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The Implant Files, whose investigation in Belgium is led by "Le Soir", highlight the malfunctions of the Evaluation Commission for medical devices.
TheThe first part of our major survey on the safety of medical devices that tens of thousands of Belgians are implanted each year revealed that nearly 4,000 incidents had been reported since 2013 to the Federal Agency for Medicines and Health Products. A figure that the Agency itself estimates represents only one-fifth of the problems that actually occur.
When an incident is found on an implant, the Medical Devices Evaluation Board must meet and provide an opinion to the Minister of Health. Several audits have however stressed that we are far from the account. This commission has 23 members and must bring together at least ten members to deliberate validly. However, since the beginning of 2017, there are on average only 3.3 members present at the meetings. The speed of badysis of the incidents during these calls also: on March 9, 2017, for example, 116 files were examined in one hour, one every 30 seconds …
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Our complete investigation into the failures of the Evaluation Commission is to be read on Le Soir +
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