An International Consortium of Journalists reveals the flaws in the medical device surveillance through the Implant Files. The New European regulation to reinforce this surveillance will only be applied gradually by 2020.
More than 250 journalists from 59 different media invested medical devices, from pacemakers to harden prostheses to insulin pumps and breast scarcity. Their research shows this Fails in matiovigilance Incomplete traceability, surveillance defects … The medical devices, some of which are Implanted for life in the human body, Are less well-controlled than drugs. In recent years scandals have broken out (breast implants PIP, contraceptive implant issure …).
1- medical device: a wide range
When we talk about medical devices, it is actually a completely heterogeneous family of products. Hearing aids are included, but also tensiometers, dressings and all implants (articular prathes, pacemakers, neurostimulators, insulin pumps, cardiac stents, gastric rings …).
2 – CE marking is essential
To be placed on the European market, the medical devices must get CE marking. For this, their file must comply with the safety standards imposed by the European Union. A check is supposed to be carried out by a notified body.
3- The patient must know what is implanted
The Surgeon that implants a device in a patient is required to indicate the name of the product and the package and serial numbers in its medical file. But the files are not always correctly filled.
4 – Monitoring Exists
In France, the National Agency for the Safety of Medicines and Health Products (Ansm) carries out inspections in medical device manufacturers. For products in risk, clinical studies must be carried out before they are put on the market. There are also material-related surveys based on reports of adverse effects. High health authority also evaluates the medical devices for possible reimbursement through Social Security. European and American health authorities have currently in their sights the strips implanted in women suffering from prolapse (organ descent). Different investigations are in progress. In France, preliminary results estimate the rate of severe complications at 3.8%. The ANSM invites all concerns to report on: www.signalement-sante.gouv.fr.
5 – A new European regulation in 2020
The European regulation on medical devices will be increased by 2020, but its implementation will extend until 2027. Clinical students will become mandatory for all implantable devices. All manufacturers will be responsible for ensuring compliance with the regulations. Message bodies respond to a new description and will be better regulated. A European database listing all studies and incidents will be available.