Setting Up a Digital Chain for Surgical Guides in a Hospital
Thomas Pajot · Ludovic Benichou · Roman H. Khonsari · Serge Ketoff
J Stomatol Oral Maxillofac Surg · 2020 · 121(4):347-351
How can a hospital design and manufacture its own implant surgical guides in full regulatory compliance? Dr Serge Ketoff, senior author, describes the concrete implementation of an in-house digital chain.
In brief
- 3D printing allows custom surgical guides to be made directly in the hospital.
- The European regulatory framework (EU 2017/745) is met without CE marking, under manufacturer status.
- Every step, from patient to guide, is adapted to hospital constraints.
Background
The digital revolution has transformed implantology: assisted planning and custom surgical guides are now routine. The challenge is to produce these devices in-house within a large urban hospital while complying with European regulations on medical devices manufactured within a healthcare institution.
Controlled regulatory compliance
EU Regulation 2017/745 allows a healthcare institution to locally manufacture custom-made devices without CE marking, provided it registers as a manufacturer and meets safety and performance requirements. The article details how each link of the chain — patient pathway and guide manufacturing — was aligned with these requirements.
Relevance for the profession
This work serves as a reproducible model for departments wishing to internalise guide manufacturing: governance, traceability and collaboration between clinicians, engineers and hospital pharmacists.
Key points
- Custom guide manufacturing in-house, without CE marking.
- EU 2017/745 compliance under declared manufacturer status.
- Complete digital chain, from patient to sterile guide.
- Reproducible model for other institutions.
Reference : Pajot T, Benichou L, Moreau E, Tallon V, Meningaud JP, Khonsari RH, Ketoff S. Implementation of a digital chain for the design and manufacture of implant-based surgical guides in a hospital setting. J Stomatol Oral Maxillofac Surg. 2020;121(4):347-351.
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