COCIR’s First Report on PFAS Public Consultation: Safeguarding Medical Imaging and Radiotherapy
Impact of PFAS Restrictions on Healthcare and Industry
On 2 June 2023, COCIR submitted its First Report to the public consultation on PFAS restrictions, highlighting the critical impact the proposed regulation could have on the medical imaging and radiotherapy sectors. This Position Paper emphasizes the need for a derogation of at least 13.5 years to ensure healthcare continuity, patient safety, and the competitiveness of EU manufacturers.
COCIR’s analysis shows that approximately 10 tonnes of PFAS are used annually in medical imaging and radiotherapy devices across Europe, almost entirely as fluoropolymers. This represents 0.0012% of the total PFAS usage in the EU and 0.02% of the medical devices sector’s total usage. Despite its minimal share, PFAS are essential for the safety and performance of medical devices, necessitating strategic regulatory consideration.
1. Essential Role of PFAS in Medical Imaging and Radiotherapy
Why PFAS Are Irreplaceable in Medical Devices
PFAS are used in critical components of medical imaging and radiotherapy devices due to their unique properties, including:
- High thermal stability – Essential for components exposed to extreme temperatures, such as MRI superconducting magnets.
- Chemical resistance and biocompatibility – Required for parts in contact with patients or sterilized frequently.
- Electrical insulation and flexibility – Crucial for cables and connectors in X-ray, CT, MRI, and radiotherapy equipment.
Challenge: Lack of Viable Alternatives
COCIR’s report underscores that no drop-in alternatives are currently available to replace PFAS without compromising:
- Patient safety – Due to inferior biocompatibility and electrical insulation in alternative materials.
- Device performance – Risk of reduced image quality, safety hazards, and clinical efficacy.
- Product lifecycle and sustainability – Increased waste due to lower durability of alternatives.
2. Socio-Economic Impact of PFAS Restrictions
Potential Consequences Without a Derogation
If PFAS restrictions are implemented without a 13.5-year derogation, COCIR projects significant socio-economic impacts, including:
- Healthcare Disruption:
- Critical medical devices such as MRI, CT, and radiotherapy equipment would face severe shortages.
- Reduced access to diagnostic and therapeutic procedures, particularly affecting cancer patients.
- Economic Impact on Industry and Jobs:
- €10 billion annual revenue loss for EU medical device manufacturers due to interrupted supply chains and production halts.
- Job losses and relocation of manufacturing outside the EU, impacting the European medical technology ecosystem.
- Negative impact on innovation as R&D resources are diverted to redesigning existing products for PFAS compliance.
Impact on Circular Economy and Refurbishment
- Disruption of refurbishment practices – Current regulations enable the reuse of spare parts containing PFAS, supporting a circular economy. Without a derogation, refurbishing medical devices would become impossible, leading to:
- Premature disposal of high-value medical devices.
- Increased environmental impact due to the need for new raw materials.
3. COCIR’s Strategic Recommendations
Call for a 13.5-Year Derogation and Review Clause
COCIR strongly recommends a 13.5-year derogation for PFAS use in medical imaging and radiotherapy devices to:
- Ensure continuity of healthcare services and patient safety.
- Allow sufficient time for research and development of safe and viable alternatives.
- Maintain EU competitiveness in the global medical technology industry.
Review Clause for Future Adaptation
COCIR also advocates for a review clause that:
- Evaluates the need for continued derogations for specific applications if no alternatives become available.
- Enables regulatory flexibility to adapt to technological advancements and new scientific evidence.
Balancing Healthcare Needs and Environmental Goals
COCIR’s Position Paper emphasizes the importance of a balanced regulatory approach to PFAS restrictions, ensuring that:
- Healthcare continuity and patient safety are preserved by maintaining the availability of essential medical imaging and radiotherapy devices.
- Innovation and competitiveness of the European medical technology industry are protected.
- Environmental sustainability goals are met without compromising critical healthcare services.