Sterilizing and Storing: Best Practices in Implantology

Sterilizing and Storing: Best Practices in Implantology

In implantology, strict adherence to aseptic protocols is a fundamental prerequisite for the success of surgical procedures. The sterilization of surgical instruments, followed by proper storage, directly impacts the prevention of postoperative infections, patient safety, and the durability of clinical outcomes. This article outlines the essential steps of the sterilization cycle and the storage criteria that must be met to comply with health authority guidelines.

1. The Importance of Sterilization in Implant Surgery

Implant procedures expose deep tissues to external environments. Even minimal contamination can lead to serious infectious complications such as peri-implantitis, early implant failure, or even osteitis. According to the French National Authority for Health (HAS), controlling infection risk requires a precisely defined instrument treatment circuit: cleaning, sterilization, storage, and traceability.

The goal of sterilization is the complete elimination of all living microorganisms, including bacterial spores. Adhering to this process is a medico-legal obligation in any surgical setting.

2. Key Steps in the Sterilization Process

Pre-disinfection and Cleaning

Treatment begins immediately after surgery. Reusable instruments must be immersed in an enzymatic-detergent solution to prevent protein fixation. Cleaning is then performed manually or in an ultrasonic bath, with special attention to hard-to-reach areas such as grooves or hinges.

Packaging

Thoroughly dried instruments are sealed in sterilization pouches with external chemical indicators. These pouches must comply with ISO 11607, ensuring their integrity throughout the sterilization cycle. Instruments should be arranged to allow optimal steam circulation.

Sterilization Cycle

The recommended method is saturated steam sterilization under pressure (autoclaving) at 134 °C for 18 minutes. This method complies with ANSM guidelines for critical medical devices. The cycle must be validated using chemical indicators (class 5 or 6) and biological indicators (spores of Geobacillus stearothermophilus).

Traceability

Each sterilization cycle must be documented. Self-adhesive traceability labels on pouches or containers must indicate the sterilization date, expiration date, and cycle number. All data must be archived in the patient’s file.

3. Storing Sterile Instruments

Environmental Conditions

Sterile items must be stored:

away from light,

in a dry, clean environment,

at a stable room temperature (15–25 °C),

away from high-traffic or humid areas (e.g., sinks, windows).

Shelf Life

Sterility duration depends on the type of packaging:

Heat-sealed pouches: up to 3 months if stored optimally and the pouch remains intact.

Rigid containers with filters: up to 6 months, according to manufacturer guidelines.

Any breach in package integrity (tears, moisture, or opening) invalidates sterility.

4. Mistakes to Avoid

Delaying pre-disinfection, which promotes biofilm formation.

Overloading pouches, limiting steam penetration.

Storing in unsuitable areas, exposed to moisture or temperature fluctuations.

Using items past their sterility expiration date.

Lack of traceability, hindering identification during inspections or contamination events.

Conclusion

Following sterilization and storage protocols is not just a regulatory formality—it is a clinical responsibility. It engages the practitioner’s legal and ethical duty and is critical to ensuring patient safety in implant surgery. By applying these best practices, professionals ensure a reliable surgical environment.

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