News

National Academies of Medicine, Pharmacy & Surgery support remanufacturing in France

The national academies of medicine, pharmacy, and surgery in France have taken a positive stance on the reprocessing of single-use medical devices. The tri-academy working group published a statement at the beginning of November.
14. December 2023
Frankreich, Remanufacturing, Rethink Remanufacturing

National Academies of Medicine, Pharmacy & Surgery support remanufacturing in France

The national academies of medicine, pharmacy, and surgery in France have taken a positive stance on the reprocessing of single-use medical devices. The tri-academy working group published a statement at the beginning of November.

In summary, the three academies recommend a strict, objective, and comprehensive national assessment regarding medical remanufacturing. They are in favour of examining and evaluating the possibilities offered by European legislation.

The three academies are in favour of an EU-wide study that evaluates the experiences with medical remanufacturing of various countries – those that allow reprocessing and those that do not.

Currently, France does not allow medical remanufacturing. However, the country is planning an experiment on the feasibility of remanufacturing from 2024 as part of its “Ecological planning of the healthcare system” roadmap. It wants to determine the legal framework and practices that would ensure the safety of care.

The study is available at the following link:

https://www.academie-medecine.fr/wp-content/uploads/2023/11/RETRAITT-DMUU-avis-ANM-ANP-ANC-2023.11.07.pdf

They also point out specific points for the French parliament to consider in its discussion of the draft law. This highlights the complexity of the issue.

In addition, the scientists specifically call for existing concepts to be questioned, such as, Does it even makes sense for manufacturers to qualify certain products as “single-use” at the design stage?

Source: https://www.academie-medecine.fr/

 

New Posts

Post-Market Surveillance: Why, how, what?

Post-Market Surveillance: Why, how, what?

Outlined below are reasons why PMS is relevant for all stakeholders:   1. Ensuring Patient Safety: PMS allows the early detection of previously unknown risks that only emerge during the practical use of medical devices. This early identification enables...