Live! #75 – Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers

Device Advice by RQM+

This show was recorded 18 January 2024. Download the slides from this presentation (including bonus slides not presented) by submitting the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com.

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Brief

With the forthcoming restrictions on Per- and Polyfluoroalkyl Substances (PFAS), medical device manufacturers are on the brink of a significant industry shift. PFAS, known for their versatile properties, have been integral in the production of various medical devices. However, with the phase-out of these substances by the end of 2025, manufacturers must navigate the transition with precision and strategic foresight.

This session will begin with a short presentation to set the stage, and will be followed by a panel discussion bringing together RQM+'s leading experts in regulatory affairs, quality assurance, and lab services, to delineate a proactive approach for manufacturers.

We will dissect the three-step process required to phase out PFAS used in medical devices, addressing the identification of alternative materials, the intricacies of materials testing and verification, and the critical steps for successful documentation submission to regulatory bodies.

Topics with timestamps

00:00:00 - Introduction and Agenda Setting
00:02:12 - Introduction of Panelists
00:04:51 - Impact of 3M Exiting the Business
00:07:42 - Understanding the Supply Chain and Material Changes
00:10:32 - Concerns with Finding Alternative Materials
00:13:28 - Preliminary Testing for Material Replacements
00:16:07 - Limitations in Impact Assessment and Supplier Engagement
00:18:39 - Environmental Concerns and Supply Continuity
00:21:28 - Regulatory Impact
00:24:23 - Identifying and Restricting PFAS
00:27:26 - Implications of Material Changes in Medical Devices
00:30:11 - Considerations for Material Changes under EU Regulations
00:32:51 - Data on Dose Response for Safety Standards
00:35:21 - The Challenges of Chemical Characterization
00:38:08 - Considering Potential Material Changes in FDA Submissions
00:41:00 - Potential Impact on Performance Specifications
00:43:45 - Evaluating Biological Safety Risks
00:46:34 - Minimizing Testing Burden and Overwhelming Notified Bodies
00:49:06 - The Importance of Clinical Evaluations
00:51:45 - Impact on Clinical Evaluation and Biological Safety
00:54:27 - Sensitivity and Analytical Instrumentation
00:57:18 - Chemical Characterization and Contamination
01:00:04 - The Importance of CEM characterization and supplier controls
01:02:46 - The Importance of FDA Buy-in
01:05:48 - Explaining the Thinking Behind the Process
01:08:38 - Risks in Material Manufacturing
01:11:31 - The Benefits and Challenges of Targeted Analysis
01:14:12 - Material Change and Analytical Terms
01:17:07 - Detailed Risk Assessment and Impact Assessment
01:20:16 - Ensuring the Availability of Critical Products
01:22:21 - Conclusion

Panelists

• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation
• Kevin Rowland – Director of R&D
• Taryn Meade – Director of Biological Evaluation Consulting
• James Wrenn – Director of Solutions Delivery
• Alexia Haralambous – Senior Principal (former FDA)

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