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

Vinck I, Vijverman A, Vollebregt E, Broeckx N, Wouters K, Piët M, Bacic N, Vlayen J, Thiry N, Neyt M
Record ID 32018000228
English
Original Title: Verantwoord gebruik van hoog-risico medische hulpmiddelen: het voorbeeld van 3D geprinte medische hulpmiddelen | Utilisation responsable des dispositifs médicaux à haut risque : l’exemple de l’impression 3D
Authors' results and conclusions: 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.
Details
Project Status: Completed
Year Published: 2018
URL for published report: https://doi.org/10.57598/R297C
URL for additional information: https://kce.fgov.be/en/responsible-use-of-high-risk-medical-devices-the-example-of-3d-printed-medical-devices
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Belgium
DOI: 10.57598/R297C
MeSH Terms
  • Printing, Three-Dimensional
  • Device Approval
  • Equipment and Supplies
  • European Union
  • Government Regulation
  • Belgium
Keywords
  • Printing Three dimensional
  • Device Approval
  • Equipment and Supplies
  • European Union
  • Government regulation
Contact
Organisation Name: Belgian Health Care Knowledge Centre
Contact Address: Administrative Centre Botanique, Doorbuilding (10th floor), Boulevard du Jardin Botanique 55, B-1000 Brussels, Belgium tel: +32 2 287 33 88 fax: +32 2 287 33 85
Contact Name: info@kce.fgov.be
Contact Email: info@kce.fgov.be
Copyright: Belgian Health Care Knowledge Centre (KCE)
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