordi Labs employs a process by which statistical evaluation of mass spectral data is used to accurately and quickly differentiate those compounds that are common (within the expected error of the analytical methods applied) and those that are new or changed for the new, PFAS-free, device. Focusing downstream toxicological risk assessment on these compounds allows a study sponsor to save precious time in getting the new PFAS-free device on the market ensuring patients are not exposed to PFAS or new potentially toxic chemicals from replacement materials.

RQM+ and Jordi Labs team of experts are eager to guide you through the complexities of PFAS regulations and their impact on your products. If you have already made material changes to your device, we can immediately help by providing testing to support equivalence with current devices. To find out more about how we can help with extractables and leachables, contact us today.

For more information on emerging concerns with PFAS materials you can download our white paper: Are We Equipped to Handle a PFAS-Free Future?

PFAS White paper


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