📊 What's it all about?
French cardiology enters a new sustainable era!
From January 1, 2026 and for a period of 2 years, certain DMUU will be able to be reprocessed and reused, as part of a supervised experiment.
What is the purpose of this decree?
Fixed by Article 66 of the Social Security Financing Act for 2024, this decree aims to test the technical feasibility, as well as the economic and ecological impacts of this reuse. The experiment should make it possible to envisage the possible perpetuation and extension of the system. If so, it will help define a specific legal and technical framework guaranteeing the safety and effectiveness of care.
The origins of this measure
This historic breakthrough has its roots in thinking that began back in 2022, at the "Sustainability in Cardiac EP" symposium, organized by and at Liryc. Since then, more than three years of in-depth work have been carried out, under the impetus of Dr. Josselin Duchateau and with the active support of the entire cardiology community.
The issues behind the decree on the reuse of SUMDs
Reducing hospital waste, reducing the carbon footprint, optimizing the costs of interventions and securing supply chains, particularly in times of tension or shortage.
What are the conditions for experimentation?
- Applicable scope: only the SUMDs listed in the decree's appendix (including electrophysiology, mapping and cardiac ablation devices) may be reprocessed.
- Patient information: participating establishments must inform patients and collect any objections they may have to the use of reprocessed devices.
- Safety and traceability: each SUMD must pass through strict controls, be identified and traced, with a documented quality system and follow-up.
- Organization and follow-up : a steering committee and an evaluation committee are monitoring the experiment to analyze its results and decide whether to continue or discontinue it.
Establishments are invited to apply to the Minister of Health, and a call for applications, the content of which is set by decree, will be launched.
Rules for use in open and closed circuits
Healthcare facilities participating in the experiment can use single-use medical devices that have been reprocessed:
- Either in a so-called "open circuit", when the medical device has been reprocessed and "CE" recertified by the manufacturer
- Or in a so-called "closed circuit", when the medical device has been reprocessed by an external reprocessing company at the request of the healthcare facility and under a contract whose content and terms and conditions are set by order of the minister in charge of healthcare. Devices reprocessed in a closed circuit must, in all cases, be returned by the external reprocessing company to the healthcare establishment.
💡 Role of the REFeR-RYTHMO network :
The French Interventional Rhythmology Network supports academic and industrial sponsors in the development (preclinical, clinical and post-marketing) of interventional rhythmology medical devices. With 17 partner establishments, including CHU, CIC-IT and IHU, the network can:
- Accompany volunteer centers in their participation in experimentation, guaranteeing organization and traceability;
- Provide technical, scientific and clinical expertise to secure the use of reprocessed DMUU;
- Capitalize and share feedback and best practices between establishments.
This experiment is a unique opportunity to strengthen French clinical practice and expertise in interventional rhythmology.
Want to find out more?
We invite you to read the decree available on this link.