Today, there are no standards, no references regarding the reliability of electronic components used in medical devices
In recent years, medical devices have evolved rapidly, and electronics are more and more present.
Until then, component reliability had few impact, but more and more frequently, an electronics failure has immediate consequences on the patient, from the emergency operation to the death in worst case scenario. In addition, the estimation and demonstration of reliability is essential to authorize the device to be used.
Unlike other applications such as aeronautics, space, nuclear where reliability is already mandatory, medical devices (especially implantable) are limited in terms of redundancy and the reliability of the system depends directly on the reliability of the electronic components.
However, to date, there are no standards, no references regarding the reliability of electronic components used in medical devices.
RECOME AND OUR PARTNERS
Tame-Component and the medical branch of TRONICO group, together with the LARIS and OUEST VALORISATION laboratory, have the ambitious project to create a standardized medical grade for electronic components named RECOME.
This project, which goes beyond our borders, is already supported by the Pays de la Loire, BPI France, France Relance as well as reknown actors of implantable medical devices: CARMAT, UROMEMS, FINE HEART and electronics: VISHAY, Exxelia, NCAB et TechCI
RECOME is a project aiming to fiabilize medical electronics, more particularly for the conception and fabrication of critical medical devices (classes II, III and implantable)
Through RECOME, our objectives are
• To define a standard to qualify electronic components and validate their use in medical applications.
• Harmonizing the requirements of the medical sector, this standard will be the pillar on which all medical device manufacturers, equipment manufacturers, electronic subcontractors and component manufacturers will rely on.
• To create a database of qualified components which would be for the manufacturers of medical devices, an economic gain, logistic as well as an accelerated conception by guiding them in their technological choices
THE DIFFERENT STEPS
The purpose of the RECOME project is to create an environment to demonstrate the reliability of components for medical use:
– Optimization of reliability models, taking into account the stresses related to bio-compatibility
– Validation of reliability models
– Redaction of an experimental standard
– Creation of a database of qualified components
– Distribution of qualified components
It is planned to carry out this work on 10 major families of components, each represented by 5 references of components, in order to be representative of the manufacturers present on the market.
Tame-Component and its partners intend to provide the answer to increase the reliability of current and future medical devices so that new medical technologies can keep all their promises while minimizing the risks for users.