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Traceability in the Dental Office: A Regulatory and Clinical Imperative

A Strict Regulatory Framework

Traceability in a dental practice is not merely a best practice; it is a regulatory requirement, particularly for invasive procedures such as implant placement. In France, several legal texts frame this obligation:

The French Public Health Code (CSP, articles R.1112-2 and following) mandates maintaining a patient’s medical file, including the procedures performed, implanted medical devices, and any incidents.

The European Regulation (EU) 2017/745 on medical devices (MDR) introduces the concept of a Unique Device Identification (UDI) system, allowing tracking of a medical device from manufacture to use.

The HAS (French National Authority for Health) highlights, in its recommendations on infection risk management, that traceability is an integral part of healthcare safety.

Why is Traceability Crucial in Implantology?

Implantology exposes patients to a high risk of infection due to the invasive nature of the procedures. Traceability allows:

Quick identification of the origin of an incident (implant failure, infection, product recall...),

Ensuring upward and downward traceability (from the patient to the device and vice versa),

Meeting medico-legal requirements in case of disputes,

Proving the sterility of devices used.

It also serves as a cornerstone of infection risk management, ensuring that only compliant and properly sterilized devices are used.

What Must Be Traced in the Practice?

Traceability applies at different levels:

1. Implantable Medical Devices (IMDs)

Each implant, cover screw, prosthetic abutment, or membrane must be individually traced. The device label (containing the UDI) must be affixed to the patient’s file.

2. Sterilized Reusable Equipment

It is necessary to document:

The sterilization date and cycle,

The identity of the person validating the sterilization,

The integrity of the packaging before use.

3. Single-Use Sterile Consumables

Although non-implantable, recording their lot number strengthens safety, especially in case of product recalls.

4. Incidents and Non-Conformities

Any adverse event (autoclave failure, sterilization error, breach of sterility...) must be documented and analyzed.

How to Implement Effective Traceability?

1. Systematic Labeling

Devices must have detachable labels (usually provided by the manufacturer) that are placed in the patient’s file or a dedicated registry.

2. Digitization of Records

Modern practice management software allows digital traceability via UDI barcode scanning, facilitating tracking and future retrieval.

3. Written Protocols and Staff Training

The team must be trained on traceability procedures and the importance of strict compliance. Internal audits can reinforce good practices.

4. Secure Archiving

Data must be stored for at least 10 years after implant placement (Article R.1112-2 of the CSP), and sometimes up to 20 years according to some recommendations.

Conclusion

Traceability is central to ensuring quality and safety in implantology. It should not be seen as a constraint but as a safeguard for both the practitioner and the patient. By structuring traceability around clear protocols and adapted tools, the dental practice strengthens both its regulatory compliance and its clinical credibility.