Responsible use of high-risk medical devices: the example of 3D printed medical devices

3D printing illustration

KCE Reports 297 (2018)

3D printing is generating increased interest in the medical sector, namely in orthopaedics and dentistry, but there is no evidence that 3D-printed implants are as effective or safe as “classical” products. Yet they can currently be used without restrictions by doctors, even when they are “at high risk” (that is, more often than not, implantable). This is why we suggested that the placement of these implants be limited to certain specialised centres until such time that their added value – or at least their safety – has been established.

During this time, INAMI was able to provide for their reimbursement, but at the same level as that of the classical alternative which already exists.

The question of traceability is also worrying. Since the scandal involving PIP breast implants, Europe had decided to implement stricter traceability requirements, in particular with a unique identification code (UDI) for each implant. Belgium also stipulates mandatory registration of high-risk implants in a Central Implant Registry maintained by the Belgian Federal Agency for Medicines and Health Products (AFMPS) as well as an implant card for each patient.

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