COCIR’s Second Report on PFAS Public Consultation: Ensuring Healthcare Continuity and Patient Safety
Addressing PFAS Restrictions in Medical Imaging and Radiotherapy
On 22 September 2023, COCIR submitted its Second Report to the public consultation on the restriction of per- and polyfluoroalkyl substances (PFAS). This report is a comprehensive follow-up to the initial submission in May 2023, providing in-depth analysis and expanded socio-economic impact assessments. The focus is on the use of PFAS in medical imaging and radiotherapy devices, highlighting critical concerns and proposing strategic recommendations to ensure healthcare continuity and patient safety.
Key Challenges and Findings
1. Essential Role of PFAS in Medical Imaging and Radiotherapy Devices
PFAS are integral to the performance and safety of medical imaging and radiotherapy equipment. They are used in:
- Electrical components and cables for insulation, flexibility, and fire resistance.
- Lubricants, elastomers, and adhesives to ensure durability, chemical resistance, and biocompatibility.
- Specialized applications such as X-ray films, ultrasound probes, and MRI components, where unique properties are required for precision imaging and patient safety.
Challenge: No Available Alternatives
Currently, no drop-in alternatives provide the same performance and safety standards required by medical devices. Substituting PFAS would necessitate:
- Extensive redesign and testing of medical devices, impacting time-to-market and increasing costs.
- Risk of inferior performance, potentially compromising patient safety and clinical outcomes.
2. Socio-Economic Impact on Healthcare and Industry
Potential Consequences Without a Derogation
COCIR’s analysis reveals severe socio-economic impacts if PFAS restrictions are implemented without a 13.5-year derogation:
- Reduced access to healthcare:
- An estimated 1 to 6 billion fewer diagnostic examinations over 15 years, affecting cancer detection and treatment.
- Delays in medical imaging and radiotherapy procedures, leading to longer waiting times and worsened patient outcomes.
- Economic impact on industry and jobs:
- Loss of approximately 100,000 jobs in the EU medical device sector.
- €10 billion annual revenue loss for EU manufacturers due to competitive disadvantage compared to non-EU competitors.
- Risk of relocation of manufacturing plants outside the EU, permanently impacting the European medical technology industry.
3. Environmental and Regulatory Considerations
Impact on Circular Economy and Waste Management
COCIR emphasizes the importance of allowing the reuse of spare parts containing PFAS to:
- Extend the lifespan of medical devices already in use, supporting circular economy principles.
- Prevent premature disposal of high-value medical equipment, reducing environmental impact.
Proposed Solution: 13.5-Year Derogation and Review Clause
To mitigate the socio-economic and environmental impact, COCIR recommends:
- A 13.5-year derogation for PFAS use in medical imaging and radiotherapy devices.
- A review clause for extending derogations if no alternatives become available or if redesign challenges persist.
Conclusion: Ensuring Continuity in Patient Care and Industry Competitiveness
COCIR is committed to phasing out PFAS wherever feasible alternatives are available, without compromising patient safety or clinical performance. This Position Paper highlights the critical need for a balanced approach to PFAS regulation that:
- Protects patient safety and healthcare access by maintaining continuity of essential medical imaging and radiotherapy services.
- Preserves EU competitiveness by avoiding premature obsolescence of medical devices and supporting the European circular economy.